Randomized Trial of Telephonic Pain Self-management to Promote Opioid Tapering
Phase: NA
Conditions: Chronic Pain
Sponsor: University of Washington

 
 
 
 
 
 
 
 
 
IRB APPROVED PROTOCOL 
 
Study Title: Strategies to Improve Pain and Enjoy Life (STRIPE) 
 
NCT: NCT03743402 
 
Date of final Document: 4/7/2021 
 
 
Date submitted to IRB: 4/8/2021 
 
Date IRB Approved: 6/7/2021 
 
Date IRB Made Effective as of: 5/6/2021 
 
 
 
 

 
Protocol Template 
(Use with Core Data Form) 
Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 1 of 46 
 
Revised 6/21/2018 
INSTRUCTIONS:  
• 
Complete this Protocol Template only when there is no existing authored protocol provided for 
this study.  
• 
If you are doing a data-only study with no prospective or interventional components, use the 
Data Only Protocol Template instead. 
• 
This Protocol Template is to be used in conjunction with the SMART KP IRB Core Data Form. 
• 
Enter your responses to each question directly below the BLUE text in the fillable field. 
• 
When completing this Protocol Template, if a section does not apply to your study then enter 
“N/A.” 
1. Protocol  
Protocol Title 
Pain Self-Management Training for Opioid Taper 
 
 
Principal Investigator  
Denise Boudreau, PhD 
 
 
Version Date 
 April 7, 2021 
 
Form Author 
Rachel Hays 
 
 
2. Objectives 
Describe in plain language the purpose, specific aims, or objectives and indicate the primary 
goal(s) of the study (e.g. safety, tolerability, effectiveness, feasibility, pilot study, etc.).  State the 
hypotheses to be tested. State primary and any secondary study endpoints. 
This study will adapt and test a University of Washington (UW) developed/piloted pain self-
management training for prescription opioid taper intervention at Kaiser Permanente 
Washington (KPW). To address patients’ fears of opioid taper that limited recruitment into our 
pilot study, we will begin with randomization to pain self-management training and then offer the 
option of self-paced opioid taper: Pain Self-Management Training for Opioid Taper (PSMOT).  
The optional taper will occur through recommendations from the research interventionist the 
patient’s primary care provider (PCP). This study aims to enroll 250 participants and randomize 
them into either 1) a nurse or physician assistant research interventionist guided PSMOT or 2) 
regular care (no intervention). Specifically, we will test the effectiveness of this intervention, 
compared with control group on opioid dose and pain outcomes among patients on high dose (≥ 
40 mg morphine equivalent dose) long-term opioid therapy (LtOT) for chronic non-cancer pain 
(CNCP) in a pragmatic randomized trial. 
 
The objectives of this study are: 
 

 
Protocol Template 
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Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 2 of 46 
 
Revised 6/21/2018 
• 
To adapt our previously developed prescription opioid taper support intervention by a 
physician assistant into a telephone-delivered pain self- management training that 
provides the option for supported opioid taper (PSMOT) through the patient’s PCP. We 
will recruit participants who receive care from multiple primary care clinics. The 
intervention will be administered by a KPWA research interventionist  (a physician 
assistant or registered nurse) who will be trained and supervised by a UW pain 
psychiatrist and UW research clinician and will include guidance in opioid and non-opioid 
medication prescribing. This training and guidance will be consistent with KPWA 
guidelines. 
 
• 
To test in a randomized trial the effects of this PSMOT intervention on: a) opioid 
outcomes: daily opioid dose (primary outcome), percent dose reduction from baseline, 
problem opioid use (interview, questionnaire, and electronic health record text 
indicators), and patient-reported opioid problems; and b) pain-related outcomes: PEG 
(self-report of Pain intensity, Enjoyment of life interference, General activity interference 
-  primary outcome), pain self-efficacy, and depression symptoms 
 
We will test the effectiveness of this intervention, compared with  control group, on opioid dose 
and pain outcomes among patients on high dose (≥ 40 mg morphine equivalent dose) LtOT for 
CNCP in a pragmatic randomized controlled trial. This intervention will have two components: 
 
• 
telephone-delivered evidence-based pain self-management training with supplemental 
materials including: 
 
o A participant workbook 
o The Pain Survival Guide book 
o Audio files of relaxation techniques (these will be available both as in a CD 
format and we are working with Eagles to create a study website that will host 
these files. : www.stripestudy.org  
o 
A web-based video of successfully tapered patients with motivational interviewing 
debriefing: www.stripestudy.org     
• 
Voluntary, self-paced opioid taper through recommendations to the PCP 
o Including opioid and non-opioid prescribing guidance from the research 
interventionist to the patient’s PCP. 
 
