Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study
Phase: NA
Conditions: Acupuncture, Pain Management, Emergency Department, Acute Pain
Sponsor: Case Western Reserve University

 
 
 
 
  
FULL PROTOCOL TITLE 
Acupuncture in the Emergency Department for Pain 
Management: A BraveNet Multi-Center Feasibility Study 
(ACUITY) 
Principal Investigators: 
Jeffery Dusek, PhD 
Director of Research 
University Hospitals Connor Integrative Health Network 
UH Cleveland Medical Center 
Associate Professor,  
Family Medicine and Community Health 
Case Western Reserve University School of Medicine 
 
M. Diane McKee, MD 
Professor and Chair,  
Family Medicine and Community Health,  
University of Massachusetts Medical School 
 
 
Supported by:  
The National Center for Complementary and Integrative Health  
1 R01 AT010598-01A1 
Study Intervention Provided by:  
NA 
Sponsor of IND (IDE):  
NA 
 
 

 
 
 
 
  
Tool Revision History 
Version Number: 1 
Version Date:  03/11/2021 
Summary of Revisions Made: NA 
 
Version Number 2: 
Version Date: 04/19/2021 
Summary of Revisions Made:  
 
Protocol: Updated needle sizes; Added more info/clarification about ear seeds; 
Added information about topical Arnica cream to prevent bruising, for muscle pain, or 
in event of hematoma; Updated Inclusion/Exclusion criteria; Updated randomization 
process (REDCap OR Envelopes); Added a screening bubble in work flow diagram; 
Updated window for follow-ups from +/- 2 days to +/- 4 days; Added that 
acupuncturist will share Acupuncture After Care summary with AQ patients (with ear 
seeds and arnica info); Updated platform used for remote interviews from Zoom to 
“the audio only function of a HIPAA-compliant commercial tele-health platform (e.g. 
Zoom Health Professional or Doxy.me)” 
 
RCT Consent: Language about personal phone use/Twilio possibly/possibly not 
being available while in the ER; Updated ED to ER; Updated platform used for 
remote interviews from Zoom to “the audio only function of a HIPAA-compliant 
commercial tele-health platform (e.g. Zoom Health Professional or Doxy.me)” 
 
Study Information Sheet for both Provider and Patient: Updated platform used for 
remote interviews from Zoom to “the audio only function of a HIPAA-compliant 
commercial tele-health platform (e.g. Zoom Health Professional or Doxy.me).”; 
Updated ED to ER for patients 
 
Version Number 3: 
Version Date: 05/12/2021 
Summary of Revisions Made: 
 
RCT Consent: Language about use of personal phones and Twilio messaging while 
in the ER has been removed from the protocol 
 
Updated  the  Co-investigators to include Dr. Vago. 
 
Version Number 4 
Version Date: 05/21/2021 
Summary of Revision Made: 
 
Study Design: included additional 15 pilot patients (5 per site) into the Sample Size and 
Population 
 
Protocol: removed UH specific research credentialing to allow study staff at Einstein 
Coordinating Center to be research credentialed at all three sites 
 
Outcomes: updated language for Primary Outcomes measures and Secondary 
Outcomes measures 
 
Inclusion Criteria: removed the 3V acuity level as this designation may not be standard 
at all sites, replaced with the standard 3 acuity level 

9 December 2022 
 
Exclusion Criteria: removal of ‘Patient arriving via ambulance or skipping triage’ 
exclusion criteria 
 
Study Enrollment Procedures: added language describing the patient’s refusal to provide 
their phone number and email address as being a declination of participation in the 
study; added procedural language for distributing remuneration for completing the 
Qualitative Interview; added documentation language for tracking Qualitative Interview 
and number of phone call attempts 
 
RCT Consent: included the updated version of the Informed Consent that reflects the 
changes to the protocol listed above 
 
Provider Qualitative Interview Study Information Sheet: included the updated version of 
the provider information sheet that reflects the changes to the protocol listed above 
 
Patient Qualitative Interview Study Information Sheet: included the updated version of 
the patient information sheet that reflects the changes to the protocol listed above 
 
Updated the Executive, Steering and ED Physician and Site PI committees. 
 
Quality Assurance: added ACUITY QA Monthly Consent and Eligibility Data Review Tool 
and timing for review and completion of Eligibility Checklist 
 
Version Number 5 
Version Date: 08/19/2021 
Summary of Revision Made: 
 
 
Study Enrollment Procedure: added the use of a pre-treatment flyer to the recruiting 
procedure 
 
Study Interventions: Arnica removed from the Acupuncture After Care sheet 
 
Study Procedures: the addition of satisfaction questions asked during the Post-
Treatment assessment was noted in the Schedule of Evaluations with a detailed listing 
in the Follow-Up Visits section  
 
Study Enrollment Procedures: added study staff assessment of patient capacity to 
understand and sign documents prior to informed consent process and the addition of  
instruction to only continue with study activity after written consent is obtained to 
Recruitment Methods and Consent Process sections; and removal of clinical consent 
procedure 
 
Description of evaluation: added study staff assessment of patient capacity to 
understand and sign documents prior to informed consent process and the addition of  
instruction to only continue with study activity after written consent is obtained to 
Consenting Procedure section; and removal of clinical consent procedure 
 
Supplement/Appendices: replaced informed consents and information sheets with 
current documents 
 
Safety Assessment:  removal of clinical consent procedure 
 
Data Management: added paper collection of PRO at 1-week and 4-week follow-ups 
 
 
 
Version Number 6 
Version Date: 12/09/2022 
Summary of Revisions Made: 

9 December 2022 
 
 
Study Team Roster: added study team members names and contact information 
 
Primary Outcomes and Secondary Outcomes: outcomes were updated to align with the 
study objectives 
 
Study Enrollment Procedures: updated provider/staff Qualitative Interview enrollment 
procedures 
 
Schedule of Evaluation: added Feasibility Survey 
 
Study Procedures: sample Feasibility Survey added and outlined 
 
Data Analysis: provider acceptability questions updated; added study staff as possible 
qualitative interviewees 
 
Outcomes: provider acceptability questions updated 
 
Appendix: updated all existing Patient interview Study Information Sheets with new 
contact information; added Study Staff Interview Consent forms; added ED Provider 
Feasibility Study Information Sheet; added all VUMC written consent forms and study 
information sheets.   

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TABLE OF CONTENTS 
Page 
FULL PROTOCOL TITLE ............................................................................................... 1 
Tool Revision History .................................................................................................... 2 
TABLE OF CONTENTS .................................................................................................. 5 
STUDY TEAM ROSTER ................................................................................................. 8 
PARTICIPATING STUDY SITES .................................................................................. 10 
PRÉCIS ......................................................................................................................... 10 
1. STUDY OBJECTIVES ............................................................................................... 11 
1.1 
Primary Objective ............................................................................................ 11 
1.2 
Secondary Objectives ..................................................................................... 11 
2. BACKGROUND AND RATIONALE .......................................................................... 12 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ................ 12 
2.2 
Study Rationale ............................................................................................... 14 
3. STUDY DESIGN ........................................................................................................ 16 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................... 19 
4.1 
Inclusion Criteria .............................................................................................. 19 
4.2 
Exclusion Criteria ............................................................................................ 19 
4.3 
Study Enrollment Procedures .......................................................................... 20 
5. STUDY INTERVENTIONS ........................................................................................ 24 
5.1 
Interventions, Administration, and Duration ..................................................... 24 
5.2 
Handling of Study Interventions ....................................................................... 25 
5.3 
Concomitant Interventions ............................................................................... 25 
5.3.1 Allowed Interventions ................................................................................... 25 
5.3.2 Required Interventions ................................................................................. 25 
5.3.3 Prohibited Interventions ............................................................................... 26 
5.4 
Adherence Assessment .................................................................................. 26 
6. STUDY PROCEDURES ............................................................................................ 26 
6.1 
Schedule of Evaluations .................................................................................. 26 
6.2 
Description of Evaluations ............................................................................... 30 
6.2.1 Screening Evaluation ................................................................................... 30 
6.2.2 Enrollment, Baseline, and/or Randomization ............................................... 32 
6.2.3 Blinding ........................................................................................................ 33 

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6.2.4 Follow-up Visits ............................................................................................ 33 
6.2.5 Completion/Final Evaluation ........................................................................ 34 
7. SAFETY ASSESSMENTS ........................................................................................ 35 
7.1 
Specification of Safety Parameters ................................................................. 36 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters
 
36 
7.3 
Adverse Events and Serious Adverse Events ................................................. 36 
7.4 
Reporting Procedures ..................................................................................... 36 
7.5 
Follow-up for Adverse Events.......................................................................... 37 
7.6 
Safety Monitoring ............................................................................................ 37 
8. INTERVENTION DISCONTINUATION ...................................................................... 37 
9. STATISTICAL CONSIDERATIONS .......................................................................... 37 
9.1 
General Design Issues .................................................................................... 37 
9.2 
Sample Size and Randomization .................................................................... 37 
9.3  
Definition of Populations .................................................................................. 38 
9.4 
Interim Analyses and Stopping Rules .............................................................. 38 
9.5 
Outcomes ........................................................................................................ 38 
9.5.1 Primary Outcome ......................................................................................... 40 
9.5.2 Secondary Outcomes .................................................................................. 40 
9.6 
Data Analyses ................................................................................................. 41 
10. DATA COLLECTION AND QUALITY ASSURANCE ............................................. 46 
10.1 Data Collection Forms ..................................................................................... 46 
10.2 Data Management ........................................................................................... 46 
10.3 Quality Assurance ........................................................................................... 46 
10.3.1 
Training .................................................................................................... 46 
10.3.2 
Metrics...................................................................................................... 47 
10.3.3 
Protocol Deviations .................................................................................. 49 
10.3.4 
Monitoring ................................................................................................ 50 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................ 50 
11.1 Institutional Review Board (IRB) Review ......................................................... 50 
11.2 Informed Consent Forms ................................................................................. 50 
11.3 Participant Confidentiality ................................................................................ 50 
11.4 Study Discontinuation ...................................................................................... 51 
12. COMMITTEES ......................................................................................................... 51 

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13. PUBLICATION OF RESEARCH FINDINGS ........................................................... 52 
14. REFERENCES ........................................................................................................ 53 
15. SUPPLEMENTS/APPENDICES ................................... Error! Bookmark not defined. 
15. SUPPLEMENTS/APPENDICES ............................................................................. 53 
Appendix A: Informed Consent Documents ............................................................. 57 
A.1 Patient Written Informed Consent ........................................................................... 57 
A.2 Study Staff Written Informed Consent ........................... Error! Bookmark not defined. 
A.3 Patient Qualitative Interview Study Information Sheet... Error! Bookmark not defined. 
A.4 ED Provider Qualitative Interview Study Information SheetError! Bookmark not defined. 
 
 

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STUDY TEAM ROSTER  
MPI’s: 
Jeffery A. Dusek, PhD 
Director of Research 
University Hospitals Connor Integrative Health Network  
Cleveland Medical Center 
11000 Euclid Ave 
Cleveland, Ohio 44106 
617-519-8082 
Jeffery.Dusek@UHhospitals.org 
Associate Professor,  
Family Medicine and Community Health 
Case Western Reserve University School of Medicine 
Cleveland, Ohio 44106 
617-519-8082 
jxd578@case.edu 
 
M. Diane McKee, MD 
Chair, Department of Family Medicine and Community Health 
University of Massachusetts Medical School 
55 Lake Avenue North 
917-484-1583 
Worcester, MA 01655 
M.Diane.McKee@umassmed.edu 
Director, BraveNet Coordinating Center at Einstein 
Professor of Family and Social Medicine 
Albert Einstein College of Medicine 
1300 Morris Park Ave 
Bronx, NY 10461 
917-484-1583 
Diane.Mckee@einsteinmed.edu 
 
Co-I’s: 
Alison Karasz, PhD 
Associate Professor, Department of Family and Social Medicine 
Albert Einstein College of Medicine 
1300 Morris Park Avenue 
Bronx, NY 10461 
718-430-8756 
alison.karasz@einsteinmed.org 
 
Robert M. Hughes, DO 
Assistant Professor, Dept. of Emergency Med. 
Medical Director, System Operations Center 
Medical Director, Clinical Decision Unit 
University Hospitals, Cleveland Medical Center 
(216)844-1636 
Robert.Hughes@UHhospitals.org 
 
Alan B. Storrow, MD 
Associate Professor and Associate Director for Research,  
Department of Emergency Medicine 
Vanderbilt University Medical Center 

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Nashville, TN 37232 
615-936-5934 
alan.storrow@vumc.org 
 
Christopher Coyne, MD, MPH  
Associate Professor 
Director of Clinical Research 
Fellowship Director, Clinical Research Scholar Fellowship 
Department of Emergency Medicine 
Department of Radiation Medicine and Applied Sciences 
UC San Diego Health | T: (619) 543-7342  
200 W. Arbor Drive, MC8676  San Diego, CA  92103 
cjcoyne@health.ucsd.edu 
 
David R. Vago, Ph.D. 
Associate Professor 
Department of Physical Medicine & Rehabilitation 
Department of Psychiatry 
Vanderbilt University Medical Center 
Nashville, TN 37232 
615-975-9555 
david.vago@vanderbilt.edu 
 
Gene A Kallenberg, M.D. 
Professor and Chief, Division of Family Medicine 
Vice Chair, Department of Family Medicine and Public Health 
University of California San Diego 
9500 Gilman Drive 
La Jolla, California 92093-0807 
619-543-5476 
gkallenberg@ucsd.edu 
 
Ryung S. Kim, PhD 
Associate Professor 
Department of Epidemiology and Population Health 
Albert Einstein College of Medicine 
1300 Morris Park Avenue 
Bronx, NY 10461 
718-430-3378 
ryung.kim@einsteinmed.org 
 
Arya Nielsen, PhD       
Assistant Clinical Professor 
Department of Family Medicine & Community Health 
Mount Sinai Medical Center 
1325 Madison Avenue Suite L5-40 
New York, NY 10029 
914-388-2816 
Arya.Nielsen@mountsinai.org 
 
Multi-Site Study Coordinator: 
Jessica Surdam, MPH, CCRC   
Research Specialist III 

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University Hospitals Connor Integrative Health Network 
Cleveland Medical Center 
11000 Euclid Ave 
Cleveland, Ohio 44106 
216-844-7925 
Jessica.Surdam@UHhospitals.org 
PARTICIPATING STUDY SITES 
Case Western Reserve University/University Hospitals of Cleveland – Lead Site 
Jeffery A. Dusek, PhD 
Director of Research 
University Hospitals Connor Integrative Health Network  
Cleveland Medical Center 
11000 Euclid Ave 
Cleveland, Ohio 44106 
617-519-8082 
Jeffery.Dusek@UHhospitals.org 
 
 
Einstein School of Medicine – Coordinating Center 
Alison Karasz, PhD 
Associate Professor, Department of Family and Social Medicine 
Albert Einstein College of Medicine 
1300 Morris Park Avenue 
Bronx, NY 10461 
718-430-8756 
alison.karasz@einstein.yu.edu 
 
Vanderbilt University Medical Center 
Allan B. Storrow, MD 
Associate Professor and Associate Director for Research,  
Department of Emergency Medicine 
Vanderbilt University Medical Center 
615-936-5934 
alan.storrow@vumc.org 
 
University of California San Diego 
Gene A Kallenberg, M.D. 
Professor and Chief, Division of Family Medicine 
Vice Chair, Department of Family Medicine and Public Health 
University of California San Diego 
9500 Gilman Drive 
La Jolla, California 92093-0807 
(619) 543-5476 
gkallenberg@ucsd.edu 
 
PRÉCIS  
 
Study Title  
Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center 

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Feasibility Study (ACUITY) 
Objectives  
The objectives of this study are to: conduct a feasibility randomized control trial (RCT), to 
examine the feasibility of data collection in the RCT, develop a responsive acupuncture 
intervention and assess implementation and treatment outcomes in emergency departments 
associated with 3 BraveNet research sites. (UH Cleveland Medical Center ED (site 1), the 
Vanderbilt University Medical Center (VUMC) ED (site 2) and the Hillcrest University of California 
San Diego (UCSD) ED (site 3)). This study will include qualitative interviews and structured 
observation to assess feasibility of implementation.  
Design and Outcomes   
This is a multi-site single visit, un-blinded, feasibility randomized control trial of acupuncture in 
the ED.    
Interventions and Duration  
Acupuncture for pain management in the Emergency Department (ED) will be compared to usual 
care. The interventions will be administered during the ED visit. During that time, pre-, post- and 
discharge assessments will be administered.  Follow up assessments will take place at one and 
four weeks post ED visit.  
Sample Size and Population  
The target population are adults presenting to the ED with acute non-emergent (musculoskeletal, 
back, pelvic, non-cardiac chest, abdominal, flank or head) pain ≥4 on a 0-10-point Numeric 
Rating Scale (NRS) due to non-penetrating injury. A total of 150 patients (50 patients per 
recruiting site) plus 15 pilot (5 per recruiting site) will be recruited study-wide. 
Additionally, 30 (10/site) ED stakeholders, including providers (physicians, nurse practitioners, 
physician assistants, and registered nurses) and ED staff employed for at least one year 
including the study period, as well as acupuncturists who are employed or credentialed by one of 
the participating institutions to perform acupuncture in the emergency department as part of the 
study will be interviewed about their perspectives and experiences related to implementation of 
the acupuncture study in the ED. 
 
Patients who are randomized to the acupuncture group will be contacted to participate in a brief 
qualitative interview about 3 weeks after their ED visit. The expectation is that up to 15 patient 
participants per site (n=45 total) will consent to the qualitative interviews about their experience 
of receiving acupuncture as part of the RCT. 
STUDY OBJECTIVES 
1.1 
Primary Objective 
The primary objective is to refine procedures for conducting a future fully powered multi-site RCT 
in 3 EDs. 
1.2 
Secondary Objectives 
The secondary objectives of this study are to: examine the feasibility of data collection in the 
RCT, develop a responsive acupuncture intervention and assess implementation and treatment 
outcomes in emergency departments associated with 3 BraveNet research sites. This study will 
include qualitative interviews and structured observation to assess feasibility of implementation.  

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2. BACKGROUND AND RATIONALE 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
Pain Burden in the United States: Pain affects an estimated 100 million adults in the United 
States.1 The annual cost related to pain in the U.S.—including costs due to lost productivity, as 
well as medical care—is estimated to be between $560 to $635 billion.1,2 The burden of pain 
extends beyond costs. Pain is a public health problem, a major driver of health care seeking and 
for taking medications, a major cause of disability, and a key factor in quality of life and 
productivity.1 Unrelieved pain can negatively impact every area of an individual’s life, including 
employment, personal relationships, and social activities, and may induce ‘fear, demoralization, 
anxiety, and depression’.3 Pain accounts for up to 78% of ED visits,4,5 where acute pain 
continues to be undermanaged and/or improperly managed.4,6 
 
Usual ED Care for Pain Management and the Opioid Epidemic: In 2012,U.S. providers 
prescribed 50 times more opioids than the rest of the world combined,7 reflecting a persistent 
national epidemic causing 130 deaths daily.8 Unique to the current U.S. opioid epidemic is the 
role of medical prescribing.9 While recent programs focused on the ED have resulted in a 
decrease of ED opioid prescriptions nationally,10 opioids remain a primary method of acute pain 
treatment.11 The probability of long-term opioid use increases after as few as five days of 
prescribed opioids as the initial treatment of pain.12 In a large study, 17% of opioid-naive ED 
patients prescribed opioids for acute pain were still receiving opioids 1 year later.13 In addition to 
addictive potential, the immediate adverse effect profile of opioids can be underappreciated 
given their common use. Both major (respiratory distress) and minor adverse effects 
(constipation, nausea/vomiting, dizziness, sedation, pruritus and urinary retention) are 
burdensome for patients and negatively impact health and well-being. Options that demonstrate 
feasibility, efficacy, and effectiveness are needed to treat pain and mitigate reliance on opioids. 
 
Acupuncture therapy in the treatment of pain: The Joint Commission has urged caution 
regarding opioid use in hospitals,14 revising their pain management standard, effective Jan 1, 
2018, requiring their accredited hospitals and facilities provide non-pharmacologic therapy 
options for pain, with acupuncture as one option.15 Acupuncture therapy is defined as the 
insertion of needles or the application of heat, pressure or electrical stimulation at a point or 
points on the surface of the body, predetermined on the basis of the theory of the physiological 
interrelationship of body organs with an associated point or combination of points for diseases, 
disorders and dysfunctions of the body for the purpose of achieving a therapeutic or prophylactic 
effect.16  
 
Acupuncture therapy for chronic pain: Poorly managed or acute exacerbation of chronic pain 
is not uncommon in the ED.17 In an individual patient data meta-analysis (39 trials and 20,837 
patients), acupuncture was found to be superior to placebo/sham controls and usual care in the 
treatment of chronic pain (low back, neck, shoulder, osteoarthritis of the knee and 
headache/migraine), where 85% of benefit persisted at one year following care.18 Acupuncture is 
recommended by the NIH for low back pain and knee osteoarthritis.19 It is a primary treatment 
option recommended for chronic low back and neck pain without serious pathology by the Global 
Spine Care Initiative.20 For acute/subacute low back pain, a common presentation in the ED, a 
systematic review21 supported the ACP recommendation of acupuncture as a first-line 
treatment.22    
 
Acupuncture therapy for anxiety: Catastrophizing and anxiety are shown to increase patient 
self-reported pain levels in the ED.23 Moreover, anxiety plays a role in post-operative and post-
procedural complications.24 Acupuncture’s effect on pain can also reduce anxiety, depression, 
nausea and vomiting and facilitate restful sleep and increase a patient’s well-being.9 
Acupuncture reduces anxiety in many clinical settings.25,26,27  

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Acupuncture therapy safety: Acupuncture has a low risk of adverse events. The NIH 
Consensus Statement on Acupuncture published in 1998 found that ‘the incidence of adverse 
effects is substantially lower than that of many drugs or other accepted procedures for the same 
conditions.28 Systematic reviews and surveys have clarified that acupuncture is safe when 
performed by appropriately trained practitioners29-36 with infrequent minor side effects such as 
feeling relaxed, elated, tired or having sensation or itching at point of insertion.33 Rare serious 
complications such as infection or pneumothorax are directly related to insufficient training.34,35,37   
 
Need for Pragmatic Trials and Implementation Evaluations with Acupuncture: Well-
designed pragmatic trials are needed to clarify the feasibility and effectiveness of acupuncture 
for acute pain. Pragmatic clinical trials (PCTs) are performed in real-world clinical settings with 
highly generalizable populations to generate actionable clinical evidence at a fraction of the 
typical cost/time needed to conduct a traditional clinical trial.38,39 PCTs are part of the NIH’s 
vision for bridging the gap between research and care,39,40 and are also supported through 
initiatives at the Center for Medicare & Medicaid, the Agency for Healthcare Research and 
Quality, the Patient Centered Outcomes Research Institute (PCORI), Practice-Based Research 
Networks (PBRNs) and community-based participatory research initiatives across the Federal 
government.41 Designed to inform clinical decisions, to improve practice and policy, PCTs 
engage patients, practitioners, and health system communities. Classical efficacy RCTs such as 
‘traditional randomized controlled trials’ (tRCTs) compare interventions against a control using 
rigid study protocols and minimal variation in a highly defined and carefully selected population. 
In 17 years, only 14% of tRCT research findings led to widespread changes in care.38,42 The NIH 
Collaboratory on pragmatic trials recommends early/ongoing stakeholder engagement.39 
Accordingly, our study incorporates a mixed methods implementation evaluation which will 1) 
carefully assess process outcomes (acceptability, feasibility, and intervention fidelity); and 2) 
collect interview and observational data with the goal of understanding barriers and facilitators to 
implementation.  
 
Acupuncture for Acute Pain in ED:  Reviewing the scientific literature, we find five credible 
RCTs43-47 and several observational studies48-51 that explored the effect of acupuncture in the ED 
on pain intensity. There were only two strong RCTs. In the first, acupuncture was found to be 
superior to parenteral morphine for pain relief with fewer adverse effects.45 In a second, a 
multicenter randomized non-inferiority trial, acupuncture was found comparable to 
pharmacotherapy for acute pain relief in ED patients.47 However, systematic reviews52-56 from 
2012-2018 conclude that although results of acupuncture in the ED are promising, there is 
insufficient evidence to recommend acupuncture in the ED and future multi-center RCTs 
are required.  
 
Further, we find critical gaps in the current evidence43-47 necessitating additional 
research.  
1. No RCT43-47 has enrolled many minority patients, limiting the applicability of results.  
2. Study sample sizes have been small43,44,46 and only one study included multiple-sites.47  
3. The multi-site study47 restricted enrollment to migraine, ankle sprain or acute low back 
pain, thereby limiting the applicability and generalizability of results.  
4. All but one study47 left the selection of acupuncture points for the treated conditions to 
the acupuncturist’s discretion, leaving room for wide variability of the acupuncture 
delivered.57  
5. Only the multi-site study47 reported blinding of data collectors, but since data were 
collected on paper, the risk of assessor un-blinding remained.  
6. Only two studies assessed ED opioid utilization,46,47 but neither assessed opioid use at 
follow-up.  
7. While two studies utilized auricular acupuncture therapy43,46 neither study examined 
pain relief beyond two days after discharge.  

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8. The multi-site study47 surveyed patients’ views of acupuncture at ED discharge and two 
days later; however ED providers’ perceptions on acupuncture for pain relief are 
unknown. 
9. No RCT43-47 has included systematic implementation and/or process data.  
 
These gaps will be filled by this study. Since acupuncture therapy may provide a means to 
safely reduce pain in the ED without reliance on opioids, and in light of the risks and challenges 
associated with opioids and the ongoing inadequate treatment of ED pain, studying the impact 
of acupuncture therapy on pain and opioid-related outcomes in ED patients is both timely 
and important. Implementation outcomes and process data collected in the study will inform 
future research.  
 
2.2 
Study Rationale 
PRELIMINARY DATA  
Observational Study 1: Abbott Northwestern Hospital Emergency Department (ANW ED) 
Using supplemental funding from his R01 NIH grant (1R01AT006518), Dr. Dusek conducted 
an observational study of acupuncture in the ED.51 Acupuncture was available for about 15-20 
hours per week from November 2013 to December 2014 in the 35-bed ANW ED. Acupuncture 
was provided by a licensed acupuncturist upon referral of ED physicians or mid-level providers. 
The primary outcome was change in pain intensity from before to after acupuncture using a 0-10 
verbal NRS pain scale.58,59 The 0-10 NRS is commonly used in the ED, and scores correlate with 
the visual analog scale.60 It has also been used in clinical trials.61 Anxiety was also measured on 
the NRS at the same time. The acupuncturist collected pain and anxiety scores before/after 
acupuncture via an EPIC-based flowsheet used in Dusek’s R01 study of acute patients.62-64  
Results: Acupuncture was well-accepted by providers: 73% referred at least one patient for 
acupuncture during the study period. Of 436 patients referred, 279 were approached by the 
acupuncturist during their ED visit. Informed consent was obtained from 89% (248/279) of 
patients. The final sample consisted of 182 patients presenting with acute pain who received 
acupuncture and had a post-treatment score. The sample was representative of the overall ANW 
ED population: average age was 45.3 (16.7 SD), 67.6% were female and 39.0% were non-white. 
In the final sample, 49% (88/182) of patients received pain medications prior to acupuncture and 
reported a mean of 6.88 on the pain pre-treatment score and a 30-min post-treatment change of 
-2.68 units (SD 2.23). In comparison, 51% (94/182) received no pain medications before 
acupuncture and reported 6.71 on the pain pre-treatment score and a 30-min post-treatment 
change of -2.37 units (SD 2.23). As a -2.0 unit decrease in pain on NRS is considered clinically 
significant,65 patients in both groups exceeded this threshold. Finally, across both groups, the 
pre-treatment anxiety score was 4.73 (3.43 SD) and the 30-min post-treatment change was -
2.27 units (SD 2.66). Pain and anxiety change scores were correlated (p=0.004). 
 “Lessons learned” from the observational study: (1) majority (73%) of ED providers accepted 
acupuncture via referrals; (2) majority (90%) of patients accepted acupuncture; (3) clinically 
significant decreases were found in both “pain medication” and “no pain medication” groups; (4) 
only 25% of “no pain medication” patients required opioid medications after acupuncture and 
prior to ED discharge; and (5) both pain and anxiety levels were reduced via acupuncture. We 
acknowledge limitations to this study: there was no comparison group; patients were not 
randomized; the acupuncturist was involved in data collection; and patients were referred to 
acupuncture by their physicians. To overcome these limitations, we conducted the following pilot 
RCT. 
 
Pilot Randomized Control Trial (RCT): (ANW ED) 
Dr. Dusek conducted a pilot RCT (article in preparation) with a primary goal of developing 
the operational procedures necessary for implementing a large-scale RCT. Patients presenting 
to the ANW ED were screened to participate in the pilot RCT by a study coordinator (SC) 
stationed at the triage desk. Those determined to be eligible (Eligibility Criteria below in Section 

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C) were equally randomized to either Acupuncture or Usual Care. Following randomization, the 
SC collected the “pre” time point data via electronic tablet using a specialized study database 
(StudyTrax). For all subjects and all time points, the SC was blind to patient responses as the 
database obscured patient responses from the SC. For patients randomized to Acupuncture, the 
acupuncturist informed the SC when the intervention was complete (~45 minutes), which 
triggered the SC to collect “post” data. For patients randomized to Usual Care, at 60 min (+/- 15 
min) the SC collected post-data. Then the SC followed patient track board, so patients marked 
for discharge could provide ED discharge scores.  
Results: During the 7 month study period, the SC screened 418 patients for eligibility criteria, 
including but not limited to pain score > 4. Following screening, 59 were deemed eligible, and 46 
consented and randomized to Acupuncture (n=23) or Usual Care (n=23) with 2 subjects in the 
Acupuncture group withdrawing after consent. The average age was 36.3 (15.5 SD), 78% were 
female and 55.0% were non-white. Those randomized to Acupuncture reported a pre-treatment 
pain score of 8.18 (SD 1.62), a 60-min post-treatment pain decrease of  -3.0 units (SD 2.51), 
decrease at ED discharge of -2.71 units (SD 1.86) and reduction at 30-day follow-up of  -5.28 
(3.0) units. The Usual Care group had a pre-treatment pain score of 7.91 (SD 1.41), a 60-min 
post-treatment pain decrease of -1.56 units (SD 2.37), decrease at ED discharge of -2.53 units 
(SD 2.27) and reduction at 30-day follow-up of -3.41 (4.0) units. Since the aim of the pilot RCT 
was to determine feasibility, as a result no between-group analyses were conducted.  
“Lessons learned” included that: (1) an RCT was feasible in a busy ED; (2) ~14% (59/418) of 
screened patients met eligibility criteria; (3) ~78% (46/59) of eligible patients consented to 
participate; (4) ~78% of both Acupuncture and Usual Care patients provided post-treatment and 
ED discharge scores; (5) electronic data collection was feasible for blinding the study team 
assessor to patient scores; but (6) only ~35% (16/46) of both groups completed the 30-day 
follow-up via phone call, so new methods for follow-up are needed. 
 
Observational Study 2: University Hospitals (UH) Broadview Heights ED 
Upon joining University Hospitals & Case Western Reserve University in Oct 2018, Dr. 
Dusek launched a 4-week observational study to replicate/extend the procedures used in the 
ANW ED observational study (above). Changes included the use of auricular ear seeds to 
potentially extend pain relief, and reducing 30 day follow-up to a 1-week (+/-2 days) phone call. 
Goals were to: (1) determine whether auricular ear seeds would be tolerated by patients; and (2) 
preliminarily explore if ear seeds provided extended pain relief at 1-week. 
Results: During the study period, the acupuncturist was referred and then approached 24 
patients. Informed consent was obtained from 79% (19/24) of patients. The average pain pre-
treatment score was 4.68, and the post-treatment change was a decrease of -2.07 units and ED 
discharge change was a reduction of -1.68 units. Ear seeds were used in a majority (14/19) of 
patients. Phone calls were only successful in 8 patients due to the holidays. Seven of eight 
patients reported retaining the ear seeds in place until the 1-week follow-up. The 1-week pain 
reduction was of -3.68 units.  
“Lessons learned”: (1) extended auricular therapy (ear seeds) was well tolerated by patients; 
and (2) ear seeds may provide pain relief at 1-week. 
 
Rationale for the Proposed Study: Despite these positive findings in the pilot RCT and two 
observational studies, there are several issues that need to be addressed before proceeding to a 
future definitive study. First, a better understanding of process outcomes such as 
recruitment/reach, stakeholder acceptability, and intervention fidelity are needed to ensure 
optimal recruitment and minimal patient attrition. We will assess these outcomes carefully in this 
study. We are also introducing several improvements at the outset. For example, to improve 
retention, we will reduce the follow up period to 1-week and use text messaging features of 
REDCap. To improve fidelity, we will develop a ‘responsive’ manualized-based intervention 
(consensus protocol with options) and a corresponding fidelity assessment tool. Finally, 
intervention observations and interviews with stakeholders (ED providers and administrators, ED 

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patients and study acupuncturists) will provide valuable explanatory data regarding barriers and 
facilitators to implementation that will be useful for a future, multi-site, pragmatic, definitive RCT. 
Taken together, our understanding of the current gaps in the literature, promising results 
from our observational studies, and our operational knowledge gained from the pilot RCT 
combine to provide the necessary evidence and expertise to support the conduct of the 
proposed, multi-site feasibility clinical trial. 
 
Aim 1: Develop a Manualized Acupuncture Intervention 
 
The responsive manualization will allow adequate standardization of the acupuncture 
approach to allow for reproducible treatment, but also include a possible set of additional options 
for the acupuncturist to choose from to suit the specific clinical presentation. We will convene a 
group with expertise in acupuncture for acute pain to participate in a modified Delphi process on 
consensus steps and staging of an acupuncture intervention. This process adapts the Medical 
Research Council’s guidance of 200066 and 200867 in developing and evaluating complex 
interventions that have interacting components. Responsive manualization has been engaged as 
a means of promoting standardization as well as flexibility in acupuncture research68 for trials on 
depression,69 stroke,70 and chronic pain.71,72 The Delphi technique, developed by the Rand 
Corporation in the 1950s, is a widely used and accepted method for achieving convergence of 
opinion concerning real-world knowledge solicited from experts within certain topic areas73 and 
has been used in the development of research protocols and manuals.74 The technique typically 
involves a formal process of gathering information from experts via questionnaire and then in at 
least one or two subsequent rounds, evaluating contributions with experts and arriving at a 
consensus. Our first round will work with practitioners experienced in acute pain in ED/inpatient 
settings to create a list of questions the investigators and practitioners confirm are essential for 
consensus. The second round will submit those questions to the panel of experienced 
acupuncture consultants for their input and suggest changes; the final round will confirm 
consensus on findings. Our consensus acupuncture intervention may include an interview, 
palpation, common acupuncture points on the body and ears for pain, optional points, points for 
extended auricular therapy and any additional techniques that are amenable to the acute care 
setting. Dr. Arya Nielsen, who is experienced in manual development for acupuncture trials, will 
lead the responsive manualization process (as in a PCORI-funded study75) and serve as the 
study’s acupuncture expert. In accord with the responsive manualization effort, Dr. Nielsen will 
lead the development and definition of the treatment fidelity assessment parameters with the 
acute care acupuncture experts. 
3. STUDY DESIGN 
Type/design of trial  
This is a multi-site single visit, feasibility randomized control trial of acupuncture in the ED versus 
Usual Care.  
Specific unit(s) of assignment and unit(s) of observation. 
The unit of assignment is at the patient level.  Specifically, acute pain patients enrolled in the ED will 
be randomly assigned to either acupuncture or usual care. The unit of observation is the patient. 
Primary and secondary outcomes  
The primary outcomes of the study will be the recruitment and retention patients into the study. The 
secondary outcomes will be the development of a responsive acupuncture intervention and 
assessment of implementation and treatment outcomes in emergency departments associated with 3 
BraveNet research sites. Secondary outcomes will be assessed via qualitative interviews and 
structured observation to assess feasibility of implementation.  
Study population and groups/arms including sample size  

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The study population are: (1) One hundred fifty (50/site) plus 15 pilot (5/site) adults presenting to the 
ED with acute non-emergent (musculoskeletal, back, pelvic, non-cardiac chest, abdominal, flank or 
head) pain ≥4 on a 0-10-point NRS due to non-penetrating injury. (2) Thirty ED stakeholders (10/site) 
including ED providers (physicians, nurse practitioners, physician assistants, and registered nurses) 
and ED staff employed at one of the three sites for at least one year including the study period as well 
as acupuncturists who are employed or credentialed by one of the participating institutions to perform 
acupuncture in the emergency department as part of the study. (3) Of the 150 subject noted above, 
patients who are randomized to the acupuncture group will be contacted to participate in a brief 
qualitative interview about 3 weeks after their ED visit. The expectation is that up to 15 patient 
participants per site will consent to the qualitative interviews about their experience of receiving 
acupuncture as part of the RCT. 4) Approximately 15 ACUITY study staff (n =~5/site); 
Study locations 
Randomized Control Trial 
Subjects will be recruited as described above from: the UH Cleveland Medical Center ED (site 1), the 
VUMC ED (site 2) and the Hillcrest UCSD ED (site 3). 
 
Structured Field Observation 
About three, 6 hour shifts will be observed at each site during active patient recruitment and 
treatment. 
 
