PROUD Study - Preventing Opioid Use Disorders
Phase: PHASE4
Conditions: Anesthesia, Opioid Use
Sponsor: Emory University

Study No.:STUDY00002021
Emory University IRB 
IRB use only 
Document Approved On:4/08/2021
IRB Form BIO 08102020
Version Date: 4.6.2021
PROUD Study - Preventing Opioid Use Disorders
NCT04766996
 Date: April 6, 2021
STUDY00002021

Protocol Title:  PROUD Study – Preventing Opioid Use Disorders 
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PROTOCOL TITLE: PROUD Study – Preventing Opioid Use Disorders 
PRINCIPAL INVESTIGATOR: 
Name:  
 
Department:  
 
Telephone Number:  
 
Name:  
 
Department:  
 
Telephone Number:  
 
Email Address:  
 
Name:  
 
Department:  
 
Telephone 
 
Email Address:  
 
VERSION:  Version 4.0_12.22.2020 
FUNDING SOURCE: Woodruff Health Sciences Interprofessional Education and Collaborative 
Practice Council Synergy Award.  
REVISION HISTORY 
Revision # 
Version 
Date 
Summary of Changes 
2
12.17.2020 
1. Correction of page numbers on protocol table of 
contents 
2. Expanded description of use of aromatherapy in Section
5 of the protocol 
3. Provided rationale for excluding non-English speaking
subjects in Sections 10 and 21 of the protocol 
4. Clarified language about screening of potential
participants in Sections 10 and 12 of the protocol 
5. Updated the two consent forms with minor revisions
and added language to the biomedical consent regarding 
registering the study with clinicaltrials.gov 

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6. Expanded description of Breath 2 Relax application in 
Section 5 of the protocol 
7. Attached the survey for the provider arm of the study 
3
12.21.2020 
1. Corrected protocol numbering 
 
4
12.22.2020 
1. In Section 5: Study Intervention/Investigational Agent 
on page 9 the statement “Oil should not be placed on the 
skin and is noted as such in the patient education 
materials.” Was added to the section on aromatherapy. 
5
3.22.2021 
1. On page 9 the statement “No medications will be used 
off label.”  was removed. 
2. The schematic on page 10 was updated by removing 
tranexamic acid from the protocol.  This medication is 
requested by the surgeon to decrease bleeding as a part of 
the surgery but is not a part of the study protocol. 
3. The following language was added to section 21 per OCR 
request “Some of the medications in the opioid free 
protocol may not be covered by insurance.  If a medication 
is not covered by insurance the patient will be able to 
contact their surgeon through the study patient hotline to 
determine if they want to proceed with the protocol or 
withdraw.”
6
4.1.2021 
1. The medications that are a part of the protocol were 
clarified to indicate which are “study driven medications” 
in the pre-, intra- and post-operative periods. 
2. Section E21 was updated to align with the PRA from the 
OCR. 

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Table of Contents 
 
1. 
Study Summary ........................................................................................................................ 4 
2. 
Objectives ................................................................................................................................ 6 
3. 
Background .............................................................................................................................. 6 
4. 
Study Endpoints ....................................................................................................................... 8 
5. 
Study Intervention/Investigational Agent ............................................................................... 9 
6. 
Procedures Involved .............................................................................................................. 11 
7. 
Data and Specimen Banking .................................................................................................. 12 
8. 
Sharing of Results with Participants ...................................................................................... 13 
9. 
Study Timelines ...................................................................................................................... 13 
10. 
Inclusion and Exclusion Criteria ......................................................................................... 14 
11. 
Vulnerable Populations ...................................................................................................... 15 
12. 
Local Number of Participants............................................................................................. 15 
13. 
Recruitment Methods ........................................................................................................ 15 
14. 
Withdrawal of Participants ................................................................................................ 16 
15. 
Risks to Participants ........................................................................................................... 16 
16. 
Potential Benefits to Participants ...................................................................................... 17 
17. 
Compensation to Participants ........................................................................................... 17 
18. 
Data Management and Confidentiality ............................................................................. 17 
19. 
Provisions to Monitor the Data to Ensure the Safety of Participants ............................... 18 
20. 
Provisions to Protect the Privacy Interests of Participants ............................................... 18 
21. 
Economic Burden to Participants ...................................................................................... 18 
22. 
Consent Process ................................................................................................................. 19 
23. 
Setting ................................................................................................................................ 19 
24. 
Resources Available ........................................................................................................... 20 
25. 
Multi-Site Research when Emory is the Lead Site ............................................................. 20 
26. 
References ......................................................................................................................... 20 
 
 
 
 
 

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1. Study Summary 
Study Title 
PROUD Study – Preventing Opioid Use Disorders 
 
Study Design 
Matched Prospective Case with Retrospective Control 
Study and Staff Surveys 
 
Primary Objective 
Pilot opioid free surgical protocol while collecting key 
outcome measures to determine overall opioid 
requirements.
 
Secondary Objective(s) 
Assess the two core competencies for 
interprofessional collaborative practice 
(Interprofessional Communication and Teams; and 
Teamwork) among the interdisciplinary patient care 
team that implements the opioid free surgical 
protocol. 
 