Hypotheses pertaining to opioid use: Patients receiving LtOT for chronic non-cancer pain 
(CNCP) randomized to the PSMOT intervention, as compared with those randomized to a 
control group, will have lower opioid doses, greater percent reduction of opioid dose, lower 
proportions with problem opioid use, and lower levels of patient-reported opioid-related 
problems at 6 and 12 months after randomization.  
 
Hypotheses pertaining to pain outcomes: Patients receiving LtOT for CNCP randomized to the 
PSMOT intervention, as compared with those randomized to the control arm, will have lower 
PEG scores, higher levels of pain self-efficacy, and lower levels of depressive symptoms at 6 
and 12 months after randomization. The proposed trial will determine whether pain self-

 
Protocol Template 
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Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 3 of 46 
 
Revised 6/21/2018 
management training can promote prescription opioid taper in higher-dose long-term opioid 
therapy patients without increasing pain levels or activity interference. If this trial is successful, 
then prescribers and patients may be able to pursue supported opioid taper without fear of 
escalating pain. 
 
 
 
3. Background 
a. Scientific Background 
Provide the scientific or scholarly background for, rationale for, and significance of the research 
based on the existing literature and how will it add to existing knowledge. A list of references or 
bibliography must be included as part of this document or uploaded separately. 
The evidence that LtOT improves chronic pain and function in patients with CNCP is weak, but 
there is strong evidence of dose-dependent risk for serious harms such as opioid abuse, 
Opioid Use Disorder (OUD), overdose, and death. LtOT patients are a high-risk group with high 
rates of substance use, mental disorders, problem opioid use, and adverse effects of opioids, 
including OUD, overdose, and death. Rapid opioid detoxification of these LtOT patients may 
lead to illicit opioid use, but gradual, supported opioid taper may reduce risks of opioid adverse 
events. While many LtOT patients are interested in opioid taper or discontinuation, they also 
fear increased pain. In a previous, NIDA-funded R34 pilot study of prescription opioid taper 
support, this study PI demonstrated that over 18 weeks opioids can be tapered more effectively 
than in control arm (43% vs 19% dose reduction) with no increase in pain intensity and 
significantly reduced activity interference for those receiving taper support. We have been 
funded by the National Institute on Drug Abuse (NIDA) to study this intervention in the KPWA 
delivery system.  See grant proposal for bibliography.  
 
 
 
b. Preliminary Data 
Describe any relevant preliminary data.  
In a previous, NIDA-funded R34 pilot study of prescription opioid taper support, this study PI 
(Sullivan) demonstrated that over 18 weeks opioids can be tapered more effectively than in 
control arm (i.e., only usual care) (43% vs 19% dose reduction) with no increase in pain 
intensity and significantly reduced activity interference scores at 22 and 34 weeks (p<0.05 and 
p=0.05, respectively) for those receiving taper support compared to controls. Those in the taper 
support group had significantly higher self-efficacy for managing pain and significantly lower 
levels of perceived opioid-related psychosocial problems (e.g., loss of interest in usual activities, 
trouble concentrating, feeling down or sluggish) at 22 weeks. This pilot also adds to growing 
literature that cognitive behavioral therapies (CBT) for pain can be provided successfully by 
health professionals other than psychologists. 
 