Qualitative Interviews 
Patient qualitative interviews will be conducted via the audio-only function of a HIPAA-compliant 
commercial tele-health platform: (e.g. Zoom Health Professional or Doxy.me) or over the phone and 
will be recorded and transcribed. Provider and Study Staff interviews will happen in person in a 
private room or via the audio-only function of a HIPAA-compliant commercial tele-health platform: 
(e.g. Zoom Health Professional or Doxy.me) or over the phone. Study staff at the Einstein 
Coordinating Center conducting the interviews via secure online platform will be in a private room 
when interviewing the participants. 
 Approximate duration of enrollment period and follow-up  
Patients will be enrolled for approximately 4 weeks. Each site will enroll for 6-9 months, and 
enrollment at the last site will be completed approximately 12 months after enrollment at the first site 
begins. 
Description of intervention and administration 
 
Intervention Arms  
 
Acupuncture therapy. At each ED recruiting site, acupuncture intervention will be provided by one of 
two licensed acupuncturists with the option of a third backup acupuncturist for flexibility in coverage. 
Since there will be various pain presentations (musculoskeletal: back, neck, limb pain, abdominal or 
flank pain, headache etc), the acupuncture intervention will adhere to the responsive manualized 
protocol (developed in Year 1 of the grant). The responsive manualized protocol promotes 
standardization as well as flexibility based on the acupuncturist’s assessment of a patient’s 
presentation within a predetermined framework and contextual considerations such as accessibility of 
various parts of a patient’s body. Receiving acupuncture will not affect the patient’s usual care in that 
any medications (including opioid medications) will be administered as usual, as clinically needed, 
after collection of ‘post’ scores and under the direction of the patient’s emergency care provider team.  
 
Consistent with pragmatic trials,39 we have chosen to compare Acupuncture therapy to Usual Care 
rather than to a sham acupuncture treatment. At this stage of investigating acupuncture in the ED, we 
agree with the current consensus view in the acupuncture research community that research designs 
such as those used to study new pharmaceutical treatments are not adequate in the study of 

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effectiveness for therapies like acupuncture.66 Further rationale for this choice stems from the 
consensus of the DoD/NIH Acupuncture for the Treatment of Acute Pain Workshop.67 After two days 
of meeting with experts in statistics, acute pain and acupuncture, there was agreement from DoD, VA 
and civilian experts that design of acupuncture studies should compare acupuncture plus usual care 
to usual care alone. Our proposal is also consistent with the NIH Collaboratory recommendation for 
pragmatic trials (PCTs, see section above).40  
 
The study acupuncturists will adhere to the following approach: 
 
The responsive manualized acupuncture therapy intervention will be based on staging an 
interview/conversation, palpation, and selection of points or methods for treatment based on 
presenting factors. The acupuncturist will record the specific acupuncture points, the number 
of needles used, length of needle retention, length of session time, any limitations on session 
time, points used for extended auricular therapy, if applicable, and response from point 
stimulation based on parameters of the manualization protocol (Aim 1). A consensus of 
common points utilized for acute pain in the ED can be expected with additional points to be 
used at the discretion of the acupuncturist treating a patient. Hand rotation and perturbation of 
needles to de qi status is allowed; electrical stimulation or moxibustion are not included in this 
trial. Needle retention time can vary and may range from 5-40 minutes, but commonly will be 
15-30 minutes. Total session time may vary due to the patients’ tolerance of the treatment, 
acupuncturists’ assessment of the patient or workflow consideration of the ED, such as a 
patient needing to leave the room for imaging to be performed. 
 
Sterile, single-use non-coated acupuncture needles will be used for this study. Needles in 
sizes .22x13mm, .25x25mm, .25x40mm, and .30x40mm, and will be available. The choice of 
needle size used will be left to the discretion of the acupuncturists treating the patient. 
 
Treatment regimen: Each patient randomized to the Acupuncture arm will be provided no 
more than one treatment per admission to the ED. Due to workflow considerations of the ED 
of this pragmatic RCT, it is possible that some patients randomized to the Acupuncture arm of 
the study will not receive acupuncture.  
 
Acupuncturists will attempt to provide the acupuncture intervention as close to the beginning 
of the patient’s ED visit as possible, after evaluation by the attending ED provider. The 
rationale for this decision is to help evaluate the use of acupuncture as a first line intervention 
for pain relief.  
 
Extended therapy pressure: Ear seeds will be retained on auricular acupuncture points in 
order to “extend the treatment benefit after ED care”. We will use vaccaria seed with latex 
adhesive, and have a non-latex alternative for patients with latex allergy. Use and location of 
the ear seeds will be at the discretion of the acupuncturist. Patients will keep them on the ears 
after discharge from the ED, and are directed to leave them on until they fall off or remove 
them if they become uncomfortable. The ear seeds can be peeled off and thrown into the 
trash. 
 
Acupuncturists will be nationally board certified and remain current with the National 
Commission for the Certification of Acupuncture and Oriental Medicine (NCCAOM) which 
includes passing of infection control standards exam; they will also have a valid and current 
state acupuncture license. 
 
During active enrollment for each site, Dr. Nielsen will lead weekly team meetings with treating 
acupuncturists to discuss cases and use of the manual, exploring whether the manual may restrict an 
acupuncturist’s ability to respond to unique patient presentations. These discussions will provide an 
ongoing assessment of usability based on these stakeholders’ experience or insights in the ED. 
 
Usual Care: Patients assigned to the Usual Care arm will receive care and treatment for pain and any 
other symptoms or conditions as would usually be provided in the ED, in accordance with the relevant 
pain management and care policy at each participating ED. Furthermore, we have designed our study 

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so that the medications provided to Usual Care patients will have enough time to take effect serving 
as a more pragmatic control to the Acupuncture arm than sham acupuncture. 
 
Randomization 
Random assignments will be made by the study statistician in permuted blocks of size 2 and 4. The 
block size will also be randomly generated to minimize correct prediction of assignments and 
preserve approximate balance between groups, using the rand function in SAS. Administrative 
personnel from the BraveNet Coordinating Center will prepare each randomization packet in a sealed 
envelope and send these to each site in batches. A date/signature label will be placed over the 
envelope seal. Randomization envelopes will be stored in locked cabinets and opened by study staff 
(SC or RA) after completion of the informed consent process and baseline data collection. 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 
Inclusion Criteria 
Participants must meet all of the inclusion criteria to participate in this study. 
 
Randomized Control Trial 
 
Inclusion Criteria 
1. 
≥18 years of age 
2. 
Ability to communicate in English 
3. 
Level 3, 4, 5 on triage rate scale 
4. 
Acute musculoskeletal, back, pelvic, non-cardiac chest, abdominal, and 
headache pain (≥4 on the NRS) due to non-penetrating injury. 
  
 
 
Qualitative Interviews 
 
 
Inclusion Criteria 
1. 
ED providers (physicians, nurse practitioners, physician assistants, and 
registered nurses)  and ED staff employed in the UH Cleveland Medical Center 
ED (site 1), the VUMC ED (site 2) and the Hillcrest UCSD (site 3) for at least 
one year including the study period. 
2. 
Acupuncturists who are employed or credentialed by one of the participating 
institutions to perform acupuncture in the emergency department as part of the 
study. 
3. 
ACUITY study staff from the three recruiting ACUITY sites (UH, VUMC, UCSD) 
4. 
Patients who received acupuncture as part of the RCT. 
5. 
Access to the internet and a smart phone, computer or tablet. 
4.2 
Exclusion Criteria 
All candidates meeting any of the exclusion criteria at baseline will be excluded from study 
participation 
Randomized Control Trial 
 
Exclusion Criteria 
1. 
Fever exceeding 100° F 
2.  
Presenting with a chief complaint of a psychological / psychiatric concern 

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3. 
Presenting with chief complaint of Migraine 
4. 
Current Pregnancy 
5. 
Self-reported or documented opioid medication taken orally within 4 hours 
6. 
Presenting with chief complaint of Joint Dislocation 
7. 
Presenting with chief complaint of Bone Fracture 
8. 
Confirmed or suspected COVID-19 
 
Qualitative Interviews 
N/A 
4.3 
Study Enrollment Procedures  
Recruitment Methods  
 
Randomized Control Trial: When a patient arrives in the participating ED (UH Cleveland Medical Center 
ED (site 1), the Vanderbilt University Medical Center (VUMC) ED (site 2) and the Hillcrest University of 
California San Diego (UCSD) ED (site 3)), they will be triaged by the triage nurse per current ED 
procedures. Pending permission of site ED leadership, pre-treatment study flyers can be posted at 
triage, in waiting areas, or in treatment spaces to offer a passive introduction to the study. Within the 
triage unit, potential subjects will be identified/flagged by nursing staff and/or a member of the research 
staff. Patients who rate pain four or greater on the 11-point NRS scale will be considered for the study. 
At that time, the Study Coordinator (SC) or the Research Assistant (RA) will verify the patient’s initial 
eligibility (age, understanding of English language, presence of pain) using the EHR. If the patient is 
potentially eligible, the SC or RA, if able, will approach the patient while in the waiting room to be seen 
by their provider to hand them the patient recruitment flyer. The SC or RA will continue to monitor his or 
her status and location within the ED using the EHR. The patient will then be roomed and seen by the 
ED clinical provider. If the ED provider determines that patient does not have a clinical condition 
prohibiting study participation, s/he will sign a study approval form and give back to the SC or RA. 
Thereafter, the SC or RA will approach the potential subject to introduce the study. If the person is 
interested in study participation after they have been assigned to a room, the SC or RA will assess 
patient’s capacity to understand and sign documentation, if patient is capable then they will seek to 
obtain informed consent. The consent will inform the patient that if they are randomized to receive 
acupuncture a study team member may contact them to ask if they would like to participate in an 
additional interview, and that they may refuse to participate in the interview portion of the study without 
affecting their participation in the other portion of the research. They will be informed that the interview 
will be recorded and transcribed and that a study information sheet will be shared and reviewed with 
them prior to the start of the interview. If the patient is not interested in participating in the study or 
refuses to provide their phone number and email for follow up assessments, a reason for refusal will be 
documented by the SC or RA in our computerized study database.  
 
Individuals who participate in the ED data collection procedures will be remunerated $25 and those who 
complete the 1-week and 4-week follow-up assessments will be remunerated an additional $25 per visit.  
Remuneration will happen within 45 days of the patients’ ED stay. There is no current plan for 
recruitment or advertisement materials due to the nature of this study and immediate recruitment of 
subjects. 
 
Qualitative Interviews:  
Patient Interview Recruitment Methods: Patients who participate in the RCT will have been informed as 
part of the informed consent process that they may be contacted to participate in a qualitative interview 
if they are assigned to the acupuncture group, and they will have been given the option to opt out of 
being contacted for the interview. Study staff from the Einstein Coordinating Center, who will be 

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research credentialed, will contact the patients in the acupuncture group via email and/or phone within a 
week of their ED visit to schedule the interview and to share the study information sheet for them to 
review. Participant contact with the research staff for qualitative interviews will be documented in 
REDCap with up to 5 attempts to schedule the qualitative interview. 
 
ACUITY Study Staff Interview Recruitment Methods  will be scheduled to occur either in person in a 
private room, when possible, or remotely via a HIPAA-compliant commercial tele-health platform: (e.g. 
Zoom Health Professional or Doxy.me) by research credentialed study staff from Einstein Coordinating 
Center. Study staff will have the choice of audio or video interview.  Einstein Coordinating Center staff 
conducting the interviews remotely will be in a private room when interviewing the participants. A 
stamped copy of the informed consent document will be shared with the participant before the 
scheduled informed consent process, and the consent will be signed and dated by the participant and 
by the Einstein staff conducting the informed consent process, either in person or electronically using 
UH REDCap, before beginning the interview. The interviews will take approximately 45 minutes to 
complete and will be recorded and transcribed. A short demographics survey will be securely emailed to 
the participant during the interview via an @uhhospitals.org email address and will be completed and 
emailed back before the conclusion of the interview. 
 
Provider Interview Recruitment Methods: We will use staff rosters to identify physicians, nurse 
practitioners, physician assistants, nurses and ED staff who have been employed by in the ED at one of 
the three sites during the data collection period and to identify ACUITY study staff and the 
acupuncturists performing the intervention as part of the study. Research Credentialed study staff from 
the Einstein Coordinating Center or local study staff who have been trained to conduct the qualitative 
interviews will contact these providers and staff, whether in person, or by email, followed by phone, to 
invite them to participate and to share study information sheet for them to review.  
 
All individuals who participate in the qualitative interviews will be remunerated $25 within 30 days of the 
interview. The qualitative interview team from Einstein Coordinating Center will inform respective site 
study staff once a patient’s qualitative interview is complete. Site study staff will contact the patient with 
the e-gift card code or mail a physical gift card and will mark in REDCap when this was completed.   
 
Documentation of reasons for ineligibility.   
We will maintain a screening and enrollment log to document ineligibility reasons and for non-
participation of eligible candidates. 
 
Consent Process 
Randomized Control Trial Consent Process  
The consent process will occur after the patient has gone through the triage process and been assigned 
to a room within the ED.  The consent process will be conducted by dedicated research staff (SC or RA) 
that have been trained in obtaining informed consent. The status and location of the patient will be 
monitored by research staff using the EHR to ensure the patient is approached at an appropriate time. 
 
All potential participants will be examined by an ED provider to ensure they do not need emergent care 
and have sufficient mental capacity to participate in the study. If the ED provider determines that patient 
does not have a clinical condition prohibiting study participation, s/he will sign a study approval form. 
Research staff will assess patient capacity to understand and sign study documentation prior to 
obtaining consent. If patient is capable to continue, research staff (SC or RA) will consent potential 
participants. In doing so, they will explain the study, including benefits, risks and interventions. The 
research staff will stress to the patient that participation is voluntary and they may withdraw from the 
study at any time. Consent decline or withdrawal from the study will not affect the patient’s continued 
care in the ED. As per other studies conducted by the PI, the research staff will be trained to answer all 
questions that may arise. Privacy will be ensured by conducting all study related interactions, including 
the consent process, within the patient’s private ED treatment room. Patients will be provided ample 

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time to go through the consent process and ask any questions. Time for decision making will be 
minimized due to the fast-paced and urgent nature of the ED. After a member of the research staff 
explains the consent form, study requirements and answers all of the patient’s questions about the 
study, patients will provide written consent. Only the participating patients themselves will be allowed to 
provide consent for inclusion into the study. No legally authorized representative (LAR) may enroll a 
patient into the study. Study activity may only continue after the patient has provided written consent. If 
a patient declines to participate or is unable to sign the consent document, a reason for refusal will be 
asked and documented in the study database. It will be considered a declination of participation if a 
patient refuses to provide study staff with their phone number and email address during the baseline 
assessment. Patients who decline participation will not be allowed to opt into the study for the remainder 
of that particular ED visit. However, they would be eligible to participate at a future ED visit if interested 
and if the study is still in the recruitment phase. If a patient enrolls in the study, he or she will no longer 
be eligible for study participation during future ED visits within the recruitment period. We will utilize the 
EHR, and the 21 CFR Part 11 compliant data collection tool (e.g., REDCap), to verify the patient has not 
previously participated in the study. 
 
Qualitative Interviews  Consent Processes  
Patient Interview Consent Process: Patients who are consented to participate in the RCT will be 
informed as part of that consent process that if they are randomized to receive acupuncture as part of 
the study, we may approach them to invite them to participate in an interview. The consent form will 
include language informing the patient that the interview will take place via the audio-only function of a 
HIPAA-compliant commercial tele-health platform: (e.g. Zoom Health Professional or Doxy.me) and will 
be recorded and transcribed. There will also be an option for the participant to opt out of being 
contacted for the interview. Research credentialed study staff at the Einstein Coordinating Center will 
contact participants randomized to the acupuncture arm within a week after their ED visit to schedule 
the interview and to share the study information sheet to review. Participant contact with the research 
staff for qualitative interviews will be documented in REDCap with up to 5 attempts to schedule the 
qualitative interview. At the time of the interview, the interviewer will review the study information sheet 
with the patient. This document will explain that the interview will be recorded and transcribed, and will 
reiterate the voluntariness of participation. The document will explain that if the participant continues 
with the interview, they are agreeing that they have read the information and that they voluntarily agree 
to participate and to be recorded for transcription purposes.  
 
Provider Interview Consent Process: Identified providers/staff and study staff will be contacted by 
research credentialed study staff at The Einstein Coordinating Center, either in person during their site 
visit or via email followed by phone, and invited to participate in the interview. They will schedule the 
interview at the providers’ convenience. A study information sheet will be shared via email with the 
provider ahead of the interview, and will be reviewed at the beginning of the scheduled interview. This 
document will explain that the interview will be recorded and transcribed, and will reiterate the 
voluntariness of participation. The document will explain that if the participant continues with the 
interview, they are agreeing that they have read the information and that they voluntarily agree to 
participate and to be recorded and transcribed. 
 
The research staff conducting the informed consent process will introduce the study as an investigation 
to describe perspectives and experiences related to implementation of the acupuncture study in the ED. 
The study information sheet will be reviewed with each participant, and participants will be encouraged 
to ask questions throughout the process. Research staff will stress the points that this is a voluntary 
study, and that a participant is able to refuse to take part in any part of the study or to withdraw from the 
study at any time, without any impact on their care or on their employment/consulting privileges at the 
sites. Consent to be interviewed and for the interview to be recorded will be obtained verbally. Only 
individuals able to consent of their own volition will be enrolled. 
 

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ACUITY Study Staff Interview Consent Process: Research credentialed study staff at The Einstein 
Coordinating Center will contact identified ACUITY study staff by email followed by telephone and invite 
them to participate in the interview. If the staff member agrees to participate, the Einstein staff member 
will email a copy of the stamped consent form to review ahead of the scheduled informed consent 
process and interview. The informed consent process and interview will take place wither in person in a 
private room when possible, or remotely via a HIPAA-compliant commercial tele-health platform. The 
written informed consent process will be captured in UH REDCap when the done remotely. The 
research staff conducting the informed consent process will introduce the study as an investigation to 
describe perspectives and experiences related to implementation of the acupuncture study. The 
informed consent document will be reviewed with each participant, and participants will be encouraged 
to ask questions throughout the process. This informed consent document will explain that the interview 
will be recorded and transcribed, and will reiterate the voluntariness of participation. 
 
Einstein staff will stress the points that this is a voluntary study, and that a participant is able to refuse to 
take part in any part of the study or to withdraw from the study at any time, without any impact on their 
care or on their student standing, employment or consulting privileges at the sites. Only individuals able 
to consent of their own volition will be enrolled. 
 
Structured Observations Consent Process:  
Observations of screening and recruitment will be conducted by UH Research Credentialed study staff.  
The study coordinator or research assistant who recruit patients in the ED will introduce the additional 
study staff and explain that they are observing the interactions and taking notes. They will be given the 
opportunity to verbally refuse to be observed during consent.  The consent form will also have an option 
to opt out of further observation of study procedures.  Study staff in the ED, including the acupuncturists, 
will provide written consent ahead of time to be observed during the observation site visit. 
 
Provider Feasibility Survey Consent Process:  
We will use staff rosters to identify physicians, nurse practitioners, physician assistants, nurses and ED 
staff who have been employed by in the ED at one of the three sites during the data collection period. A 
recruitment email will be set via REDCap to invite participation. Providers and staff who are interested 
will click a link to the feasibility study information sheet. Those who wish to participate will click “yes” and 
be directed to the survey.  Up to 4 reminder emails will be sent. 
 
We will also distribute a recruitment flyer in the ED at each site, inviting ED providers and staff to 
participate.  The flyer will include a QR code that links directly to the study information sheet. Those who 
wish to participate will click “yes” and be directed to the survey.  A $5 incentive will be provided to 
participants who complete the feasibility survey.  Contact information to send the incentive will be 
collected in a separate REDCap form from the survey to maintain confidentiality. 
 
Randomization 
Random assignments will be made by the study statistician in permuted blocks of size 2 and 4. The 
block size will also be randomly generated to minimize correct prediction of assignments and preserve 
approximate balance between groups, using the rand function in SAS. The randomization module will 
be built into REDCap. Study staff (SC or RA) will enable randomization in REDCap for each participant 
after completion of the informed consent process and baseline data collection. If the REDCap 
randomization module is not available, envelopes will be used. Personnel from the Albert Einstein 
School of Medicine will prepare each randomization packet in a sealed envelope and send these to 
each site in batches. A date/signature label will be placed over the envelope seal. Randomization 
envelopes will be stored in locked cabinets and opened by study staff (SC or RA) after completion of the 
informed consent process and baseline data collection. 

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5. STUDY INTERVENTIONS  
5.1 
Interventions, Administration, and Duration  
At each ED site, acupuncture intervention will be provided by one of two licensed acupuncturists with 
the option of a third backup acupuncturist for flexibility in coverage. Since there will be various pain 
presentations (musculoskeletal: back, neck, limb pain, abdominal or flank pain, headache etc.), the 
acupuncture intervention will adhere to the manualized protocol (developed in year 1 of the grant). The 
manualized protocol promotes standardization as well as flexibility based on the acupuncturist’s 
assessment of the patient’s presentation within a predetermined framework and contextual 
considerations such as accessibility of various parts of a patient’s body. Receiving acupuncture will not 
affect the patient’s usual care in that any medications (including opioid medications) will be administered 
as usual, as needed, after collection of ‘post’ scores and under the direction of the patient’s emergency 
care provider team.  
 
Consistent with pragmatic trials,39 we have chosen to compare Acupuncture therapy to Usual Care 
rather than to a sham acupuncture treatment. At this stage of investigating acupuncture in the ED, we 
agree with the current consensus view in the acupuncture research community that research designs 
such as those used to study new pharmaceutical treatments are not adequate in the study of 
effectiveness for therapies like acupuncture.76 Further rationale for this choice stems from the 
consensus of the DoD/NIH Acupuncture for the Treatment of Acute Pain Workshop.67 After two days of 
meeting with experts in statistics, acute pain and acupuncture, there was agreement from DoD, VA and 
civilian experts that design of acupuncture studies should compare acupuncture plus usual care to usual 
care alone. Our proposal is also consistent with the NIH Collaboratory recommendation for pragmatic 
trials.40  
 
The study acupuncturists will adhere to the following approach: 
 
The acupuncture therapy intervention will be based on staging an interview/conversation, palpation, 
and selection of points or methods for treatment based on presenting factors. The acupuncturist will 
record the specific acupuncture points, the number of needles used, length of needle retention if 
applicable, length of session time, any limitations on session time, points used for extended 
auricular therapy, if applicable, and response from point stimulation based on parameters of the 
responsive manualization protocol (Aim 1). A consensus of common points utilized for acute pain in 
the ED can be expected with additional points at the discretion of the acupuncturist treating the 
patient. Hand rotation and perturbation of needles to de qi status is allowed; electrical stimulation or 
moxibustion are not included in this trial. Needle retention time can vary and may range from 5-40 
minutes, but commonly will be 15-30 minutes. Total session time may vary due to the patients’ 
tolerance of the treatment, acupuncturists’ assessment of the patient or workflow consideration of 
the ED, such as a patient needing to leave the room for imaging to be performed. 
 
Sterile, single-use non-coated acupuncture needles will be used for this study. Needles in sizes of 
.22x13mm, .25x25mm, .25x40mm, and .30x40mm, and will be available. The choice of needle size 
used will be left to the discretion of the acupuncturists treating the patient. 
 
Treatment regimen: Each patient randomized to the Acupuncture arm will be provided no more than 
one treatment per admission to the ED. Due to workflow considerations of the ED of this pragmatic 
RCT, it is possible that some patients randomized to the Acupuncture arm of the study will not 
receive acupuncture.  
 
Extended therapy pressure: Ear seeds will be retained on auricular acupuncture points in order to 
“extend the treatment benefit after ED care”. We will use vaccaria seed with latex adhesive, and 
have a non-latex alternative for patients with latex allergy. Use and location of the ear seeds will be 
at the discretion of the acupuncturist. Patients will keep them on the ears after discharge from the 
ED, and are directed to leave them on until they fall off or remove them if they become 
uncomfortable. The ear seeds can be peeled off and thrown into the trash 

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 
Acupuncturists will attempt to provide the acupuncture intervention as close to the beginning of the 
patient’s ED visit as possible, after evaluation by the attending ED provider. The rationale for this 
decision is to help evaluate the use of acupuncture as a first line intervention for pain relief.  
 
Acupuncturists will be nationally board certified and remain current with the National Commission for 
the Certification of Acupuncture and Oriental Medicine (NCCAOM) which includes passing of 
infection control standards exam; they will also have a valid and current state acupuncture license. 
 
Acupuncturists will provide the participant with the Acupuncture Post Care information sheet 
(attached to the IRB smart application) at the completion of the acupuncture treatment. This sheet 
has information about the ear seeds and general after care instructions. 
 
Usual Care: Patients assigned to the Usual Care arm will receive care and treatment for pain and any 
other symptoms or conditions as would usually be provided in the ED, in accordance with the relevant 
pain management and care policy at each participating ED. Furthermore, we have designed our study 
(see Figure 1) so that the medications provided to Usual Care patients will have enough time to take 
effect serving as a more pragmatic control to the Acupuncture arm than sham acupuncture. 
 
Based on our successful prior experience with our observational study and RCT, the likelihood of 
adverse physical, psychological, social, and legal risks is expected to be very small. Acupuncture 
carries very slight risks for  
• 
Bleeding,  
• 
Bruising,  
• 
Fainting (acushock) 
• 
Needling pain 
 
In the event a patient experiences an adverse event (AE), they will be treated by providers in the site ED 
and will have access to emergency response equipment as necessary. 
 
Acupuncture involves inserting thin, sterile needles in the skin. The needles are not inserted into the 
skin very far. Sometimes the needles cause slight discomfort or minor bleeding. Any acupuncturist who 
provides treatments in this study will be licensed by the state in which they practice. 
 
Monitoring of the study for AEs will be continuous throughout the study. In the event of an AE or SAE, it 
will be reported to the UH IRB in compliance with UH IRB standards. 
5.2 
Handling of Study Interventions  
Sterile, single-use non-coated acupuncture needles will be used for this study. Needle sizes of 
.22x13mm, .25x25mm, .25x40mm, and .30x40mm will be available. The choice of needle size used will 
be left to the discretion of the acupuncturists treating the patient.  Ear seeds will be retained on auricular 
acupuncture points in order to “extend the treatment benefit after ED care”. We will use vaccaria seed 
with latex adhesive, and have a non-latex alternative for patients with latex allergy. Use and location of 
the ear seeds will be at the discretion of the acupuncturist. 
5.3 
Concomitant Interventions  
5.3.1 Allowed Interventions 
As the study is taking place in the active clinical ED, the responsible ED clinician will have the ability to 
prescribe any medications or interventions to maintain the health of a participant regardless of the 
treatment assignment of the participant. 
5.3.2 Required Interventions 
Acupuncture is required for those in the treatment group 

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5.3.3 Prohibited Interventions 
For those in the treatment group, pain medications will be delayed until after completion of acupuncture 
intervention. 
5.4 
Adherence Assessment  
N/A 
6. STUDY PROCEDURES  
6.1 
Schedule of Evaluations 
Randomized Control Trial 
 
Treatment Variables. Main patient reported treatment outcomes (PROs) include pain intensity and 
anxiety. The use of self-reported pain ratings to assess pain is standard clinical practice.68,69 Although 
self-report of pain intensity is subjective, a reliable physiological measure to quantify pain has not been 
identified.70 These measures will be collected via tablet computer in the PHI-approved data collection 
tool (REDCap). A similar process was used in Dusek’s pilot RCT. The study staff will hand the patient a 
tablet for confidential self-administration. Once the patient completes the questionnaires, the answers 
will be masked so the research staff will not have access to the scores. To keep research staff blinded 
to scores, the data collection tool will be designed so that the study staff will only be able to determine 
that valid pain and anxiety scores were entered by the patient. In other words, staff will not have access 
to the actual pain or anxiety scores until the statistician conducts the final analysis. Data will be collected 
as shown in Table below.  
 
Treatment Variables 
Measure/Source 
Data Collection Time point 
Pre-
Treatment 
Post-
Treatment 
ED 
Discharge 
1-week and 
4-week 
Follow-up 
Primary Assessment  (* and bold) 
 Pain Intensity  
Numeric Rating 
Scale, 0-1058,59 
X 
X* 
X* 
X^ 
 Anxiety  
Numeric Rating 
Scale, 0-1058,59 
X 
X* 
X* 
X^ 
Secondary Assessment (^ and italic) 
 All pain medications in 
the ED 
EHR 
 
 
X^ 
 
 Pain 
medication/opioid use 
Self-report 
 
 
 
X^ 
Baseline variables of interest 
 
 
 
 Demographics  
EHR data and self-
report 
X 
 
 
 
 Current Medications  
Self-report 
X 
 
 
 
 Opioid use – last 30 
days 
X 
 
 
 
 Previous acupuncture 
use  
X 
 
 
 

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 ED visits in last year  
X 
 
 
 
Other variables of interest 
 
 
 
 Expectancy 
Self-report 
X 
 
 
 
 Satisfaction questions 
 
 
X 
X 
X 
 ED impact  
(ACUPUNCTURE 
ONLY) 
 
 
 
X 
 
 
Qualitative Interviews  
 
Patient Interview Guide 
 
 
 
Provider Interview Guide 

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Study Staff Interview Guide 
 
 
 
 
 
Structured Observations 

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Feasibility Survey  

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6.2 
Description of Evaluations  
6.2.1 Screening Evaluation 
At each ED, the Study Coordinator (SC) or Research Assistant (SC) and acupuncturist will work as a 
team, staffing an average 2.5, 4-6 hour recruitment/intervention sessions per week, varying the times 

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and days across sites as this may influence adoption. As in Figure 1, after the ED RN conducts the 
initial triage activity, the SC or RA (“study staff”) will identify and conduct initial eligibility pre-screening in 
the in the ED triage unit. The patient will then be roomed and seen by the ED clinical provider. If the ED 
provider determines that patient does not have a clinical condition prohibiting study participation, s/he 
will sign a study approval form (see below). The study staff will then approach the patient for study 
participation. 
 
Provider sign off 
 
Consenting Procedure 
We have requested a partial HIPAA waiver for prescreening. Therefore, patients will only be consented 
once the screening process is over and eligibility is confirmed. 
The consent process will occur after the patient has gone through the triage process and been assigned 
to a room within the ED.  The consent process will be conducted by dedicated research staff (SC or RA) 
that have been trained in obtaining informed consent and who have current Human Subjects Protection 
and Good Clinical Practice certifications. The status and location of the patient will be monitored by 

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research staff using the EHR to ensure the patient is approached at an appropriate time. 
 
All potential participants will be examined by an ED provider to ensure they do not need emergent care 
and have sufficient mental capacity to participate in the study. If the ED provider determines that patient 
does not have a clinical condition prohibiting study participation, s/he will sign a study approval form. 
Research staff will assess patient capacity to understand and sign study documentation prior to 
obtaining consent. If patient is capable to continue research staff (SC or RA) will consent potential 
participants. In doing so, they will explain the study, including benefits, risks and interventions. The 
research staff will stress to the patient that participation is voluntary and they may withdraw from the 
study at any time. Consent decline or withdrawal from the study will not affect the patient’s continued 
care in the ED. As per other studies conducted by the PI, the research staff will be trained to answer all 
questions that may arise. Privacy will be ensured by conducting all study related interactions, including 
the consent process, within the patient’s private ED treatment room. Patients will be provided ample 
time to go through the consent process and ask any questions. Time for decision making will be 
minimized due to the fast-paced and urgent nature of the ED. After a member of the research staff 
explains the consent form, study requirements and answers all of the patient’s questions about the 
study, patients will provide written consent. Only the participating patients themselves will be allowed to 
provide consent for inclusion into the study. No legally authorized representative (LAR) may enroll a 
patient into the study. Study activity may only continue after the patient has provided written consent. If 
a patient declines to participate or is unable to sign consent documents, a reason for refusal will be 
asked and documented in the study database. It will be considered a declination of participation if a 
patient refuses to provide study staff with their phone number and email address during the baseline 
assessment. Patients who decline participation will not be allowed to opt into the study for the remainder 
of that particular ED visit. However, they would be eligible to participate at a future ED visit if interested 
and if the study is still in the recruitment phase. If a patient enrolls in the study, he or she will no longer 
be eligible for study participation during future ED visits within the recruitment period. We will utilize the 
EHR, and the 21 CFR Part 11 compliant data collection tool (e.g., REDCap), to verify the patient has not 
previously participated in the study. 
 
Documentation of Informed Consent will follow Connor Integrative Health Network’s Standard Operation 
Procedures (SOP) for Obtaining Informed Consent and Re-Consent, which includes a Research 
Informed Consent Documentation template.  The Documentation form captures the date and time of 
consent, the name of the study and IRB number, name of person consenting, individuals present during 
consent process, the names of anyone else involved in the decision making process, the name of the 
staff member obtaining informed consent, if the subject verbalized understanding of the study, if the 
consent process happened in a private setting, if the subject received a copy of the signed consent, etc. 
This form will be signed by the person obtaining consent and by the PI and retained with the original 
copy of the signed consent.  
 
Screening 
All screening activities must be completed before consent and study enrollment.  Consent and study 
enrollment will happen shortly after screening given the nature of the ED environment and emergent 
nature of the patients’ acute pain. Study staff will use the EHR and information from the triage nurse to 
determine initial eligibility. All potential participants will be examined by an ED provider to ensure they 
do not need emergent care and have sufficient mental capacity to participate in the study. If the ED 
provider determines that patient does not have a clinical condition prohibiting study participation, s/he 
will sign a study approval form. 
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment 
Subjects are considered enrolled once the informed consent document has been signed and 
randomization has occurred. Only one written informed consent document will be used, as we have 

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requested a partial HIPAA waiver for screening. 
Baseline Assessments 
o Pre-Treatment Pain Intensity Assessment (Pre) using a 0-10 NRS58,59 will be collected: a) for 
acupuncture patients, before administration of acupuncture; b) for usual care patients who 
receive a pain medication order within 60 minutes (+/- 15 minutes) of being roomed, just before 
or at administration of pain medication; or c) for usual care patients who have not received a 
medication order within 60 minutes (+/- 15 minutes) of being roomed, at 60 minutes (+/- 15 
minutes). The collection time window of 60 minutes was based on median time from being 
roomed to first pain medication (54 minutes) using data obtained from the ANW ED pilot study 
(See Figure 1).  Pre-treatment pain assessments will be timed to be completed immediately prior 
to the administration of either the acupuncture or usual care treatments. 
 
o Anxiety scores using a 0-10 NRS58,59  
 
o Expectancy will be measured with the following questions. 
o By the end of the treatment period in the ER, how much improvement in your pain symptoms 
do you think will occur? 
0%    10%    20%     30%     40%    50%     60%    70%     80%   90%    100% 
 
Now, please close your eyes for a few moments and try to identify what you really feel about 
the treatment and its likely success.  Then answer the following questions: 
 
o At this point, how much do you really feel that the treatment will help you to reduce your pain 
symptoms? 
1            2            3            4            5            6           7            8            9           
Not at all                                         Somewhat                               Very much 
 
o By the end of your treatment period in the ER, how much improvement in your pain 
symptoms do you really feel will occur?    
0%     10%     20%     30%     40%     50%     60%     70%     80%    90%     100% 
Randomization 
Immediately after screening, obtaining informed consent from eligible patients, and collecting baseline 
data, the study staff will randomize patients to either Acupuncture or Usual Care.  
6.2.3 Blinding 
Data collectors in the ED will be masked to study outcomes of a given patient by use of electronic data 
collection methods. 
6.2.4 Follow-up Visits 
Post Treatment Assessment 
 Post-Treatment Pain Assessment (Post) using a 0-10 NRS will be collected within 60 minutes (+/- 
15 minutes) of the Pre-Treatment score, thus including the acupuncture and usual care periods. 
Based on pharmacokinetics of the most common pain medications used in emergency care one 
hour is the maximum time to effectiveness for any pain medication currently administered in most 
EDs.  
 Anxiety scores using a 0-10 NRS will be collected at the same time as pain intensity.  
 
Satisfaction and will be measured through brief questions. All participants will be asked to answer;  
o “How satisfied are you with how your pain was managed during your ED visit” on the 5-
point Likert scale.  

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o “Overall how satisfied are you with your treatment during your ED visit?” on the same 
Likert Scale. CI across sites as well as across patient groups such as different presenting 
complaints and patient demographics. 
 
ED Discharge Assessment 
ED Discharge Assessment (ED Discharge) will be obtained within 15 minutes of patients’ discharge 
from the ED, for both acupuncture and usual care patients. If the study staff’s shift has ended and it has 
been longer than 15 minutes since collecting post-treatment scores, study staff will collect discharge 
scores from the participant and leave for the day. Discharge scores will not be attempted to be collected 
if the participant is discharged within 15 minutes of when post treatment scores were collected. This will 
not be considered missing data. 
 
Pain Assessment (Post) using a 0-10 NRS  
 
Anxiety scores using a 0-10 NRS 
 
Satisfaction and will be measured through brief questions. All participants will be asked to 
answer;  
o “How satisfied are you with how your pain was managed during your ED visit” on the 5-
point Likert scale.  
o “Overall how satisfied are you with your treatment during your ED visit?” on the same 
Likert Scale. CI across sites as well as across patient groups such as different presenting 
complaints and patient demographics. 
 
ED Impact and will be measured through a brief question given to Acupuncture patients only at 
ED discharge, participants will be asked to answer;  
o “Please rate the impact of acupuncture on your ED visit today.” on the 5-point Likert 
scale. 
 
All pain medications utilized in the ED will be obtained from the EHR after patient discharge. 
 
One Week Follow-Up Assessment Visit 
1 week follow-up Assessment (Follow-up) will be obtained via REDCap based text message or email (or 
phone call from research staff) at 1 week (+/- 4 days) of patient’s ED discharge for both arms. To 
maintain assessor blinding, any 1-week phone calls (if needed) will be conducted by a research staff 
(SC or RA) who did not interact with the patient during their study participation in the ED. 
 