Research 
Intervention(s)/Interactions 
Prospective Intervention group: 
Interventions: 
x Guided mindfulness exercises  
x Self-administered aromatherapy 
x Non-opioid drug regimen during the 5 week 
study period 
x Three self-guided training videos 
Interactions: 
x Normal clinical visits with Dr. Thomas 
Bradbury, M.D. 
x One, pre-surgery pain and medication 
assessment survey 
x Seven, post-surgery pain, medication, and 
physical activity surveys 
 
Retrospective Controls: 
Interventions: 
x
None
Interactions:  
x None 
 
Professional Staff: 
Interventions: 

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x None 
Interactions: 
x Three, team assessment surveys seeking their 
opinion about interprofessional teamwork and 
communication.  
R Survey One: Late January, prior to 
implementation of the opioid free 
surgical protocol 
R Survey Two: Early April, 2 months after 
implementation of the opioid free 
surgical protocol 
R Survey Three: Early June, 2 months 
after the last prospective study 
participant undergoing surgery using 
the opioid free surgical protocol has 
been discharged 
 
Study Population 
Intervention group: 
60 prospective study participants undergoing 
unilateral total hip replacement surgery between the 
months of February – May 2021 
 
Control: 
60 retrospective controls selected from the Emory 
Healthcare System Clinical Data Warehouse that 
underwent unilateral total hip replacement surgery 
between the months of February – May 2020 
 
Matching:  
Cases and Controls will be matched in a 1:1 ratio using 
demographic attributes such as age, sex, race, and 
ethnicity 
 
Professional Staff: 
All staff that participate in the implementation of the 
opioid free surgical protocol. We estimate a 
population of 50 providers 
 
Sample Size 
60 intervention / 60 control / 50 staff 
Study Duration for 
individual participants 
Intervention group: 
x Five weeks 
R Two weeks pre-surgery 
R Day of surgery 

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R Three weeks after surgery 
 
Professional Staff group: 
x Six months 
 
Study Specific 
Abbreviations/ Definitions  
CDW – Emory Healthcare System Clinical Data 
Warehouse
EUOSH – Emory University Orthopaedic and Spine 
Hospital 
Mg – milligram 
NIEPAS - Nebraska Interprofessional Education 
Attitude Scale 
 
Funding Source (if any)
Woodruff Health Sciences Interprofessional Education 
and Collaborative Practice Council Synergy Award 
 
2. Objectives 
Purpose: The objective of this study is to pilot an opioid free anesthetic protocol for patients 
undergoing total hip replacement at EUOSH.  The protocol was developed by an 
interprofessional team, who identified alternative pharmacologic methods to block pain 
pathways to reduce or even eliminate the need for opioids in the intra- and postoperative 
periods, with the goal of decreasing or eliminating exposure to opioids. A secondary objective is 
to assess two core competencies for interprofessional collaborative practice (Interprofessional 
Communication and Teams; and Teamwork) within the interprofessional care team 
implementing the opioid free protocol. 
Specific Aim 1a:  Pilot the opioid free protocol, collecting key outcome measures to determine 
overall opioid requirements.  We hypothesize that total post-operative opioid requirements prior 
to discharge will be lower in patients who do not receive intraoperative opioids compared with 
the control group that received standard care, including intraoperative opioids. A retrospective 
review of patients from the CDW who underwent the same procedure at the same hospital in 
the same 4-month time period one-year prior will serve as the control group.  
Specific Aim 1b:  Assess within the interprofessional care team that implements the opioid free 
protocol two core competencies for interprofessional collaborative practice (Interprofessional 
Communication and Teams; and Teamwork) using a pre-test/post-test design.  We hypothesize
that perceptions of strong communication and teamwork will be associated with more successful 
implementation of the opioid free protocol. 
3. Background 
From 1999 to 2018, more than 232,000 people died in the United States from overdoses 
involving prescription opioids.  Overdose deaths involving prescription opioids were more than 

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four times higher in 2018 than in 1999 (CDC National Center for Health Statistics, 2020).  
According to the National Institute on Drug Abuse, in 2017 there were 1,014 overdose deaths 
involving opioids in Georgia (GA) - a rate of 9.7 deaths per 100,000 persons. Of these deaths, 
568 (56%) involved prescription opioids. One typical point of opioid introduction: more than 50 
million of Americans each year have surgery, and opioids continue to be the primary means of 
managing acute surgical pain, both intraoperatively and postoperatively. However, the use of 
opioids for acute surgical pain is not without risk. Johnson et al., 2016 found as many as 13% of 
opioid naïve individuals undergoing orthopedic surgery may go on to have chronic opioid use. 
In a retrospective study of over 36,000 opioid-naïve patients undergoing elective surgery 
between 2013 and 2014, the incidence of chronic opioid use after surgery was approximately 
6% and remained stable regardless of whether the surgical procedure was major or minor 
(Brummett et al., 2017). Although current studies vary in their findings, roughly 1 in 30 patients 
exposed to opioids after major surgery continue to use them after three months (Clarke et al., 
2014).   
Patients who receive opioids for pain in the acute perioperative period often require increased 
opioid doses to maintain the same analgesic effects (Chia et al., 1999). This is attributed to 
either acute tolerance to the analgesic effects of opioids, or from opioid-induced hyperalgesia 
(OIH). OIH is defined as nociceptive sensitization caused by exposure to opioids (Chu et al., 
2008). Central sensitization (hyperalgesia) underlies the transition of acute pain to chronic pain 
disorders, but can also be produced by high dose and high potency opioids such as those 
administered intraoperatively.  Many of the same mechanisms account for both central pain 
and opioid hyperalgesia (Rivat & Ballantyne, 2016). 
Hyperalgesia and tolerance are very different pharmacologic phenomena that can lead to similar 
net increases in opioid dosing over time. This is the opioid paradox: the more opioids used 
intraoperatively, the more opioids required postoperatively. This paradox has been found in 
surgical patients up to 2 days postoperatively (Joly et al., 2005). Altogether, this body of evidence 
underscores the need to develop and evaluate pre- and post-operative patient-centered pain 
management plans based on known risks and protective factors for opioid misuse.  
It is clear that minimizing opioid misuse risk in surgical patients requires partnerships across 
multiple disciplines to ensure a coordinated, evidence based approach to care in the pre-, intra- 
and post-operative periods. 
 