The primary barrier to feasibility of this intervention is recruiting and enrolling patients in the trial. 
We surveyed 31 current KP LtOT patients concerning their willingness to participate in such a 
trial: 74% said they would participate in “a study that offered training in skills for chronic pain 
management done over the phone”, 71% said they would be willing to “try tapering your daily 
dose of opioid pain medication if you were promised that the dose reduction would only continue 
if your pain level did not get a lot worse.” This “pledge of non-abandonment” by PCPs to 
patients undergoing opioid taper is a crucial component of our intervention. It has proven to be a 

 
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powerful tool to promote opioid taper in other integrated care settings that have tried it. Few of 
the previous pilot study participants experienced significant pain exacerbation with opioid taper. 
 
Our proposed strategy of recruitment and treatment through phone contact will minimize costs 
and inconvenience to patients. Drs. Sullivan and Turner successfully administered the pain self-
management training over the phone to patients in the pilot study (44% of pilot study 
participants had at least one phone session). Among participants randomized to taper support 
who completed the 22-week assessment, 81% rated the intervention as very or extremely 
helpful. Among the participants who completed this rating at the 34-week assessment, 73% 
rated the intervention as very or extremely helpful 
 
Additionally, using KPWHRI’s JIFFI tool, the study programmer identified that the clinics with the 
largest number of LtOT users on high dose opioids are Olympia, Everett and Capitol Hill 
Medical Centers. Therefore, we will target the intervention in those clinics first but may need to 
expand to other clinics to meet our targeted enrolment.  
 
 
4. Study Design 
Describe the overall approach of the study (e.g. prospective, interventional, observational, 
retrospective, etc.).  If your study includes more than one group, arm, or subject population, 
describe that here (for example, a study of both subjects and their caregivers, or a study with 
both a prospective interventional arm and a retrospective chart review arm).  
This study is a pragmatic randomized trial that includes data collected from electronic health 
records (EHR – KPWHRI Virtual Data Warehouse),patient self-report, and data on the training 
sessions. There are two arms in the trial: a research interventionist guided Pain Self-
Management Opioid Taper (PSMOT) or control group (no intervention, usual care).  In addition, 
the education intervention has a sub-arm which involves an opportunity to taper opioid 
medication dosing. The goal of the tapering is to gradually decrease opioid dosing by ~ 10% per 
month. 
 
 
Pre-intervention Clinic Visit 
Preliminary data suggests that the KP Washington Clinics with the most LtOT users are: 
Olympia, Everett and Capitol Hill Medical Centers. Prior to rolling out the intervention at these or 
other clinics (clinics to be decided upon with KPWA Drs. Levy and Mehta), Drs. Sullivan and 
Boudreau along with the research interventionist  will 1) present the intervention to the Primary 
Care Providers and care teams at those clinics and 2) attend at least two morning team huddles 
at the clinics. The purpose of this presentation and attendance at morning huddles is not only to 
be awareness of the intervention taking place at the clinic, but also to get buy-in from the care 
teams and answer any questions they may have.  It is important for providers to be supportive 
of this intervention because the study team may be communicating to them prescribing 
recommendations for their patients and the implementation of those recommendations 
(tapering) is an important outcome of this study. The study team will also send letters to PCPs 
informing them when one of their patients is randomized to the intervention arm of the study 
(see letter to PCP).  Dr. Boudreau is working closely with the delivery system on the trial. She 
meets and corresponds regularly with Dr. Khushboo Mehta (Family Medicine provider and 
Program Chief of Family Medicine), Dr. Sarah Levy (Medical Director, Continuum of Care), Dr. 
Angela Sparks (Family Medicine Physician and Medical Director, Clinical Knowledge 

 
Protocol Template 
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     KP WA Implementation Date: 07/23/2018 
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Revised 6/21/2018 
Development and Support), and Melissa Sturgis, PharmD, BCACP (Clinical Pharmacy 
Operations Coordinator, Quality and Clinical Operations). They will all be clinical champions of 
the trial.  
 
Screening, Randomization, and Follow-up 
 
Potentially eligible participants will be identified by the study programmer using KPWA EHR 
data that located in the KPWHRI Virtual Data Warehouse. Potentially eligible patients will then 
be screened by phone twice for additional eligibility requirements before being consented and 
enrolled into the study. Eligible participants will be randomized based on their primary care clinic 
and baseline opioid dose into one of the trial arms. Both groups will be surveyed on physical 
health, pain, medication use, and mental health at baseline (prior to randomization), 6 months 
and 12 months. The total length of enrollment/follow-up in the trial for both groups is one year. 
See Figure 1 for the study process.  
 