Pain Assessment (Post) using a 0-10 NRS  
 
Anxiety scores using a 0-10 NRS 
 
Satisfaction and will be measured through brief questions. All participants will be asked to 
answer;  
o “How satisfied are you with how your pain was managed during your ED visit” on the 5-
point Likert scale.  
o “Overall how satisfied are you with your treatment during your ED visit?” on the same 
Likert Scale.  
 
Pain medications utilized from ED discharge to 1 week after discharge will be obtained from 
patients via phone call, email, or text messaging via the secure REDCap electronic data 
collection tool. 
6.2.5 Completion/Final Evaluation 
Four Week Follow-Up Assessment Visit 
4 week follow-up Assessment (Follow-up) will be obtained via REDCap based text message or email (or 
phone call from research staff) at 4 week (+/- 4 days) of patient’s ED discharge for both arms. To 
maintain assessor blinding, any 4-week phone calls (if needed) will be conducted by a research staff 
(SC or RA) who did not interact with the patient during their study participation in the ED. 
 
Pain Assessment (Post) using a 0-10 NRS  
 
Anxiety scores using a 0-10 NRS 
 
Satisfaction and will be measured through brief questions. All participants will be asked to 

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answer;  
o “How satisfied are you with how your pain was managed during your ED visit” on the 5-
point Likert scale.  
o “Overall how satisfied are you with your treatment during your ED visit?” on the same 
Likert Scale.  
 
Pain medications utilized from ED Discharge to 4 weeks after discharge will be obtained from 
patients via phone call, email, or text messaging via the secure REDCap electronic data 
collection tool. 
 
Early Termination 
The study doctor or the sponsor can stop a subject’s participation at any time without their consent for 
the following reasons: 
 
If it appears to be medically harmful to them; 
 
If they fail to follow directions for participating in the study; 
 
If it is discovered that they do not meet the study requirements; 
 
If the study is canceled; or  
 
For administrative reasons, including competitive enrollment (e.g. the target number of 
subjects has entered the study.) 
 
If the patient’s clinical condition worsens emergently as determined by the ED 
physician/clinician. 
6.3 
Provider Feasibility Assessment 
A recruitment email will be sent via REDCap to invite participation. Providers and staff who are 
interested will click a link to the feasibility study information sheet. Those who wish to participate will 
click “yes” and be directed to the survey. We will also distribute a recruitment flyer in the ED at each 
site, inviting ED providers and staff to participate.  The flyer will include a QR code that links directly to 
the study information sheet. Those who wish to participate will click “yes” and be directed to the survey.  
Feasibility surveys will be completed online by interested participants at their convenience. 
 
Demographic information including: gender, ethnicity, race, age, how long they have worked in 
the ED, occupation, contact with the ACUITY study and in what context 
 
If the provider has ever received acupuncture and if so, how often 
 
General opinion about acupuncture 
o Do you view acupuncture in general as an appropriate intervention for the ED setting? 
Likert scale (1-very appropriate—5-Very inappropriate) 
o Do you view acupuncture in general as helpful in managing patient pain in the ED? Likert 
scale (1-Very helpful—5- Not at all helpful) 
 
Delivery of ACUITY study in the ED 
o Were you satisfied with how the ACUITY acupuncture intervention was delivered in your 
setting? Likert scale (1-Very satisfied—5-Very dissatisfied)  
o Did the ACUITY project impose a burden on ED staff in your setting? Not a burden, 
Somewhat of a burden, Moderate burden, Extreme burden 
 
7. SAFETY ASSESSMENTS  
Monitoring of the study for AEs will be continuous throughout the study. In the event of an AE or SAE, it 
will be reported to the UH IRB in compliance with UH IRB standards. 
 
The investigative team will monitor the data security, data integrity, and patient safety. The study team 
will meet at least every 2-4 weeks to assess for adherence to protocol and review any safety events.  
Based on our successful prior experience with our observational study and RCT), the likelihood of 

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adverse physical, psychological, social, and legal risks is expected to be very small. Acupuncture 
carries very slight risks for: 
 
 
Bleeding,  
 
Bruising,  
 
Fainting (acushock) 
 
Needling pain 
 
In the event a patient experiences an adverse event (AE), they will be treated by providers in the site ED 
and will have access to emergency response equipment as necessary. 
 
Acupuncture involves inserting thin, sterile needles in the skin. The needles are not inserted into the 
skin very far. Sometimes the needles cause slight discomfort or minor bleeding. Any acupuncturist who 
provides treatments in this study will be licensed by the state in which they practice. 
7.1 
Specification of Safety Parameters 
N/A 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
N/A 
7.3 
Adverse Events and Serious Adverse Events  
An adverse event (AE) is any unfavorable and unintended diagnosis, symptom, sign (including an 
abnormal laboratory finding), syndrome or disease which either occurs during the study, having been 
absent at baseline, or if present at baseline, appears to worsen. Adverse events are to be recording 
regardless of their relationship to the study intervention and through follow-up.   
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life 
threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in 
persistent or significant disability/incapacity, or is a congenital anomaly. 
7.4 
Reporting Procedures 
RESPONSIBLE INDIVIDUALS 
 
The site Principal Investigator (PI) is responsible for assessing all AE and SAEs. The site PI will monitor 
AE reporting and complete the AE PI Report in the ACUITY REDCap for events reported at the 1 and 4 
week follow-ups. Research staff are responsible for documenting the events determined to be and AE or 
SAE, as well as any adverse events ocurring in the ED or reported by a subjects physician, in the 
ACUITY Subject AE Log and reporting these events to the Clinical Coordinating Center within the 
required timelines.  
 
PROCEDURES 
 
Reporting Adverse Events: The PI or their delegated research staff will review reported events to 
determine if they qualify as an AE/SAE and assign causality and severity/intensity in REDCap. 
Research staff will document AE on the Subject ACUITY AE and External AE Summary logs after 
becoming aware of the event. Subject AE logs will be filed with the individual subject’s research files. 
The External Summary AE log must be provided to the Clinical Coordination Center upon request, 
including for Quality Assurance, sIRB Continuing Review, and Study Close Out. 
 
Reporting Serious Adverse Events: Research staff will document SAE on the Subject ACUITY AE log 
after becoming aware of the event. The PI or their delegated research staff will review, sign off on SAE 

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and assign causality and severity/intensity. If the event satisfies all three of the FDA requirements for 
reporting SAEs it will be reported to the IRB; 
a. Serious 
b. Unanticipated, and 
c. Related to study product or study procedures  
 
If the event is clarified as an SAE and deemed reportable to the IRB, delegated research staff will report 
event to the IRB within 5 days of being notified of event via the University Hospital’s Cleveland Medical 
Center’s (UHCMC) IRB’s “Reportable New information Smart Form” (RNI). If more information becomes 
available to CIHN regarding SAE, delegated research staff will inform and follow-up with IRB.  
7.5 
Follow-up for Adverse Events 
Delegated research staff is responsible for all follow-up associated with AEs and SAEs and reporting 
this information to the IRB until the AE occurs. 
7.6 
Safety Monitoring  
The NCCIH requires that all Human Subjects research studies undergo independent monitoring, and 
NCCIH Program Officials will provide specific guidelines to the PI for the study.  According an 
Independent Monitoring Committee will be assembled by the PI with approval required by the NCCIH. 
8. INTERVENTION DISCONTINUATION  
Early Termination 
The study doctor or the sponsor can stop a subject’s participation at any time without their consent for 
the following reasons: 
 
If it appears to be medically harmful to them; 
 
If they fail to follow directions for participating in the study; 
 
If it is discovered that they do not meet the study requirements; 
 
If the study is canceled; or  
 
For administrative reasons, including competitive enrollment (e.g. the target number of 
subjects has entered the study.) 
 
If the patient’s clinical condition worsens emergently as determined by physician. 
9. STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
 
Primary Objective 
The primary objective is to refine procedures for conducting a future fully powered multi-site RCT 
in 3 EDs. 
 
Secondary Objectives 
The secondary objectives of this study are to: examine the feasibility of data collection in the 
RCT, develop a responsive acupuncture intervention and assess implementation and treatment 
outcomes in emergency departments associated with 3 BraveNet research sites. This study will 
include qualitative interviews and structured observation to assess feasibility of implementation.  
9.2 
Sample Size and Randomization 
Sample size justification for feasibility study 
We justify the sample size of the proposed feasibility study by first considering the sample size that 

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would be required for the future UG3/UH3 multi-site non-inferiority RCT. Per NCCIH guidance77 and the 
literature,78-80 we recognize that results from pilot/feasibility studies are not suitable for determining 
power. Rather clinically significant differences are required for the power calculation.78-80 The verbally 
administered NRS has been validated and a minimum clinically significant change for acute pain 
intensity has been shown range from 1.3 (95% CI 1.0, 1.5)65,81 to 2.0.  
 
For non-inferiority trials it more conservative to use the lower estimate of clinical significance. Following 
convention we divide the minimally reported clinically significant change by two82 to obtain a non-
inferiority margin of 0.65 (=1.3/2). That is, to test whether Acupuncture group is at most 0.65 units 
inferior to the Usual Care group, a sample sizes of 510 (255 Acupuncture vs 255 Usual Care) will 
achieve 80% power to detect non-inferiority. We will use a one-sided Mann-Whitney test with type 1 
error 0.05.  
 
The power calculation is based on the assumption that pain improvement between the Acupuncture 
therapy and Usual Care groups is equivalent and that the actual score distributions are normal. We 
assumed a standard deviation of 2.52 for the Acupuncture group based on our previous collection of 
pain scores related to our previous single-site pilot acupuncture in the ED , and 3.2 for the Usual Care 
group, an estimate drawn from a study measuring effects of IV morphine at 60 minutes in the ED.95 
Using the same retention rate for the post-treatment PRO data collection of the pilot RCT (~78%), the 
target sample increases to a total sample size of 654 (327 Acupuncture vs 327 Usual Care) for a future 
UG3/UH3 efficacy RCT.   
 
Since the goal of the current U01 proposal is to test feasibility of the study procedures used in the 
single-site pilot RCT, we plan to enroll 150 participants (50 per site). Additionally, a pilot 5 subjects per 
site will be consented and brought through the study protocol, but will not be counted toward the n=150 
enrollment. The 150 enrollment number is both pragmatic for achieving our goals related to assessing 
feasibility, acceptability and fidelity and is about 25% of the eventual sample size required for a future 
definitive non-inferiority study. We contend that our ability to recruit about 25% of the anticipated sample 
size for a future definitive RCT would demonstrate our collective capabilities to recruit across 3 EDs 
across the United States..   
Treatment Assignment Procedures 
Random assignments will be made by the study statistician in permuted blocks of size 2 and 4. The 
block size will also be randomly generated to minimize correct prediction of assignments and preserve 
approximate balance between groups, using the rand function in SAS. Administrative personnel from 
the BraveNet Coordinating Center will prepare each randomization packet in a sealed envelope and 
send these to each site in batches. A date/signature label will be placed over the envelope seal. 
Randomization envelopes will be stored in locked cabinets and opened by study staff (SC or RA) after 
completion of the informed consent process and baseline data collection. 
9.3  
Definition of Populations 
N/A 
9.4 
Interim Analyses and Stopping Rules 
N/A 
9.5 
Outcomes  
Implementation and Treatment Outcomes 
All data analyses will be preceded by extensive data checking and verification to identify and resolve the 
reasons for missing values, inconsistencies, and out-of-range values. Although we anticipate little 
missing data based on our experience, we will carefully examine whether missingness is completely at 
random, at random or informative. Models proposed for analysis can handle incomplete data but do 

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require at least that missingness be at random. Descriptive statistics of primary outcomes: pain intensity 
change scores for Pre-Treatment to Post-Treatment and Pre-treatment to ED Discharge as well as 
secondary outcomes will be conducted to assess their distribution overall and by sites as well as 
demographic characteristics (e.g. sex, age group, race, household income, pain location among others). 
The variables will be summarized using descriptive statistics (sample size, mean, standard deviation, 
median, minimum, and maximum) for continuous variables and by the number and percentage of 
patients for categorical variables. We will report 95% exact confidence interval of median83 for the key 
continuous variables and 95% exact binomial confidence interval84 for categorical variables. All 
assessments will include sex as a biological variable as described below. 
 
Feasibility of Recruitment and Retention  
We will assess recruitment rates (# enrolled / # eligible), pace of accrual, data completeness, and 
retention at each data collection point, overall and across sites. We will assess variables across different 
patient groups (including age, race, sex), and across the study arms. Provider adoption will be assessed 
by the proportion of their eligible patients that clinicians approve for study participation. We will assess 
variables across different provider characteristics (including age, race, sex), and across the study sites. 
Completeness of data collection and retention at each time point: we will also track completeness of 
data collection, and patterns and proportions of missing data at each time point. We will compare these 
proportions overall and across sites and by demographics as described above. 
 
Acceptability 
At ED discharge, 1-week and 4-week follow-up, all participants will be asked to answer; “How satisfied 
are you with how your pain was managed during your ED visit” on the 5-point Likert scale. A second 
question is “Overall how satisfied are you with your treatment during your ED visit?” on the same Likert 
Scale. At the end of enrollment, the SC or RA at each site will contact ED staff to complete a brief 
survey (via REDCap) to assess their general satisfaction with the acupuncture intervention by 
answering “Do you view acupuncture in general as an appropriate intervention for the ED setting?” 
Likert scale (1-very appropriate—5-Very inappropriate) and “Do you view acupuncture in general as 
helpful in managing patient pain in the ED?” Likert scale (1-Very helpful—5- Not at all helpful). And two 
questions regarding the delivery of ACUITY study in the ED: “Were you satisfied with how the ACUITY 
acupuncture intervention was delivered in your setting?” Likert scale (1-Very satisfied—5-Very 
dissatisfied) and “Did the ACUITY project impose a burden on ED staff in your setting?” Not a burden, 
Somewhat of a burden, Moderate burden, Extreme burden.  We will compare across sites and across 
patient groups (e.g. pain location, patient demographics etc). We will calculate the proportion of subjects 
answering each question and 95% exact CI across sites as well as across patient groups such as 
different presenting complaints and patient demographics. We will assess variables across different 
provider characteristics (including age, race, sex), and across the study sites.  
 
Fidelity 
Assessing fidelity will reveal proportion of patients who are treated in a manner consistent with the 
manualized intervention and treatment fidelity parameters determined by consensus of acupuncture 
experts in accord with Aim 1. We expect that the treatment fidelity measures will include: the dose 
(minimum number of needles, minimum points treated, minimum duration of needle retention time), and 
the delivery (was the intervention delivered as planned or cut short due to ED flow).85 Dr. Nielsen will 
review the documentation of all acupuncture interventions and assess manual fidelity. She will assess 
the proportion of cases where acupuncturists treated the patient ‘off manual’ (and why), as well as 
assessing whether minimum standards for number of needles used, points treated and needle retention 
time were met. Assessment will be across different practitioners, times of day, sites, and by participant 
demographics (e.g. sex and pain complaints.   
 
Qualitative Analysis 
Drs. McKee and Karasz have collaborated frequently, using large, mixed methods data sets to bring 
together implementation data and conduct detailed analyses. To analyze interview and observational 

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data, we will use QSR’s NVivo, a computer program that facilitates 1) the rapid organization and 
retrieval of thematically linked data; and 2) the use of quantitative grouping variables to classify cases 
and generate complex comparisons. In a first step of thematic analysis, a preliminary coding scheme 
will be developed and applied to a subset of the data and then revised as needed. This process will be 
repeated on subsets of data until it is judged sufficiently accurate and comprehensive. Data will be 
uploaded into NVivo and coded. Memos will be created for each interview describing the major themes 
emerging in the transcript. Next, coded data will be retrieved and used to create case summaries of key 
themes related to implementation processes at each site. Quantitative implementation outcome data 
collected in Aim 2 will be used where relevant to create groups for the purpose of comparison. Within 
site analyses will include comparisons of relevant groups (e.g. comparing perceptions of the intervention 
across different genders and ethnic groups; patients who achieve satisfactory pain relief vs those who 
do not; providers who are more vs less satisfied with the protocol, among others). In the cross site 
analyses, we will examine differences in barriers, facilitators and implementation processes across sites 
with the goal of generating inferences regarding the important factors shaping differences in 
implementation outcomes (e.g. presuming that sites differ on rates of recruitment, examining our 
qualitative data to generate hypotheses regarding the causes of this documented difference).  
 
Potential Challenges and Alternate Strategies  
As noted above, we expect to recruit 50 subjects (+ 5 pilot subjects) in 9 months of active enrollment at 
each site. Results from our pilot RCT indicate a 78% enrollment rate. Using more conservative 
estimates of eligible patients consenting to participate (e.g. 50%), we would still have ample opportunity 
to recruit enough patients in 9 months/site. However, if recruitment lags, we can extend the duration of 
recruitment by 3 months or increase the number of enrollment hours per week at each site. 
 
9.5.1 Primary Outcome   
The primary objective of the current protocol is to conduct a feasibility RCT to examine the feasibility of 
refined data collection procedures, and examine intervention implementation and treatment outcomes 
across sites. As well as, evaluate the feasibility of research procedures, including data quality 
completeness, participant recruitment and retention, and using study records. 
Data Completeness  
Using study records and administrative data, we will track recruitment (proportion of eligible patients 
recruited), document recruitment rates (time to recruit intended sample), and rates of loss to follow up. 
Data collection forms collected at each time point will be evaluated for quality and completeness. In 
addition, all quantitative data analyses will be preceded by extensive data checking and verification to 
identify and resolve the reasons for missing values, inconsistencies, and out-of-range values. Although 
we anticipate some missing data based on our experience, we will carefully examine whether 
missingness is completely at random (MCAR), at random (MAR) or informative (MNAR). Models 
proposed for analysis can handle incomplete data but do require at least that missingness be at 
random. Modelling will consider using multiple imputation techniques of covariates to reduce potential 
biases.  
Recruitment/Retention  
To assess recruitment, we will track the number of eligible patients presenting to the ED during the time 
of enrolling sessions and the proportion who agree to participate. Basic demographics and presenting 
complaint will be collected for all eligible patients, allowing us to identify subgroups who are more or less 
likely to participate. Similarly approaches will be used to assess rates of loss to follow up at all data 
collection points. We will assess variables across different patient groups (including age, race, sex), and 
across the study arms as well as overall and by sites. 
9.5.2 Secondary Outcome   
The secondary objectives of this study are to: develop a responsive acupuncture intervention and 

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assess implementation in emergency departments associated with 3 BraveNet research sites for 
acceptability and fidelity. This study will include qualitative interviews and structured observation to 
assess feasibility of implementation.  
To evaluate implementation of the acupuncture intervention, using both quantitative data (study records, 
stakeholder surveys) and qualitative data (interviews and observations), we base our selection of 
implementation outcomes on the synthesis and recommendations outlined by Proctor et al in their 
authoritative 2011 paper.86 We include all of the early phase outcomes, excluding cost, proposed in this 
widely cited framework, including: Feasibility (“practicability”), provider adoption, perceptions of 
appropriateness, acceptability, and treatment fidelity. These will be assessed both quantitatively and 
qualitatively. In addition to implementation outcomes, we will also examine implementation processes, 
strategies, stakeholder experiences, and barriers and facilitators to implementation using both 
qualitative interviews and real-time observations. 
Structured Observation 
Observations will be focused largely on the influences of actors and contextual factors on 
implementation uptake/feasibility. Examples could include: disruptive behavior or manifestations of 
severe illness/pain; staff strategies to mitigate or address these in order to facilitate treatment uptake; 
provider statements or interactions that interfere with uptake; environmental variables (a ‘slow night’ in 
the ED that results in extra rooms to be used for the intervention, or the difference between a weekend 
and weekday night); etc. Observation notes will form the basis of a complete detailed field observation 
to be analyzed along with interview data using the strategies described below. 
Qualitative Interviews 
We will use a semi-structured interview guide that focuses on likely implementation barriers and 
facilitators, including: interactions and communications with the research team, patient flow, burden of 
the intervention, perceived need and benefits of the intervention, etc. As described above, we will use 
the domains of the Consolidated Framework for Implementation Research (CFIR)87 to organize the topic 
guides that will be developed for the qualitative interviews. Interview recordings will stored to a secure 
server and interviews will be professionally transcribed. 
9.6 
Data Analyses  
Aim 2: Conduct a feasibility RCT to examine the feasibility of data collection, intervention 
implementation and treatment outcomes overall and across sites. 
 
Aim 2a. Evaluate the feasibility of research procedures, including data quality completeness, 
and participant recruitment and retention, using study records 
 
Overall Approach. Using study records and administrative data we will track recruitment (proportion of 
eligible patients recruited), document recruitment rates (time to recruit intended sample), and rates of 
loss to follow up. Data collection forms collected at each time point will be evaluated for quality and 
completeness. In addition, all quantitative data analyses will be preceded by extensive data checking 
and verification to identify and resolve the reasons for missing values, inconsistencies, and out-of-range 
values. Although we anticipate some missing data based on our experience, we will carefully examine 
whether missingness is completely at random (MCAR), at random (MAR) or informative (MNAR). 
Models proposed for analysis can handle incomplete data but do require at least that missingness be at 
random. Modelling will consider using multiple imputation techniques of covariates to reduce potential 
biases. To assess recruitment, we will track the number of eligible patients presenting to the ED and the 
proportion who agree to participate. Basic demographics and presenting complaint will be collected for 
all eligible patients, allowing us to identify subgroups who are more or less likely to participate. Similarly 
approaches will be used to assess rates of loss to follow up at all data collection points. We will assess 
variables across different patient groups (including age, race, sex), and across the study arms as well 
as overall and by sites.  

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Aim 2b. Evaluate the implementation of the acupuncture intervention, using both quantitative 
data (study records, stakeholder surveys) and qualitative data (interviews and observations). 
 
Overall approach.  We base our selection of implementation outcomes on the synthesis and 
recommendations outlined by Proctor et al in their authoritative 2011 paper.86 We include all of the early 
phase outcomes, excluding cost, proposed in this widely cited framework, including: Feasibility 
(“practicability”), provider adoption, perceptions of appropriateness, acceptability, and treatment fidelity. 
These will be assessed both quantitatively and qualitatively. In addition to implementation outcomes, we 
will also examine implementation processes, strategies, stakeholder experiences, and barriers and 
facilitators to implementation using both qualitative interviews and real-time observations. For a list of 
implementation constructs, variables, and data sources, see Table 1.   
 
Table 1: Implementation Variables and Sources 
Construct 
Variable 
Data Collection/Source 
Outcomes 
 
 
Feasibility 
 
Recruitment 
 
Uptake 
 
# recruited patients / # eligible  
# completed sessions  /# recruited 
 
Study records 
Provider assessment, real-time 
observations, qualitative 
interviews 
Adoption 
# approved / # recruited 
Study records 
Appropriateness  
Suitability for ED setting 
1 item survey, qualitative 
interviews 
Acceptability 
Satisfaction/helpfulness  
1 item survey, qualitative 
interviews 
Fidelity 
Adherence to Responsive 
Manualization 
Dr. Nielson reviews study 
records and discusses with 
study acupuncturists 
Stakeholder strategies 
Barriers and facilitators 
Processes and steps taken 
Strengths/weaknesses of the 
program 
Contextual influences at patient, 
provider, local, and institutional level 
Qualitative Interviews 
Qualitative interviews/structured 
observation 
 
Aim 2b1. Assess Implementation outcomes: feasibility, adoption, appropriateness, and acceptability. 
 
Feasibility is defined as the degree to which AC can be successfully implemented in the ED setting. This 
is operationalized as recruitment (see Aim 2a); and uptake (the proportion of recruited patients who 
receive a complete AC session, measured by a single question assessment: “Did patient xx receive a 
completed treatment session at this visit?”). Feasibility of the study will also be assessed qualitatively, 
through stakeholder interviews focusing on barriers and facilitators to implementation, and real-time 
observations of the uptake of the intervention in the ED setting. For a description of qualitative data 
collection and analysis, see section 2b2 below.  
 
Provider adoption is defined as the intention to engage with the innovation/intervention. This is 
operationalized as the proportion of an ED physician’s recruited patients who are approved for study 
participation. As elsewhere, we will assess variables across different provider characteristics (including 
age, race, sex), overall and across the study sites to assess group differences in this outcome and 
those below. 
 

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Perception of appropriateness is defined as the perceived suitability of the intervention to the ED 
setting. ED providers will be asked: “To what degree do you view the acupuncture intervention as useful 
or suitable for this ED setting?” (1-very appropriate—5-Very inappropriate); Perceptions of 
appropriateness will also be explored through qualitative interviews.  
 
‘Acceptability’ is defined as perceptions of the palatability of an innovation, or satisfaction by 
stakeholders with aspects of an innovation. It is more specific than overall satisfaction with a 
service.99 For this study, acceptability among ED staff is operationalized in our quantitative 
assessment as satisfaction with the acupuncture intervention as delivered in the ED setting. 
Providers will answer two questions regarding their general opinion about acupuncture: “Do you 
view acupuncture in general as an appropriate intervention for the ED setting?” Likert scale (1-very 
appropriate—5-Very inappropriate) and “Do you view acupuncture in general as helpful in managing 
patient pain in the ED?” Likert scale (1-Very helpful—5- Not at all helpful). And two questions regarding 
the delivery of ACUITY study in the ED: “Were you satisfied with how the ACUITY acupuncture 
intervention was delivered in your setting?” Likert scale (1-Very satisfied—5-Very dissatisfied) and “Did 
the ACUITY project impose a burden on ED staff in your setting?” Not a burden, Somewhat of a burden, 
Moderate burden, Extreme burden.  
 Acceptability of the intervention will also be explored in depth in semi structured stakeholder interviews.  
 
 ‘Fidelity’ in this study is defined as the proportion of patients who are treated in a manner consistent 
with the manualized intervention. The exact treatment fidelity parameters will be determined by 
consensus of acupuncture experts in accord with Aim 1. We expect that the treatment fidelity measures 
will include: the dose (minimum number of needles, minimum number of points treated, minimum 
duration of needle retention time), and the session delivery (was the intervention delivered as planned 
or cut short due to ED flow). Dr. Nielsen will review the chart documentation of all acupuncture 
interventions and assess manual fidelity. She will assess the proportion of cases where acupuncturists 
treated the patient ‘off manual’ (and why), as well as assessing whether minimum standards for number 
of needles used, points treated and needle retention time were met. Assessment will be across different 
practitioners, times of day, sites, and by participant demographics (e.g. sex) and presenting complaints.   
 
Aim 2b2. Assess implementation processes, strategies, and barriers/facilitators to implementation using 
semi structured stakeholder interviews and structured observations 
 
Overall approach for qualitative data collection in Aim 2b1 and 2b2.  
We will conduct qualitative interviews with a broad range of relevant staff stakeholders (n~10/site), 
including ED providers, ED staff, and acupuncturists. A second component is field observation in 
participating EDs. 
 
Dr. Karasz will conduct structured observations at each of the three sites during one 2-day field visit to 
each site, observing the implementation of acupuncture in the ED in real time. The observations will be 
recorded in detailed field notes and transcribed into a full description when the observation is complete.  
 
Lessons learned from field observation and preliminary analysis of process implementation at each site 
may inform implementation at subsequent sites. 
 
The success of program implementation depends on many factors, as described in Damschroder, et al’s 
influential CFIR framework.87 The CFIR includes 5 ‘domains’ influencing implementation: the 
intervention, inner and outer setting, individuals, and processes. We will use the CFIR domains to 
structure our inquiry and to make sure that our qualitative data collection instruments, coding system, 
and interim reports reflect the complex multiple levels of influence that will shape the conduct and 
outcomes of the acupuncture intervention. We provide some examples of how CFIR domains will be 
operationalized as interview topics in the Table 2. 
 

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Table 2: CFIR Domains of Influence/Topics/Sample Questions 
CFIR Domain 
Sample Interview 
Guide Topics 
Sample question 
Intervention 
 
Complexity 
Burden 
Need/utility 
How useful was this intervention? How difficult was it to get it 
going in the ED? What was the burden and who bore the 
burden?  
Individuals 
Stakeholder 
Characteristics, 
attitudes, 
perceptions/The 
Pain Episode 
How receptive were patients/nurses/front desk staff, etc. to 
the intervention?  
Outer  
Setting 
The larger 
political/historical 
context 
Socio-economic 
factors 
How has the opioid epidemic influenced your views of the 
Acupuncture intervention?  
How do socioeconomic factors influence your patients’ pain 
and other treatment needs?  
Inner  
Setting 
Characteristics of 
the ER such as 
norms, values, 
readiness for 
change  
Crowding/staffing/s
pace/other 
resources 
How receptive were ED staff to this intervention? Why? 
What time of day/day of week was it easiest to implement 
the Acupuncture intervention? Most difficult? 
How did communication among staff influence the 
implementation  
Processes 
Stakeholder 
strategies and 
processes 
What was your process in planning for this intervention? 
Whose help was needed in moving this intervention forward 
and how did you engage them?--What efforts did the 
Champion make to move this forward?  
 
Qualitative Interview Methods. 
 
Stakeholder sample. We will recruit a sample at each site that reflects key stakeholders, including both 
staff and patients, at that site. The staff stakeholder list will be prepared in consultation between 
project leadership and local collaborators. It will include the physician/providers whose patients were 
included in the trial, nurses and other medical providers, and the acupuncturist, and may include study 
staff. A purposive sample of patient stakeholders will be recruited to reflect the diversity of patients 
assigned to the intervention. Patients who received acupuncture (n~15 per site) will be purposefully 
sampled to include multiple presenting complaints and both sexes, as well as older and younger 
patients.  In keeping with good practices in qualitative research, sample sizes are not determined in 
advance. Sample sizes are determined by the emergence of data saturation, when no new themes arise 
in the analysis.  
 
Interview guide. We will develop a semi-structured interview guide that focuses on likely implementation 
barriers and facilitators, including: interactions and communications with the research team, patient flow, 
burden of the intervention, perceived need and benefits of the intervention, etc. As described above, we 
will use the domains of the CFIR to organize the topic guides that will be developed for the qualitative 
interviews. Interview recordings will be moved from the handheld digital recording device to a secure 
server immediately after each interview. Interviews will be professionally transcribed.  
 
Structured Observation Methods. 
 

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Observational data provides an important perspective that differs from that of individual interviews. 
While interviews permit an in-depth exploration of reasoning, motives, and perspectives, they are also 
highly vulnerable to various types of bias. Observational data, by contrast, provides powerful, real time 
evidence regarding stakeholder behaviors and interactions within the local environment. During a 2-3-
day site visit to each site, the Implementation Team leader, Dr. Karasz, will conduct structured 
observations of protocol implementation. The length and timing of each observation will be determined 
through consultation with project leadership and local staff. If possible, observations will be conducted a 
different times reflecting the normal ebb and flow of patient care at the local site. Daytime, night, 
weekend, and week day observational periods will be included as feasible in the sample.  Observations 
will be focused largely the influences of actors and contextual factors on implementation 
uptake/feasibility. Examples could include: disruptive behavior or manifestations of severe illness/pain; 
staff strategies to mitigate or address these in order to facilitate treatment uptake; provider statements 
or interactions that interfere with uptake; environmental variables (a ‘slow night’ in the ED that results 
in extra rooms to be used for the intervention, or the difference between a weekend and weekday night); 
etc. Following the observation, the report form will form the basis of a complete detailed field 
observation will be analyzed along with interview data using the strategies described below. 
 
Analysis of Aim 2b. To analyze qualitative interview and observational data, we will use QSR’s NVivo, 
a computer program that facilitates 1) the rapid organization and retrieval of thematically linked data; 
and 2) the use of quantitative grouping variables to classify cases and generate complex comparisons. 
Interview and observational data will be transcribed and uploaded into a case library organized by site. 
In a first step, we will conduct a thematic qualitative analysis. First, a preliminary coding scheme will be 
developed, based on the framework. The scheme will then be applied to a subset of the data by 
members of the Implementation Team. Any differences in coding decisions will be discussed, and the 
coding scheme will be revised as needed. This process will be repeated on a second subset of the data, 
and the coding scheme subsequently revised in an iterative process until it is judged sufficiently 
accurate and comprehensive. At this point, the data will be uploaded into NVivo and coded by members 
of the team. Memos will be created for each interview describing the major themes emerging in the 
transcript. Memos will be used to determine the emergence of data saturation, described above.  
 
Next, the coded data will be retrieved and used to create case summaries of key themes related to 
implementation processes at each site. The matrix functionality in NVivo will be used to conduct 
comparative analyses both within and across sites. Within site analyses will include comparisons of 
relevant groups. For example, we will compare different sexes and ethnic groups of patients in terms of 
their perceptions of the intervention. Examples of comparisons include: younger vs. elderly patients; 
night observations compared to day observations; weekday observations vs weekend observations In 
the cross site analyses, we will examine differences in barriers, facilitators and implementation 
processes across the three sites with the goal of generating inferences regarding the important factors 
shaping differences in implementation outcomes. For example, presuming that the sites differ on rates 
of recruitment, we will examine our qualitative data to generate hypotheses regarding the causes of this 
documented difference. Similarly, sites that succeed better with recruitment, retention, or fidelity to the 
intervention will be compared to sites that are less successful. 
 
Mixed methods analysis. Quantitative and qualitative data collected in Aim 2 will be integrated in a 
mixed methods analysis. We will use findings from the quantitative survey questions to create 
comparison groups for qualitative analysis. For example, providers who judge the protocol as 
‘acceptable’ will be compared to those who do not. We will conduct comparative analyses to understand 
how qualitative themes are associated with these implementation outcomes.  

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10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
See attached RCT Data Collection Forms in Appendix B. Observation, Interview and Feasibility data 
collection sheets can be found in Section 6.1. 
10.2 Data Management  
In our pilot RCT, we developed and successfully used a basic electronic data collection tool 
(StudyTRAX). In Year 1, we will build a comprehensive study management database and data collection 
platform using REDCap and confirm the ability to blind assessors to patient scores and text message 
subjects for the 1-week follow-up assessment. Our team has successfully used REDCap for multisite 
data collection in the BraveNet PBRN as well as across Dr. McKee’s multi-clinic studies. 
Informed consents and HIPAA authorizations will be collected as hard copy paper documents; these will 
be kept by the study team in individual patient binders in locked filing cabinets of a secure, badge-
access location at each site.  
 
Demographic and baseline data will be collected both by the SC and through EHR data extraction at 
baseline. The data collected by research staff will be entered directly into an electronic data collection 
tool. There will be no hard copies of this data. 
Patient Reported Outcomes (PROs) (pain intensity and anxiety) will be collected by study staff (SC or 
RA), rather than by the acupuncturists delivering treatments. All PROs will be entered directly by the 
study participant on a tablet via REDCap and will disappear from view once entered so neither the 
participant nor research staff will have access to the scores. The scores will then be exported to a 
password protected database. There will be no hard copies of this data. 
 
Satisfaction data will be collected as part of ED-discharge and at 1-week and 4-week follow up for 
patients. ED staff will complete a one-time brief survey at the end of the enrollment period. 
 
EHR data will be electronically extracted by each site with HIPAA protected identifiers as limited 
datasets. The data extracted from EHR will be verified by MRN and date with our electronic platforms. 
EHR extracted data will include demographic data, pain medication use in the ED, and opioid 
prescriptions at discharge. Both Dusek and McKee have extensive experience in use of EHR data. 
There will be no hard copies of this data. 
1-week and 4-week follow-up data (PROs, pain medication/opioid use) will be collected either directly 
from the participant through the electronic data collection tool (via text message prompt) or collected on 
paper survey and entered by a member of the research team if the follow-up is completed over the 
phone. As above, all 1-week and 4-week contacts will be conducted by a research staff (SC or RA) who 
did not interact with the patient during their study participation in the ED. 
 
All electronic data will be kept in password protected databases behind an electronic firewall at sites and 
then securely sent to the Einstein Coordinating Center and maintained on password protected PCs by a 
designated data manager. Data in hard copy form will be stored in locked file cabinets within a secure, 
badge-access location at each site. Upon completion of study enrollment, members of the study team 
will verify the information contained within the database. After answering all queries in the database, the 
information contained will be locked and exported for analysis. Both the source (electronic data 
collection) data and exported databases will be stored as required by the respective rules and 
regulations (e.g., HIPAA authorizations will be maintained for at least six years). 
10.3 Quality Assurance  
10.3.1 Training 
The site Study Coordinator (SC) will ensure that all study personnel have completed all required 

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institution-specific and protocol-specific trainings and that these trainings are documented appropriately 
on the Training Log.  The SC will also ensure that new personnel are appropriately documented on the 
Delegation of Responsibilities Log (DOR).  While training should be completed and documented in real 
time, the Multi-Site Study Coordinator (MSC) will verify that all training is current and appropriately 
documented on a quarterly basis, as noted in section 10.3.2 below. 
Institution-specific Training  
All study staff will complete CITI or NIH Human Subjects training prior to commencement of study 
activities. The site staff is also required to receive Good Clinical Practice (GCP) training through CITI or 
the Society for Behavioral Health. Staff training certificates will be stored in the Regulatory Binder in 
REDCap and documented on the Training Log.   
Protocol-specific Training 
Below is a summary of required initial training by role for new study personnel. 
PI, Study Coordinators, Research Assistants and anyone recruiting patients: 
 Review and express understanding of the Site Initiation Visit (SIV) training slides 
 Review and express understanding of the IRB protocol 
 Review and express understanding of the NCCIH protocol 
 Review and express understanding of the Informed Consents and Study Information Sheets 
 Review and express understanding of the MOP 
ED Physician and Students who are not recruiting patients: 
 Review and express understanding of the IRB protocol 
 Review and express understanding of the Informed Consents and Study Information Sheets 
Statistician  
 Review and express understanding of the IRB protocol 
10.3.2 Metrics 
Quality Assurance (QA) activities will be conducted at each subject study visit, as well as on a monthly, 
quarterly and annual schedule. Additional QA activities and reviews will be conducted on an as-needed 
basis in response to staff or process changes.    
The following tools will be used to document QA activities for this study: 
• 
ACUITY QA Essential Documents Review Tool 
• 
ACUITY QA Monthly Consent and Eligibility Data Review Tool 
• 
ACUITY QA Participant Data Review Tool 
• 
ACUITY QA Quarterly Review Tool 
• 
ACUITY QA Annual Review Tool 
 
In addition the following checklists and reminders have been developed for this study’s QA process: 
• 
ACUITY Eligibility Checklist 
• 
ACUITY Informed Consent Documentation 
• 
ACUITY ED Visit checklist 
• 
ACUITY Interview Visit Checklist 
• 
ACUITY Protocol Deviation Log 
 
ED Visit QA Activities: 

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The following is a detailed description of ED Visit QA activities  
ED Visit: 
 
Prior to the ED shifts, the SC or Research Assistant (RA) will verify that the most current IRB-
approved study consent documents are available for use.  If re-consenting is required throughout 
the subject’s participation in the study, the SC/RA will verify that the most current IRB approved 
consent is available prior to the study visit.  
 