Interprofessional teamwork and collaborative practice are emerging as key elements of 
efficient and productive work in promoting health and treating patients. The vision for these 
collaborations is one where different health and/or social professionals share a team identity 
and work closely together to solve problems and improve delivery of care (Committee on 
Measuring the Impact of Interprofessional Education on Collaborative Practice and Patient 
Outcomes, 2015). 
Patients have complex health needs requiring more than one discipline to address issues 
regarding their health status (Lumague et al., 2008). In 2001 the Institute of Medicine 

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Committee on Quality of Health Care in America recommended that healthcare professionals 
working in interprofessional teams can best communicate and address these complex and 
challenging needs (Lumague et al., 2008; Institute of Medicine Committee on Quality of Health 
Care in America, 2001). This interprofessional approach may allow sharing of expertise and 
perspectives to form a common goal of restoring or maintaining an individual's health and 
improving outcomes while combining resources (Lumague et al., 2008; Barker & Oandasan, 
2005). 
 
Effective interprofessional collaboration occurs when a team of differing specialties work 
towards a shared goal, communicate respectfully, intentionally value and harness each other’s 
professional experience, and ultimately improve patient outcomes (Gilbert et al., 2010). 
Reduction and/or elimination of opioid administration during the perioperative period requires 
the commitment to the shared goal from several specialties including nursing, medicine, 
anesthesia, administration, pharmacy, and the patient. Although collaboration between 
healthcare providers is required to implement opioid-free analgesia in the perioperative 
continuum, it is unclear how best to build an interprofessional team and which team dynamics 
are required for success. Differing values and perceptions of collaboration within the group can 
both enhance and become a barrier to successful collaboration (Sicotte et al., 2002). There 
exists a gap in current evidence related to characteristics of an ideal team, its dynamics, and 
how to best formulate its existence. However, a clear theme identifies teamwork and 
communication as main contributors to the success or failure of interprofessional teams 
(Garrett, 2016). Interprofessional collaboration, teamwork and communication are implicated 
in improved patient outcomes, so their incorporation into the opioid free anesthesia protocol 
implementation will be important.
In order to reduce opioid consumption within the perioperative environment and its 
contribution to the opioid crisis, it will require interprofessional collaboration (Kaye et al., 
2019). Traditionally, teams are structured in a hierarchical manner with a designated leader 
making decisions and others simply following orders. This structure fails to address the holistic 
needs of the patient and the complexity of the issue at hand, resulting in poor outcomes for 
patients, potentially including an overabundance of opioid prescriptions. Recruiting all 
members of the team to be individually responsible for their professional expertise, 
communicate respectfully with other members of the team, encourage ideas and collaboration, 
and work towards a shared goal are characteristics of a highly functioning team using teamwork 
and communication (Interprofessional Education Collaborative, 2016). With the support of 
leadership, an interprofessional team utilizing teamwork and communication will implement an 
opioid free protocol, working together to decrease or eliminate opioid consumption within the 
perioperative period. 
4. Study Endpoints  
The primary prospective study end point will be the enrollment and follow up for 60 
patients undergoing primary total hip replacement with the opioid free protocol. The 
primary retrospective study end point will be the collection of the data for all patients in 

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the 3 months preceding the implementation of the opioid free protocol who will serve 
as the control group. 
The secondary end point will be the collection of teamwork and communication surveys 
from the providers implementing the protocol. 
 
5. Study Intervention/Investigational Agent 
Description: The intervention is the use of an opioid free protocol for patients 
undergoing primary total hip replacement at EUOSH with Dr. Thomas Bradbury.  The 
protocol requires patients to take non-opioid prescription medications and participate 
in integrative health interventions (e.g. aromatherapy and meditation) for two weeks 
prior to surgery.  Patients will then undergo an anesthetic protocol during their surgery 
which aims to eliminate or minimize the use of opioid analgesics.  Finally, the patient 
will utilize non-opioid pain medications for three weeks after surgery, although they will 
be prescribed an opioid analgesic for pain rescue. 
Lavender aromatherapy is being used in this study to create a positive association between the 
smell and relaxation and sleep.  It will be used by participants for two weeks before surgery and 
after surgery every six hours and at bedtime. Participants will be provided with a bottle of the 
aromatherapy along with the protocol prescriptions.  They will place 2 to 3 drops of the 
lavender liquid on a cotton ball or tissue and place the cotton ball or tissue near enough to 
appreciate the smell. Oil should not be placed on the skin and is noted as such in the patient 
education materials. The purpose of the aromatherapy is not to diagnose, cure, treat or prevent 
disease, but rather as a holistic means to associate a smell with relaxation and sleep. 
Meditation will be used as a part of this study both before and after surgery as a holistic 
way to mitigate stress and pain. Meditation will be done using a freely available mobile 
application called Breath2Relax.  The application is a portable stress management tool 
that provides detailed instructions and practice exercises to learn diaphragmatic 
breathing.  The application does not require the input of any information, e.g. name, 
email, health or personal information.  Further, no information or data will be collected 
from the application.  Patient use of the application will only be by self-report. 
All preoperative and postoperative medications will be prescribed by the attending 
surgeon, Dr. Bradbury, or his team.  All prescriptions will follow normal Emory physician 
prescribing protocols.  No investigational medications will be used.  All intraoperative 
medications are already currently available as part of the anesthetic armamentarium 
and are readily available in the operating suite. 
The preoperative medication regimen includes: 
ͻ Pregabalin 25mg*:  Twice a day for two weeks before surgery  
ͻ Meloxicam 7.5mg*:  Twice a day for two weeks before surgery 
ͻ Prilosec 20mg*:  Daily for two weeks before surgery 
ͻ Aromatherapy:  Every 6 hours and at bedtime 
 

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ͻ Guided Meditation:  Twice daily 
ͻ Voltaren 1% topical arthritis gel* up to 4 times daily  
* indicates study driven medication 
 
 
The intraoperative medication regimen and timing is as follows: 
The postoperative medication regimen is as follows: 
ͻ Baby aspirin 81mg:  Twice daily for 6 weeks after surgery 
ͻ Tylenol/Acetaminophen 1000mg*:  Every 8 hours for three weeks after 
surgery 
ͻ Pregabalin 25mg*:  Twice a day for two weeks after surgery 
ͻ Prednisone 5mg*:  Daily for three weeks after surgery 
ͻ Meloxicam 7.5mg*:  Twice a day, with food, for two weeks after surgery 
ͻ Prilosec 20mg*:  Daily day for two weeks after surgery 
ͻ Tramadol 50mg* up to three times a day as needed will be provided for 
rescue pain 
* indicates study driven medication 
 
 
A study patient hotline will also be created using a Google number that will directly connect the 
patient to the surgeon, Dr. Bradbury, or his designee.  Study participants will be able to use this 
number both preoperatively and postoperatively for any concerns related to pain control or 
medication issues.  No one aside from study personnel, the surgeon, or his designee will have 

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access to this telephone number or the records pertaining to this number (i.e. 
incoming/outgoing calls). 
 
A pre-test/post-test survey design will be used to assess the perceptions of the providers 
implementing the opioid free protocol.  Specifically, the Nebraska Interprofessional Education 
Attitude Scale (NIPEAS) subsections related to teamwork and communication will be assessed.  
In addition, demographic questions and perceptions about the opioid free protocol will be 
asked in the survey. Throughout this protocol, we will refer to the demographic, perceptions 
and NIPEAS survey as simply the NIPEAS survey.  The surveys will be sent to the providers via 
RedCap, and all data will be stored in RedCap.  Surveys will be provided to all consented 
perioperative suite professional staff prior to protocol implementation, halfway through the 
recruitment period and after the last participant has been discharged from the hospital.  
 
The NIEPAS scale is validated to measure the attitude and perception of health care 
professionals according to the competencies defined by the Interprofessional Education 
Collaborative (Beck Dallaghan et al., 2016). Upon review of alternative pre- and post- attitude 
scales, others were deemed inappropriate due to reasons such as validity established on 
demographics other than our target population, competencies measured not appropriate for 
our study, and/or the scale was best for measurement outside of the perioperative area 
(Dominguez et al., 2015). The NIEPAS is a 19 item, five point Likert scale. The tool will be 
deployed before protocol implementation and halfway through the recruitment period to 
assess the team’s understanding and level of participation in interprofessional practice. The 
post test will be deployed after the last participant has been discharged from the hospital to 
assess whether the team’s perception of interprofessional practice increased after participating 
in the implementation process. A correlation with the success of the protocol can be made to 
recommend the effect of interprofessional practice on the success of implementing an opioid 
free protocol for surgery.  
 
 
6. Procedures Involved 
All patients who will be undergoing a primary total hip replacement by Dr. Thomas 
Bradbury at EUOSH and who meet the inclusion/exclusion criteria, will be invited to 
participate in the study.  Inclusion criteria are:  patients aged 18 years to 89 years, 
undergoing a primary total hip replacement with Dr. Thomas Bradbury.  Exclusion 
criteria are:  non-English speaking, preoperative opioid use, comorbid condition of 
diabetes mellitus type 1 or 2, concurrent surgeries, inability or unwillingness to undergo 
subarachnoid block as part of the anesthetic plan, and contraindications for one or more 
prescriptions.  Approximately 60 participants will be recruited as a convenience sample 
between February and May 2021.  All participants will be required to sign informed 
consent.  In addition, any providers implementing the opioid free protocol who 
participate in the pre-test/post-test survey of collaborative practice will be required to 
provide informed consent. 
 

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Participants enrolling in the opioid free protocol will be provided with a small bottle of 
lavender aromatherapy and the prescriptions for the preoperative medications after 
providing informed consent, but prior to leaving the surgeons office.  These individuals 
will also receive a copy of a printed education manual and 3 video links to educational 
videos that describe the protocol pre-surgery, day of surgery and after surgery. 
Participants enrolled in the opioid free protocol will be sent an electronic survey the day 
before their scheduled surgery.  This survey will ask about their pain levels and 
compliance with the protocol.  The survey will be sent via RedCap using the email 
feature to the participant’s mobile number. 
Participants enrolled in the opioid free protocol will also be sent electronic surveys 
beginning postoperative day 1 and continuing through postoperative day 7.  These 
surveys will ask about their pain levels, use of opioid analgesics and compliance with the 
protocol. The survey will be sent via RedCap using the email feature to the participant’s 
mobile number. 
Risks to participants enrolled in the opioid free protocol will be no greater than standard 
care. Any patients whose pain is not sufficiently managed by the opioid free protocol 
will be administered, or provided with opioid analgesics as needed by the 
surgeon/intraoperative anesthetic team.  All participants will be discharged after 
surgery with an opioid analgesic prescription for rescue pain management. 
The perioperative data for patients enrolled in the opioid free protocol will be pulled 
from the CDW to determine total intraoperative and postoperative opioid requirements 
prior to discharge.  These will be measured using morphine milligram equivalents and 
compared with the control group. 
Risks to participants in the retrospective arm of the protocol will be minimal. Data will 
be maintained in a secure drive, accessible only to the research team. While a small risk 
of data compromise always exists, the use of password protections and a secured drive 
will ensure this risk is minimal. Sixty patients matched on key variables, e.g. age, sex, 
race/ethnicity, will be recruited from the Clinical Data Warehouse from the year 2020, 
one year prior to the study period.  We anticipate recruiting controls whose surgery 
dates fell between February and May 2020.  The total intraoperative and postoperative 
opioid requirements prior to discharge will be measured using morphine milligram 
equivalents. 
All professional staff in the perioperative suite will be eligible to participate in the study. 
Professional staff who elect to participate in the study and complete the NIEPAS surveys will 
provide written informed consent prior to being sent the NIEPAS survey.  The NIEPAS survey 
will be provided to the entire perioperative suite staff prior to protocol implementation, 
halfway through the recruitment period and after the last participant has been discharged from 
the hospital. The surveys will be sent to the providers via RedCap, and all data will be stored in 
RedCap. Data will be maintained in a secure drive, accessible only to the research team. While a 
small risk of data compromise always exists, the use of password protections and a secured 
drive will ensure this risk is minimal. 