The SC/RA will review and complete the REDCap Eligibility Criteria form before study 
activities begin. 
 
The SC/RA will review and complete the Eligibility Checklist. 
 
The SC/RA will document the consent process using the ACUITY Research IC Documentation 
Form. Before the subject leaves the clinic, the SC/RA will review the consent documentation and 
confirm adherence to the consent processes described in the MOP.  
 
At visit completion, the SC/RA will complete the ED Visit Checklist that captures the required 
elements of the visit.    
 
Queries and alerts, generated by the electronic data capture (EDC) system, occurring during the 
clinical visit will be corrected as soon as notified during data entry or as soon as time allows 
following the visit. 
 
Observation Visit QA Activities 
 
The interviewer will document the consent process with any ACUITY study staff being observed 
that day, using the ACUITY Research IC Documentation Form.  
 
Qualitative Interviews Visit QA Activities:  
 
Prior to confirming subject study visits, the site interviewer will verify that the subject is 
scheduled for the appropriate appointment. 
 
Prior to conducting the consent and interview, the interviewer will complete the ACUITY 
Consent Flow Sheet and send it to the MSC for review and signature.  The interviewer will refer 
to the is document when conducting the consents. 
 
During the visit, the interviewer will ensure that the subject still meets the eligibility requirements. 
 
The interviewer will document the consent process using either the ACUITY Research IC 
Documentation Form for ACUITY study staff written consent OR the ACUITY Consent with 
Signature Waiver Documentation Form for the patient and ED provider verbal consents.  
 
At visit completion, the interviewer will complete the Interview Visit Checklist that captures the 
required elements of the visit.    
 
Monthly QA Activities 
The following is a detailed description of the Monthly QA review activities, which will be documented on 
the QA Monthly Consent and Eligibility Data Review Tool 
 
Consent Process Completion and Documentation: The site PI will review 100% of the site’s 
executed consents using the QA Participant Data Review Tool. 
 
Eligibility Criteria and Documentation: the site PI will review 100% of the Eligibility checklists and 
source documentation. 
Quarterly QA Activities 

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The following is a detailed description of the Quarterly QA review activities, which will be documented 
on the QA Quarterly Review Tool. 
 
Consent Process Completion and Documentation: The SC or designee will review 100% of the 
site’s executed consents using the QA Participant Data Review Tool.   
 
The SC will use the QA Participant Data Review Tool to review completion and accuracy of the 
source documents and the eCRFs for 100% of subjects at the site every 3 months. 
 
The SC will cross-check eCRF data for accuracy and completeness every 3 months. The SC will 
also review query reports to confirm that all manual and automatic queries have been resolved. 
 
Training Logs will be reviewed by the SC every 3 months to verify training is current and properly 
documented.  This will include a review for institution-specific and protocol-specific trainings.  
 
The Site Regulatory Binders in REDCap are updated by the SC when changes to licenses, 
certifications, credentials, IRB documents or CVs are made during the study. The SC will review 
the Site Regulatory Binder every 3 months to verify that all documents (paper and electronic) are 
maintained. This review will be documented and summarized in the ACUITY Essential 
Documents Review Tool.  At least annually, the MSC will conduct a complete review of the 
each Site Regulatory Binder. 
 
Annual QA Activities 
The following is a detailed description of the Annual QA review activities, which will be documented on 
the ACUITY QA Annual Review Tool. 
The procedures and processes to ensure protocol adherence among the study personnel are set forth in 
the Manual of Procedures (MOP). The MOP is reviewed by the MSC every 12 months for applicability 
and accuracy.   
This QA Plan will be reviewed for applicability and accuracy and updated as necessary every 12 months 
by the MSC.  Additional QA needs identified at a study site will be communicated to the MSC. The MSC 
and MPI’s will evaluate the need to update the QA plan, tools, and logs. 
10.3.3 Protocol Deviations 
A protocol deviation is any alteration/modification to the IRB-approved protocol that is not approved by 
the IRB prior to its initiation or implementation. Protocol deviations may result in determinations of non-
compliance, serious or continuing. 
 
1. Minor Protocol Deviation: An incident involving noncompliance with the protocol but one that 
typically does not have a significant effect on the subject’s rights, safety, welfare, or on the 
integrity of the resultant data 
2. Major Protocol Deviation: A more serious incident involving noncompliance with the protocol 
usually involving critical study parameters. Major protocol deviations generally affect the 
subject’s rights, safety, or welfare, or the integrity of the study data. A major protocol deviation 
can also be called a protocol violation. 
 
Per UH IRB, protocol deviations must be reported by the PI or their designated research staff to the IRB 
within 5 days for major deviations, and at continuing review for minor deviations. Deviations are reported 
electronically by the MSC or designee using the appropriate category on the UHCMC IRB’s RNI form. 
 
Research staff will document the protocol deviation on the ACUITY Protocol Deviation Log after 
becoming aware of the event. The site PI or their delegated research staff will review and sign off on the 
deviation and designate it as major or minor. The site PI or delegated staff is responsible for reporting 

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the deviation to the MSC within 3 days for major deviations and quarterly for minor deviations.  The 
MSC is responsible for all follow-up associated with protocol deviations and reporting this information to 
the UH IRB. 
 
10.3.4 Monitoring 
Each site will maintain the QA tools/logs either in a QA binder (for paper documents) or electronic folder. 
SCs will be responsible for site-specific QA activities. The MSC will be responsible for QA activities at 
the lead study site and will provide oversight for QA activities for the entire study.   
Each SC will provide a Quality Assurance Summary Report to the MSC one month before the Data 
Safety and Monitoring Committee (DSMC) Report is due. The MSC will compile the site reports into a 
comprehensive, study-wide report that will be provided to NCCIH.  The MSC will also summarize the 
information for inclusion in the DSMC Report.  This summary will document the following: 
 
QA activities completed since the prior report submittal, including: 
o Frequency of reviews 
o Number of charts reviewed  
o Items covered by the review 
 
Identification of problem areas  
 
Corrective Action Plan(s) 
 
In addition, the PI will propose an independent monitoring committee (requires NCCIH approval) to 
overview the study from a data and safety perspective. 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review  
This protocol and the informed consent document (Appendix A) and any subsequent modifications will 
be reviewed and approved by the IRB or ethics committee responsible for oversight of the study.  
11.2 Informed Consent Forms 
A signed consent form will be obtained from each participant. Only the participating patients themselves 
will be allowed to provide consent for inclusion into the study. No legally authorized representative 
(LAR) may enroll a patient into the study. The consent form will describe the purpose of the study, the 
procedures to be followed, and the risks and benefits of participation. A copy will be given to each 
participant or legal guardian and this fact will be documented in the participant’s record.  
11.3 Participant Confidentiality  
Any data, specimens, forms, reports, video recordings, and other records that leave the site will be 
identified only by a participant identification number (Participant ID, PID) to maintain confidentiality.  
All electronic data will be kept in password protected databases behind an electronic firewall at sites and 
then securely sent to the Einstein Coordinating Center and maintained on password protected PCs by a 
designated data manager. The Einstein Coordinating Center will securely share data collected at their 
site and those received from the other two sites with Case Western Reserve University 
(CWRU)/University Hospitals (UH), the lead site and IRB of record. Data shared with CWRU/UH will be 
stored in a password protected database behind an electronic firewall on a secure UH server. Data in 
hard copy form will be stored in locked file cabinets within a secure, badge-access location at each site. 

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Upon completion of study enrollment, members of the study team will verify the information contained 
within the database. After answering all queries in the database, the information contained will be locked 
and exported for analysis. Both the source (electronic data collection) data and exported databases will 
be stored as required by the respective rules and regulations (e.g., HIPAA authorizations will be 
maintained for at least six years). 
Information will not be released without written permission of the participant, except as necessary for 
monitoring by IRB, the FDA, the NCCIH, and the OHRP. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCIH, the OHRP, the FDA, or other 
government agencies as part of their duties to ensure that research participants are protected.  
12. COMMITTEES 
The 3-year project is designed to conduct and evaluate a feasibility study in 3 clinical sites, in 
preparation for a definitive, pragmatic, non-inferiority study of acupuncture vs usual care for pain in the 
emergency department (ED) setting.  
 
To pursue these aims, we have assembled an experienced multidisciplinary team. In order to 
effectively manage these activities, we will organize the following groups. As this is a U01 
Cooperative Agreement, the NCCIH Representative would sit on the Steering Committee as 
available.  
The Executive Committee will include Drs. Dusek and McKee as multi-PIs.  They will meet 
weekly to ensure that the overall aims of the project are met in accordance with the projected 
timeline. 
The Steering Committee will consist of Drs. McKee and Dusek as multi-PIs, Dr. Nielsen, 
Jessica Surdam (Overall Study Coordinator) and the site PIs (Dr. Vago [Vanderbilt University 
Medical Center], Dr. Kallenberg [University of California- San Diego], Dr. Dave Clark [NCCIH] 
and Drs. Kim and Karasz [Einstein Data Coordinating Center]. This team will meet monthly to 
oversee implementation of the study. 
The ED Physician and Site PI Committee will consist of Drs. McKee and Dusek as multi-PIs, 
Dr. Hughes (UH/CWRU), Drs. Vago and Storrow (VUMC), Drs. Kallenberg and Coyne (UCSD) 
and Jessica Surdam (Overall Study Coordinator).  This team will meet monthly to oversee the 
clinical implementation of the study protocol in preparation for the UG3/UH3 proposal. 
The Independent Monitoring Committee will consist of several experts in the field of 
Complementary and Integrative Health.  These include Dr. Natalia Morone MD, Dr. Scott Mist 
PhD, LAc, PhD, Dr. Maria Chao PhD and Dr. Roger Davis ScD.  The IMC will meet quarterly (or 
as needed) with responsibility to oversee study accrual, as well as data and safety. The UH IRB 
is serving as the sIRB. 
The Data Coordinating Center includes Drs. McKee, Karasz, Kim, Qi and Ms. Lechuga will 
meet monthly and as needed to ensure development of the REDCap data collection system and 
data analytics.  
The UH/Case Site will function as a Clinical Coordinating Center with Dr. Dusek MPI and 
Jessica Surdam MPH (Overall Study Coordinator) serving in that capacity.  Dr. McKee MPI will 
periodically attend meetings (as needed). 
The Qualitative Interview team includes Dr. Karasz, and Ms. Khurshid will be responsible conducting 
the structured qualitative interviews and structured observations. 
 

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Site Research Teams will consist of the site PI, ED physician champion, Study Coordinator, 
Research Assistant, and study acupuncturists. Dr. Nielsen (the study acupuncture expert will 
attend as needed.  These teams will meet regularly leading up to and during the implementation 
of the feasibility study at their site, under the direction of the site PI. 
 
Acupuncture Protocol team will be led by Drs. Nielsen and Dusek. Together they will convene 
a modified Delphi process with 5-8 experienced acupuncture experts.  The results of the Delphi 
process will be a responsive acupuncture protocol for use in the U01.  This team will also 
convene the study acupuncturists during the course of the active recruitment phase of the trial to 
ensure collaborative communication. 
13. PUBLICATION OF RESEARCH FINDINGS  
Publication of the results of this trial will be governed by the policies and procedures developed by the 
ACUITY Executive and Steering Committees. Any presentation, abstract, or manuscript will be made 
available for review by the sponsor and the NCCIH prior to submission.  
 
 

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14. REFERENCES  
1. 
Institute of Medicine, Committee on Advancing Pain Research, Care and Education. Relieving Pain in America: A 
Blueprint for Transforming Prevention, Care, Education, and Research. The National Academies Collection: Reports funded by 
National Institutes of Health. National Academies Press (US); 2011. 
2. 
Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. Aug 2012;13(8):715-24. 
doi:10.1016/j.jpain.2012.03.009 
3. 
Reuben D, Alvanzo A, Ashikaga T, et al. NIH Pathways to Prevention Workshop: The Role of Opioids in the 
Treatment of Chronic Pain Ann Intern Med. 2015;162(4):295-300. doi:doi: 10.7326/M14-2775 
4. 
Todd KH, Ducharme J, Choiniere M, et al. Pain in the emergency department: results of the pain and emergency 
medicine initiative (PEMI) multicenter study. J Pain. Jun 2007;8(6):460-6. doi:10.1016/j.jpain.2006.12.005 
5. 
Mazer-Amirshahi M, Mullins P, Rasooly I, van den Anker J, Pines J. Rising opioid prescribing in adult U.S. emergency 
department visits: 2001-2010. Acad Emerg Med. 2014;21(3):236-43. doi:doi: 10.111/acem.12328 
6. 
Carter D, Sendziuk P, Eliott JA, Braunack-Mayer A. Why is Pain Still Under-Treated in the Emergency Department? 
Two New Hypotheses. Bioethics. Mar 2016;30(3):195-202. doi:10.1111/bioe.12170 
7. 
Manchikanti L, Helm S, 2nd, Fellows B, et al. Opioid epidemic in the United States. Pain Physician. Jul 2012;15(3 
Suppl):ES9-38.  
8. 
hhs.gov. Help, resources and information: national opioids crisis; the opioid epidemic in numbers. US Department of 
Health and Human Services. Accessed January 6, 2019. https://www.hhs.gov/opioids/  
9. 
Tick H, Nielsen A, Pelletier KR, et al. Evidence-based Nonpharmacologic Strategies for Comprehensive Pain Care: 
The Consortium Pain Task Force White Paper. Explore (NY). May/June 2018;14(3):177-211. 
doi:https://doi.org/10.1016/j.explore.2018.02.001 
10. 
Axeen S, Seabury SA, Menchine M. Emergency Department Contribution to the Prescription Opioid Epidemic. Annals 
of Emergency Medicine. 2018/06/01/ 2018;71(6):659-667.e3. doi:https://doi.org/10.1016/j.annemergmed.2017.12.007 
11. 
Cantrill S, Brown M, Carlisle R, et al. Clinical policy: critical issues in the prescribing of opioids for adult patients in the 
emergency department. Ann Emerg Med. 2012;60(4):499-525. doi:doi: 10.1016/j.annemergmed.2012.06.013. 
12. 
Shah A, Hayes CJ, Martin BC. Characteristics of initial prescription episodes and likelihood of long-term opioid use - 
United States, 2006-2015. MMWR Morb Mortal Wkly Rep. Mar 17 2017;66(10):265-269. doi:10.15585/mmwr.mm6610a1 
13. 
Hoppe JA, Kim H, Heard K. Association of emergency department opioid initiation with recurrent opioid use. Ann 
Emerg Med. May 2015;65(5):493-499 e4. doi:10.1016/j.annemergmed.2014.11.015 
14. 
Safe use of opioids in hospitals. The Joint Commission. Sentinel Event Alert. Aug 8 2012;(49):1-5.  
15. 
Joint Commission enhances pain assessment and management requirements for accredited hospitals. Perspectives, 
the Official Newsletter of The Joint Commission. Accessed November 27, 2017. 
https://www.jointcommission.org/assets/1/18/Joint_Commission_Enhances_Pain_Assessment_and_Management_Requiremen
ts_for_Accredited_Hospitals1.PDF  
16. 
NPG. Acupuncture State Law Summary. Accessed January 22, 2019. https://theacupunctureobserver.com/wp-
content/uploads/2014/02/State+Law+Summary.pdf. 
17. 
Rash JA, Poulin PA, Shergill Y, et al. Chronic Pain in the Emergency Department: A Pilot Interdisciplinary Program 
Demonstrates Improvements in Disability, Psychosocial Function, and Healthcare Utilization. Pain Res Manag. 
2018;2018:1875967. doi:10.1155/2018/1875967 
18. 
Vickers AJ, Vertosick EA, Lewith G, et al. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-
Analysis. J Pain. May 2018;19(5):455-474. doi:10.1016/j.jpain.2017.11.005 
19. 
Nahin RL, Boineau R, Khalsa PS, Stussman BJ, Weber WJ. Evidence-based evaluation of complementary health 
approaches for pain management in the United States. Mayo Clin Proc. Sep 2016;91(9):1292-306. 
doi:10.1016/j.mayocp.2016.06.007 
20. 
Chou R, Cote P, Randhawa K, et al. The Global Spine Care Initiative: applying evidence-based guidelines on the non-
invasive management of back and neck pain to low- and middle-income communities. Eur Spine J. Sep 2018;27(Suppl 6):851-
860. doi:10.1007/s00586-017-5433-8 
21. 
Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back pain: a systematic review for an American 
College of Physicians clinical practice guideline. Ann Intern Med. Feb 14 2017;166(7):493-505. doi:10.7326/m16-2459 
22. 
Qaseem A, Wilt TJ, McLean RM, Forciea M, Clinical Guidelines Committee of the American College of Physicians. 
Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College 
of Physicians. Annals of Internal Medicine. 2017;166(7):514-530. doi:10.7326/M16-2367 
23. 
Block PR, Thorn BE, Kapoor S, White J. Pain Catastrophizing, rather than Vital Signs, Associated with Pain Intensity 
in Patients Presenting to the Emergency Department for Pain. Pain Management Nursing. 2017/04/01/ 2017;18(2):102-109. 
doi:https://doi.org/10.1016/j.pmn.2016.12.001 
24. 
Kain ZN, Caldwell-Andrews AA. Preoperative psychological preparation of the child for surgery: an update. 
Anesthesiol Clin North America. Dec 2005;23(4):597-614, vii. doi:10.1016/j.atc.2005.07.003 
25. 
Wang SM, Peloquin C, Kain ZN. The use of auricular acupuncture to reduce preoperative anxiety. Anesth Analg. 
November 2001;93(5):1178-1180.  
26. 
Wang SM, Maranets I, Weinberg ME, Caldwell-Andrews AA, Kain ZN. Parental auricular acupuncture as an adjunct 
for parental presence during induction of anesthesia. Anesthesiology. Jun 2004;100(6):1399-404.  
27. 
Wiles MD, Mamdani J, Pullman M, Andrzejowski JC. A randomised controlled trial examining the effect of acupuncture 
at the EX-HN3 (Yintang) point on pre-operative anxiety levels in neurosurgical patients. Anaesthesia. Jan 16 2017;72(3):335-
342. doi:10.1111/anae.13785 

Page 54 of 143 
Version 12.09.2022; Version 6 
 
 
28. 
NIH Consensus Conference. Acupuncture. Jama. Nov 04 1998;280(17):1518-24.  
29. 
Adams D, Cheng F, Jou H, Aung S, Yasui Y, Vohra S. The safety of pediatric acupuncture: a systematic review. 
Pediatrics. 14/02/21%4 Notes%F Adams N0001 2011;128(6):1575-1587.  
30. 
Bergqvist D. Vascular injuries caused by acupuncture. A systematic review. Int Angiol. February 2013;32(1):1-8.  
31. 
Ernst E, White AR. Prospective studies of the safety of acupuncture: a systematic review. Am J Med. Apr 15 
2001;110(6):481-5.  
32. 
MacPherson H, Thomas K, Walters S, Fitter M. A prospective survey of adverse events and treatment reactions 
following 34,000 consultations with professional acupuncturists. Acupunct Med. 2001;19(2):93-102.  
33. 
MacPherson H, Thomas K. Short term reactions to acupuncture--a cross-sectional survey of patient reports. Acupunct 
Med. September 2005;23(3):112-120.  
34. 
White A. A cumulative review of the range and incidence of significant adverse events associated with acupuncture. 
Acupunct Med. September 2004;22(3):122-133.  
35. 
Yamashita H, Tsukayama H, White AR, Tanno Y, Sugishita C, Ernst E. Systematic review of adverse events following 
acupuncture: the Japanese literature. Complement Ther Med. June 2001;9(2):98-104.  
36. 
Zhao XF, Du Y, Liu PG, Wang S. Acupuncture for stroke: evidence of effectiveness, safety, and cost from systematic 
reviews. Top Stroke Rehabil. May-Jun 2012;19(3):226-33. doi:10.1310/tsr1903-226 
37. 
Yamashita H, Tsukayama H. Safety of acupuncture practice in Japan: patient reactions, therapist negligence and error 
reduction strategies. Evid Based Complement Alternat Med. Dec 2007;5(4):391-8.  
38. 
NIH Introduction to pragmatic clinical trials. NIH Collaboratory. Accessed September 27, 2018. 
https://www.nihcollaboratory.org/Products/Introduction%20to%20pragmatic%20clinical%20trials.pdf 
39. 
Weinfurt KP, Hernandez AF, Coronado GD, et al. Pragmatic clinical trials embedded in healthcare systems: 
generalizable lessons from the NIH Collaboratory. BMC Med Res Methodol. Sep 18 2017;17(1):144. doi:10.1186/s12874-017-
0420-7 
40. 
Rethinking Clinical Trials:  Living Textbook of Pragmatic Clinical Trials. Accessed September 27, 2018. 
http://rethinkingclinicaltrials.org/ 
41. 
Concannon TW, Guise JM, Dolor RJ, et al. A national strategy to develop pragmatic clinical trials infrastructure. Clin 
Transl Sci. Apr 2014;7(2):164-71. doi:10.1111/cts.12143 
42. 
Balas EA, Boren SA. Medical clinical knowledge for health care improvement. In: Bemmel J, AT M, eds. Yearbook of 
medical informatics. Schattauer ; Verlagsgesellschaft mbH;; 2000:65-70. 
43. 
Goertz C, Niemtzow R, Burns S, Fritts M, Crawford C, Jonas W. Auricular acupuncture in the treatment of acute pain 
syndromes: a pilot study. Mil Med. 2006;171(10):1010-1014.  
44. 
Harkin C, Parker R. A prospective, randomised control trial of acupuncture for select common conditions within the 
emergency department. J Chinese Med. 2007;85:45-52.  
45. 
Grissa MH, Baccouche H, Boubaker H, et al. Acupuncture vs intravenous morphine in the management of acute pain 
in the ED. Am J Emerg Med. Nov 2016;34(11):2112-2116. doi:10.1016/j.ajem.2016.07.028 
46. 
Fox LM, Murakami M, Danesh H, Manini AF. Battlefield acupuncture to treat low back pain in the emergency 
department. Am J Emerg Med. Jun 2018;36(6):1045-1048. doi:10.1016/j.ajem.2018.02.038 
47. 
Cohen MM, Smit V, Andrianopoulos N, et al. Acupuncture for analgesia in the emergency department: a multicentre, 
randomised, equivalence and non-inferiority trial. Med J Aust. Jun 19 2017;206(11):494-499.  
48. 
Arnold AA, Ross BE, Silka PA. Efficacy and feasibility of acupuncture for patients in the ED with acute, nonpenetrating 
musculoskeletal injury of the extremities. Am J Emerg Med. 2009/03/01/ 2009;27(3):280-284. 
doi:https://doi.org/10.1016/j.ajem.2008.02.018 
49. 
Zhang AL, Parker SJ, Smit de V, Taylor DM, Xue CC. Acupuncture and standard emergency department care for pain 
and/or nausea and its impact on emergency care delivery: a feasibility study. Acupunct Med. Jun 2014;32(3):250-6. 
doi:10.1136/acupmed-2013-010501 
50. 
Liu YT, Chiu CW, Chang CF, et al. Efficacy and Safety of Acupuncture for Acute Low Back Pain in Emergency 
Department: A Pilot Cohort Study. Evid Based Complement Alternat Med. 2015;2015:179731. doi:10.1155/2015/179731 
51. 
Reinstein AS, Erickson LO, Griffin KH, et al. Acceptability, adaptation, and clinical outcomes of acupuncture provided 
in the emergency department: a retrospective pilot study. Pain Med. Jan 30 2017;18(1):169-178. doi:10.1093/pm/pnv114 
52. 
Kim K, Lee B, Ryu J, Choi T, Yang G. The role of acupuncture in emergency department settings: a systematic 
review. Complement Ther Med. 2013;21(1):65-72.  
53. 
Jan AL, Aldridge ES, Rogers IR, Visser EJ, Bulsara MK, Niemtzow RC. Review article: does acupuncture have a role 
in providing analgesia in the emergency setting? A systematic review and meta-analysis. Emerg Med Australas. Oct 
2017;29(5):490-498. doi:10.1111/1742-6723.12832 
54. 
Chia KL, Lam RPK, Lam CK, Tsui SH. Acupuncture in the emergency department: a systematic review of randomised 
controlled trials. Acupunct Med. Mar 26 2018;36(3):183-192. doi:10.1136/acupmed-2017-011547 
55. 
Jan AL, Aldridge ES, Rogers IR, Visser EJ, Bulsara MK, Niemtzow RC. Does Ear Acupuncture Have a Role for Pain 
Relief in the Emergency Setting? A Systematic Review and Meta-Analysis. Med Acupunct. Oct 1 2017;29(5):276-289. 
doi:10.1089/acu.2017.1237 
56. 
Sakamoto JT, Ward HB, Vissoci JRN, Eucker SA. Are non-pharmacologic pain interventions effective at reducing pain 
in adult patients visiting the Emergency Department? A Systematic Review and Meta-analysis. Acad Emerg Med. Mar 15 
2018;25(8):940-957. doi:10.1111/acem.13411 
57. 
Jan AL, Rogers I, Visser EJ. Acupuncture for analgesia in the emergency department: a multicentre, randomised, 
equivalence and non-inferiority trial. Med J Aust. Mar 5 2018;208(4):188-189.  

Page 55 of 143 
Version 12.09.2022; Version 6 
 
 
58. 
Gagliese L, Weizblit N, Ellis W, Chan VW. The measurement of postoperative pain: a comparison of intensity scales in 
younger and older surgical patients. Pain. Oct 2005;117(3):412-20. doi:10.1016/j.pain.2005.07.004 
59. 
Paice JA, Cohen FL. Validity of a verbally administered numeric rating scale to measure cancer pain intensity. Cancer 
Nurs. Apr 1997;20(2):88-93.  
60. 
Berthier F, Potel G, Leconte P, Touze MD, Baron D. Comparative study of methods of measuring acute pain intensity 
in an ED. Am J Emerg Med. Mar 1998;16(2):132-6.  
61. 
Mohan H, Ryan J, Whelan B, Wakai A. The end of the line? The Visual Analogue Scale and Verbal Numerical Rating 
Scale as pain assessment tools in the emergency department. Emerg Med J. May 2010;27(5):372-5. 
doi:10.1136/emj.2007.048611 
62. 
Dusek JA, Finch M, Plotnikoff G, Knutson L. The impact of integrative medicine on pain management in a tertiary care 
hospital. J Patient Saf. Mar 2010;6(1):48-51. doi:10.1097/PTS.0b013e3181d10ad5 
63. 
Johnson JR, Crespin DJ, Griffin KH, Finch MD, Dusek JA. Effects of integrative medicine on pain and anxiety among 
oncology inpatients. J Natl Cancer Inst Monogr. Nov 2014;2014(50):330-7. doi:10.1093/jncimonographs/lgu030 
64. 
Crespin DJ, Griffin KH, Johnson JR, et al. Acupuncture provides short-term pain relief for patients in a total joint 
replacement program. Pain Med. Jun 2015;16(6):1195-203. doi:10.1111/pme.12685 
65. 
Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use 
in the emergency department. Acad Emerg Med. Apr 2003;10(4):390-2.  
66. 
Campbell M, Fitzpatrick R, Haines A, et al. Framework for design and evaluation of complex interventions to improve 
health. BMJ. 2000;321(7262):694-696. doi:10.1136/bmj.321.7262.694 
67. 
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: 
the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi:10.1136/bmj.a1655 
68. 
Schnyer RN, Allen JJ. Bridging the gap in complementary and alternative medicine research: manualization as a 
means of promoting standardization and flexibility of treatment in clinical trials of acupuncture. J Altern Complement Med. Oct 
2002;8(5):623-34. doi:10.1089/107555302320825147 
69. 
MacPherson H, Schroer S. Acupuncture as a complex intervention for depression: a consensus method to develop a 
standardised treatment protocol for a randomised controlled trial. Complement Ther Med. Jun 2007;15(2):92-100. 
doi:10.1016/j.ctim.2006.09.006 
70. 
Schnyer RN, Wayne PM, Kaptchuk TJ, Cheng X, Zhang Z, Stason WB. Standardization of individualized treatments in 
a randomized controlled trial of acupuncture for stroke rehabilitation. J Altern Complement Med. Mar 2006;12(2):106-9. 
doi:10.1089/acm.2006.12.106 
71. 
Schnyer RN, Iuliano D, Kay J, Shields M, Wayne P. Development of protocols for randomized sham-controlled trials of 
complex treatment interventions: Japanese acupuncture for endometriosis-related pelvic pain. J Altern Complement Med. Jun 
2008;14(5):515-22. doi:10.1089/acm.2007.0826 
72. 
Kligler B, Nielsen A, Kohrrer C, et al. Acupuncture therapy in a group setting for chronic pain. Pain Med. Jun 08 
2017;(0):1-11. doi:doi: 10.1093/pm/pnx134 
73. 
Hsu CC, Sandford BA. The Delphi technique: making sense of consensus. Practical Assessment, Research & 
Evaluation (PARE). 2007;12(10) 
74. 
Smith CA, Grant S, Lyttleton J, Cochrane S. Using a Delphi consensus process to develop an acupuncture treatment 
protocol by consensus for women undergoing Assisted Reproductive Technology (ART) treatment. BMC Complement Altern 
Med. Jul 07 2012;12:88. doi:10.1186/1472-6882-12-88 
75. 
McKee MD, Nielsen A, Anderson B, et al. Comparison of Individual to Group Delivery of Acupuncture Therapy for 
Chronic Musculoskeletal Pain in Urban Primary Care. 2019;in review 
76. 
Fonnebo V, Grimsgaard S, Walach H, et al. Researching complementary and alternative treatments--the gatekeepers 
are not at home. BMC Med Res Methodol. Feb 11 2007;7:7. doi:10.1186/1471-2288-7-7 
77. 
NCCIH. Pilot Studies: Common Uses and Misuses. NIH National Center for Complementary and Integrative Health. 
Updated Sept 24, 2017. Accessed January 22, 2019. https://nccih.nih.gov/grants/whatnccihfunds/pilot_studies 
78. 
Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power 
calculations for study proposals. Arch Gen Psychiatry. May 2006;63(5):484-9. doi:10.1001/archpsyc.63.5.484 
79. 
Keefe RS, Kraemer HC, Epstein RS, et al. Defining a clinically meaningful effect for the design and interpretation of 
randomized controlled trials. Innov Clin Neurosci. May 2013;10(5-6 Suppl A):4s-19s.  
80. 
Kistin C, Silverstein M. Pilot Studies: A Critical but Potentially Misused Component of Interventional Research. JAMA. 
Oct 20 2015;314(15):1561-2. doi:10.1001/jama.2015.10962 
81. 
Olsen MF, Bjerre E, Hansen MD, Tendal B, Hilden J, Hrobjartsson A. Minimum clinically important differences in 
chronic pain vary considerably by baseline pain and methodological factors: systematic review of empirical studies. J Clin 
Epidemiol. Sep 2018;101:87-106.e2. doi:10.1016/j.jclinepi.2018.05.007 
82. 
Greene CJ, Morland LA, Durkalski VL, Frueh BC. Noninferiority and equivalence designs: issues and implications for 
mental health research. J Trauma Stress. Oct 2008;21(5):433-9. doi:10.1002/jts.20367 
83. 
Nielsen A, Ocker L, Majd I, et al. Acupuncture Intervention Protocol: Consensus Process for a Pragmatic Randomized 
Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults: An NIH HEAL Initiative Funded 
Project. Global Advances in Health and Medicine. 2021;10:21649561211007091.  
84. 
Proctor E, Silmere H, Raghavan R, et al. Outcomes for implementation research: conceptual distinctions, 
measurement challenges, and research agenda. Adm Policy Ment Health. Mar 2011;38(2):65-76. doi:10.1007/s10488-010-
0319-7 

Page 56 of 143 
Version 12.09.2022; Version 6 
 
 
85. 
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health 
services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. Aug 7 
2009;4:50. doi:10.1186/1748-5908-4-50 
 
 
 

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15. SUPPLEMENTS/APPENDICES 
Appendix A: Informed Consent Documents 
 
 
 
Table of Contents for Appendix A 
A.1 Patient Written Informed Consent 
A.1.1 UH 
A.1.2 UCSD 
A 1.3 VUMC 
 
A.2 Study Staff Written Informed Consent 
 
A.2.1 UH Observation Consent 
A.2.2 UCSD Observation Consent 
A.2.3 VUMC Observation Consent 
A.2.4 UH Interview Consent 
A.2.5 UCSD Interview Consent 
A.2.6 VUMC Interview Consent 
 
A.3 Patient Qualitative Interview Study Information Sheet 
 
 
A.3.1 UH 
 
 
A.3.2 UCSD 
 
 
A.3.3 VUMC 
 
A.4 ED Provider Qualitative Interview Study Information Sheet 
 
 
A.4.1 UH 
 
 
A.4.2 UCSD 
 
 
A.4.3 VUMC 
A.5 ED Provider Feasibility Survey Study Information Sheet 
 
A.5.1 UH 
 
A.5.2 UCSD 
 
A.5.3 VUMC 
 
Appendix B: RCT Data Collection Instruments 
 
 
 
 
 
 

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A.1 Patient Written Informed Consent 
 
A.1.1 UH Patient Written Informed Consent 
 
Key Information: The following is a short summary of this study to help you decide whether or not 
to be a part of this study.  More detailed information is listed later on in this form. 
 
Why am I being invited to take part in a research study? 
You are being asked to take part in this study because you came to the emergency room ER and are 
experiencing pain. 
 
Things I should know about a research study 
 
Someone will explain this research study to you. 
 
Whether or not you take part is up to you. 
 
You can choose not to take part. 
 
You can agree to take part and later change your mind. 
 
Your decision will not be held against you. 
 
You can ask all the questions you want before you decide. 
 
Introduction/Purpose 
The purpose of this research is to determine if we are able to deliver acupuncture for pain relief in the 
ER, and to study see if acupuncture for pain relief in the ER is effective. This research will be carried out 
at three sites: UH Cleveland Medical Center and Ahuja Medical Ceneter ERs, the Vanderbilt University 
Medical Center ER and the Hillcrest University of California San Diego (UCSD) ER. 
 
There will be a total of 165 patient participants across three research sites, with 55 enrolling from each 
site. Additionally, around 30 ER providers and staff will be interviewed to gain their perspective and 
experience related to how the study was carried out 
 
Key Study Procedures  
If you agree to participate, you will be randomly assigned to one of two groups. The treatment group will 
receive acupuncture and usual care during this ER visit, and the control group will receive usual care. 
Whichever group you are assigned to, we will also ask you a series of short questions about your 
symptoms before treatment, immediately after treatment, again before you are discharged from the ER, 
and then twice more via email, text or over the phone one week and one month after discharge. For the 
one week and one month follow up questionnaires, we’ll also ask about your pain medication usage 
during the time since you were discharged.   
 
If you are assigned to the acupuncture group, we may contact you to participate in an additional 
interview about your perspectives and experiences as a participant in the study who received 
acupuncture. The interview will be conducted via telephone or an approved telehealth application, and 
will be recorded and transcribed. Participation in the interview is completely voluntary and refusing to 
participate will not affect your participation in the rest of the study. If you agree to the interview, a study 
information sheet about the interview will be shared and reviewed with you before the interview begins 
and you will have an opportunity to ask questions or to refuse to participate. 
 

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There is a chance that additional study staff may also observe study procedures during your visit to the 
ER. Researchers will seek to observe the actions and interactions of relevant persons, including ER 
providers, other ER staff, patients, and the Site Study Coordinator or Site Research Assistant over the 
course of the your entire ER visit. 
 
More detailed information about the study procedures can be found under “Detailed Study Procedures”. 
 
Key Risks 
There are few potential risks of taking part in this study. Acupuncture carries very slight risks for 
bleeding, bruising, fainting, and needling pain. If you experience any of these, you will be treated by 
providers here in the ER.  
 
Some of the questions that we will ask you might make you feel uncomfortable. You can skip any 
question you do not wish to answer.  
 
As with any research study, there is a slight risk of losing privacy and confidentiality. We will keep all 
paper records secure in locked file cabinets. All electronic records are kept on a password-protected 
database to which only research staff has access.  
 
More detailed information about the risks of this study can be found under “Detailed Risks” 
 
Benefits 
You may not benefit from participation. Those randomized to acupuncture may have improved pain 
control but this cannot be guaranteed. You may experience better pain management, and reduced usage 
of opioid analgesics through the use of acupuncture if you are in the acupuncture group. This research 
may benefit future patients by improving the use of acupuncture along with usual care for pain 
management in the ER. 
 