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7. Data and Specimen Banking  
We will not be collecting specimens as a part of this study. 
 
8. Sharing of Results with Participants 
Direct study results will not be disclosed to participants enrolled in the opioid free 
protocol. If participants ask if they were administered an opioid analgesic during their 
surgery, the anesthesia and/or surgery team will provide that information to the 
participant. 
If the preliminary results demonstrate that the opioid free protocol is not meeting the 
analgesic needs of the patient, an alternative plan will be necessary.  To that end, the 
anesthesia and surgical teams in the operating room will be able to administer opioid 
analgesics as needed. Further, every participant will be provided with a postoperative 
prescription for tramadol.  The patient will be provided with instructions to take this 
medication if the opioid free protocol is not meeting their pain needs.  In addition, a 
study patient hotline will also be created using a google number that will directly 
connect the patient to the surgeon, 
, or his designee.  Study participants 
will be able to use this number both preoperatively and postoperatively for any 
concerns related to pain control or medication issues.  No one aside from study 
personnel, the surgeon or his designee will have access to this telephone number or the 
records pertaining to this number (i.e. incoming/outgoing calls). 
Key findings will not be provided to the prospective or retrospective study participants.   
Individuals participating in the NIEPAS surveys will be provided with the summative 
results of the surveys, as well as the relationship between teamwork and 
communication and successful implementation of the protocol.  These results will be 
provided by PI Steven Waronker as a PowerPoint slide deck to the anesthesia team, and 
by PI Noreen Peyatt as a PowerPoint slide deck to the nursing team (pre-, intra- and 
post-operative). 
9. Study Timelines 
The protocol will be introduced to the perioperative teams in January with 
accompanying training materials up to and including printed materials, video materials 
and in-person/virtual training. 
The recruitment period for participants enrolling in the opioid free protocol is four 
months (February 1, 2021 – May 31, 2021), pending IRB approval.  Approximately 60 
participants will be recruited as a convenience sample.  For individuals participating in 
the opioid free protocol, their time commitment will be 5 weeks.  After enrolling in the 
study and providing informed consent, they will begin the opioid free protocol 2 weeks 

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prior to their surgery date.  Participants are discharged to home the same day as their 
hip replacement surgery.  They will then continue the protocol for 3 additional weeks. 
The recruitment period for retrospective participants identified in the CDW will also be 
four months.  Approximately 60 patients matched on key variables to the prospective 
sample, e.g. age, sex, race/ethnicity, will be recruited from the Clinical Data Warehouse 
from the year 2020, one year prior to the study period.  We anticipate recruiting 
controls whose surgery dates fall between February and May 2020.  There will be no 
time commitment from this group of participants.
All professional staff in the perioperative suite will be offered participation in the study 
and the option to complete the NIEPAS surveys after providing informed consent.  The 
time commitment anticipated for this group is approximately 15 minutes per survey, 
with 3 separate survey periods (prior to protocol implementation, halfway through the 
recruitment period and after the last participant has been discharged from the hospital).  
The survey periods will take place in approximately late January 2021, early April 2021 
and early June 2021. 
Primary analysis is anticipated to be completed within three months, or by August 31, 
2021. 
 
10.Inclusion and Exclusion Criteria 
Screening of potential participants for the opioid free protocol will require the office 
personal to communicate with 
 if there are any patients on the schedule 
who are listed as having a consult for primary total hip replacement surgery.  No chart 
or record review will be required.  Clinic is held every Tuesday and Thursday from 7am 
until 4pm.  Any individuals who will be in clinic undergoing consult for a primary total 
hip replacement will be screened by 
 or a member of the research team to 
ensure inclusion/exclusion criteria are met.  The screening will be a self-report by 
patients, and not a medical record or chart review.  Approximately 60 participants will 
be recruited as a convenience sample.   
Inclusion criteria for the opioid free protocol are:  patients aged 18 years to 89 years, 
undergoing a primary total hip replacement with
.  Exclusion 
criteria for the opioid free protocol are:  non-English speaking, preoperative opioid use, 
comorbid condition of diabetes mellitus type 1 or 2, concurrent surgeries, inability or 
unwillingness to undergo subarachnoid block as part of the anesthetic plan, and 
contraindications for one or more prescriptions. Non-English speaking subjects will not 
be included given the significant amount of materials that are provided to participants 
in the study, and the need to convert these materials into other languages.  As a pilot 
study, this requirement would be time prohibitive. If the protocol demonstrates success, 
future studies could include non-English speaking participants.  Additionally, adults that 
are unable to provide informed consent, minors, pregnant women and prisoners will not 
be included in this portion of the study. 