Alternatives to Study Participation  
The only alternative to participating in this study is to not participate. 
 
Detailed Information: The following is more detailed information about this study in addition to 
the information listed above. 
 
Detailed Study Procedures 
If you are assigned to the treatment group, after answering a few questions about your symptoms on a 
tablet you will receive acupuncture from a nationally board certified acupuncturist.  The acupuncturist 
will describe details of the treatment, risks, cost and benefits in your private room. After that, you will 
receive the acupuncture treatment in your private room. Treatment will last between 30-45 minutes. 
Please note that if assigned to the acupuncture group, any pain medications that your provider may 
prescribe will be delayed while you receive treatment with acupuncture. Your individual acupuncture 
treatment will be based on your particular situation and will be determined by the treating acupuncturist. 
Sterile, single-use non-coated acupuncture needles will be used for this study. After the treatment, and 
again within 15 minutes of discharge, you will be asked the same series of questions on the tablet. One 
week and again one month after discharge you will be asked the same series of questions, and a few 
more about your pain relief medication usage since discharge, and your satisfaction with your treatment. 
You may choose to receive a link to the questionnaires via text message or email, or you can choose to 
have a study team member call you to complete the questionnaire. The study team will also view your 

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medical record to collect information about any pain medications used during your ER visit, and your 
demographics. 
 
Qualitative Interviews: Additionally, 15 participants assigned to the treatment group from each research 
site will participate in an interview with study staff. Study staff will contact some participants who 
received acupuncture as part of the study by phone or by email to invite them to participate in the 
interview. The purpose of the interview is to describe perspectives and experiences related to the how the 
study of acupuncture in emergency room (ER) was carried out. We may or may not contact you to 
participate in the interview portion of the research. If we contact you, you may refuse to participate. 
Before the start of the interview, a study information sheet will be shared and reviewed with you and you 
will be given an opportunity to ask questions and/or to refuse participation in the interview.  Refusing to 
participate in the interview will not affect your care or your participation in the rest of the study. 
 
The interview will last approximately 45 minutes and will be conducted via telephone or an approved 
telehealth application. The interview will take place between 2-4 weeks after your visit to the ER. The 
interview will be securely recorded and transcribed. Both the transcription and the recording will be kept 
in password protected databases behind an electronic firewall at sites and then securely sent to the 
Einstein Coordinating Center and maintained on password protected PCs by a designated data manager. 
Once transcription is verified, we will destroy the recording of the interview. The transcription will 
contain no identifying information.  
 
If you are assigned to the acupuncture group, do you consent to being contacted for the interview portion 
of this research? 
 
□ Yes 
 
□ I prefer an audio-only interview (by telephone) 
 
□ I prefer an audio and video interview (by telehealth) 
 
 
□ No 
 
If you are assigned to the control group, after answering a few questions about your symptoms on a 
tablet, you will receive usual ER care. Within 60 minutes, and again within 15 minutes before you are 
discharged, you will be asked the same series of questions on the tablet. One week and again one month 
after discharge you will be asked the same series of questions, and a few more about your pain relief 
medication usage since discharge, and your satisfaction with your treatment. You may choose to receive 
a link to the questionnaires via text message or email, or you can choose to have a study team member 
call you to complete the questionnaire. If you choose to receive a link to the questionnaire, a member of 
the study team may call you for follow up if we notice that the questionnaires have not been completed. 
The study team will also view your medical record to collect information about any pain medications 
used during your ER visit, and your demographics. 
 
Structured observation: For those assigned to either the treatment or control groups, there is a chance 
that additional research study staff may also observe study procedures during your visit to the ER. These 
researchers will seek to observe the actions and interactions of relevant persons, including ER providers, 
other ER staff, patients, and the research study staff over the course of the your entire ER visit. You may 
refuse to be observed by study staff and still participate in the research study.  If applicable, do you 
consent to have your participation in this research study while in the ER observed by study staff today? 
 
 
 
□ Yes 
 
 
□ No 

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□ NA 
 
Courtesy calls: A member of the research study staff will call you 2-3 days after your ER visit to ensure 
that you have received the e-gift card for your time and to remind you that we will be sending a link or 
calling you in a few days to complete the one week follow up survey. Study staff will also call to remind 
you a few days before the four week follow up survey. 
 
Detailed Risks 
The potential risks associated with participation in this study are minimal. Acupuncture carries very 
slight risks for bleeding, bruising, fainting (acushock), and needling pain. In the event you experience an 
adverse event (AE), you will be treated by providers in the site ER and will have access to emergency 
response equipment as necessary. 
 
Acupuncture involves inserting thin, sterile needles in the skin. The needles are not inserted into the skin 
very far. Sometimes the needles cause slight discomfort or minor bleeding. The acupuncturist will 
explain the risks of acupuncture in detail and ask you to sign a separate acupuncture consent form. The 
acupuncturist will review this consent form with you. Any acupuncturist who provides treatments in this 
study will be licensed by the state in which they practice. 
 
Some of the questions in the questionnaire might make you feel uncomfortable. You can skip any 
question they do not wish to answer. 
 
As with any research study, there is a slight risk of losing privacy and confidentiality. We will keep all 
paper records secure in locked file cabinets. All electronic records are kept on a password-protected 
database to which only research staff has access. 
 
Financial Information 
There will be no cost to you and your insurance will not be billed to take part in this study. For your 
participation during your ER visit, you will receive a $25 e-gift card which will be emailed to you after 
your ER visit. For answering the follow up questions on the phone one week after discharge, you will 
receive an additional $25 e-gift card, and for answering the follow up questions on the phone 4 weeks 
after discharge, you will receive a final $25 e-gift card. If assigned to the acupuncture group and selected 
to participate in the interview, you will receive an additional $25 e- gift card within 30 days of the 
completion of the interview. 
 
Research-Related Injury  
In the event you suffer a research related injury as a result of being in this study, University Hospitals is 
available to provide medical treatment for such injury. Provision of such medical treatment does not 
imply any negligence or other wrongdoing on the part of University Hospitals, the Sponsor or any of the 
physicians or other study personnel. If you believe that you have been injured as a result of participating 
in the study, please immediately contact the Principal Investigator or your study doctor at University 
Hospitals. If you cannot reach the Principal Investigator or your study doctor, do not delay treatment. 
You may seek treatment by another doctor. If you are seen or treated by a doctor other than the Principal 
Investigator or your study doctor, you should inform such doctor that you are in this study and, if 
possible, take this document with you to assist with your treatment. Always contact the Principal 
Investigator or your study doctor to alert them of any treatment you receive for an injury or illness you 
experience during this Study.  
 

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The costs for medical treatment as a result of a research related injury may be billed to you or your 
medical insurance plan, if applicable. Medical insurance plans may or may not cover costs for medical 
treatment of research related injuries. If you have insurance, you should check with your medical 
insurance plan before deciding to participate in this research study. In the event your medical insurance 
plan covers some or all of the treatment costs, you may still be responsible for co-pays or deductibles as 
required by your medical insurance plan.   
 
Neither Sponsor nor University Hospitals has set aside any money to pay you or to pay for your 
treatment if you suffer a research related injury as a result of being in the study.  There are no plans for 
University Hospitals or Sponsor to provide other forms of compensation (such as lost wages or other 
indirect losses) to you for research related injuries.  You are not waiving any legal rights by signing this 
form, including the right to seek compensation for an injury.  To help avoid injury, it is very important to 
follow all study directions. 
 
Clinical Trial Information 
U.S. NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL TRIAL DATABASE: A description 
of this clinical trial will be available on http:///www.clinicaltrials.gov, as required by U.S. Law.  This 
website will not include information that can identify you.  At most, the website will include a summary 
of the results.  You can search this website at any time to find out information about the trial and basic 
results. 
 
Termination of Participation 
Your decision to participate in this study is voluntary. You may choose to not participate or you may 
withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise 
entitled and without any effect on your future medical care.   
 
The study doctor or the sponsor can stop your participation at any time without your consent for the 
following reasons: 
 
• 
If it appears to be medically harmful to you; 
• 
If you fail to follow directions for participating in the study; 
• 
If it is discovered that you do not meet the study requirements; 
• 
If the study is canceled; or  
• 
For administrative reasons, including competitive enrollment (e.g. the target number of  
subjects has entered the study.)  
 
Confidentiality 
All electronic data will be kept in password protected databases behind an electronic firewall at sites and 
then securely sent to the Einstein Coordinating Center and maintained on password protected PCs by a 
designated data manager. Data in hard copy form will be stored in locked file cabinets within a secure, 
badge-access location at each site.  Recordings of the interview with the acupuncture group participants 
will be transcribed, and then the recording will be destroyed. The transcription will contain no 
identifying information. 
 
Future use of De-Identified Data 
Identifiers might be removed from your identifiable private information and after such removal the 
information could be used for future research studies or distributed to another investigator for future 
research studies without additional informed or consent. 
 

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It is possible, that in the future, additional research sites may be added. In this event, de-identified and or 
aggregate data collected during this research project may be shared with research personnel at these 
additional sites.  
 
Your identifiable data will not be used for any future projects. 
 
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The 
researchers with this Certificate may not disclose or use information, documents, or biospecimens that 
may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, 
suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have 
consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be 
disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local 
law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, 
state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other scientific 
research, as allowed by federal regulations protecting research subjects. 
 
The Certificate cannot be used to refuse a request for information from personnel of the United States 
federal or state government agency sponsoring the project that is needed for auditing or program 
evaluation by The National Institutes of Health which is funding this project or for information that must 
be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).  You 
should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing 
information about yourself or your involvement in this research. If you want your research information 
released to an insurer, medical care provider, or any other person not connected with the research, you 
must provide consent to allow the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or 
local law of your name, address, phone number, email address, medical record number and date of birth 
 
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have 
consented to in this informed consent document (your name, address, phone number, email address, 
medical record number and date of birth). 
 
Privacy of Protected Health Information (HIPAA) 
The Health Insurance Portability & Accountability Act (HIPAA) is a Federal law that helps to protect the 
privacy of your health information and to whom this information may be shared within and outside of 
University Hospitals.  This Authorization form is specifically for a research study entitled “Acupuncture 
in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study” 
(ACUITY) and will tell you what health information (called Protected Health Information or PHI) will 
be collected for this research study, who will see your PHI and in what ways they can use the 
information.  In order for the Principal Investigator, Jeffery Dusek, and the research study staff to collect 
and use your PHI, you must sign this authorization form.  You will receive a copy of this signed 
Authorization for your records.  If you do not sign this form, you may not join this study.  Your decision 
to allow the use and disclosure of your PHI is voluntary and will have no impact on your treatment at 
University Hospitals. By signing this form, you are allowing the researchers for this study to use and 
disclose your PHI in the manner described below.   
 
Generally the Principal Investigator and study staff at University Hospitals and Case Western Reserve 
University who are working on this research project will know that you are in a research study and will 

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see and use your PHI.  The researchers working on this study will collect the following PHI about you: 
your name, address, phone number, email address, medical record number and date of birth. This PHI 
will be used to contact you later for follow up, to extract information about your emergency department 
treatment, and for data analysis purposes. Your access to your PHI may be limited during the study to 
protect the study results.   
 
Your PHI may also be shared with the following groups/persons associated with this research study or 
involved in the review of research: the study’s Clinical Coordinating Center at Albert Einstein College of 
Medicine, the National Institutes of Health (study sponsor), other staff from the Principal Investigator’s 
medical practice group; University Hospitals, including the Center for Clinical Research and the Law 
Department; Government representatives or Federal agencies, when required by law.  
 
It is possible, that in the future, additional research sites may be added. In this event, your PHI that was 
collected during this research project may be shared with research personnel at these additional sites.   
 
Your permission to use and disclose your PHI does not expire.  However, you have the right to change 
your mind at any time and revoke your authorization.  If you revoke your authorization, the researchers 
will continue to use the information that they previously collected, but they will not collect any 
additional information.  Also, if you revoke your authorization you may no longer be able to participate 
in the research study.  To revoke your permission, you must do so in writing by sending a letter to Jeffery 
Dusek, Director of Research, Connor Integrative Health Network, University Hospitals Cleveland 
Medical Center, 11100 Euclid Avenue, Wearn 548, Cleveland, Ohio 44106; If you have a complaint or 
concerns about the privacy of your health information, you may also write to the UH Privacy Officer,  
Management Service Center, 3605 Warrensville Center, MSC 9105, Shaker Heights, OH 44122 or to the 
Federal Department of Health and Human Services (DHHS) at DHHS Regional Manager, Office of Civil 
Rights, US Department of Health and Human Services Government Center, JF Kennedy Federal 
Building, Room 1875, Boston, MA 02203.  Complaints should be sent within 180 days of finding out 
about the problem.    
 
The researchers and staff agree to protect your health information by using and disclosing it only as 
permitted by you in this Authorization and as directed by state and Federal law. University Hospitals is 
committed to protecting your confidentiality.  Please understand that once your PHI has been disclosed 
to anyone outside of University Hospitals, there is a risk that your PHI may no longer be protected; 
however other Federal and State laws may provide continued protection of your information.   
 
Summary of Your Rights as a Participant in a Research Study 
Your participation in this research study is voluntary.  Refusing to participate will not alter your usual 
health care or involve any penalty or loss of benefits to which you are otherwise entitled.  If you decide 
to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.  If 
information generated from this study is published or presented, your identity will not be revealed.  In the 
event new information becomes available that may affect the risks or benefits associated with this study 
or your willingness to participate in it, you will be notified so that you can decide whether or not to 
continue participating.  If you experience physical injury or illness as a result of participating in this 
research study, medical care is available at University Hospitals Cleveland Medical Center (UHCMC), 
University Hospitals Ahuja Medical Center (UHAMC)or elsewhere; however, UH has no plans to 
provide free care or compensation for lost wages. 
 
Disclosure of Your Study Records 

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Efforts will be made to keep the personal information in your research record private and confidential, 
but absolute confidentiality cannot be guaranteed.  The University Hospitals Cleveland Medical Center 
Institutional Review Board may review your study records.  If this study is regulated by the Food and 
Drug Administration (FDA), there is a possibility that the FDA might inspect your records. In addition, 
for treatment studies, the study sponsor and possibly foreign regulatory agencies may also review your 
records. If your records are reviewed your identity could become known.  
 
Contact Information 
 
______________________________ has described to you what is going to be done, the risks, hazards, 
and benefits involved. The Principal Investigator Jeffery Dusek, PhD can also be contacted at 617-519-
8082. If you have any questions, concerns or complaints about the study in the future, you may also 
contact them later. 
 
If the researchers cannot be reached, or if you would like to talk to someone other than the researcher(s) 
about; concerns regarding the study; research participant’s rights; research- related injury; or other 
human subject issues, please call the University Hospitals Cleveland Medical Center’s Research Subject 
Rights phone line at (216) 983-4979 or write to: The Associate Chief Scientific Officer, The Center for 
Clinical Research, University Hospitals Cleveland Medical Center, 11100 Euclid Avenue, Lakeside 
1400, Cleveland, Ohio, 44106-7061. 
 
Signature 
Signing below indicates that you have been informed about the research study in which you voluntarily 
agree to participate; that you have asked any questions about the study that you may have; and that the 
information given to you has permitted you to make a fully informed and free decision about your 
participation in the study.  By signing this consent form, you do not waive any legal rights, and the 
investigator(s) or sponsor(s) are not relieved of any liability they may have.  A copy of this consent form 
will be provided to you. 
 
 
x 
 
Signature of Participant                                                                                Date            Time 
x 
 
Printed Name of Participant 
 
 
 
x 
 
 
Signature of person obtaining informed consent                                            Date            Time 
x 
 
Printed name of person obtaining informed consent  
 
 
 

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A.1.2 UCSD Patient Written Informed Consent 
 
Key Information: The following is a short summary of this study to help you decide whether 
or not to be a part of this study. More detailed information is listed later on in this form. 
 
Why am I being invited to take part in a research study? 
You are being asked to take part in this study because you came to the emergency room (ER) and are 
experiencing pain. 
 
Things I should know about a research study 
 
Someone will explain this research study to you. 
 
Whether or not you take part is up to you. 
 
You can choose not to take part. 
 
You can agree to take part and later change your mind. 
 
Your decision will not be held against you. 
 
You can ask all the questions you want before you decide. 
 
Introduction/Purpose 
The purpose of this research is to determine if we are able to deliver acupuncture for pain relief in 
the ER, and to study see if acupuncture for pain relief in the ER is effective. This research will be 
carried out at three sites: UH Cleveland Medical Center ER, the Vanderbilt University Medical 
Center ER and the UC San Diego (UCSD) Health ER, Hillcrest location.  There will be a total of 165 
patient participants across three research sites, with 55 enrolling from each site. Additionally, around 
30 ER providers and staff will be interviewed to gain their perspective and experience related to 
how the study was carried out 
 
Key Study Procedures 
If you agree to participate, you will be randomly assigned to one of two groups. The treatment 
group will receive acupuncture and usual care during this ER visit, and the control group will 
receive usual care. Whichever group you are assigned to, we will also ask you a series of short 
questions about your symptoms before treatment, immediately after treatment, again before you are 
discharged from the ER, and then twice more via email, text or over the phone one week and one 
month after discharge. For the one week and one month follow up questionnaires, we’ll also ask 
about your pain medication usage during the time since you were discharged. 
 
If you are assigned to the acupuncture group, we may contact you to participate in an additional 
interview about your perspectives and experiences as a participant in the study who received 
acupuncture. The interview will be conducted via telephone or an approved telehealth application, 
and will be recorded and transcribed. Participation in the interview is completely voluntary and 
refusing to participate will not affect your participation in the rest of the study. If you agree to the 
interview, a study information sheet about the interview will be shared and reviewed with you 
before the interview begins and you will have an opportunity to ask questions or to refuse to 
participate. 
 
There is a chance that additional study staff may also observe study procedures during your visit to 
the ER. Researchers will seek to observe the actions and interactions of relevant persons, including 
ER providers, other ER staff, patients, and the Site Study Coordinator or Site Research Assistant over 

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the course of the your entire ER visit. 
 
More detailed information about the study procedures can be found under “Detailed Study 
Procedures”. 
 
Key Risks 
There are few potential risks of taking part in this study. Acupuncture carries very slight risks for 
bleeding, bruising, fainting, and needling pain. If you experience any of these, you will be treated by 
providers here in the ER. 
 
Some of the questions that we will ask you might make you feel uncomfortable. You can skip any 
question you do not wish to answer. 
 
As with any research study, there is a slight risk of losing privacy and confidentiality. We will 
keep all paper records secure in locked file cabinets. All electronic records are kept on a 
password-protected database to which only research staff has access. 
 
More detailed information about the risks of this study can be found under “Detailed Risks” 
 
Benefits 
You may not benefit from participation. Those randomized to acupuncture may have improved pain 
control but this cannot be guaranteed. You may experience better pain management, and reduced 
usage of opioid analgesics through the use of acupuncture if you are in the acupuncture group. This 
research may benefit future patients by improving the use of acupuncture along with usual care for 
pain management in the ER. 
 
Alternatives to Study Participation 
The only alternative to participating in this study is to not participate. 
 
Detailed Information: The following is more detailed information about this study in 
addition to the information listed above. 
 
Detailed Study Procedures 
If you are assigned to the treatment group, after answering a few questions about your symptoms 
on a tablet you will receive acupuncture from a nationally board certified acupuncturist. The 
acupuncturist will describe details of the treatment, risks, cost and benefits in your private room. 
After that, you will receive the acupuncture treatment in your private room. Treatment will last 
between 30-45 minutes. Please note that if assigned to the acupuncture group, any pain medications 
that your provider may prescribe will be delayed while you receive treatment with acupuncture. 
Your individual acupuncture treatment will be based on your particular situation and will be 
determined by the treating acupuncturist. Sterile, single-use non-coated acupuncture needles will be 
used for this study. After the treatment, and again within 15 minutes of discharge, you will be asked 
the same series of questions on the tablet. One week and again one month after discharge you will be 
asked the same series of questions, and a few more about your pain relief medication usage since 
discharge, and your satisfaction with your treatment. You may choose to receive a link to the 
questionnaires via text message or email, or you can choose to have a study team member call you to 
complete the questionnaire. The study team will also view your medical record to collect information 
about any pain medications used during your ER visit, and your demographics. 

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Qualitative Interviews: Additionally, 15 participants assigned to the treatment group from each 
research site will participate in an interview with study staff. Study staff will contact some 
participants who received acupuncture as part of the study by phone or by email to invite them to 
participate in the interview. The purpose of the interview is to describe perspectives and experiences 
related to the how the study of acupuncture in emergency room (ER) was carried out. We may or 
may not contact you to participate in the interview portion of the research. If we contact you, you 
may refuse to participate. Before the start of the interview, a study information sheet will be shared 
and reviewed with you and you will be given an opportunity to ask questions and/or to refuse 
participation in the interview. Refusing to participate in the interview will not affect your care or 
your participation in the rest of the study. 
 
The interview will last approximately 45 minutes and will be conducted via telephone or an 
approved telehealth application. The interview will take place between 2-4 weeks after your visit to 
the ER. The interview will be securely recorded and transcribed. Both the transcription and the 
recording will be kept in password protected databases behind an electronic firewall at sites and then 
securely sent to the Einstein Coordinating Center and maintained on password protected PCs by a 
designated data manager. Once transcription is verified, we will destroy the recording of the 
interview. The transcription will contain no identifying information. 
 
If you are assigned to the acupuncture group, do you consent to being contacted for the interview 
portion of this research? 
 
□ Yes 
 
 
□ No 
 
□ I prefer an audio-only interview (by telephone) 
□ I prefer an audio and video interview (by telehealth) 

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If you are assigned to the control group, after answering a few questions about your 
symptoms on a tablet, you will receive usual ER care. Within 60 minutes, and again within 
15 minutes before you are discharged, you will be asked the same series of questions on the 
tablet. One week and again one month after discharge you will be asked the same series of 
questions, and a few more about your pain relief medication usage since discharge, and your 
satisfaction with your treatment. You may choose to receive a link to the questionnaires via 
text message or email, or you can choose to have a study team member call you to complete 
the questionnaire. If you choose to receive a link to the questionnaire, a member of the study 
team may call you for follow up if we notice that the questionnaires have not been 
completed. The study team will also view your medical record to collect information about 
any pain medications used during your ER visit, and your demographics. 
 
Structured observation: For those assigned to either the treatment or control groups, there 
is a chance that additional research study staff may also observe study procedures during 
your visit to the ER. These researchers will seek to observe the actions and interactions of 
relevant persons, including ER providers, other ER staff, patients, and the research study 
staff over the course of the your entire ER visit. You may refuse to be observed by study 
staff and still participate in the research study. If applicable, do you consent to have your 
participation in this research study while in the ER observed by study staff today? 
 
□ Yes 
□ No 
□ NA 
 
Courtesy calls: A member of the research study staff will call you 2-3 days after your ER 
visit to ensure that you have received the e-gift card for your time and to remind you that 
we will be sending a link or calling you in a few days to complete the one week follow up 
survey. Study staff will also call to remind you a few days before the four week follow up 
survey. 
 
Detailed Risks 
The potential risks associated with participation in this study are minimal. Acupuncture 
carries very slight risks for bleeding, bruising, fainting (acushock), and needling pain. In the 
event you experience an adverse event (AE), you will be treated by providers in the site ER 
and will have access to emergency response equipment as necessary. 
 
Acupuncture involves inserting thin, sterile needles in the skin. The needles are not inserted 
into the skin very far. Sometimes the needles cause slight discomfort or minor bleeding. The 
acupuncturist will explain the risks of acupuncture in detail and ask you to sign a separate 
acupuncture consent form. The acupuncturist will review this consent form with you. Any 
acupuncturist who provides treatments in this study will be licensed by the state in which 
they practice. 
 
Some of the questions in the questionnaire might make you feel uncomfortable. You can 
skip any question they do not wish to answer. 

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As with any research study, there is a slight risk of losing privacy and confidentiality. We 
will keep all paper records secure in locked file cabinets. All electronic records are kept 
on a password-protected database to which only research staff has access. 
 
Financial Information 
There will be no cost to you and your insurance will not be billed to take part in this study. 
For your participation during your ER visit, you will receive a $25 e-gift card which will be 
emailed to you after your ER visit. For answering the follow up questions on the phone one 
week after discharge, you will receive an additional $25 e-gift card, and for answering the 
follow up questions on the phone 4 weeks after discharge, you will receive a final $25 e-gift 
card. If assigned to the acupuncture group and selected to participate in the interview, you 
will receive an additional $25 e- gift card within 30 days of the completion of the interview. 
Research-Related Injury 
In the event you suffer a research related injury as a result of being in this study, UCSD 
Health is available to provide medical treatment for such injury. Provision of such medical 
treatment does not imply any negligence or other wrongdoing on the part of UCSD Health, 
the Sponsor or any of the physicians or other study personnel. If you believe that you have 
been injured as a result of participating in the study, please immediately contact the 
Principal Investigator or your study doctor at UCSD Health. If you cannot reach the 
Principal Investigator or your study doctor, do not delay treatment. You may seek treatment 
by another doctor. If you are seen or treated by a doctor other than the Principal Investigator 
or your study doctor, you should inform such doctor that you are in this study and, if 
possible, take this document with you to assist with your treatment. Always contact the 
Principal Investigator or your study doctor to alert them of any treatment you receive for an 
injury or illness you experience during this Study. 
 
The costs for medical treatment as a result of a research related injury may be billed to you 
or your medical insurance plan, if applicable. Medical insurance plans may or may not cover 
costs for medical treatment of research related injuries. If you have insurance, you should 
check with your medical insurance plan before deciding to participate in this research study. 
In the event your medical insurance plan covers some or all of the treatment costs, you may 
still be responsible for co-pays or deductibles as required by your medical insurance plan. 
 
Neither Sponsor nor UCSD Health has set aside any money to pay you or to pay for your 
treatment if you suffer a research related injury as a result of being in the study. There are no 
plans for UCSD Health or Sponsor to provide other forms of compensation (such as lost 
wages or other indirect losses) to you for research related injuries. You are not waiving any 
legal rights by signing this form, including the right to seek compensation for an injury. To 
help avoid injury, it is very important to follow all study directions. 
 
Clinical Trial Information 
U.S. NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL TRIAL DATABASE: A 
description of this clinical trial will be available on http:///www.clinicaltrials.gov, as 
required by 

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U.S. Law. This website will not include information that can identify you. At most, the 
website will include a summary of the results. You can search this website at any time to 
find out information about the trial and basic results. 
 
Termination of Participation 
Your decision to participate in this study is voluntary. You may choose to not participate or 
you may withdraw from the study for any reason without penalty or loss of benefits to which 
you are otherwise entitled and without any effect on your future medical care. 
 
The study doctor or the sponsor can stop your participation at any time without your consent 
for the following reasons: 
 
• 
If it appears to be medically harmful to you; 
• 
If you fail to follow directions for participating in the study; 
• 
If it is discovered that you do not meet the study requirements; 
• 
If the study is canceled; or 
• 
For administrative reasons, including competitive enrollment (e.g. the target 
number of subjects has entered the study.) 
 
Confidentiality 
All electronic data will be kept in password protected databases behind an electronic 
firewall at sites and then securely sent to the Einstein Coordinating Center and maintained 
on password protected PCs by a designated data manager. Data in hard copy form will be 
stored in locked file cabinets within a secure, badge-access location at each site. Recordings 
of the interview with the acupuncture group participants will be transcribed, and then the 
recording will be destroyed. The transcription will contain no identifying information. 
 
Future use of De-Identified Data 
Identifiers might be removed from your identifiable private information and after such 
removal the information could be used for future research studies or distributed to another 
investigator for future research studies without additional informed or consent. 
 
It is possible, that in the future, additional research sites may be added. In this event, 
de- identified and or aggregate data collected during this research project may be 
shared with research personnel at these additional sites. 
 
Your identifiable data will not be used for any future projects. 
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, 
documents, or biospecimens that may identify you in any federal, state, or local civil, 
criminal, administrative, legislative, or other action, suit, or proceeding, or be used as 
evidence, for example, if there is a court subpoena, unless you have consented for this use. 
Information, documents, or biospecimens protected by this Certificate cannot be disclosed 
to anyone else who is not connected with the research except, if there is a federal, state, or 
local law that requires disclosure (such as to report child abuse or communicable diseases 

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but not for federal, state, or local civil, criminal, administrative, legislative, or other 
proceedings, see below); if you have consented to the disclosure, including for your 
medical treatment; or if it is used for other scientific research, as allowed by federal 
regulations protecting research subjects. 
 
The Certificate cannot be used to refuse a request for information from personnel of the 
United States federal or state government agency sponsoring the project that is needed for 
auditing or program evaluation by The National Institutes of Health which is funding this 
project or for information that must be disclosed in order to meet the requirements of the 
federal Food and Drug Administration (FDA). You should understand that a Certificate of 
Confidentiality does not prevent you from voluntarily releasing information about yourself 
or your involvement in this research. If you want your research information released to an 
insurer, medical care provider, or any other person not connected with the research, you 
must provide consent to allow the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by 
federal, state, or local law of your name, address, phone number, email address, medical 
record number and date of birth 
 
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you 
have consented to in this informed consent document (your name, address, phone number, 
email address, medical record number and date of birth). 
 
Privacy of Protected Health Information (HIPAA) 
The Health Insurance Portability & Accountability Act (HIPAA) is a Federal law that helps 
to protect the privacy of your health information and to whom this information may be 
shared within and outside of University Hospitals. This Authorization form is specifically 
for a research study entitled “Acupuncture in the Emergency Department for Pain 
Management: A BraveNet Multi-Center Feasibility Study” (ACUITY) and will tell you what 
health information (called Protected Health Information or PHI) will be collected for this 
research study, who will see your PHI and in what ways they can use the information. In 
order for the Principal Investigator, Gene A. Kallenberg, MD, and the research study staff to 
collect and use your PHI, you must sign this authorization form. You will receive a copy of 
this signed Authorization for your records. If you do not sign this form, you may not join 
this study. Your decision to allow the use and disclosure of your PHI is voluntary and will 
have no impact on your treatment at UCSD Health. By signing this form, you are allowing 
the researchers for this study to use and disclose your PHI in the manner described below. 
 
Generally the Principal Investigator and study staff at UCSD Health who are working on 
this research project will know that you are in a research study and will see and use your 
PHI. The researchers working on this study will collect the following PHI about you: your 
name, address, phone number, email address, medical record number and date of birth. This 
PHI will be used to contact you later for follow up, to extractinformation about your 
emergency department treatment, and for data analysis purposes. Your access to your PHI 
may be limited during the study to protect the study results. 
 

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Your PHI may also be shared with the following groups/persons associated with this 
research study or involved in the review of research: the study’s Clinical Coordinating 
Center at Albert Einstein College of Medicine, the National Institutes of Health (study 
sponsor), other staff from the Principal Investigator’s medical practice group; UCSD 
Health; University Hospitals, including the Center for Clinical Research and the Law 
Department; Government representatives or Federal agencies, when required by law. 
 
It is possible, that in the future, additional research sites may be added. In this event, your 
PHI that was collected during this research project may be shared with research personnel at 
these additional sites. 
 
Your permission to use and disclose your PHI does not expire. However, you have the right to 
change your mind at any time and revoke your authorization. If you revoke your authorization, 
the researchers will continue to use the information that they previously collected, but they will 
not collect any additional information. Also, if you revoke your authorization you may no longer 
be able to participate in the research study. To revoke your permission, you must do so in 
writing by sending a letter to Gene A. Kallenberg, MD, Director, UCSD Centers for Integrative 
Health, University of California, San Diego, 9500 Gilman Dr. La Jolla, CA 92093; If you have a 
complaint or concerns about the privacy of your health information, you may also write to the 
UCSD Campus Privacy Officer, Pegah K. Parsi, JD, MBA - CIPP/EU/US, CIPM at 
pparsi@ucsd.edu or 858-822-4439, or to the Federal Department of Health and Human Services 
(DHHS) at DHHS Regional Manager, Office of Civil Rights, US Department of Health and 
Human Services Government Center, JF Kennedy Federal Building, Room 1875, Boston, MA 
02203. Complaints should be sent within 180 days of finding out about the problem. 
 
The researchers and staff agree to protect your health information by using and disclosing it 
only as permitted by you in this Authorization and as directed by state and Federal law. 
University Hospitals is committed to protecting your confidentiality. Please understand that 
once your PHI has been disclosed to anyone outside of UCSD Health, there is a risk that 
your PHI may no longer be protected; however other Federal and State laws may provide 
continued protection of your information. 
 
Summary of Your Rights as a Participant in a Research Study 
 
Your participation in this research study is voluntary. Refusing to participate will not alter 
your usual health care or involve any penalty or loss of benefits to which you are otherwise 
entitled. 
If you decide to join the study, you may withdraw at any time and for any reason without 
penalty or loss of benefits. If information generated from this study is published or presented, 
your identity will not be revealed. In the event new information becomes available that may 
affect the risks or benefits associated with this study or your willingness to participate in it, 
you will be notified so that you can decide whether or not to continue participating. If you 
experience physical injury or illness as a result of participating in this research study, 
medical care is available at University of California, San Diego (UCSD) Health or 
elsewhere; however, UCSD Health has no plans to provide free care or compensation for 
lost wages. 

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Disclosure of Your Study Records 
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals 
Cleveland Medical Center Institutional Review Board and the UCSD Institutional Review 
Board may review your study records. If this study is regulated by the Food and Drug 
Administration (FDA), there is a possibility that the FDA might inspect your records. In 
addition, for treatment studies, the study sponsor and possibly foreign regulatory agencies 
may also review your records. If your records are reviewed your identity could become 
known. 
 
Contact Information 
 
  
has described to you what is going to be done, the 
risks, hazards, and benefits involved. The Principal Investigator, Gene A. Kallenberg, 
and/or his research associates have described to you what is going to be done, and the risks, 
hazards, and benefits involved. He can be contacted at gkallenberg@health.ucsd.edu or at 
619-543-5490.  If you have any questions, concerns or complaints about the study in the 
future, you may also contact him later. 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research-
related injury; or other human subject issues, please call the UCSD Human Research 
Protections Program Office at 858-246-HRPP (858-246-4777). The Principal Investigator, 
Gene A. Kallenberg, and/or his research associates have described to you what is going to 
be done, and the risks, hazards, and benefits involved. He can be contacted at 
gkallenberg@health.ucsd.edu or at 619-543-5490.  If you have any questions, concerns or 
complaints about the study in the future, you may also contact him later. 
 
 
Signature 
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you 
may have; and that the information given to you has permitted you to make a fully informed 
and free   decision about your participation in the study. By signing this consent form, you 
do not waive any legal rights, and the investigator(s) or sponsor(s) are not relieved of any 
liability they may have. A copy of this consent form will be provided to you. 
 
 
x 
Signature of Participant 
Date 
Time 
x 
Printed Name of Participant 
 
 

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x 
Signature of person obtaining informed consent 
Date 
Time 
x 
Printed name of person obtaining informed consent 
 
 
 

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A.1.3 VUMC Patient Written Informed Consent  
 
Key Information: The following is a short summary of this study to help you decide 
whether or not to be a part of this study.  More detailed information is listed later on in this 
form. 
 
Why am I being invited to take part in a research study? 
You are being asked to take part in this study because you came to the emergency department 
(ED) and are experiencing pain. 
 
Things I should know about a research study 
 
Someone will explain this research study to you. 
 
Whether or not you take part is up to you. 
 
You can choose not to take part. 
 
You can agree to take part and later change your mind. 
 
Your decision will not be held against you. 
 
You can ask all the questions you want before you decide. 
 
Introduction/Purpose 
The purpose of this research is to determine if we are able to deliver acupuncture for pain relief 
in the ED, and to study see if acupuncture for pain relief in the ED is effective. This research will 
be carried out at three sites: UH Cleveland Medical Center ED, the Vanderbilt University 
Medical Center ED and the Hillcrest University of California San Diego (UCSD) ED. 
There will be a total of 165 patient participants across three research sites, with 55 enrolling from 
each site. Additionally, around 30 ED providers and staff will be interviewed to gain their 
perspective and experience related to how the study was carried out 
 
Key Study Procedures  
If you agree to participate, you will be randomly assigned to one of two groups. The treatment 
group will receive acupuncture and usual care during this ED visit, and the control group will 
receive usual care. Whichever group you are assigned to, we will also ask you a series of short 
questions about your symptoms before treatment, immediately after treatment, again before you 
are discharged from the ED, and then twice more via email, text or over the phone one week and 
one month after discharge. For the one week and one month follow up questionnaires, we’ll also 
ask about your pain medication usage during the time since you were discharged.   
 
If you are assigned to the acupuncture group, we may contact you to participate in an additional 
interview about your perspectives and experiences as a participant in the study who received 
acupuncture. The interview will be conducted via the audio function of Zoom Health 
Professional, recorded and transcribed. Participation in the interview is completely voluntary and 
refusing to participate will not affect your participation in the rest of the study. If you agree to 
the interview, a study information sheet about the interview will be shared and reviewed with 
you before the interview begins and you will have an opportunity to ask questions or to refuse to 
participate. 
 

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There is a chance that additional study staff may also observe study procedures during your visit 
to the ED. Researchers will seek to observe the actions and interactions of relevant persons, 
including ED providers, other ED staff, patients, and the Site Study Coordinator or Site Research 
Assistant over the course of the your entire ED visit. 
 
More detailed information about the study procedures can be found under “Detailed Study 
Procedures”. 
 
Key Risks 
There are few potential risks of taking part in this study. Acupuncture carries very slight risks for 
bleeding, bruising, fainting, and needling pain. If you experience any of these, you will be treated 
by providers here in the ED.  
 