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Protocol Version: Version 6.0_4.6.2021 
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Participants in the retrospective sample will be identified in the CDW.  Inclusion criteria 
for the retrospective sample are:  patients aged 18 years to 89 years, undergoing a 
primary total hip replacement with 
.  Exclusion criteria for 
retrospective sample are:  preoperative opioid use, comorbid condition of diabetes 
mellitus type 1 or 2, concurrent surgeries, and did not have a subarachnoid block as part 
of the anesthetic.   
All professional staff in the perioperative suite will be offered participation in the study 
and the option to complete the NIEPAS surveys after providing informed consent.  
Inclusion criteria for the professional staff include: care for patients undergoing primary 
total hip replacement in the pre-, intra- or post-operative period, and willingness to 
provide informed consent.  Exclusion criteria for the professional staff include:  
Unwillingness or inability to provide informed consent, non-English speaking. Non-
English speaking subjects will not be included given the significant amount of materials 
that are provided to participants in the study, and the need to convert these materials 
into other languages.  As a pilot study, this requirement would be time prohibitive. If the 
protocol demonstrates success, future studies could include non-English speaking 
participants.   
 
11.Vulnerable Populations 
Not applicable 

12.Local Number of Participants 
A total of 60 participants will be included in the prospective study sample and will 
receive the opioid free protocol.  A total of 60 participants will be included in the 
retrospective study sample and will be identified in the CDW.  An estimated number of 
50 professional staff work in the perioperative suite and will be offered participation to 
complete the NIEPAS surveys. 
 
13.Recruitment Methods 
Screening of potential participants for the opioid free protocol will require the office 
personal to communicate with 
 if there are any patients on the schedule 
who are listed as having a consult for primary total hip replacement surgery.  No chart 
or record review will be required.  Clinic is held every Tuesday and Thursday from 7am 
until 4pm.  Any individuals who will be in clinic undergoing consult for a primary total 
hip replacement will be screened by 
 or a member of the research team to 
ensure inclusion/exclusion criteria are met.  If inclusion/exclusion criteria are met and 
the individual will be scheduled for surgery between February 1, 2021 and May 31, 
2021, informed consent will be obtained by 
 or a member of the research 
team.  No payment or additional travel will be required of these participants. 
Recruitment of participants in the retrospective sample will be based on matching key 
variables to the prospective sample, e.g. age, sex, race/ethnicity, and will be recruited 

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Protocol Version: Version 6.0_4.6.2021 
IRB Form BIO 08102020 
from the CDW from the year 2020, one year prior to the study period.  We will recruit 
controls whose surgery dates fall between February and May 2020.  No payment or 
additional travel will be required of these participants. 
Professional staff meeting inclusion/exclusion criteria for participation in the NIEPAS 
surveys will be identified by members of the research team embedded within EUOSH, 
specifically 
 
 
The additional time commitment from participants in this group will be 
approximately 15 minutes per survey, with a total of 3 surveys provided.  No payment 
will be provided to these participants. 
No advertising materials will be used for recruitment in any part of this study. 
No additional travel will be required of participants enrolled in the opioid free protocol, 
in the retrospective sample, or from professional staff participating in the NIEPAS 
surveys. 
 
14.Withdrawal of Participants 
Participants enrolled in the opioid free protocol may elect to withdraw from the study at 
any time and for any reason.  Any participant who chooses to withdraw will simply call 
the number provided on the informed consent, or email the address provided on the 
informed consent, and indicate their wish to withdraw.  Once a participant has 
withdrawn, a note will be made on the informed consent and no additional data will be 
collected. 
Participants enrolled in the opioid free protocol whose pain cannot be managed by the 
protocol will be removed from the protocol and provided with opioid analgesics as 
appropriate by the anesthesia/surgical team.  Data will continue to be collected on 
these individuals for the duration of the study. 
Participants in the retrospective arm of the study will not be eligible to withdraw from 
the study. 
Professional staff participating in the NIEPAS surveys may choose to withdraw from the 
study at any time and for any reason.  Any participant who chooses to withdraw will 
simply call the number provided on the informed consent, or email the address 
provided on the informed consent, and indicate their wish to withdraw.  Once a 
participant has withdrawn, a note will be made on the informed consent and they will 
no longer be sent the NIEPAS surveys. 
 
15.Risks to Participants 
For participants enrolled in the opioid free protocol, the greatest risk is that their pain 
would not be sufficiently managed with the protocol.  In this circumstance, participants 
whose pain cannot be managed by the protocol will be removed from the protocol and 
provided with opioid analgesics as appropriate by the anesthesia/surgical team. 

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Protocol Version: Version 6.0_4.6.2021 
IRB Form BIO 08102020 
For participants in the retrospective arm of the study, there is a small risk of data 
compromise if data security is breached.  Data will be maintained on a password 
protected, secure drive accessible only to the research team to minimize this risk. 
For professional staff completing the NIEPAS surveys there is a small risk of data 
compromise, if data security is breached.  Data will be maintained on a password 
protected, secure drive accessible only to the research team to minimize this risk. 
16.Potential Benefits to Participants 
Potential benefits to participants in the opioid free protocol are the avoidance of opioid 
analgesics and the accompanying side effect profiles, such as constipation, nausea and 
clouding of consciousness. 
There are no direct benefits to the participants in the retrospective arm of the study. 
There are no direct benefits to the participants in the professional staff arm. 
 
17.Compensation to Participants 
There will not be compensation for any participants in any arm of this study. 
 
 
18.Data Management and Confidentiality 
Data will be collected via two methodologies, RedCap surveys and CDW data query. All data 
collected in RedCap is secured via the RedCap HIPAA compliant security apparatus with 
required dual authentication methodology and encryption. Data collected via clinical record is 
stored in the CDW in encrypted data tables accessible to only users with healthcare credentials 
and healthcare VPN access. Any data retrieved from these two sources will be transmitted via 
Emory OneDrive, a HIPAA compliant file sharing server, provided by the Microsoft Corporation. 
OneDrive also allows for the secure storage of patient data that requires dual authentication to 
access data in addition to appropriate permissions.  
 