Some of the questions that we will ask you might make you feel uncomfortable. You can skip 
any question you do not wish to answer.  
 
As with any research study, there is a slight risk of losing privacy and confidentiality. We will 
keep all paper records secure in locked file cabinets. All electronic records are kept on a 
password-protected database to which only research staff has access.  
 
More detailed information about the risks of this study can be found under “Detailed Risks” 
 
Benefits 
You may not benefit from participation. Those randomized to acupuncture may have improved 
pain control but this cannot be guaranteed. You may experience better pain management, and 
reduced usage of opioid analgesics through the use of acupuncture if you are in the acupuncture 
group. This research may benefit future patients by improving the use of acupuncture along with 
usual care for pain management in the ED. 
 
Alternatives to Study Participation  
The only alternative to participating in this study is to not participate. 
 
Detailed Information: The following is more detailed information about this study in 
addition to the information listed above. 
 
Detailed Study Procedures 
If you are assigned to the treatment group, after answering a few questions about your 
symptoms on a tablet or your smartphone, you will receive acupuncture from a nationally board 
certified acupuncturist.  The acupuncturist will describe details of the treatment, risks, cost and 
benefits in your private room.  After that, you will receive the acupuncture treatment in your 
private room. Treatment will last between 30-45 minutes. Please note that if assigned to the 
acupuncture group, any pain medications that your provider may prescribe will be delayed while 
you receive treatment with acupuncture. Your individual acupuncture treatment will be based on 
your particular situation and will be determined by the treating acupuncturist. Sterile, single-use 
non-coated acupuncture needles will be used for this study. After the treatment, and again within 
15 minutes of discharge, you will be asked the same series of questions on the tablet or your own 

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smartphone. One week and again one month after discharge you will be asked the same series of 
questions, and a few more about your pain relief medication usage since discharge, and your 
satisfaction with your treatment. You may choose to receive a link to the questionnaires via text 
message or email, or you can choose to have a study team member call you to complete the 
questionnaire. If you choose to receive a link to the questionnaire, a member of the study team 
may call you for follow up if we notice that the questionnaires have not been completed. The 
study team will also view your medical record to collect information about any pain medications 
used during your ED visit, and your demographics. 
 
Qualitative Interviews: Additionally, 15 participants assigned to the treatment group from each 
research site will participate in an interview with study staff. Study staff will contact some 
participants who received acupuncture as part of the study by phone or by email to invite them to 
participate in the interview. The purpose of the interview is to describe perspectives and 
experiences related to the how the study of acupuncture in emergency room (ER) was carried 
out. We may or may not contact you to participate in the interview portion of the research. If we 
contact you, you may refuse to participate. Before the start of the interview, a study information 
sheet will be shared and reviewed with you and you will be given an opportunity to ask questions 
and/or to refuse participation in the interview.  Refusing to participate in the interview will not 
affect your care or your participation in the rest of the study. 
 
The interview will last approximately 45 minutes and will be conducted via telephone or an 
approved telehealth application. The interview will take place between 2-4 weeks after your visit 
to the ER. The interview will be securely recorded and transcribed. Both the transcription and the 
recording will be kept in password protected databases behind an electronic firewall at sites and 
then securely sent to the Einstein Coordinating Center and maintained on password protected 
PCs by a designated data manager. Once transcription is verified, we will destroy the recording 
of the interview. The transcription will contain no identifying information.  
 
If you are assigned to the acupuncture group, do you consent to being contacted for the interview 
portion of this research? 
 
□ Yes 
 
□ I prefer an audio-only interview (by telephone) 
 
□ I prefer an audio and video interview (by telehealth) 
 
 
□ No 
 
If you are assigned to the control group, after answering a few questions about your symptoms 
on a tablet, you will receive usual ER care. Within 60 minutes, and again within 15 minutes 
before you are discharged, you will be asked the same series of questions on the tablet. One 
week and again one month after discharge you will be asked the same series of questions, and a 
few more about your pain relief medication usage since discharge, and your satisfaction with 
your treatment. You may choose to receive a link to the questionnaires via text message or email, 
or you can choose to have a study team member call you to complete the questionnaire. If you 
choose to receive a link to the questionnaire, a member of the study team may call you for follow 
up if we notice that the questionnaires have not been completed. The study team will also view 

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your medical record to collect information about any pain medications used during your ED 
visit, and your demographics. 
 
Structured observation: For those assigned to either the treatment or control groups, there is a 
chance that additional research study staff may also observe study procedures during your visit to 
the ER. These researchers will seek to observe the actions and interactions of relevant persons, 
including ER providers, other ER staff, patients, and the research study staff over the course of 
your entire ER visit. You may refuse to be observed by study staff and still participate in the 
research study.  Do you consent to have your participation in this research study while in the ER 
observed by study staff today? 
 
 
 
□ Yes 
 
 
□ No 
 
 
□ NA 
 
Courtesy calls: A member of the research study staff will call you 2-3 days after your ER visit 
to ensure that you have received the gift card for your time and to remind you that we will be 
sending a link or calling you in a few days to complete the one week follow up survey. Study 
staff will also call to remind you a few days before the four week follow up survey. 
 
Detailed Risks 
The potential risks associated with participation in this study are minimal. Acupuncture carries 
very slight risks for bleeding, bruising, fainting (acushock), and needling pain. In the event you 
experience an adverse event (AE), you will be treated by providers in the site ER and will have 
access to emergency response equipment as necessary. 
 
Acupuncture involves inserting thin, sterile needles in the skin. The needles are not inserted into 
the skin very far. Sometimes the needles cause slight discomfort or minor bleeding. The 
acupuncturist will explain the risks of acupuncture in detail and ask you to sign a separate 
acupuncture consent form. The acupuncturist will review this consent form with you. Any 
acupuncturist who provides treatments in this study will be licensed by the state in which they 
practice. 
 
Some of the questions in the questionnaire might make you feel uncomfortable. You can skip 
any question they do not wish to answer. 
 
As with any research study, there is a slight risk of losing privacy and confidentiality. We will 
keep all paper records secure in locked file cabinets. All electronic records are kept on a 
password-protected database to which only research staff has access. 
 
Financial Information 
There is no cost to you for taking part in this study.  
You will receive compensation for your participation as below.  
 
For completion of the study procedures during your ER visit, you will receive a $25 
gift card.  

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 
For answering the follow up questions on the phone one week after discharge, you 
will receive a check for $25 in the mail 
 
For answering the follow up questions on the phone 4 weeks after discharge, you will 
receive a check for $25 in the mail. 
 
If assigned to the acupuncture group and selected to participate in the interview, you 
will receive a check for $25 in the mail following completion of the interview. 
You will only receive compensation for the portions of the study completed.  The maximum 
amount you may receive is $100. 
 
Research-Related Injury  
Payment in case you are injured because of this research study: 
If it is determined by Vanderbilt and the Investigator with Sponsor input that an injury occurred 
as a direct result of the tests or treatments that are done for research, then you and/or your 
insurance will not have to pay for the cost of immediate medical care provided at Vanderbilt to 
treat the injury.  
There are no plans for Vanderbilt or the Sponsor to pay for any injury caused by the usual care 
you would normally receive for treating your illness or the costs of any additional care. There are 
no plans for Vanderbilt or the Sponsor to give you money for the injury.  
 
Who to call for any questions or in case you are injured 
If you should have any questions about this research study or if you feel you have been hurt by 
being a part of this study, please feel free to contact Dr. Alan Storrow at (615) 936-5934 or you 
may call the Research Coordinator, Karen Miller, RN. Karen can be reached at (615) 936-4790. 
If you cannot reach a member of the study team, please call (615) 936-0253 and have the study 
doctor paged.  
For additional information about giving consent or your rights as a person in this study, to 
discuss problems, concerns, and questions, or to offer input, please feel free to call the 
Vanderbilt University Institutional Review Board Office at (615) 322- 2918 or toll free at (866) 
224-8273.  
 
Clinical Trial Information 
U.S. NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL TRIAL DATABASE: A 
description of this clinical trial will be available on http:///www.clinicaltrials.gov, as required by 
U.S. Law.  This website will not include information that can identify you.  At most, the website 
will include a summary of the results.  You can search this website at any time to find out 
information about the trial and basic results. 
 
Termination of Participation 
Your decision to participate in this study is voluntary. You may choose to not participate or you 
may withdraw from the study for any reason without penalty or loss of benefits to which you are 
otherwise entitled and without any effect on your future medical care.   
 
The study doctor or the sponsor can stop your participation at any time without your consent for 
the following reasons: 
 

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• 
If it appears to be medically harmful to you; 
• 
If you fail to follow directions for participating in the study; 
• 
If it is discovered that you do not meet the study requirements; 
• 
If the study is canceled; or  
• 
For administrative reasons, including competitive enrollment (e.g. the target number of  
subjects has entered the study.)  
 
Confidentiality 
All electronic data will be kept in password protected databases behind an electronic firewall at 
sites and then securely sent to the Einstein Coordinating Center and maintained on password 
protected PCs by a designated data manager. Data in hard copy form will be stored in locked file 
cabinets within a secure, badge-access location at each site.  Recordings of the interview with the 
acupuncture group participants will be transcribed, and then the recording will be destroyed. The 
transcription will contain no identifying information. 
 
Future use of De-Identified Data 
This study may have support from the National Institutes of Health. If so, your study information 
is protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to 
refuse to give out your information even if requested using legal means. It does not protect 
information that we have to report by law, such as child abuse or some infectious diseases. The 
Certificate does not prevent us from disclosing your information if we learn of possible harm to 
yourself or others, or if you need medical help. Disclosures that you consent to in this document 
are not protected. This includes putting research data in the medical record or sharing research 
data for this study or future research. Disclosures that you make yourself are also not protected 
 
Your medical record will contain a note saying you are in a research study and may contain some 
research information about you. Anyone you authorize to receive your medical record will also 
get this information. 
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a 
court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects. 
 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by The National Institutes of Health which is funding this project or for 
information that must be disclosed in order to meet the requirements of the federal Food and 
Drug Administration (FDA).  You should understand that a Certificate of Confidentiality does 

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not prevent you from voluntarily releasing information about yourself or your involvement in 
this research. If you want your research information released to an insurer, medical care 
provider, or any other person not connected with the research, you must provide consent to allow 
the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, 
state, or local law of your name, address, phone number, email address, medical record number 
and date of birth 
 
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you 
have consented to in this informed consent document (your name, address, phone number, email 
address, medical record number and date of birth). 
 
Signature 
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study.  By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have.  A copy of this consent form will be provided to you. 
 
 
x 
 
Signature of Participant                                                                                Date            Time 
x 
 
Printed Name of Participant 
 
 
 
x 
 
 
Signature of person obtaining informed consent                                            Date            Time 
x 
 
Printed name of person obtaining informed consent  
 
 
 
 
 
 

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A.2 Study Staff Observation Written Consent 
 
A.2.1 UH Study Staff Observation Written Consent 
 
Key Information: The following is a short summary of this study to help you decide 
whether or not to be a part of this study.  More detailed information is listed later on in this 
form. 
 
Why am I being invited to take part in a research study? 
You are being asked to participate because you are ACUITY study staff (UH IRB 
STUDY20200618). 
 
Things I should know about a research study 
 
Someone will explain this research study to you. 
 
Whether or not you take part is up to you. 
 
You can choose not to take part. 
 
You can agree to take part and later change your mind. 
 
Your decision will not be held against you. 
 
You can ask all the questions you want before you decide. 
 
Introduction/Purpose 
The purpose of this research is conduct a feasibility randomized control trial (RCT) to examine 
the feasibility of data collection, acupuncture intervention implementation and treatment 
outcomes in emergency departments associated with 3 BraveNet research sites. (UH Cleveland 
Medical Center and Ahuja Medical Center EDs (site 1), the Vanderbilt University Medical 
Center (VUMC) ED (site 2) and the Hillcrest University of California San Diego (UCSD) ED 
(site 3)). This study includes structured observation to help assess feasibility. Successful conduct 
of the proposed multi-site study will inform implementation of a future, definitive, pragmatic, 
multi-site, non-inferiority RCT of Acupuncture compared with Usual Care. 
 
Key Study Procedures  
Participation in this study will consist of being observed during the following applicable 
activities: screening, recruitment, consent and RCT study procedures in the ED. More detailed 
information about the study procedures can be found under “Detailed Study Procedures”. 
 
Key Risks 
There are no physical risks to participating in this study. More detailed information about the 
risks of this study can be found under “Detailed Risks” 
 
Benefits 
There is no direct benefit to participating in this study. This research may benefit future patients 
by improving the use of acupuncture along with usual care for pain management in the ED. 
 
Alternatives to Study Participation  
The only alternative is not to participate in the study. 
 

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Detailed Information: The following is more detailed information about this study in 
addition to the information listed above. 
 
Detailed Study Procedures 
Two to three 4-6 hour shifts (for a total of approximately 12 hours) will be observed at each site 
during active patient recruitment and treatment by the Einstein Coordinating Center PI and/or the 
Einstein Coordinating Center Research Coordinator. These study staff are UH Research 
Credentialed. 
 
During the observation days, the study staff from Einstein will shadow local study staff as they 
screen, recruit, and consent patients and during study procedures including the receipt of 
acupuncture and data collection. No PHI or PII will be collected during this observation.   
 
Through field notes, Einstein study staff will document behaviors and interactions during ED 
visits with the goal of developing hypotheses regarding factors influencing key study outcomes. 
Einstein study staff will remain in the ED and seek to record all key interactions between 
patients, research and ED staff. 
 
Detailed Risks 
There are no physical risks to participating in this study. As with any research study, there is a 
slight risk of losing privacy and confidentiality. We will not collect any identifying information 
in our observation notes. We will keep all paper records secure in locked file cabinets. All 
electronic records are kept on a password-protected database to which only research staff has 
access. 
 
Financial Information 
There will be no cost to you to participate in this research and there will be no compensation. 
Clinical Trial Information 
U.S. NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL TRIAL DATABASE: A 
description of this clinical trial will be available on http:///www.clinicaltrials.gov, as required by 
U.S. Law.  This website will not include information that can identify you.  At most, the website 
will include a summary of the results.  You can search this website at any time to find out 
information about the trial and basic results. 
 
Student/Employee Rights 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisor. 
 
Confidentiality 
No identifying information will be collected during observation. All electronic data will be kept 
in password protected databases behind an electronic firewall at sites and then securely sent to 
the Einstein Coordinating Center and maintained on password protected PCs by a designated 
data manager. Data in hard copy form will be stored in locked file cabinets within a secure, 
badge-access location at each site.  Recordings of the interview with the acupuncture group 
participants will be transcribed, and then the recording will be destroyed. The transcription will 
contain no identifying information. 
 

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It is possible, that in the future, additional research sites may be added. In this event, the data 
collected during this research project may be shared with research personnel at these additional 
sites.   
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a 
court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects. 
 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by the National Center for Complementary and Integrative Health which is 
funding this project or for information that must be disclosed in order to meet the requirements 
of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of 
Confidentiality does not prevent you from voluntarily releasing information about yourself or 
your involvement in this research. If you want your research information released to an insurer, 
medical care provider, or any other person not connected with the research, you must provide 
consent to allow the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, 
state, or local law of any anonymous observation data collected. 
 
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you 
have consented to in this informed consent document. 
 
Summary of Your Rights as a Participant in a Research Study 
Your participation in this research study is voluntary.  Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  
If you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits.  If information generated from this study is published or presented, your 
identity will not be revealed.  In the event new information becomes available that may affect the 
risks or benefits associated with this study or your willingness to participate in it, you will be 
notified so that you can decide whether or not to continue participating.  If you experience 
physical injury or illness as a result of participating in this research study, medical care is 
available at University Hospitals Cleveland Medical Center (UHCMC), Ahuja Medical Center 
(UHAMC)or elsewhere; however, UHCMC has no plans to provide free care or compensation 
for lost wages. 
 
Disclosure of Your Study Records 

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Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed.  The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the 
FDA might inspect your records. In addition, for treatment studies, the study sponsor and 
possibly foreign regulatory agencies may also review your records. If your records are reviewed 
your identity could become known.  
 
 
Contact Information 
______________________________ has described to you what is going to be done, the risks, 
hazards, and benefits involved. The Principal Investigator Jeffery Dusek can also be contacted at 
Jeffery.Dusek@UHhospitals.org or 216-519-8082 If you have any questions, concerns or 
complaints about the study in the future, you may also contact them later. 
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, please call the University Hospitals Cleveland Medical 
Center’s Research Subject Rights phone line at (216) 983-4979 or write to: The Associate Chief 
Scientific Officer, The Center for Clinical Research, University Hospitals Cleveland Medical 
Center, 11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061. 
 
 
Signature 
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study.  By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have.  A copy of this consent form will be provided to you. 
 
x 
Signature of Participant                                                                                Date            Time 
x 
Printed Name of Participant 
 
 
x 
Signature of person obtaining informed consent                                            Date            Time 
x 
Printed name of person obtaining informed consent  
 
 
 

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Version 12.09.2022; Version 6 
 
 
A.2.2 UCSD Study Staff Observation Written Consent 
 
Key Information: The following is a short summary of this study to help you decide 
whether or not to be a part of this study.  More detailed information is listed later on in this 
form. 
 
Why am I being invited to take part in a research study? 
You are being asked to participate because you are ACUITY study staff (UH IRB 
STUDY20200618). 
 
Things I should know about a research study 
 
Someone will explain this research study to you. 
 
Whether or not you take part is up to you. 
 
You can choose not to take part. 
 
You can agree to take part and later change your mind. 
 
Your decision will not be held against you. 
 
You can ask all the questions you want before you decide. 
 
Introduction/Purpose 
The purpose of this research is conduct a feasibility randomized control trial (RCT) to examine 
the feasibility of data collection, acupuncture intervention implementation and treatment 
outcomes in emergency departments associated with 3 BraveNet research sites. (UH Cleveland 
Medical Center ED (site 1), the Vanderbilt University Medical Center (VUMC) ED (site 2) and 
the Hillcrest University of California San Diego (UCSD) ED (site 3)). This study includes 
structured observation to help assess feasibility. Successful conduct of the proposed multi-site 
study will inform implementation of a future, definitive, pragmatic, multi-site, non-inferiority 
RCT of Acupuncture compared with Usual Care. 
 
Key Study Procedures  
Participation in this study will consist of being observed during the following applicable 
activities: screening, recruitment, consent and RCT study procedures in the ED. More detailed 
information about the study procedures can be found under “Detailed Study Procedures”. 
 
Key Risks 
There are no physical risks to participating in this study. More detailed information about the 
risks of this study can be found under “Detailed Risks” 
 
Benefits 
There is no direct benefit to participating in this study. This research may benefit future patients 
by improving the use of acupuncture along with usual care for pain management in the ED. 
 
Alternatives to Study Participation  
The only alternative is not to participate in the study. 
 
Detailed Information: The following is more detailed information about this study in 
addition to the information listed above. 

Page 88 of 143 
Version 12.09.2022; Version 6 
 
 
 
Detailed Study Procedures 
Two to three 4-6 hour shifts (for a total of approximately 12 hours) will be observed at each site 
during active patient recruitment and treatment by the Einstein Coordinating Center PI and/or the 
Einstein Coordinating Center Research Coordinator. These study staff are UH Research 
Credentialed. 
 
During the observation days, the study staff from Einstein will shadow local study staff as they 
screen, recruit, and consent patients and during study procedures including the receipt of 
acupuncture and data collection. No PHI or PII will be collected during this observation.   
 
Through field notes, Einstein study staff will document behaviors and interactions during ED 
visits with the goal of developing hypotheses regarding factors influencing key study outcomes. 
Einstein study staff will remain in the ED and seek to record all key interactions between 
patients, research and ED staff. 
 
Detailed Risks 
There are no physical risks to participating in this study. As with any research study, there is a 
slight risk of losing privacy and confidentiality. We will not collect any identifying information 
in our observation notes. We will keep all paper records secure in locked file cabinets. All 
electronic records are kept on a password-protected database to which only research staff has 
access. 
 
Financial Information/Costs for Participating 
There will be no cost to you to participate in this research and there will be no compensation. 
Clinical Trial Information 
U.S. NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL TRIAL DATABASE: A 
description of this clinical trial will be available on http:///www.clinicaltrials.gov, as required by 
U.S. Law.  This website will not include information that can identify you.  At most, the website 
will include a summary of the results.  You can search this website at any time to find out 
information about the trial and basic results. 
 
Student/Employee Rights 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisor. 
 
Confidentiality 
No identifying information will be collected during observation. All electronic data will be kept 
in password protected databases behind an electronic firewall at sites and then securely sent to 
the Einstein Coordinating Center and maintained on password protected PCs by a designated 
data manager. Data in hard copy form will be stored in locked file cabinets within a secure, 
badge-access location at each site.  Recordings of the interview with the acupuncture group 
participants will be transcribed, and then the recording will be destroyed. The transcription will 
contain no identifying information. 
 

Page 89 of 143 
Version 12.09.2022; Version 6 
 
 
It is possible, that in the future, additional research sites may be added. In this event, the data 
collected during this research project may be shared with research personnel at these additional 
sites.   
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a 
court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects. 
 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by the National Center for Complementary and Integrative Health which is 
funding this project or for information that must be disclosed in order to meet the requirements 
of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of 
Confidentiality does not prevent you from voluntarily releasing information about yourself or 
your involvement in this research. If you want your research information released to an insurer, 
medical care provider, or any other person not connected with the research, you must provide 
consent to allow the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, 
state, or local law of any anonymous observation data collected. 
 
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you 
have consented to in this informed consent document. 
 
Summary of Your Rights as a Participant in a Research Study 
Your participation in this research study is voluntary.  Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  
If you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits.  If information generated from this study is published or presented, your 
identity will not be revealed.  In the event new information becomes available that may affect the 
risks or benefits associated with this study or your willingness to participate in it, you will be 
notified so that you can decide whether or not to continue participating. 
 
Disclosure of Your Study Records 
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed.  The University Hospitals 
Cleveland Medical Center Institutional Review Board (reviewing IRB), and the UCSD 
Institutional Review Board may review your study records.  If this study is regulated by the Food 
and Drug Administration (FDA), there is a possibility that the FDA might inspect your records. 

Page 90 of 143 
Version 12.09.2022; Version 6 
 
 
In addition, for treatment studies, the study sponsor and possibly foreign regulatory agencies 
may also review your records. If your records are reviewed your identity could become known.  
 
Contact Information 
________________ has described to you what is going to be done, and the risks, hazards, and 
benefits involved. He can be contacted at gkallenberg@health.ucsd.edu or at 619-543-5490.  If 
you have any questions, concerns or complaints about the study in the future, you may also 
contact him later.  
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, you may call the Human Research Protections Program 
Office at 858-246-HRPP (858-246-4777) to inquire about your rights as a research subject or to 
report research-related problems. 
 
 
Signature 
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study.  By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have.  A copy of this consent form will be provided to you. 
 
x 
Signature of Participant                                                                                Date            Time 
x 
Printed Name of Participant 
 
 
x 
Signature of person obtaining informed consent                                            Date            Time 
x 
Printed name of person obtaining informed consent  
 
 
 

Page 91 of 143 
Version 12.09.2022; Version 6 
 
 
A.2.3 VUMC Study Staff Observation Written Consent 
 
Key Information: The following is a short summary of this study to help you decide 
whether or not to be a part of this study.  More detailed information is listed later on in this 
form. 
 
Why am I being invited to take part in a research study? 
You are being asked to participate because you are ACUITY study staff (Vanderbilt University 
Medical Center IRB #210616). 
 
Things I should know about a research study 
 
Someone will explain this research study to you. 
 
Whether or not you take part is up to you. 
 
You can choose not to take part. 
 
You can agree to take part and later change your mind. 
 
Your decision will not be held against you. 
 
You can ask all the questions you want before you decide. 
 
Introduction/Purpose 
The purpose of this research is to conduct a feasibility randomized control trial (RCT) to 
examine the feasibility of data collection, acupuncture intervention implementation and 
treatment outcomes in emergency departments associated with 3 BraveNet research sites. (UH 
Cleveland Medical Center ED (site 1), the Vanderbilt University Medical Center (VUMC) ED 
(site 2) and the Hillcrest University of California San Diego (UCSD) ED (site 3)). This study 
includes structured observation to help assess feasibility. Successful conduct of the proposed 
multi-site study will inform implementation of a future, definitive, pragmatic, multi-site, non-
inferiority RCT of Acupuncture compared with Usual Care. 
 
Key Study Procedures  
Participation in this study will consist of being observed during the following applicable 
activities: screening, recruitment, consent and RCT study procedures in the ED. More detailed 
information about the study procedures can be found under “Detailed Study Procedures”. 
 
Key Risks 
There are no physical risks to participating in this study. More detailed information about the 
risks of this study can be found under “Detailed Risks” 
 
Benefits 
There is no direct benefit to participating in this study. This research may benefit future patients 
by improving the use of acupuncture along with usual care for pain management in the ED. 
 
Alternatives to Study Participation  
The only alternative is not to participate in the study. 
 
Detailed Information: The following is more detailed information about this study in 
addition to the information listed above. 

Page 92 of 143 
Version 12.09.2022; Version 6 
 
 
Detailed Study Procedures 
Two to three 4-6 hour shifts (for a total of approximately 12 hours) will be observed at each site 
during active patient recruitment and treatment by the Einstein Coordinating Center PI and/or the 
Einstein Coordinating Center Research Coordinator.  
 
During the observation days, the study staff from Einstein will shadow local study staff as they 
screen, recruit, and consent patients and during study procedures including the receipt of 
acupuncture and data collection. No PHI or PII will be collected during this observation.   
 
Through field notes, Einstein study staff will document behaviors and interactions during ED 
visits with the goal of developing hypotheses regarding factors influencing key study outcomes. 
Einstein study staff will remain in the ED and seek to record all key interactions between 
patients, research and ED staff. 
 
Detailed Risks 
There are no physical risks to participating in this study. As with any research study, there is a 
slight risk of losing privacy and confidentiality. We will not collect any identifying information 
in our observation notes. We will keep all paper records secure in locked file cabinets. All 
electronic records are kept on a password-protected database to which only research staff has 
access. 
 
Financial Information 
There will be no cost to you to participate in this research and there will be no compensation. 
 
Clinical Trial Information 
U.S. NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL TRIAL DATABASE: A 
description of this clinical trial will be available on http:///www.clinicaltrials.gov, as required by 
U.S. Law.  This website will not include information that can identify you.  At most, the website 
will include a summary of the results.  You can search this website at any time to find out 
information about the trial and basic results. 
 
Student/Employee Rights 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisor. 
 
Confidentiality 
No identifying information will be collected during observation. All electronic data will be kept 
in password protected databases behind an electronic firewall at sites and then securely sent to 
the Einstein Coordinating Center and maintained on password protected PCs by a designated 
data manager. Data in hard copy form will be stored in locked file cabinets within a secure, 
badge-access location at each site.  Recordings of the interview with the acupuncture group 
participants will be transcribed, and then the recording will be destroyed. The transcription will 
contain no identifying information. 
 
It is possible, that in the future, additional research sites may be added. In this event, the data 
collected during this research project may be shared with research personnel at these additional 
sites.   

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This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a 
court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects. 
 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by the National Center for Complementary and Integrative Health which is 
funding this project or for information that must be disclosed in order to meet the requirements 
of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of 
Confidentiality does not prevent you from voluntarily releasing information about yourself or 
your involvement in this research. If you want your research information released to an insurer, 
medical care provider, or any other person not connected with the research, you must provide 
consent to allow the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, 
state, or local law of any anonymous observation data collected. 
 
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you 
have consented to in this informed consent document. 
 
Summary of Your Rights as a Participant in a Research Study 
Your participation in this research study is voluntary.  Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  
If you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits.  If information generated from this study is published or presented, your 
identity will not be revealed.  In the event new information becomes available that may affect the 
risks or benefits associated with this study or your willingness to participate in it, you will be 
notified so that you can decide whether or not to continue participating.   
If it is determined by Vanderbilt and the Investigator that an injury occurred as a direct result of 
the tests or treatments that are done for research, then you and/or your insurance will not 
have to pay for the cost of immediate medical care provided at Vanderbilt to treat the injury.  
There are no plans for Vanderbilt to pay for any injury caused by the usual care you would 
normally receive for treating your illness or the costs of any additional care. There are no plans 
for Vanderbilt to give you money for the injury. 
 
Disclosure of Your Study Records 
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed.  The University Hospitals 

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Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the 
FDA might inspect your records. In addition, for treatment studies, the study sponsor and 
possibly foreign regulatory agencies may also review your records. If your records are reviewed 
your identity could become known.  
 
 
Contact Information 
______________________________ has described to you what is going to be done, the risks, 
hazards, and benefits involved. The Principal Investigator Dr. Alan Storrow at (615) 936-5934 
or you may call the Research Coordinator, Karen Miller, RN. Karen can be reached at (615) 
936-4790.If you have any questions, concerns or complaints about the study in the future, you 
may also contact them later. 
 
 
For additional information about giving consent or your rights as a person in this study, to 
discuss problems, concerns, and questions, or to offer input, please feel free to call the 
Vanderbilt University Institutional Review Board Office at (615) 322- 2918 or toll free at (866) 
224-8273.  
 
Signature 
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study.  By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have.  A copy of this consent form will be provided to you. 
 
x 
Signature of Participant                                                                                Date            Time 
x 
Printed Name of Participant 
 
 
x 
Signature of person obtaining informed consent                                            Date            Time 
x 
Printed name of person obtaining informed consent  
 
 
 
 

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A.2.4 UH Study Staff Interview Written Consent 
 
Key Information: The following is a short summary of this study to help you decide 
whether or not to be a part of this study.  More detailed information is listed later on in this 
form. 
 
Why am I being invited to take part in a research study? 
You are being asked to participate in this interview because you are currently or were previously 
ACUITY study staff (UH IRB STUDY20200618). 
 
Things I should know about a research study 
 
Someone will explain this research study to you. 
 
Whether or not you take part is up to you. 
 
You can choose not to take part. 
 
You can agree to take part and later change your mind. 
 
Your decision will not be held against you. 
 
You can ask all the questions you want before you decide. 
 
Introduction/Purpose 
The purpose of this research is conduct a feasibility randomized control trial (RCT) to examine 
the feasibility of data collection, acupuncture intervention implementation and treatment 
outcomes in emergency departments associated with 3 BraveNet research sites. (UH Cleveland 
Medical Center and Ahuja Medical Center EDs (site 1), the Vanderbilt University Medical 
Center (VUMC) ED (site 2) and the Hillcrest University of California San Diego (UCSD) ED 
(site 3)). This study includes qualitative interviews to help assess feasibility. Successful conduct 
of the proposed multi-site study will inform implementation of a future, definitive, pragmatic, 
multi-site, non-inferiority RCT of Acupuncture compared with Usual Care. 
 
Key Study Procedures  
Your participation in this study will involve answering a short demographics survey which will 
take about 3-5 minutes to complete and participating in a 45 minute interview where we will ask 
you questions about your perceptions and experiences related to the implementation and 
operations of ACUITY study. More detailed information about the study procedures can be 
found under “Detailed Study Procedures”. 
 
Key Risks 
There are no physical risks to participating in this study. More detailed information about the 
risks of this study can be found under “Detailed Risks” 
 
 
Benefits 
There is no direct benefit to participating in this study. This research may benefit future patients 
by improving the use of acupuncture along with usual care for pain management in the ED. 
 
Alternatives to Study Participation  
The only alternative is not to participate in the study. 

Page 96 of 143 
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Detailed Information: The following is more detailed information about this study in 
addition to the information listed above. 
 
Detailed Study Procedures 
Your participation in this study will involve answering a short demographics survey which will 
take about 3-5 minutes to complete and participating in a 45 minute interview where we will ask 
you questions about your perceptions and experiences of implementing the ACUITY study 
protocol in the ED and of ACUITY study operations. 
 
The interview will take place either in a private room in person or remotely via a HIPAA-
compliant commercial tele-health platform (e.g. Zoom Health Professional or Doxy.me) and will 
be recorded and transcribed. The recording will be destroyed once transcription is verified. The 
demographics survey will be emailed to you and completed during the interview. Your responses 
to the demographic survey will be saved with the transcript of your interview and will contain no 
identifying information. 
 
Detailed Risks 
There is no physical risk to being in this study. There is always a small risk that your information 
may be seen or accessed by someone who shouldn’t have access.   
 
We will work to prevent this by  
 Not including any identifying questions in the interview or demographics survey. 
 Storing the survey, interview recording and the transcription in a password 
protected database behind an electronic firewall at the Einstein Coordinating Center  
 Destroying the recording once transcription is verified. 
 Ensuring that the transcription contains no identifying information. 
 Ensuring that only IRB approved study personnel have access to your data 
 
 
 
 
Financial Information 
There is no cost to participate in this research. For your participation in this interview, you can 
choose between a $50 Amazon gift card or a free Connor Integrative Health Network service for 
your time. 
 
Clinical Trial Information 
U.S. NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL TRIAL DATABASE: A 
description of this clinical trial will be available on http:///www.clinicaltrials.gov, as required by 
U.S. Law.  This website will not include information that can identify you.  At most, the website 
will include a summary of the results.  You can search this website at any time to find out 
information about the trial and basic results. 
 
Student/Employee Rights 

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Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisor. 
 
Confidentiality 
We will work to protect your confidentiality by not including any identifying questions. The 
demographics survey will not be linked to your interview. The survey as well as the transcription 
and the recording of the interview will be stored in a password protected database behind an 
electronic firewall at the Einstein Coordinating Center and maintained on password protected 
PCs by a designated data manager. Once transcription is verified, we will destroy the recording 
of the interview. The survey and transcription will contain no identifying information. Data in 
hard copy form will be stored in locked file cabinets within a secure, badge-access location at 
each site.  No names or identifying information will be included in any publications or 
presentations based on these data, and your responses to this survey will remain confidential.  
 
It is possible, that in the future, additional research sites may be added. In this event, the data 
collected during this research project may be shared with research personnel at these additional 
sites.   
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a 
court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects. 
 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by the National Center for Complementary and Integrative Health which is 
funding this project or for information that must be disclosed in order to meet the requirements 
of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of 
Confidentiality does not prevent you from voluntarily releasing information about yourself or 
your involvement in this research. If you want your research information released to an insurer, 
medical care provider, or any other person not connected with the research, you must provide 
consent to allow the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you 
have consented to in this informed consent document. 
 
Summary of Your Rights as a Participant in a Research Study 
Your participation in this research study is voluntary.  Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  
If you decide to join the study, you may withdraw at any time and for any reason without penalty 

Page 98 of 143 
Version 12.09.2022; Version 6 
 
 
or loss of benefits.  If information generated from this study is published or presented, your 
identity will not be revealed.  In the event new information becomes available that may affect the 
risks or benefits associated with this study or your willingness to participate in it, you will be 
notified so that you can decide whether or not to continue participating.  If you experience 
physical injury or illness as a result of participating in this research study, medical care is 
available at University Hospitals Cleveland Medical Center (UHCMC), Ahuja Medical Center 
(UHAMC)or elsewhere; however, UHCMC has no plans to provide free care or compensation 
for lost wages. 
 
Disclosure of Your Study Records 
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed.  The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the 
FDA might inspect your records. In addition, for treatment studies, the study sponsor and 
possibly foreign regulatory agencies may also review your records. If your records are reviewed, 
your identity could become known.  
Contact Information 
______________________________ has described to you what is going to be done, the risks, 
hazards, and benefits involved. The Principal Investigator Jeffery Dusek can also be contacted at 
Jeffery.Dusek@UHhospitals.org or 216-519-8082 If you have any questions, concerns or 
complaints about the study in the future, you may also contact them later. 
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, please call the University Hospitals Cleveland Medical 
Center’s Research Subject Rights phone line at (216) 983-4979 or write to: The Associate Chief 
Scientific Officer, The Center for Clinical Research, University Hospitals Cleveland Medical 
Center, 11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061. 
 
Signature 
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study.  By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have.  A copy of this consent form will be provided to you. 
 
x 
Signature of Participant                                                                                Date            Time 
x 
Printed Name of Participant 
 
 

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x 
Signature of person obtaining informed consent                                            Date            Time 
x 
Printed name of person obtaining informed consent  
 
 
 

Page 100 of 143 
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A.2.5 UCSD Study Staff Interview Written Consent 
 
Key Information: The following is a short summary of this study to help you decide 
whether or not to be a part of this study.  More detailed information is listed later on in this 
form. 
 
Why am I being invited to take part in a research study? 
You are being asked to participate in this interview because you are currently or were previously 
ACUITY study staff (UH IRB STUDY20200618). 
 
Things I should know about a research study 
 
Someone will explain this research study to you. 
 
Whether or not you take part is up to you. 
 
You can choose not to take part. 
 
You can agree to take part and later change your mind. 
 
Your decision will not be held against you. 
 
You can ask all the questions you want before you decide. 
 
Introduction/Purpose 
The purpose of this research is conduct a feasibility randomized control trial (RCT) to examine 
the feasibility of data collection, acupuncture intervention implementation and treatment 
outcomes in emergency departments associated with 3 BraveNet research sites. (UH Cleveland 
Medical Center and Ahuja Medical Center EDs (site 1), the Vanderbilt University Medical 
Center (VUMC) ED (site 2) and the University of California San Diego Health (UCSDH) 
Hillcrest ED (site 3)). This study includes qualitative interviews to help assess feasibility. 
Successful conduct of the proposed multi-site study will inform implementation of a future, 
definitive, pragmatic, multi-site, non-inferiority RCT of Acupuncture compared with Usual Care. 
 