All data will be received and maintained by 
, listed above. 
 
Data will not be made available to anyone outside of the principal investigators and co-
investigators unless medically necessary for patient care. In addition, 
, is a honest broker for the CDW, and following IRB protocol will keep patient 
identifiers separate from full datasets with key linkage withheld from anyone besides the three 
levels of investigators listed above. All associated study staff will present and maintain CITI 
certification. 
 
Analysis will be performed using de-identified limited datasets. No analyst or study personnel 
will be granted access to data outside the scope of their normal duties as study employees. 
 

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All data will be monitored by the study co-investigator for anomalous or erroneous data that 
could affect patient care or study security. Frequency data will be used to monitor patient data 
that is categorical while continuous data will be monitored using quantitative methods such as 
outlier analysis and mean/standard deviation analysis. 
 
Data analysis will be performed using the R programming language. Means comparisons will be 
performed via ANOVA, T-Test to examine the relationship between opioid dose and surgical 
protocol. Linear regression will be used to examine the relationship between protocol dosing 
and surgical pain scores. In addition, linear regression will also be used to assess the 
relationship between intraoperative dosing and post-operative opioid need.  
 
Data will be retained for a period of four years after study end. Deleting of the files will be 
accompanied by seven-fold overwriting on all applicable disk. Any reporting or publication of 
results will only use aggregate numbers.  Further, we do not expect any publications as case 
reports that focus on individual patients.  
 
19.Provisions to Monitor the Data to Ensure the Safety of Participants 
This study does not provide more than minimal risk to the participants.  For those 
involved in the opioid free protocol, all medications and dosages being administered are 
already a part of the formulary and prescribing practices for surgical patients.  A 
comprehensive log will be kept of all adverse and serious adverse events in conjunction 
with normal reporting protocols to the institutional review board.  Adverse events are 
described as any unexpected events not requiring hospitalization as a patient.  Serious 
adverse events are any unexpected event requiring hospitalization of the patient or 
death. 
 
20.Provisions to Protect the Privacy Interests of Participants 
Clinical data is stored in the CDW in the electronic health record.  If data is to be shared 
with anyone besides the participant, they will need to follow normal HIPAA waiver 
procedures with their providers managing clinic, i.e. Emory Healthcare administration.  
RedCap data will be made available to the patient upon request in writing. 
 
21.Economic Burden to Participants 
The study sponsor does not plan to pay for any items or services as a part of this study. It is 
possible that there may be some economic burden to participants in the study as a result of 
study medications that may not be paid for by insurance. However, it is unclear if this potential 
burden would exceed the burden patients might experience even if they do not participate in 
the study given the wide range of variables that could impact this, such as the type of health 
insurance, types of co-insurance, required co-payments, deductibles, pain requirements post-
operatively and the cost of opioid medications and medications to prevent opioid related 
adverse drug effects. Participants will be prescribed medications that will be taken both in the 
preoperative and postoperative period. If the cost of those medications is burdensome to the 

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participant, they can decide to remove themselves from the study at any time and well in 
advance of their scheduled surgery. The individual would then be able to proceed with their 
surgery as planned using the current standard anesthetic approach, including the use of opioid 
analgesics. 
22.Consent Process 
Informed consent will be obtained from individuals wishing to participate in the opioid 
free protocol.  The consent process will take place in the pre-surgery clinic.  A member 
of the research team will be responsible for obtaining informed consent.  It is estimated 
that the informed consent process will take approximately 15-30 minutes per person.  
Should an individual wish to consider the options prior to deciding to participate, they 
will have until 15 days prior to their surgery day to provide informed consent and still 
participate in the study.  Participants will be informed that they may elect to withdraw 
from the study at any time and for any reason.  Any participant who chooses to 
withdraw will simply call the number provided on the informed consent, or email the 
address provided on the informed consent, and indicate their wish to withdraw. 
Individuals in the retrospective arm of the study will not be consented. 
For professional staff participating in the interprofessional/collaborative practice NIEPAS 
surveys, informed consent will be obtain by members of the research team.  The 
consent will take place at EUOSH. It is estimated that the informed consent process will 
take approximately 10-15 minutes per person.  Should an individual wish to consider 
their options prior to deciding whether to provide informed consent, they will have until 
January 31, 2021, prior to protocol implementation.  Participants will be informed that 
they may elect to withdraw from the study at any time and for any reason.  Any 
participant who chooses to withdraw will simply call the number provided on the 
informed consent, or email the address provided on the informed consent, and indicate 
their wish to withdraw. 
Participants that do not speak English will not be eligible for participation in the study. 
Non-English speaking subjects will not be included given the significant amount of 
materials that are provided to participants in the study, and the need to convert these 
materials into other languages.  As a pilot study, this requirement would be time 
prohibitive. If the protocol demonstrates success, future studies could include non-
English speaking participants. Individuals less than 18 years of age will not be included 
for participation in the study.  Age will be verified by the staff in the pre-surgery clinic. 
Individuals with cognitive impairment or the inability to provide informed consent will 
not be included in the study. 
23.Setting 
Participants for the opioid free protocol will be identified in the pre-surgery clinic held 
by 
 at EUOSH.  Participants who provide informed 
consent will be provided with prescriptions for the medications included in the protocol.  

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Protocol Version: Version 6.0_4.6.2021 
IRB Form BIO 08102020 
The intraoperative portion of the protocol will be implemented during the participant’s 
surgery at EUOSH. 
The data for participants in the retrospective arm will be retrieved from the CDW. 
Professional staff participating in the NIEPAS surveys will be recruited at EUOSH.  
Surveys will be sent via RedCap and will be available to be completed by the participant 
anywhere they have access to a computer or mobile device. 
 
24.Resources Available 
A strong interprofessional team has been built to ensure the ability of the research team 
to adequately address the complexities of this research.  The team includes medicine 
(surgery, anesthesia and administration), nursing (perioperative nursing, anesthesia and 
administration), pharmacy, and public health. 
All members of the research team have providing CITI certification for biomedical 
research.  The entire research team meets weekly via Microsoft Teams to discuss study 
progress and to ensure all parties are adequately informed about the protocol and 
research procedures.   
Per 
, he performs approximately 40 total hip replacements per month.  If 
our recruitment rate into the study is approximately 40% we should meet our goal of 60 
participants.  All surgeries will take place at EUOSH and the pre- and post-operative 
portions of the opioid free protocol will take place in the patient’s homes.  The 
professional staff participants will be able to answer the survey question in any location 
where they have access to computer or mobile services. 
Participants in the opioid free protocol will have immediate access to the surgeon for 
any issues related to their surgery or pain via the study patient hotline.  Professional 
staff participants have access to the employee emergency health and the mental health 
services hotline. 
 
25.Multi-Site Research when Emory is the Lead Site  
Not applicable. 
 
26.References 
Brummett, C. M., Waljee, J. F., Goesling, J., Moser, S., Lin, P., Englesbe, M. J., Bohnert, A. S. B., 
Kheterpal, S., & Nallamothu, B. K. (2017). New Persistent Opioid Use After Minor and Major 
Surgical Procedures in US Adults. JAMA Surgery, 152(6), e170504. 
https://doi.org/10.1001/jamasurg.2017.0504 
Clarke, H., Soneji, N., Ko, D. T., Yun, L., & Wijeysundera, D. N. (2014). Rates and risk factors for 
prolonged opioid use after major surgery: Population based cohort study. BMJ (Clinical 
Research Ed.), 348, g1251. https://doi.org/10.1136/bmj.g1251 
 

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Beck Dallaghan, G. L., Lyden, E., Meza, J., Stoddard, H., Bevil, C., Collier, D., Winnicki, M., & 
Nickol, D. (2016). The Nebraska Interprofessional Education Attitudes Scale: A New Instrument 
for Assessing the Attitudes of Health Professions Students. Journal of Interprofessional 
Education & Practice, 4, 33–39. https://doi.org/10.1016/j.xjep.2016.05.001 
 
Chia, Y. Y., Liu, K., Wang, J. J., Kuo, M. C., & Ho, S. T. (1999). Intraoperative High Dose Fentanyl 
Induces Postoperative Fentanyl Tolerance. Canadian Journal of Anaesthesia, 46(9), 872-877. 
 
Chu, L. F., Angst, M. S., & Clark, D. (2008). Opioid-Induced Hyperalgesia in Humans:  Molecular 
Mechanisms and Clinical Considerations. Clinical Journal of Pain, 24(6), 479-496. 
 
Rivat, C., & Ballantyne, J. (2016). The dark side of opioids in pain management: Basic science 
explains clinical observation. Pain Reports, 1(2), e570. 
https://doi.org/10.1097/PR9.0000000000000570 
 
Joly, V., Richebe, P., Guignard, B., Fletcher, D., Maurette, P., Sessler, D. I., & Chauvin, M. (2005). 
Remifentanil-Induced Postoperative Hyperalgesia and Its Prevention with Small-Dose Ketamine. 
Anesthesiology, 103(1), 147-155. 
 
Core Competencies for Interprofessional Collaborative Practice: 2016 Update. (2016). 22. 
Lumague, M., Morgan, A., Mak, D., Hanna, M., Kwong, J., Cameron, C., Zener, D., Sinclair, L., 
2006. Interprofessional Education: The Student Perspective. J. Interprof. Care 20(3), 246–253. 
 
Barker, K., & Oandasan I. (2005). Interprofessional Care Review with Medical Residents: Lessons 
Learned, Tensions Aired – A Pilot Study. J Interprof Care, 19, 207–14. 
 
Gilbert, J. H. V., Yan, J., & Hoffman, S. J. (2010). A WHO Report: Framework for Action on 
Interprofessional Education and Collaborative Practice. J Allied Health, 39 Suppl 1, 196-197. 
 
Sicotte, C., D’Amour, D., & Moreault, M.-P. (2002). Interdisciplinary collaboration within 
Quebec community health care centres. Social Science & Medicine, 55(6), 991–1003. 
https://doi.org/10.1016/S0277-9536(01)00232-5 
 
Garrett, J. H., Jr. (2016). Effective Perioperative Communication to Enhance Patient Care. AORN 
Journal, 104(2), 111–120. https://doi.org/10.1016/j.aorn.2016.06.001 
 
Kaye, A. D., Urman, R. D., Cornett, E. M., Hart, B. M., Chami, A., Gayle, J. A., & Fox, C. J. (2019). 
Enhanced recovery pathways in orthopedic surgery. Journal of Anaesthesiology, Clinical 
Pharmacology, 35(Suppl 1), S35–S39. https://doi.org/10.4103/joacp.JOACP_35_18 
 
Beck Dallaghan, G. L., Lyden, E., Meza, J., Stoddard, H., Bevil, C., Collier, D., Winnicki, M., & 
Nickol, D. (2016). The Nebraska Interprofessional Education Attitudes Scale: A New Instrument 
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Education & Practice, 4, 33–39. https://doi.org/10.1016/j.xjep.2016.05.001 

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Dominguez, D. G., Fike, D. S., MacLaughlin, E. J., & Zorek, J. A. (2015). A comparison of the 
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