Key Study Procedures  
Your participation in this study will involve answering a short demographics survey which will 
take about 3-5 minutes to complete and participating in a 45 minute interview where we will ask 
you questions about your perceptions and experiences related to the implementation and 
operations of ACUITY study.  
 
More detailed information about the study procedures can be found under “Detailed Study 
Procedures”. 
 
 
Key Risks 
There are no physical risks to participating in this study.  
 
More detailed information about the risks of this study can be found under “Detailed Risks” 
 
Benefits 
There is no direct benefit to participating in this study. This research may benefit future patients 
by improving the use of acupuncture along with usual care for pain management in the ED. 

Page 101 of 143 
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Alternatives to Study Participation  
The only alternative is not to participate in the study. 
 
Detailed Information: The following is more detailed information about this study in 
addition to the information listed above. 
 
Detailed Study Procedures 
Your participation in this study will involve answering a short demographics survey which will 
take about 3-5 minutes to complete and participating in a 45 minute interview where we will ask 
you questions about your perceptions and experiences of implementing the ACUITY study 
protocol in the ED and of ACUITY study operations. 
 
The interview will take place either in a private room in person or remotely via a HIPAA-
compliant commercial tele-health platform (e.g. Zoom Health Professional or Doxy.me) and will 
be recorded and transcribed. The recording will be destroyed once transcription is verified. The 
demographics survey will be emailed to you and completed during the interview. Your responses 
to the demographic survey will be saved with the transcript of your interview and will contain no 
identifying information. 
 
Detailed Risks 
There is no physical risk to being in this study. There is always a small risk that your information 
may be seen or accessed by someone who shouldn’t have access.   
 
We will work to prevent this by  
 Not including any identifying questions in the interview or demographics survey. 
 Storing the survey, interview recording and the transcription in a password 
protected database behind an electronic firewall at the Einstein Coordinating Center  
 Destroying the recording once transcription is verified. 
 Ensuring that the transcription contains no identifying information. 
 Ensuring that only IRB approved study personnel have access to your data 
 
Financial Information 
There is no cost to participate in this research. For your participation in this interview, you can 
choose between a $25 Amazon gift card.  
 
Clinical Trial Information 
U.S. NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL TRIAL DATABASE: A 
description of this clinical trial will be available on http:///www.clinicaltrials.gov, as required by 
U.S. Law.  This website will not include information that can identify you.  At most, the website 
will include a summary of the results.  You can search this website at any time to find out 
information about the trial and basic results. 
 
Student/Employee Rights 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisor. 

Page 102 of 143 
Version 12.09.2022; Version 6 
 
 
 
Confidentiality 
We will work to protect your confidentiality by not including any identifying questions. The 
demographics survey will not be linked to your interview. The survey as well as the transcription 
and the recording of the interview will be stored in a password protected database behind an 
electronic firewall at the Einstein Coordinating Center and maintained on password protected 
PCs by a designated data manager. Once transcription is verified, we will destroy the recording 
of the interview. The survey and transcription will contain no identifying information. Data in 
hard copy form will be stored in locked file cabinets within a secure, badge-access location at 
each site.  No names or identifying information will be included in any publications or 
presentations based on these data, and your responses to this survey will remain confidential.  
 
It is possible, that in the future, additional research sites may be added. In this event, the data 
collected during this research project may be shared with research personnel at these additional 
sites.   
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a 
court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects. 
 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by the National Center for Complementary and Integrative Health which is 
funding this project or for information that must be disclosed in order to meet the requirements 
of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of 
Confidentiality does not prevent you from voluntarily releasing information about yourself or 
your involvement in this research. If you want your research information released to an insurer, 
medical care provider, or any other person not connected with the research, you must provide 
consent to allow the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you 
have consented to in this informed consent document. 
 
Summary of Your Rights as a Participant in a Research Study 
Your participation in this research study is voluntary.  Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  
If you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits.  If information generated from this study is published or presented, your 
identity will not be revealed.  In the event new information becomes available that may affect the 

Page 103 of 143 
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risks or benefits associated with this study or your willingness to participate in it, you will be 
notified so that you can decide whether or not to continue participating.  If you experience 
physical injury or illness as a result of participating in this research study, medical care is 
available at University of California, San Diego Health (UCSDH) or elsewhere; however, 
UCSDHhas no plans to provide free care or compensation for lost wages. 
 
Disclosure of Your Study Records 
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed.  The University Hospitals 
Cleveland Medical Center Institutional Review Board (reviewing IRB), and the UCSD 
Institutional Review Board may review your study records.  If this study is regulated by the Food 
and Drug Administration (FDA), there is a possibility that the FDA might inspect your records. 
In addition, for treatment studies, the study sponsor and possibly foreign regulatory agencies 
may also review your records. If your records are reviewed, your identity could become known.  
Contact Information 
______________________________ has described to you what is going to be done, the risks, 
hazards, and benefits involved. The local Principal Investigator Gene A. Kallenberg, M.D. can 
also be contacted at gkallenberg@health.ucsd.eduor 619-543-5490. If you have any questions, 
concerns or complaints about the study in the future, you may also contact him later. 
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, you may call the Human Research Protections Program 
Office at 858-246-HRPP (858-246-4777) to inquire about your rights as a research subject or to 
report research-related problems. 
 
Signature 
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study.  By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have.  A copy of this consent form will be provided to you. 
 
x 
Signature of Participant                                                                                Date            Time 
x 
Printed Name of Participant 
 
 
x 
Signature of person obtaining informed consent                                            Date            Time 

Page 104 of 143 
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x 
Printed name of person obtaining informed consent  
 
 
 

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A.2.6 VUMC Study Staff Interview Written Consent 
 
Key Information: The following is a short summary of this study to help you decide 
whether or not to be a part of this study.  More detailed information is listed later on in this 
form. 
 
Why am I being invited to take part in a research study? 
You are being asked to participate in this interview because you are currently or were previously 
ACUITY study staff (UH IRB STUDY20200618). 
 
Things I should know about a research study 
 
Someone will explain this research study to you. 
 
Whether or not you take part is up to you. 
 
You can choose not to take part. 
 
You can agree to take part and later change your mind. 
 
Your decision will not be held against you. 
 
You can ask all the questions you want before you decide. 
 
Introduction/Purpose 
The purpose of this research is conduct a feasibility randomized control trial (RCT) to examine 
the feasibility of data collection, acupuncture intervention implementation and treatment 
outcomes in emergency departments associated with 3 BraveNet research sites. (UH Cleveland 
Medical Center and Ahuja Medical Center EDs (site 1), the Vanderbilt University Medical 
Center (VUMC) ED (site 2) and the Hillcrest University of California San Diego (UCSD) ED 
(site 3)). This study includes qualitative interviews to help assess feasibility. Successful conduct 
of the proposed multi-site study will inform implementation of a future, definitive, pragmatic, 
multi-site, non-inferiority RCT of Acupuncture compared with Usual Care. 
 
Key Study Procedures  
Your participation in this study will involve answering a short demographics survey which will 
take about 3-5 minutes to complete and participating in a 45 minute interview where we will ask 
you questions about your perceptions and experiences related to the implementation and 
operations of ACUITY study. More detailed information about the study procedures can be 
found under “Detailed Study Procedures”. 
 
Key Risks 
There are no physical risks to participating in this study. More detailed information about the 
risks of this study can be found under “Detailed Risks” 
 
 
Benefits 
There is no direct benefit to participating in this study. This research may benefit future patients 
by improving the use of acupuncture along with usual care for pain management in the ED. 
 
Alternatives to Study Participation  
The only alternative is not to participate in the study. 

Page 106 of 143 
Version 12.09.2022; Version 6 
 
 
 
Detailed Information: The following is more detailed information about this study in 
addition to the information listed above. 
 
Detailed Study Procedures 
Your participation in this study will involve answering a short demographics survey which will 
take about 3-5 minutes to complete and participating in a 45 minute interview where we will ask 
you questions about your perceptions and experiences of implementing the ACUITY study 
protocol in the ED and of ACUITY study operations. 
 
The interview will take place either in a private room in person or remotely via a HIPAA-
compliant commercial tele-health platform (e.g. Zoom Health Professional or Doxy.me) and will 
be recorded and transcribed. The recording will be destroyed once transcription is verified. The 
demographics survey will be emailed to you and completed during the interview. Your responses 
to the demographic survey will be saved with the transcript of your interview and will contain no 
identifying information. 
 
Detailed Risks 
There is no physical risk to being in this study. There is always a small risk that your information 
may be seen or accessed by someone who shouldn’t have access.   
 
We will work to prevent this by  
 Not including any identifying questions in the interview or demographics survey. 
 Storing the survey, interview recording and the transcription in a password 
protected database behind an electronic firewall at the Einstein Coordinating Center  
 Destroying the recording once transcription is verified. 
 Ensuring that the transcription contains no identifying information. 
 Ensuring that only IRB approved study personnel have access to your data 
 
 
 
 
Financial Information 
There is no cost to participate in this research. For your participation in this interview, you will 
receive a $25 Amazon gift card for your time. 
 
Clinical Trial Information 
U.S. NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL TRIAL DATABASE: A 
description of this clinical trial will be available on http:///www.clinicaltrials.gov, as required by 
U.S. Law.  This website will not include information that can identify you.  At most, the website 
will include a summary of the results.  You can search this website at any time to find out 
information about the trial and basic results. 
 
Student/Employee Rights 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisor. 

Page 107 of 143 
Version 12.09.2022; Version 6 
 
 
 
Confidentiality 
We will work to protect your confidentiality by not including any identifying questions. The 
demographics survey will not be linked to your interview. The survey as well as the transcription 
and the recording of the interview will be stored in a password protected database behind an 
electronic firewall at the Einstein Coordinating Center and maintained on password protected 
PCs by a designated data manager. Once transcription is verified, we will destroy the recording 
of the interview. The survey and transcription will contain no identifying information. Data in 
hard copy form will be stored in locked file cabinets within a secure, badge-access location at 
each site.  No names or identifying information will be included in any publications or 
presentations based on these data, and your responses to this survey will remain confidential.  
 
It is possible, that in the future, additional research sites may be added. In this event, the data 
collected during this research project may be shared with research personnel at these additional 
sites.   
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a 
court subpoena, unless you have consented for this use. Information, documents, or 
biospecimens protected by this Certificate cannot be disclosed to anyone else who is not 
connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other 
scientific research, as allowed by federal regulations protecting research subjects. 
 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by the National Center for Complementary and Integrative Health which is 
funding this project or for information that must be disclosed in order to meet the requirements 
of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of 
Confidentiality does not prevent you from voluntarily releasing information about yourself or 
your involvement in this research. If you want your research information released to an insurer, 
medical care provider, or any other person not connected with the research, you must provide 
consent to allow the researchers to release it. 
 
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you 
have consented to in this informed consent document. 
 
Summary of Your Rights as a Participant in a Research Study 
Your participation in this research study is voluntary.  Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  
If you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits.  If information generated from this study is published or presented, your 
identity will not be revealed.  In the event new information becomes available that may affect the 

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risks or benefits associated with this study or your willingness to participate in it, you will be 
notified so that you can decide whether or not to continue participating.  If you experience 
physical injury or illness as a result of participating in this research study, medical care is 
available at Vanderbilt University Medical Centeror elsewhere; however, the study sponsor has 
no plans to provide free care or compensation for lost wages. 
 
Disclosure of Your Study Records 
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed.  The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the 
FDA might inspect your records. In addition, for treatment studies, the study sponsor and 
possibly foreign regulatory agencies may also review your records. If your records are reviewed, 
your identity could become known.  
Contact Information 
______________________________ has described to you what is going to be done, the risks, 
hazards, and benefits involved. The Principal Investigator Alan Storrow can also be contacted at 
or 615-936-5934 . Or you may call the Research Coordinator, Karen Miller, RN. Karen can be 
reached at 615-936-4790. If you cannot reach a member of the study team, please call  
615-936-0253 and have the study doctor paged. If you have any questions, concerns, or 
complaints about the study in the future, you may also contact them later. 
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, please call the University Hospitals Cleveland Medical 
Center’s Research Subject Rights phone line at (216) 983-4979 or write to: The Associate Chief 
Scientific Officer, The Center for Clinical Research, University Hospitals Cleveland Medical 
Center, 11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061. 
 
Signature 
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study.  By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have.  A copy of this consent form will be provided to you. 
 
x 
Signature of Participant                                                                                Date            Time 
x 
Printed Name of Participant 
 
 

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x 
Signature of person obtaining informed consent                                            Date            Time 
x 
Printed name of person obtaining informed consent  
 
 
 

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A.3 Patient Qualitative Interview Study Information Sheet 
 
A.3.1 UH Patient Qualitative Interview Study Information Sheet 
 
Introduction/Purpose 
You are invited to participate in an interview as part of “Acupuncture in the Emergency 
Department for Pain Management: A BraveNet Multi-Center Feasibility Study.” 
(ACUITY) The purpose of the interview is to describe perspectives and experiences related to 
the how this study in emergency room (ER) was carried out. You are being asked to participate 
because you received acupuncture for pain management at a recent ER visit as part of the above 
mentioned study in the University Hospitals (UH) Cleveland Medical Center/Ahuja Medical 
Center EDs, the Vanderbilt University Medical Center (VUMC) ED, or the Hillcrest University 
of California San Diego (UCSD). This research project is being conducted by Jeffery Dusek, 
PhD, Director of Research at UH Connor Integrative Health Network and should take 45 
minutes to complete. 
 
Participation 
Your participation in the interview is voluntary. You may refuse to take part in the interview or 
exit the study at any time without penalty. Your participation in will involve a 45 minute 
interview where we will ask you questions about your perceptions and experiences related to 
how the acupuncture study in the ER was carried out. The interview will take place either over 
telephone or via an approved telehealth application and will be recorded and transcribed. The 
recording will be destroyed once transcription is verified. 
 
Risks 
There is no physical risk to being in this study.  
There is always a small risk that your information may be seen or accessed by someone who 
shouldn’t have access  
 
We will work to prevent this by  
 Not including any identifying questions in the interview. 
 Storing the recording and the transcription in a password protected database 
behind an electronic firewall at the Einstein Coordinating Center  
 Destroying the recording once transcription is verified. 
 Ensuring that the transcription contains no identifying information. 
 Ensuring that only IRB approved study personnel have access to your data. 
 
The survey questions ask about your ER visit and may be distressing to you as you think about 
your experiences. You may skip any questions you don’t want to answer and you may end the 
interview at any time for any reason. 

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Benefits 
This research study is not intended to benefit you directly. We hope that the knowledge gained 
will help us to design and carry out a larger future study of acupuncture compared with usual 
care in additional ERs. 
 
Alternatives to Study Participation 
The alternative to participation in this study is to NOT participate. This will not affect your care 
in any way. 
 
Financial Information 
Your participation in this study will not involve cost to you.  
 
For your participation in this interview, you will receive a $25 gift card within 30 days of the 
interview. 
 
Confidentiality 
We will work to protect your confidentiality by not including any identifying questions. Both the 
transcription and the recording of the interview will be stored in a password protected database 
behind an electronic firewall at the Einstein Coordinating Center and maintained on password 
protected PCs by a designated data manager. Once transcription is verified, we will destroy the 
recording of the interview. The transcription will contain no identifying information. No names 
or identifying information will be included in any publications or presentations based on these 
data, and your responses to this survey will remain confidential. 
 
Your de-identified information may be used or shared with other researchers without your 
additional informed consent. 
 
Students or Employees 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisors or professors. 
 
Summary of your rights as a participant in a research study 
Your participation in this research study is voluntary. Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If 
you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits. If information generated from this study is published or presented, your 
identity will not be revealed.  
 
Disclosure of your study records  
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the 

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FDA might inspect your records. In addition, for treatment studies, the study sponsor and 
possibly foreign regulatory agencies may also review your records. If your records are reviewed 
your identity could become known. 
 
Contact Information 
If you have questions at any time about the study or the procedures, you may contact Alison 
Karasz via email at Alison.Karasz@UHhospitals.org or via phone at (718)430-8756. 
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, please call the University Hospitals Cleveland Medical 
Center’s Research Subject Rights phone line at (216) 983-4979 or write to: The Associate Chief 
Scientific Officer, The Center for Clinical Research, University Hospitals Cleveland Medical 
Center, 11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061. 
 
By answering the interview questions, you are indicating that you agree to the following: 
• 
You have read the above information 
• 
You voluntarily agree to participate and to be recorded for transcription purposes 
• 
You are 18 years of age or older 
 
 
You may keep a copy of this form for your records. 
 
 
 

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A.3.2 UCSD Patient Qualitative Interview Study Information Sheet 
 
Introduction/Purpose 
You are invited to participate in an interview as part of “Acupuncture in the Emergency 
Department for Pain Management: A BraveNet Multi-Center Feasibility Study.” 
(ACUITY) The purpose of the interview is to describe perspectives and experiences related to 
the how this study in emergency room (ER) was carried out. You are being asked to participate 
because you received acupuncture for pain management at a recent ER visit as part of the above 
mentioned study in the University Hospitals (UH) Cleveland Medical Center ED, the Vanderbilt 
University Medical Center (VUMC) ED, or the Hillcrest University of California San Diego 
(UCSD). This research project is being conducted by Gene A. Kallenberg, MD, Director, 
UCSD Centers for Integrative Health at University of California, San Diego and should take 
45 minutes to complete. 
 
Participation 
Your participation in the interview is voluntary. You may refuse to take part in the interview or 
exit the study at any time without penalty. Your participation in will involve a 45 minute 
interview where we will ask you questions about your perceptions and experiences related to 
how the acupuncture study in the ER was carried out. The interview will take place either over 
telephone or via an approved telehealth application and will be recorded and transcribed. The 
recording will be destroyed once transcription is verified. 
 
Risks 
There is no physical risk to being in this study.  
There is always a small risk that your information may be seen or accessed by someone who 
shouldn’t have access  
 
We will work to prevent this by  
 Not including any identifying questions in the interview. 
 Storing the recording and the transcription in a password protected database 
behind an electronic firewall at the Einstein Coordinating Center  
 Destroying the recording once transcription is verified. 
 Ensuring that the transcription contains no identifying information. 
 Ensuring that only IRB approved study personnel have access to your data. 
 
The survey questions ask about your ER visit and may be distressing to you as you think about 
your experiences. You may skip any questions you don’t want to answer and you may end the 
interview at any time for any reason. 
 
Benefits 
This research study is not intended to benefit you directly. We hope that the knowledge gained 
will help us to design and carry out a larger future study of acupuncture compared with usual 
care in additional ERs. 

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Alternatives to Study Participation 
The alternative to participation in this study is to NOT participate. This will not affect your care 
in any way. 
 
Financial Information 
Your participation in this study will not involve cost to you.  
 
For your participation in this interview, you will receive a $25 gift card within 30 days of the 
interview. 
 
Confidentiality 
We will work to protect your confidentiality by not including any identifying questions. Both the 
transcription and the recording of the interview will be stored in a password protected database 
behind an electronic firewall at the Einstein Coordinating Center and maintained on password 
protected PCs by a designated data manager. Once transcription is verified, we will destroy the 
recording of the interview. The transcription will contain no identifying information. No names 
or identifying information will be included in any publications or presentations based on these 
data, and your responses to this survey will remain confidential. 
 
Your de-identified information may be used or shared with other researchers without your 
additional informed consent. 
 
Students or Employees 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisors or professors. 
 
Summary of your rights as a participant in a research study 
Your participation in this research study is voluntary. Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If 
you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits. If information generated from this study is published or presented, your 
identity will not be revealed.  
 
Disclosure of your study records  
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the 
FDA might inspect your records. In addition, for treatment studies, the study sponsor and 
possibly foreign regulatory agencies may also review your records. If your records are reviewed 
your identity could become known. 

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Contact Information 
If you have questions at any time about the study or the procedures, you may contact Arundhati 
Debneth via email at Arundhati.Debnath@EinsteinMed.edu or via phone at (484) 929-4848. 
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, please call the UCSD Human Research Protections 
Program Office at 858-246-HRPP (858-246-4777) or write to: The Associate Chief Scientific 
Officer, The Center for Clinical Research, University Hospitals Cleveland Medical Center, 
11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061. 
 
By answering the interview questions, you are indicating that you agree to the following: 
• 
You have read the above information 
• 
You voluntarily agree to participate and to be recorded for transcription purposes 
• 
You are 18 years of age or older 
 
 
You may keep a copy of this form for your records. 
 
 
 

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A.3.3 VUMC Patient Qualitative Interview Study Information Sheet 
 
Introduction/Purpose 
You are invited to participate in an interview as part of “Acupuncture in the Emergency 
Department for Pain Management: A BraveNet Multi-Center Feasibility Study.” 
(ACUITY) The purpose of the interview is to describe perspectives and experiences related to 
the how this study in emergency room (ER) was carried out. You are being asked to participate 
because you received acupuncture for pain management at a recent ER visit as part of the above 
mentioned study in the University Hospitals (UH) Cleveland Medical Center ED, the Vanderbilt 
University Medical Center (VUMC) ED, or the Hillcrest University of California San Diego 
(UCSD). This research project is being conducted by Alan Storrow, MD and should take 45 
minutes to complete. 
 
Participation 
Your participation in the interview is voluntary. You may refuse to take part in the interview or 
exit the study at any time without penalty. Your participation in will involve a 45 minute 
interview where we will ask you questions about your perceptions and experiences related to 
how the acupuncture study in the ER was carried out. The interview will take place either over 
telephone or via an approved telehealth application and will be recorded and transcribed. The 
recording will be destroyed once transcription is verified. 
 
Risks 
There is no physical risk to being in this study.  
There is always a small risk that your information may be seen or accessed by someone who 
shouldn’t have access  
 
We will work to prevent this by  
 Not including any identifying questions in the interview. 
 Storing the recording and the transcription in a password protected database 
behind an electronic firewall at the Einstein Coordinating Center  
 Destroying the recording once transcription is verified. 
 Ensuring that the transcription contains no identifying information. 
 Ensuring that only IRB approved study personnel have access to your data. 
 
The survey questions ask about your ER visit and may be distressing to you as you think about 
your experiences. You may skip any questions you don’t want to answer and you may end the 
interview at any time for any reason. 
 
Benefits 
This research study is not intended to benefit you directly. We hope that the knowledge gained 
will help us to design and carry out a larger future study of acupuncture compared with usual 
care in additional ERs. 

Page 117 of 143 
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Alternatives to Study Participation 
The alternative to participation in this study is to NOT participate. This will not affect your care 
in any way. 
 
Financial Information 
Your participation in this study will not involve cost to you.  
 
For your participation in this interview, you will receive a $25 gift card within 30 days of the 
interview. 
 
Confidentiality 
We will work to protect your confidentiality by not including any identifying questions. Both the 
transcription and the recording of the interview will be stored in a password protected database 
behind an electronic firewall at the Einstein Coordinating Center and maintained on password 
protected PCs by a designated data manager. Once transcription is verified, we will destroy the 
recording of the interview. The transcription will contain no identifying information. No names 
or identifying information will be included in any publications or presentations based on these 
data, and your responses to this survey will remain confidential. 
 
Your de-identified information may be used or shared with other researchers without your 
additional informed consent. 
 
Students or Employees 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisors or professors. 
 
Summary of your rights as a participant in a research study 
Your participation in this research study is voluntary. Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If 
you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits. If information generated from this study is published or presented, your 
identity will not be revealed.  
 
Disclosure of your study records  
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the 
FDA might inspect your records. In addition, for treatment studies, the study sponsor and 
possibly foreign regulatory agencies may also review your records. If your records are reviewed 
your identity could become known. 

Page 118 of 143 
Version 12.09.2022; Version 6 
 
 
 
Contact Information 
If you should have any questions about this research study or if you feel you have been hurt by 
being a part of this study, please feel free to contact Dr. Alan Storrow at (615) 936-5934 or you 
may call the Research Coordinator, Karen Miller, RN  at (615) 936-4790 or Arundhati 
Debnath, Interview Coordinator at Arundhati.Debnath@EinsteinMed.edu or (484) 929-4848. If 
you cannot reach a member of the study team, please call (615) 936-0253 and have the study 
doctor paged.  
 
For additional information about giving consent or your rights as a person in this study, to 
discuss problems, concerns, and questions, or to offer input, please feel free to call the 
Vanderbilt University Institutional Review Board Office at (615) 322- 2918 or toll free at (866) 
224-8273.  
 
 
By answering the interview questions, you are indicating that you agree to the following: 
• 
You have read the above information 
• 
You voluntarily agree to participate and to be recorded for transcription purposes 
• 
You are 18 years of age or older 
 
 
You may keep a copy of this form for your records. 
 
 
 

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A.4 ED Provider Qualitative Interview Study Information Sheet 
 
A.4.1 UH ED Provider Qualitative Interview Study Information Sheet 
 
Introduction/Purpose 
You are invited to participate in an interview as part of “Acupuncture in the Emergency 
Department for Pain Management: A BraveNet Multi-Center Feasibility Study.” 
(ACUITY) The purpose of the interview is to describe perspectives and experiences related to 
implementation of the acupuncture study in the emergency department (ED). You are being 
asked to participate because you are an ED provider (physician, nurse practitioner, physician 
assistant, or registered nurse), ED staff, or acupuncturists employed or credentialed in the 
University Hospitals (UH) Cleveland Medical Center/Ahuja Medical Center ED, the Vanderbilt 
University Medical Center (VUMC) ED, or the Hillcrest University of California San Diego 
(UCSD) for at least one year during the study period. This research project is being conducted by 
Jeffery Dusek, PhD, Director of Research at UH Connor Integrative Health Network and 
should take 45 minutes to complete. 
 
Participation 
Your participation in this research study is voluntary. You may refuse to take part in the study or 
exit the study at any time without penalty. Your participation in this study will involve answering 
a short demographics survey which will take about 3-5 minutes to complete and participating in 
a 45 minute interview where we will ask you questions about your perceptions and experiences 
related to the implantation of the acupuncture study in the ED. The interview will take place 
either in a private room in person or remotely over the telephone or via a HIPAA-compliant 
commercial tele-health platform (e.g. Zoom Health Professional or Doxy.me) and will be 
recorded and transcribed. The recording will be destroyed once transcription is verified. The 
demographics survey will be emailed to you and completed during the interview. Your responses 
to the demographic survey will be saved with the transcript of your interview and will contain no 
identifying information. 
 
Risks 
There is no physical risk to being in this study. There is always a small risk that your information 
may be seen or accessed by someone who shouldn’t have access.   
 
We will work to prevent this by  
 Not including any identifying questions in the interview or demographics survey. 
 Storing the survey, interview recording and the transcription in a password 
protected database behind an electronic firewall at the Einstein Coordinating Center  
 Destroying the recording once transcription is verified. 
 Ensuring that the transcription contains no identifying information. 
 Ensuring that only IRB approved study personnel have access to your data 
 

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Benefits 
This research study is not intended to benefit you directly. We hope that the knowledge gained 
will help inform design and implementation of a future, pragmatic, multi-site, non-inferiority 
randomized control trial of Acupuncture compared with Usual Care in additional BraveNet 
clinic-affiliated EDs. 
 
Alternatives to Study Participation 
The alternative to participation in this study is to NOT participate. This will not affect your 
employment in any way. 
 
Financial Information 
There is no cost to participate in this research. For your participation in this interview, you can 
choose between a $50 Amazon gift card or a free Connor Integrative Health Network service for 
your time. 
 
Confidentiality 
We will work to protect your confidentiality by not including any identifying questions. The 
demographics survey as well as the transcription and the recording of the interview will be stored 
in a password protected database behind an electronic firewall at the Einstein Coordinating 
Center and maintained on password protected PCs by a designated data manager. Once 
transcription is verified, we will destroy the recording of the interview. The survey and 
transcription will contain no identifying information. No names or identifying information will 
be included in any publications or presentations based on these data, and your responses to this 
survey will remain confidential. 
 
Your de-identified information may be used or shared with other researchers without your 
additional informed consent. 
 
Students or Employees 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisors or professors. 
 
Summary of your rights as a participant in a research study 
Your participation in this research study is voluntary. Refusing to participate will not involve any 
penalty or loss of benefits to which you are otherwise entitled. If you decide to join the study, 
you may withdraw at any time and for any reason without penalty or loss of benefits. If 
information generated from this study is published or presented, your identity will not be 
revealed.  
 
Disclosure of your study records  
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the 
FDA might inspect your records. In addition, for treatment studies, the study sponsor and 

Page 121 of 143 
Version 12.09.2022; Version 6 
 
 
possibly foreign regulatory agencies may also review your records. If your records are reviewed 
your identity could become known. 
 
Contact Information 
If you have questions at any time about the study or the procedures, you may contact Alison 
Karasz via email at Alison.Karasz@UHhospitals.org or via phone at (718)430-8756  
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, please call the University Hospitals Cleveland Medical 
Center’s Research Subject Rights phone line at (216) 983-4979 or write to: The Associate Chief 
Scientific Officer, The Center for Clinical Research, University Hospitals Cleveland Medical 
Center, 11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061. 
 
 
By continuing with the interview, you are indicating that you agree to the following: 
• 
You have read the above information 
• 
You voluntarily agree to participate and to be recorded for transcription purposes 
• 
You are 18 years of age or older 
 
 
You may keep a copy of this form for your records. 
 
 
 

Page 122 of 143 
Version 12.09.2022; Version 6 
 
 
A.4.2 UCSD ED Provider Qualitative Interview Study Information Sheet 
 
Introduction/Purpose 
You are invited to participate in an interview as part of “Acupuncture in the Emergency 
Department for Pain Management: A BraveNet Multi-Center Feasibility Study.” 
(ACUITY) The purpose of the interview is to describe perspectives and experiences related to 
implementation of the acupuncture study in the emergency department (ED). You are being 
asked to participate because you are an ED provider (physician, nurse practitioner, physician 
assistant, or registered nurse), ED staff, or acupuncturists employed or credentialed in the 
University Hospitals (UH) Cleveland Medical Center ED, the Vanderbilt University Medical 
Center (VUMC) ED, or the  University of California San Diego (UCSD) Hillcrest ED for at least 
one year during the study period. This research project is being conducted by Gene A. 
Kallenberg, MD, Director, UCSD Centers for Integrative Health at University of 
California, San Diego and should take 45 minutes to complete. 
 
Participation 
Your participation in this research study is voluntary. You may refuse to take part in the study or 
exit the study at any time without penalty. Your participation in this study will involve answering 
a short demographics survey which will take about 3-5 minutes to complete and participating in 
a 45 minute interview where we will ask you questions about your perceptions and experiences 
related to the implantation of the acupuncture study in the ED. The interview will take place 
either in a private room in person or remotely over the telephone or via a HIPAA-compliant 
commercial tele-health platform (e.g. Zoom Health Professional or Doxy.me) and will be 
recorded and transcribed. The recording will be destroyed once transcription is verified. The 
demographics survey will be emailed to you and completed during the interview. Your responses 
to the demographic survey will be saved with the transcript of your interview and will contain no 
identifying information. 
 
Risks 
There is no physical risk to being in this study. There is always a small risk that your information 
may be seen or accessed by someone who shouldn’t have access.   
 
We will work to prevent this by  
 Not including any identifying questions in the interview or demographics 
survey. 
 Storing the survey, interview recording and the transcription in a password 
protected database behind an electronic firewall at the Einstein Coordinating 
Center  
 Destroying the recording once transcription is verified. 
 Ensuring that the transcription contains no identifying information. 
 Ensuring that only IRB approved study personnel have access to your data 
 
Benefits 
This research study is not intended to benefit you directly. We hope that the knowledge gained 
will help inform design and implementation of a future, pragmatic, multi-site, non-inferiority 

Page 123 of 143 
Version 12.09.2022; Version 6 
 
 
randomized control trial of Acupuncture compared with Usual Care in additional BraveNet 
clinic-affiliated EDs. 
 
Alternatives to Study Participation 
The alternative to participation in this study is to NOT participate. This will not affect your 
employment in any way. 
 
Financial Information 
There is no cost to participate in this research. For your participation in this interview, you will 
receive a $25 e-gift card within 30 days of the interview. 
 
Confidentiality 
We will work to protect your confidentiality by not including any identifying questions. The 
demographics survey as well as the transcription and the recording of the interview will be stored 
in a password protected database behind an electronic firewall at the Einstein Coordinating 
Center and maintained on password protected PCs by a designated data manager. Once 
transcription is verified, we will destroy the recording of the interview. The survey and 
transcription will contain no identifying information. No names or identifying information will 
be included in any publications or presentations based on these data, and your responses to this 
survey will remain confidential. 
 
Your de-identified information may be used or shared with other researchers without your 
additional informed consent. 
 
Students or Employees 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisors or professors. 
 
Summary of your rights as a participant in a research study 
Your participation in this research study is voluntary. Refusing to participate will not involve any 
penalty or loss of benefits to which you are otherwise entitled. If you decide to join the study, 
you may withdraw at any time and for any reason without penalty or loss of benefits. If 
information generated from this study is published or presented, your identity will not be 
revealed.  
 
Disclosure of your study records  
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the 
FDA might inspect your records. In addition, for treatment studies, the study sponsor and 
possibly foreign regulatory agencies may also review your records. If your records are reviewed 
your identity could become known. 

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Contact Information 
If you have questions at any time about the study or the procedures, you may contact Arundhati 
Debneth via email at Arundhati.Debnath@EinsteinMed.edu or via phone at (484) 929-4848. 
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, please call please call the UCSD Human Research 
Protections Program Office at 858-246-HRPP (858-246-4777) or write to: The Associate Chief 
Scientific Officer, The Center for Clinical Research, University Hospitals Cleveland Medical 
Center, 11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061. 
 
 
By continuing with the interview, you are indicating that you agree to the following: 
• 
You have read the above information 
• 
You voluntarily agree to participate and to be recorded for transcription purposes 
• 
You are 18 years of age or older 
 
 
You may keep a copy of this form for your records. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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A.4.3 VUMC ED Provider Qualitative Interview Study Information Sheet 
 
Introduction/Purpose 
You are invited to participate in an interview as part of “Acupuncture in the Emergency 
Department for Pain Management: A BraveNet Multi-Center Feasibility Study.” 
(ACUITY) The purpose of the interview is to describe perspectives and experiences related to 
implementation of the acupuncture study in the emergency department (ED). You are being 
asked to participate because you are an ED provider (physician, nurse practitioner, physician 
assistant, or registered nurse), ED staff, or acupuncturists employed or credentialed in the 
University Hospitals (UH) Cleveland Medical Center ED, the Vanderbilt University Medical 
Center (VUMC) ED, or the Hillcrest University of California San Diego (UCSD) for at least one 
year during the study period. This research project is being conducted by Alan Storrow, MD 
and should take 45 minutes to complete. 
 
Participation 
Your participation in this research study is voluntary. You may refuse to take part in the study or 
exit the study at any time without penalty. Your participation in this study will involve answering 
a short demographics survey which will take about 3-5 minutes to complete and participating in 
a 45 minute interview where we will ask you questions about your perceptions and experiences 
related to the implantation of the acupuncture study in the ED. The interview will take place 
either in a private room in person or remotely over the telephone or via a HIPAA-compliant 
commercial tele-health platform (e.g. Zoom Health Professional or Doxy.me) and will be 
recorded and transcribed. The recording will be destroyed once transcription is verified. The 
demographics survey will be emailed to you and completed during the interview. Your responses 
to the demographic survey will be saved with the transcript of your interview and will contain no 
identifying information. 
 
Risks 
There is no physical risk to being in this study. There is always a small risk that your information 
may be seen or accessed by someone who shouldn’t have access.   
 
We will work to prevent this by  
 Not including any identifying questions in the interview or demographics 
survey. 
 Storing the survey, interview recording and the transcription in a password 
protected database behind an electronic firewall at the Einstein Coordinating 
Center  
 Destroying the recording once transcription is verified. 
 Ensuring that the transcription contains no identifying information. 
 Ensuring that only IRB approved study personnel have access to your data 
 
Benefits 
This research study is not intended to benefit you directly. We hope that the knowledge gained 
will help inform design and implementation of a future, pragmatic, multi-site, non-inferiority 

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randomized control trial of Acupuncture compared with Usual Care in additional BraveNet 
clinic-affiliated EDs. 
 
Alternatives to Study Participation 
The alternative to participation in this study is to NOT participate. This will not affect your 
employment in any way. 
 
Financial Information 
There is no cost to participate in this research. For your participation in this interview, you will 
receive a $25 gift card within 30 days of the interview. 
 
Confidentiality 
We will work to protect your confidentiality by not including any identifying questions. The 
demographics survey as well as the transcription and the recording of the interview will be stored 
in a password protected database behind an electronic firewall at the Einstein Coordinating 
Center and maintained on password protected PCs by a designated data manager. Once 
transcription is verified, we will destroy the recording of the interview. The survey and 
transcription will contain no identifying information. No names or identifying information will 
be included in any publications or presentations based on these data, and your responses to this 
survey will remain confidential. 
 
Your de-identified information may be used or shared with other researchers without your 
additional informed consent. 
 
Students or Employees 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisors or professors. 
 
Summary of your rights as a participant in a research study 
Your participation in this research study is voluntary. Refusing to participate will not involve any 
penalty or loss of benefits to which you are otherwise entitled. If you decide to join the study, 
you may withdraw at any time and for any reason without penalty or loss of benefits. If 
information generated from this study is published or presented, your identity will not be 
revealed.  
 
Disclosure of your study records  
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed. The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the 
FDA might inspect your records. In addition, for treatment studies, the study sponsor and 
possibly foreign regulatory agencies may also review your records. If your records are reviewed 
your identity could become known. 

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Contact Information 
If you should have any questions about this research study or if you feel you have been hurt by 
being a part of this study, please feel free to contact Dr. Alan Storrow at (615) 936-5934 or you 
may call the Research Coordinator, Karen Miller, RN  at (615) 936-4790 or the Interview 
Coordinator, Arundhati Debnath at Arundhati.Debnath@EinsteinMed.edu or (484) 929-4848. 
If you cannot reach a member of the study team, please call (615) 936-0253 and have the study 
doctor paged.  
 
For additional information about giving consent or your rights as a person in this study, to 
discuss problems, concerns, and questions, or to offer input, please feel free to call the 
Vanderbilt University Institutional Review Board Office at (615) 322- 2918 or toll free at (866) 
224-8273.  
 
By continuing with the interview, you are indicating that you agree to the following: 
• 
You have read the above information 
• 
You voluntarily agree to participate and to be recorded for transcription purposes 
• 
You are 18 years of age or older 
 
 
You may keep a copy of this form for your records. 
 
 
 
 
 

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A.5 ED Provider Feasibility Survey Study Information Sheet 
 
A.5.1 UH ED Provider Feasibility Survey Study Information Sheet 
 
Introduction/Purpose 
You are invited to participate in a voluntary survey to help examine the feasibility of 
acupuncture intervention implementation in emergency departments as part of the ACUITY 
study. You are being asked to participate because you are an ED provider (physician, nurse 
practitioner, physician assistant, or registered nurse), or ED staff, employed or credentialed in the 
University Hospitals (UH) Cleveland Medical Center ED, the Vanderbilt University Medical 
Center (VUMC) ED, or the Hillcrest University of California San Diego (UCSD) for at least one 
year during the study period.  The research project is being conducted by Jeffery Dusek, Director 
of Research at University Hospitals Connor Whole Health. It will take approximately 5-7 
minutes to complete. 
 
Participation 
Your participation in this survey is voluntary. You may refuse to take part in the research or exit 
the survey at any time without penalty. You are free to decline to answer any particular question 
you do not wish to answer for any reason. We hope to gather responses from about 100 ED 
providers and staff from each site for a total of 300 individuals across all sites. You will answer a 
few demographic questions and then respond to 4 questions about the feasibility of the 
acupuncture intervention in the ED.  
 
Benefits 
This research study is not intended to benefit you directly. We hope that the knowledge gained 
will help inform design and implementation of a future, pragmatic, multi-site, non-inferiority 
randomized control trial of Acupuncture compared with Usual Care in additional BraveNet 
clinic-affiliated EDs. 
 
Risks 
There is no physical risk to being in this study.  
 
There is always the risk that your information may be seen by someone who shouldn’t have 
access. We will work to prevent this by taking the following steps to protect your 
information: 
 We’ll store all electronic data in REDCap, a secure, password protected online Database 
system.  
 We will not collect any identifying information in the survey. 
 Only IRB approved study personnel will have access to your data 
 
Alternatives to Study Participation 
The alternative to participation in this study is to NOT participate. This will not affect your care 
or employment in any way. 

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Financial Information 
Your participation in this study will not involve cost to you or your insurance company. You will 
receive a $5 e-gift card for your time. 
 
Confidentiality 
We will work to protect your confidentiality by keeping the questionnaire anonymous and by not 
including any identifying questions. All electronic data will be kept in password protected 
databases behind an electronic firewall at sites and then securely sent to the Einstein 
Coordinating Center and maintained on password protected PCs by a designated data manager. 
No names or identifying information would be included in any publications or presentations 
based on these data, and your responses to this survey will remain confidential. 
 
Students or Employees 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisors or professors. 
 
Summary of your rights as a participant in a research study 
Your participation in this research study is voluntary. Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If 
you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits. Deidentified data from this study may be published, presented, or otherwise 
made publically available. If this happens, your identity will not be revealed.  
 
Contact Information 
If you have questions at any time about the study or the procedures, you may contact the study 
coordinator, Jessica Surdam at 216-844-7925 or at Jessica.Surdam@UHHospitals.org. . If you 
have any questions, concerns, or complaints about the study in the future, you may also contact 
them later. 
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, please call the University Hospitals Cleveland Medical 
Center’s Research Subject Rights phone line at (216) 983-4979 or write to: The Associate Chief 
Scientific Officer, The Center for Clinical Research, University Hospitals Cleveland Medical 
Center, 11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061. 
 
Electronic Consent 
Note: If your study has specific eligibility criteria, please add any necessary attestations here. 
Please select your choice. Clicking on the “Yes” option indicates that you agree to the following: 
 You have read the above information 
 You voluntarily agree to participate 
 You are 18 years of age or older (if applicable) 
 
You may print a copy of this form for your records. 
 

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A.5.2 UCSD ED Provider Feasibility Survey Study Information Sheet 
 
Introduction/Purpose 
You are invited to participate in a voluntary survey to help examine the feasibility of 
acupuncture intervention implementation in emergency departments as part of the ACUITY 
study. You are being asked to participate because you are an ED provider (physician, nurse 
practitioner, physician assistant, or registered nurse), or ED staff, employed or credentialed in the 
University Hospitals (UH) Cleveland Medical Center ED, the Vanderbilt University Medical 
Center (VUMC) ED, or the University of California San Diego Hillcrest ED (UCSD) for at least 
one year during the study period.  The research project is being conducted by Gene A. 
Kallenberg, MD, Director of the UCSD Centers for Integrative Health.  It will take 
approximately 5-7 minutes to complete. 
 
Participation 
Your participation in this survey is voluntary. You may refuse to take part in the research or exit 
the survey at any time without penalty. You are free to decline to answer any particular question 
you do not wish to answer for any reason. We hope to gather responses from about 100 ED 
providers and staff from each site for a total of 300 individuals across all sites. You will answer a 
few demographic questions and then respond to 4 questions about the feasibility of the 
acupuncture intervention in the ED.  
 
Benefits 
This research study is not intended to benefit you directly. We hope that the knowledge gained 
will help inform design and implementation of a future, pragmatic, multi-site, non-inferiority 
randomized control trial of Acupuncture compared with Usual Care in additional BraveNet 
clinic-affiliated EDs. 
Risks 
There is no physical risk to being in this study.  
 
There is always the risk that your information may be seen by someone who shouldn’t have 
access. We will work to prevent this by taking the following steps to protect your 
information: 
 We’ll store all electronic data in REDCap, a secure, password protected online Database 
system.  
 We will not collect any identifying information in the survey. 
 Only IRB approved study personnel will have access to your data 
 
 
Alternatives to Study Participation 
The alternative to participation in this study is to NOT participate. This will not affect your care 
or employment in any way. 
 
Financial Information 
Your participation in this study will not involve cost to you or your insurance company. You will 
receive a $5 e-gift card for your time  

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Confidentiality 
We will work to protect your confidentiality by keeping the questionnaire anonymous and by not 
including any identifying questions. All electronic data will be kept in password protected 
databases behind an electronic firewall at sites and then securely sent to the Einstein 
Coordinating Center and maintained on password protected PCs by a designated data manager. 
No names or identifying information would be included in any publications or presentations 
based on these data, and your responses to this survey will remain confidential. 
 
Students or Employees 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisors or professors. 
 
Summary of your rights as a participant in a research study 
Your participation in this research study is voluntary. Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If 
you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits. Deidentified data from this study may be published, presented, or otherwise 
made publically available. If this happens, your identity will not be revealed.  
 
Contact Information 
If you have questions at any time about the study or the procedures, you may contact the study 
coordinator, Amanda Walker at 619-837-5330 or at AcuityED@health.ucsd.edu. If you have any 
questions, concerns, or complaints about the study in the future, you may also contact them later. 
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, please call the UCSD Human Research Protections 
Program Office at 858-246-HRPP (858-246-4777).  
 
Electronic Consent 
Note: If your study has specific eligibility criteria, please add any necessary attestations here. 
Please select your choice. Clicking on the “Yes” option indicates that you agree to the following: 
 You have read the above information 
 You voluntarily agree to participate 
 You are 18 years of age or older (if applicable) 
 
You may print a copy of this form for your records. 
 
 
 

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A.5.3 VUMC ED Provider Feasibility Survey Study Information Sheet 
 
Introduction/Purpose 
You are invited to participate in a voluntary survey to help examine the feasibility of 
acupuncture intervention implementation in emergency departments as part of the ACUITY 
study. You are being asked to participate because you are an ED provider (physician, nurse 
practitioner, physician assistant, or registered nurse), or ED staff, employed or credentialed in the 
University Hospitals (UH) Cleveland Medical Center ED, the Vanderbilt University Medical 
Center (VUMC) ED, or the Hillcrest University of California San Diego (UCSD) for at least one 
year during the study period.  The research project is being conducted by Jeffery Dusek, Director 
of Research at University Hospitals Connor Whole Health. It will take approximately 5-7 
minutes to complete. 
 
Participation 
Your participation in this survey is voluntary. You may refuse to take part in the research or exit 
the survey at any time without penalty. You are free to decline to answer any particular question 
you do not wish to answer for any reason. We hope to gather responses from about 100 ED 
providers and staff from each site for a total of 300 individuals across all sites. You will answer a 
few demographic questions and then respond to 4 questions about the feasibility of the 
acupuncture intervention in the ED.  
 
Benefits 
This research study is not intended to benefit you directly. We hope that the knowledge gained 
will help inform design and implementation of a future, pragmatic, multi-site, non-inferiority 
randomized control trial of Acupuncture compared with Usual Care in additional BraveNet 
clinic-affiliated EDs. 
 
Risks 
There is no physical risk to being in this study.  
 
There is always the risk that your information may be seen by someone who should not have 
access. We will work to prevent this by taking the following steps to protect your 
information: 
 We will store all electronic data in REDCap, a secure, password protected online 
Database system.  
 We will not collect any identifying information in the survey. 
 Only IRB approved study personnel will have access to your data 
 
Alternatives to Study Participation 
The alternative to participation in this study is to NOT participate. This will not affect your care 
or employment in any way. 

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Financial Information 
Your participation in this study will not involve cost to you or your insurance company. You will 
receive a $5 e-gift card for your time. 
 
Confidentiality 
We will work to protect your confidentiality by keeping the questionnaire anonymous and by not 
including any identifying questions. All electronic data will be kept in password protected 
databases behind an electronic firewall at sites and then securely sent to the Einstein 
Coordinating Center and maintained on password protected PCs by a designated data manager. 
No names or identifying information would be included in any publications or presentations 
based on these data, and your responses to this survey will remain confidential. 
 
Students or Employees 
Choosing not to participate or withdrawing from this study will not affect your employment or 
class standing, nor will the results be shared with your supervisors or professors. 
 
Summary of your rights as a participant in a research study 
Your participation in this research study is voluntary. Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If 
you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits. Deidentified data from this study may be published, presented, or otherwise 
made publicly available. If this happens, your identity will not be revealed.  
 
Contact Information 
If you have questions at any time about the study or the procedures, you may contact the study 
coordinator, Karen F. Miller at  615-936-4790 or at karen.f.miller@vumc.org. If you have any 
questions, concerns, or complaints about the study in the future, you may also contact them later. 
 
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- related 
injury; or other human subject issues, please call the University Hospitals Cleveland Medical 
Center’s Research Subject Rights phone line at (216) 983-4979 or write to: The Associate Chief 
Scientific Officer, The Center for Clinical Research, University Hospitals Cleveland Medical 
Center, 11100 Euclid Avenue, Lakeside 1400, Cleveland, Ohio, 44106-7061. 
 
Electronic Consent 
Note: If your study has specific eligibility criteria, please add any necessary attestations here. 
Please select your choice. Clicking on the “Yes” option indicates that you agree to the following: 
 You have read the above information 
 You voluntarily agree to participate 
 You are 18 years of age or older (if applicable) 
 
You may print a copy of this form for your records. 
 
 

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Appendix B. RCT Data Collection Forms 
 
REDCap Form Flowsheet: Screening and Patient Reported Outcomes 
SCREENING FORM All Yes / No responses to be put as radio buttons.  Questions to be 
completed by research coordinator per EHR / patient report.  Questions DO NOT have to be 
answered in order.  Not patient facing, not blinded. 
What is your site? 
1. UH 
2. Vanderbilt 
3. UCSD 
SECTION 1 – Patient Identifiers.  Automatically generate sequential numbers when adding a 
new patient.  Verify MRN has not previously been randomized; if MRN has, auto populate 
exclusion with “yes”. 
1. Name: [FREE TEXT] 
2. MRN: Numerical character limit of 8 
3. Date of ED visit / screening 
SECTION 2 – Inclusion / Exclusion Criteria To be completed by research coordinator per EHR / 
patient report. 
 
1. Participant’s status based on the screening? 
a. Eligible 
b. Non eligible 
c. Unable to ascertain 
SECTION 3 – Provider Verification To be completed by research coordinator 
1. Is the Provider Sign Off form completed and signed? 
a. Yes 
b. No  (END PROCESS) 
Yes 
No 
 
 
 
Inclusion Criteria – ALL must be “Yes” 
x 
 
1. ≥18 years of age 
x 
 
2. Ability to communicate in English 
x 
 
3. Level 3, 4, 5 on triage rate scale 
x 
 
4. Acute musculoskeletal, back, pelvic, non-cardiac chest, abdominal, and 
headache pain (≥4 on the NRS) due to non-penetrating injury. 
 
 
Exclusion Criteria – ALL Must be “No” 
 
x 
5. Fever exceeding 100° F 
 
x 
6. Presenting with a chief complaint of a psychological / psychiatric concern 
 
x 
7. Presenting with chief complaint of Migraine 
 
x 
8. Current Pregnancy 
 
x 
9. Self-reported or documented opioid medication taken orally within 4 hours 
 
x 
10. Presenting with chief complaint of Joint Dislocation 
 
x 
11. Presenting with chief complaint of Bone Fracture 
 
x 
12. Confirmed or suspected COVID-19 

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c. Did not receive from Provider (END PROCESS) 
i. If yes, what is the patient’s status per the ED provider? 
1. Eligible 
2. Not eligible   
a. If not eligible, what reason was indicated?  (END 
PROCESS)  [FREE TEXT] 
SECTION 4 – Consent To be completed by research coordinator. 
1. Did the patient consent to participate? 
a. Yes 
i. If yes, which follow up method did they choose? 
1. Phone/text: 10 digit verification   
2. Email: [FREE TEXT] 
3. Both: 10 digit verification and free text  (IDEAL) 
b. No 
i. Reason for refusal?  (END PROCESS) 
1. Not interested in study 
2. Study will take too much time 
3. Family present 
4. Acupuncture or needle fear 
5. OTHER [FREE TEXT] 
 
2. Did the patient share their mailing address for remuneration? 
a. Yes 
i. If yes, please enter: [FREE TEXT] 
b. No 
 
BASELINE FORM – CHECK TO BE SURE THAT Consent section is “yes”. 
SECTION 1 – Baseline Questions To be asked and entered by research coordinator/assistant, not 
blinded. 
INSTRUCTIONS:  I will now be asking you some questions about you as well as some 
questions about your health.  
1. What area of your body is experiencing the most pain at the present moment? 
a. Abdomen 
b. Headache- not migraine 
c. Flank 
d. Chest- non-emergent 
e. Back 
f. Limb 
g. Groin 
h. OTHER  [FREE TEXT] 
2. Has your pain that lasted 4 months or longer? (Radio) 
a. Yes  
b. No 

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c. Do not know 
d. Decline to answer 
3. Are you currently taking any pain medications (Radio)? 
a. Yes 
b. No 
c. Do not know 
d. Decline to answer 
i. If yes, please identify any pain medication(s) you are taking. Please select 
all that apply. (radio): 
1. Oxycodone (OxyContin, Oxecta, Roxicodone) 
2. Oxycodone / Acetaminophen (Percocet, Endocet, Roxicet) 
3. Oxycodone and Naloxone (Targiniq ER) 
4. Fentanyl (Actiq, Duragesic, Fentora) 
5. Methadone (Dolophine, Methadose) 
6. Morphine (Astramorph, Avinza, Kadian, MS Contin, Ora-Morth 
SR) 
7. Codeine 
8. Tylenol with codeine 
9. Hydrocodone (Hysingla ER, Zohydro ER) 
10. Hydrocodone / Acetaminophen (Lorcet, Lortab, Norco, Vicodin) 
11. Hydromorphone (Dilaudid, Exalgo) 
12. Aspirin 
13. Tylenol 
14. Ibuprofen 
15. Naproxen 
16. Celebrex 
17. Other: [FREE TEXT] 
18. Do not know 
19. Decline to answer 
 
ii. IF yes, how often have you taken prescription pain medications? 
1. Several times a day 
2. Once a day 
3. Several times a week 
4. Once a week 
5. Several times per month 
6. Once per month 
7. Can’t recall 
8. Decline to answer 
9. Other: [FREE TEXT] 
 
4. Have you taken any pain medications within the last 30 days? 
a. Yes 

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b. No 
c. Do not know 
d. Decline to answer 
i. If yes, please identify the opioid(s). Please select all that apply: 
1. Oxycodone (OxyContin, Oxecta, Roxicodone) 
2. Oxycodone / Acetaminophen (Percocet, Endocet, Roxicet) 
3. Oxycodone and Naloxone (Targiniq ER) 
4. Fentanyl (Actiq, Duragesic, Fentora) 
5. Methadone (Dolophine, Methadose) 
6. Morphine (Astramorph, Avinza, Kadian, MS Contin, Ora-Morth 
SR) 
7. Codeine 
8. Tylenol with codeine 
9. Hydrocodone (Hysingla ER, Zohydro ER) 
10. Hydrocodone / Acetaminophen (Lorcet, Lortab, Norco, Vicodin) 
11. Hydromorphone (Dilaudid, Exalgo) 
12. Aspirin 
13. Tylenol 
14. Ibuprofen 
15. Naproxen 
16. Celebrex 
17. Other: [FREE TEXT] 
18. Do not know 
19. Decline to answer 
 
ii. IF yes, how often were you taking prescription pain medications? 
1. Several times a day 
2. Once a day 
3. Several times a week 
4. Once a week 
5. Several times per month 
6. Once per month 
7. Can’t recall 
8. Decline to answer 
9. Other: [FREE TEXT] 
 
5. Have you visited an emergency room for pain within the past 12 months? 
a. Yes 
b. No 
c. Do not know 
d. Decline to answer 
i. If yes, how many times in the last year? 
1. 1 

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2. 2-4 
3. 5-7 
4. 11+ 
5. Decline to answer 
 
6. Have you used any non-medication treatments for your pain? 
a. Yes 
b. No 
c. Don’t know 
d. Decline to answer 
i. If yes, what methods have you used? Please select all that apply. 
1. Physical Therapy 
2. Chiropractor 
3. Massage 
4. Exercise 
5. Acupuncture 
6. Hot / cold therapy 
7. Meditation 
8. Decline to answer 
9. OTHER [FREE TEXT] 
 
7. Have you ever received acupuncture? 
a. Yes 
b. No 
c. I don’t know 
i. If yes, was the acupuncture effective to relieve your symptoms? 
1. Yes 
2. No 
3. Do not know 
4. Decline to answer 
 
8. Please rate your confidence that non-medication treatments can reduce pain, on a 0-10 
scale, where 0 is not confident and 10 is completely confident. 
 
0       1          2          3          4          5          6         7         8          9         10       Unsure 
 
“PRE” FORM – Patient facing, same for both arms, blinded to coordinator 
 
INSTRUCTIONS: “There are some additional questions for you to answer on this iPad or your 
phone. I will be here to answer any questions you may have. Please do not show me the answers 
to these questions.  Please hand the iPad back to me when you are done or let me know when 
you have completed the survey on your phone.” 

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SECTION 1 – Demographics Patient Facing, to be answered by the patient; blinded. Questions 
need to be presented as shown here in longitudinal fashion. 
1. What is your date of birth? 
 
2. What is your ethnicity? 
a. Hispanic or Latinx 
b. Not Hispanic or Latinx 
c. Decline to answer 
 
3. What is your race? Check all that apply. 
a. American Indian or Alaska Native 
b. Asian 
c. Black or African American 
d. Native Hawaiian or other Pacific Islander 
e. White 
f. Other [FREE TEXT] 
g. Decline to answer 
 
4. My sex assigned at birth is: 
a. Female 
b. Male 
c. Intersex 
d. Decline to answer 
 
5. What is your current gender identity? 
a. Male 
b. Female 
c. Trans male/Trans man 
d. Trans female/Trans woman 
e. Genderqueer/Gender non-conforming 
f. Different Identity [FREE TEXT] 
g. Decline to answer 
 
6. How much formal education do you have? 
a. No high school diploma 
b. High school or equivalent 
c. Education beyond high school, but have not completed a bachelor’s degree 
d. College degree 
e. Graduate or professional degree 
f. Decline to answer 
 
7. What is your current marital status? 
a. Married, spouse in household 

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b. Married, spouse not in household 
c. Significant other or partner 
d. Widowed 
e. Divorced 
f. Separated 
g. Never married 
h. Decline to answer 
 
8. What is your current employment status? 
a. Working full-time 
b. Working part-time 
c. Not employed due to other responsibilities (raising children, keeping house, 
student) 
d. Retired 
e. On medical leave or disabled 
f. Unemployed, looking for work 
g. Other [FREE TEXT] 
h. Decline to answer 
 
9. What is the annual income of your household? 
a. Less than $20,000 
b. $20,000 to $50,000 
c. $50,001 to $100,000 
d. $100,001 to $150,000 
e. More than $150,000 
f. Decline to answer 
 
10. Which of the following is your primary health insurance? 
a. Medicare 
b. Medicaid 
c. Other insurance 
d. No insurance 
e. Decline to answer 
 
11. Approximately how much do you weight (in pounds)? [FREE TEXT] 
 
12. What is your approximate height?  
a. Feet 
i. 3 
ii. 4 
iii. 5 
iv. 6 
v. 7 

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b. Inches 
i. 0 
ii. 1 
iii. 2 
iv. 3 
v. 4 
vi. 5 
vii. 6 
viii. 7 
ix. 8 
x. 9 
xi. 10 
xii. 11 
 
SECTION 2 – Expectancy Questions Patient Facing, to be answered by the patient; blinded. 
Questions need to be presented as shown here in longitudinal fashion. 
1. By the end of the treatment period in the ER, how much improvement in your pain 
symptoms do you think will occur? 
0%    10%    20%    30%    40%    50%    60%    70%    80%    90%    100%    Unsure 
 
Now, please close your eyes for a few moments and try to identify what you really feel about the 
treatment and its likely success.  Then answer the following questions: 
2. At this point, how much do you really feel that the treatment will help you to reduce your 
pain symptoms? 
           1           2           3           4           5           6           7           8            9              
   Not at all                                      Somewhat                                  Very much       Unsure 
 
3. By the end of your treatment period in the ER, how much improvement in your pain 
symptoms do you really feel will occur?    
 0%     10%     20%     30%     40%     50%     60%     70%     80%     90%     100%   Unsure 
SECTION 3 – Pain  
1. Please rate your pain, right now, on a scale of 0 to 10, where 0 is no pain, and 10 is the worst 
pain imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
SECTION 4 – Anxiety  
2. Please rate your anxiety, right now, on a scale of 0 to 10, where 0 is no anxiety, and 10 is the 
worst anxiety imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
 
SECTION 5 – Randomization  (logic to open up this form) 
 Build randomization module into REDCap 

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POST ACUPUNCTURE FORM – Patient facing, blinded to coordinator 
INSTRUCTIONS: “There are some additional questions for you to answer on this iPad or your 
phone. I will be here to answer any questions you may have. Please do not show me the answers 
to these questions.  Please hand the iPad back to me when you are done or let me know when 
you have completed the survey on your phone.” 
 
SECTION 1 – Pain  
1.  Please rate your pain, right now, on a scale of 0 to 10, where 0 is no pain, and 10 is the 
worst pain imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
SECTION 2 – Anxiety  
2.  Please rate your anxiety, right now, on a scale of 0 to 10, where 0 is no anxiety, and 10 is the 
worst anxiety imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
SECTION 3 – Satisfaction 
3. How satisfied are you with how your pain was managed during your ED visit?  
 
a. Very Unsatisfied 
b. Somewhat Unsatisfied 
c. Neutral 
d. Somewhat Satisfied 
e. Very Satisfied 
 
4. Overall how satisfied are you with your treatment during your ED visit?    
 
a. Very Unsatisfied 
b. Somewhat Unsatisfied 
c. Neutral 
d. Somewhat Satisfied 
e. Very Satisfied 
 
SECTION 4 – ED Impact (Acupuncture Arm Only) 
1. Please rate the impact of acupuncture on your ED visit today. 
a. Very Negative 
b. Somewhat Negative 
c. Neutral 
d. Somewhat Positive 
e. Very Positive 
 
POST ACUPUNCTURE FORM – Coordinator facing, information gathered from Acupuncturist 

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SECTION 4 – Ear Seeds (Acupuncture Arm Only) 
1. Did the participant receive ear seeds in the ER 
a. Yes 
b. No  
 
POST USUAL CARE FORM – Patient facing, blinded to coordinator 
 
INSTRUCTIONS: “There are some additional questions for you to answer on this iPad or your 
phone. I will be here to answer any questions you may have. Please do not show me the answers 
to these questions.  Please hand the iPad back to me when you are done or let me know when 
you have completed the survey on your phone.” 
 
SECTION 1 – Pain  
1. Please rate your pain, right now, on a scale of 0 to 10, where 0 is no pain, and 10 is the 
worst pain imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
SECTION 2 – Anxiety  
2. Please rate your anxiety, right now, on a scale of 0 to 10, where 0 is no anxiety, and 10 is the 
worst anxiety imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
SECTION 3 – Satisfaction 
3. How satisfied are you with how your pain was managed during your ED visit?  
 
f. Very Unsatisfied 
g. Somewhat Unsatisfied 
h. Neutral 
i. Somewhat Satisfied 
j. Very Satisfied 
 
4. Overall how satisfied are you with your treatment during your ED visit?    
 
f. Very Unsatisfied 
g. Somewhat Unsatisfied 
h. Neutral 
i. Somewhat Satisfied 
j. Very Satisfied 
 
DISCHARGE ACUPUNCTURE FORM – Patient facing, blinded to coordinator 
 
INSTRUCTIONS: “There are some additional questions for you to answer on this iPad or your 
phone. I will be here to answer any questions you may have. Please do not show me the answers 

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to these questions.  Please hand the iPad back to me when you are done or let me know when 
you have completed the survey on your phone.” 
 
SECTION 1 – Pain  
1.  Please rate your pain, right now, on a scale of 0 to 10, where 0 is no pain, and 10 is the 
worst pain imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
SECTION 2 – Anxiety  
2.  Please rate your anxiety, right now, on a scale of 0 to 10, where 0 is no anxiety, and 10 is 
the worst anxiety imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
 
SECTION 3 – Satisfaction 
3. How satisfied are you with how your pain was managed during your ED visit?  
 
k. Very Unsatisfied 
l. Somewhat Unsatisfied 
m. Neutral 
n. Somewhat Satisfied 
o. Very Satisfied 
 
4. Overall how satisfied are you with your treatment during your ED visit?    
 
k. Very Unsatisfied 
l. Somewhat Unsatisfied 
m. Neutral 
n. Somewhat Satisfied 
o. Very Satisfied 
 
 
SECTION 4 – ED Impact 
1.   Please rate the impact of acupuncture on your ED visit today. 
a. Very Negative 
b. Somewhat Negative 
c. Neutral 
d. Somewhat Positive 
e. Very Positive 
DISCHARGE USUAL CARE FORM – Patient facing, blinded to coordinator 
 
INSTRUCTIONS: “There are some additional questions for you to answer on this iPad or on 
your phone. I will be here to answer any questions you may have. Please do not show me the 

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answers to these questions.  Please hand the iPad back to me when you are done or let me know 
when you have completed the survey on your phone.” 
 
SECTION 1 – Pain  
1. Please rate your pain, right now, on a scale of 0 to 10, where 0 is no pain, and 10 is the 
worst pain imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
SECTION 2 – Anxiety  
2. Please rate your anxiety, right now, on a scale of 0 to 10, where 0 is no anxiety, and 10 is 
the worst anxiety imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
SECTION 3 – Satisfaction 
3. How satisfied are you with how your pain was managed during your ED visit? 
 
a. Very Unsatisfied 
b. Somewhat Unsatisfied 
c. Neutral 
d. Somewhat Satisfied 
e. Very Satisfied 
 
 
4. Overall how satisfied are you with your treatment during your ED visit? 
a. Very Unsatisfied 
b. Somewhat Unsatisfied 
c. Neutral 
d. Somewhat Satisfied 
e. Very Satisfied 
 
 
FOLLOW UP FORM for 1 week F/U AND 4 week F/U – To be completed by everyone, ideally 
from an automatic text and email generated by REDCap.  If not by email, coordinator will text or 
phone the participant and enter the answers into REDCap. 
Instructions:  Below are some questions that ask you to remember what happened since 
your discharge from the Emergency Room on [er_visit_date]. 
Section 1-Medications  
1. Since your discharge from the Emergency Room on [er_visit_date], have you taken any 
pain medications for your medical condition?  
a. Yes 
b. No 
c. I don’t know 
i. 
If yes, “were these medications prescribed by a medical professional? 
Check all that apply: 
1. Yes, by Emergency room provider  

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2. Yes, by Primary Care Provider 
3. Yes, by Other medical professional [FREE TEXT] 
4. No 
5. I don’t know 
 
2. [branched from 1.a.i.1] Since your discharge, which pain medication(s) was prescribed 
by your EMERGENCY ROOM PROVIDER? Please select all that apply. (radio): 
1. Oxycodone (OxyContin, Oxecta, Roxicodone) 
2. Oxycodone / Acetaminophen (Percocet, Endocet, Roxicet) 
3. Oxycodone and Naloxone (Targiniq ER) 
4. Fentanyl (Actiq, Duragesic, Fentora) 
5. Methadone (Dolophine, Methadose) 
6. Morphine (Astramorph, Avinza, Kadian, MS Contin, Ora-Morth SR) 
7. Codeine 
8. Tylenol with codeine 
9. Hydrocodone (Hysingla ER, Zohydro ER) 
10. Hydrocodone / Acetaminophen (Lorcet, Lortab, Norco, Vicodin) 
11. Hydromorphone (Dilaudid, Exalgo) 
12. Aspirin 
13. Tylenol 
14. Ibuprofen 
15. Naproxen 
16. Celebrex 
17. Other: [FREE TEXT] 
18. Do not know 
19. Decline to answer 
 
a. How often have you taken these pain medication(s) on average? 
1. Several times a day 
2. Once a day 
3. Several times a week 
4. Once a week 
5. Several times per month 
6. Once per month 
7. Can’t recall 
8. Decline to answer 
9. Other: [FREE TEXT] 
 
3.  [branched from 1.a.i.2] Since your discharge, which pain medication(s) was prescribed 
by your PRIMARY CARE PROVIDER? Please select all that apply. (radio): 
1. Oxycodone (OxyContin, Oxecta, Roxicodone) 
2. Oxycodone / Acetaminophen (Percocet, Endocet, Roxicet) 
3. Oxycodone and Naloxone (Targiniq ER) 

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4. Fentanyl (Actiq, Duragesic, Fentora) 
5. Methadone (Dolophine, Methadose) 
6. Morphine (Astramorph, Avinza, Kadian, MS Contin, Ora-Morth 
SR) 
7. Codeine 
8. Tylenol with codeine 
9. Hydrocodone (Hysingla ER, Zohydro ER) 
10. Hydrocodone / Acetaminophen (Lorcet, Lortab, Norco, Vicodin) 
11. Hydromorphone (Dilaudid, Exalgo) 
12. Aspirin 
13. Tylenol 
14. Ibuprofen 
15. Naproxen 
16. Celebrex 
17. Other: [FREE TEXT] 
18. Do not know 
19. Decline to answer 
 
a. How often have you taken these pain medication(s) on average? 
1. Several times a day 
2. Once a day 
3. Several times a week 
4. Once a week 
5. Several times per month 
6. Once per month 
7. Can’t recall 
8. Decline to answer 
9. Other: [FREE TEXT] 
 
4.  [branched from 1.a.i.3] Since your discharge, which pain medication(s) was prescribed 
by ANOTHER MEDICAL PROFESSIONAL? Please select all that apply. (radio) 
1. Oxycodone (OxyContin, Oxecta, Roxicodone) 
2. Oxycodone / Acetaminophen (Percocet, Endocet, Roxicet) 
3. Oxycodone and Naloxone (Targiniq ER) 
4. Fentanyl (Actiq, Duragesic, Fentora) 
5. Methadone (Dolophine, Methadose) 
6. Morphine (Astramorph, Avinza, Kadian, MS Contin, Ora-Morth 
SR) 
7. Codeine 
8. Tylenol with codeine 
9. Hydrocodone (Hysingla ER, Zohydro ER) 
10. Hydrocodone / Acetaminophen (Lorcet, Lortab, Norco, Vicodin) 
11. Hydromorphone (Dilaudid, Exalgo) 

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12. Aspirin 
13. Tylenol 
14. Ibuprofen 
15. Naproxen 
16. Celebrex 
17. Other: [FREE TEXT] 
18. Do not know 
19. Decline to answer 
 
a. How often have you taken these pain medication(s) on average? 
1. Several times a day 
2. Once a day 
3. Several times a week 
4. Once a week 
5. Several times per month 
6. Once per month 
7. Can’t recall 
8. Decline to answer 
9. Other: [FREE TEXT] 
 
5. [branched from 1.a.i.4] Since your discharge from the emergency room on 
[er_visit_date], which pain medication(s) have you taken (not prescribed by your 
emergency room provider, primary care provider or other medical professional)? 
Please select all that apply 
1. Oxycodone (OxyContin, Oxecta, Roxicodone) 
2. Oxycodone / Acetaminophen (Percocet, Endocet, Roxicet) 
3. Oxycodone and Naloxone (Targiniq ER) 
4. Fentanyl (Actiq, Duragesic, Fentora) 
5. Methadone (Dolophine, Methadose) 
6. Morphine (Astramorph, Avinza, Kadian, MS Contin, Ora-Morth 
SR) 
7. Codeine 
8. Tylenol with codeine 
9. Hydrocodone (Hysingla ER, Zohydro ER) 
10. Hydrocodone / Acetaminophen (Lorcet, Lortab, Norco, Vicodin) 
11. Hydromorphone (Dilaudid, Exalgo) 
12. Aspirin 
13. Tylenol 
14. Ibuprofen 
15. Naproxen 
16. Celebrex 
17. Other: [FREE TEXT] 
18. Do not know 

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19. Decline to answer 
 
a. How often have you taken these pain medication(s) on average? 
1. Several times a day 
2. Once a day 
3. Several times a week 
4. Once a week 
5. Several times per month 
6. Once per month 
7. Can’t recall 
8. Decline to answer 
9. Other: [FREE TEXT] 
 
9. Since your discharge from the Emergency Room on [er_visit_date], have you used 
anything other than medications to manage your pain?  
a. Yes 
b. No 
c. Do not know 
i. If yes, what methods have you used? Please select all that apply. 
1. Physical Therapy 
2. Chiropractic care 
3. Massage 
4. Exercise 
5. Acupuncture 
6. Hot / cold therapy 
7. Meditation or Mindfulness 
8. Decline to answer 
9. OTHER [FREE TEXT] 
 
10.  (Acupuncture Arm Only) Since your discharge from the Emergency Room on 
[er_visit_date], have you received acupuncture? 
a. Yes 
b. No 
c. Do not know 
i. If yes, was the acupuncture effective to relieve your symptoms? 
1. Yes 
2. No 
3. Do not know 
 
11. Since your discharge from the Emergency Room on [er_visit_date], have you 
experienced new or worsening ILLNESS?  
 
a. No 

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b. Yes 
IF YES PLEASE DESCRIBE [FREE TEXT] 
 
12. Since your discharge from the Emergency Room on [er_visit_date], have you 
experienced new or worsening PAIN?  
 
a. No 
b. Yes 
c. Don’t know 
IF YES PLEASE DESCRIBE [FREE TEXT] 
 
13. Since your discharge from the Emergency Room on [er_visit_date], have you 
experienced new or worsening HEALTH ISSUES?  
 
a. No 
b. Yes 
c. Don’t know 
IF YES PLEASE DESCRIBE [FREE TEXT] 
 
 
Instructions:  Below are some questions that ask you to rate how you are feeling right now. 
 
SECTION 2 – Pain  
1. Please rate your pain, right now, on a scale of 0 to 10, where 0 is no pain, and 10 is the worst 
pain imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
 
SECTION 3 – Anxiety  
2. Please rate your anxiety, right now, on a scale of 0 to 10, where 0 is no anxiety, and 10 is the 
worst anxiety imaginable. 
0 
1            2            3            4            5            6           7            8            9         10 
 
SECTION 4 – Satisfaction 
3. “How satisfied were you with how your pain was managed during your ER visit” on the 5-
point Likert scale.  
a. Very Unsatisfied 
b. Somewhat Unsatisfied 
c. Neutral 
d. Somewhat Satisfied 
e. Very Satisfied 
 

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4. “Overall how satisfied were you with your treatment during your ER visit?” on the same 
Likert Scale. 
 
a. Very Unsatisfied 
b. Somewhat Unsatisfied 
c. Neutral 
d. Somewhat Satisfied 
e. Very Satisfied 
 
 
FOLLOW UP FORM for 1 week F/U (Acupuncture Arm Only, if Post Acupuncture Form Ear 
Seeds question is “Yes”) 
SECTION 5 – Ear Seeds  
1. Before this follow-up, did you remove the ear seeds that you received in the ER on 
[er_visit_date]  
a. Yes  
i. If yes, when did you remove them? [enter date] 
b. No (if no, you should remove them now) 
 
2. After your ER discharge, did you ever stimulate/touch the ear seeds yourself for pain 
relief?   
a. Yes 
b. No 
 
3. Any comments on the ear seeds [FREE TEXT]