Control Arm (i.e., usual care only) 
The  control arm subjects will not participant in any additional study activities other than the 
screenings, baseline, and follow-up data collection (6 and 12 months post randomization) as 
described above. Usual care is the standard of care at KPWA. 
 
Intervention Arm 
The intervention arm subjects will talk with the clinical research interventionist up to 18 times 
over a year on the phone.  The research interventionist  will: 
• 
Train participants on methods to self-manage their pain 
• 
Introduce and offer an optional opioid taper support 
• 
Work with the participant’s PCP to suggest medication dosage recommendations 
o Difficult cases may need to be reviewed with Dr. Sullivan, the research physician, 
who may need to review pieces of the participant’s medical record, specifically 
medication list and active diagnosis list to ensure the recommended medication 
dosing changes are appropriate.  The research physician will not be abstracting 
information from the chart. Dr. Sullivan has Epic read only access until 12/2021, 
when all participants will have completed the intervention. 
• 
Monitor, track and respond to adverse events (AE’s) and Critical Incidents (CIs). CI’s are 
a type of adverse event where a participant spontaneous reports risk behavior such as 
intent to harm oneself or others.  
 
While teaching participants how to manage their pain is not part of usual care at KPWA, 
gradually tapering and/or discontinuing opioids are considered standard of care at KPWA and 
included in KPWA’s “Patients on Chronic Opioid Therapy for Chronic Non-Cancer Pain Safety 
guidelines (September 2016). However, PCP’s often do not initiate tapering due to numerous 
barriers such as lack of support, lack of expertise, the need to educate patients, and time 
constraints. As such, our trial is endorsed by the KPWA delivery system and is viewed as a 
mode to improve uptake of KPWA’s standard of care around opioid tapering.  
 
 
 
 
 

 
Protocol Template 
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NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
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Revised 6/21/2018 
Figure 1. Study process 
 
 
 
5. Study Population 
 
a. Number of Subjects 
State the number (or approximate number, if appropriate) of subjects you plan to include at the 
KP region to which this study is being submitted. If applicable, distinguish between the number 

 
Protocol Template 
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NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
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Revised 6/21/2018 
of subjects who are expected to be enrolled/screened and the number of subjects needed to 
complete the research procedures (e.g. numbers of subjects excluding screen failures).  
 
As appropriate, consider different populations of subjects within the same study (e.g. 
subject/caregiver, parent/child, patient/physician). If this is a multicenter study, indicate the total 
number of subjects to be accrued across all sites.  
This study is an educational intervention with two arms: a research interventionist guided 
PSMOT (with a sub-arm of patients who decide to taper their medications) or control group (no 
intervention, usual care).  We plan on enrolling 250 participants. 125 participants in each arm. 
Eligible participants will be randomized based on their KPW primary care clinic and baseline 
opioid dose into either arm.  
 
 
Invited (contacted) 
Enrolled 
KP Washington 
825 
250 
Other sites 
- 
- 
Total 
825 
250 
 
 
 
b. Inclusion and Exclusion Criteria 
• 
Describe the criteria that define who will be included or excluded in your final study 
sample. 
• 
Describe how individuals will be screened for eligibility. 
• 
Describe the plan for disposition of data collected during recruitment/screening in the 
event of a screen failure or when a potential subject is contacted but declines 
participation (e.g. destroyed immediately, destroyed at end of study, retained for 
separate analysis or so that subjects are not contacted repeatedly about participation 
after they have declined, etc.). 
Inclusion Criteria: 
KPW enrollees: 
• 
age 18-80 years (from KPWHRI Virtual Data Warehouse (VDW)) 
• 
receiving care at a KPWA primary care clinic (from VDW) 
• 
with chronic non-cancer pain (CNCP), defined as patient-reported pain on more than 
half the days in the past 6 months (from eligibility screening) 
• 
currently on higher-dose LtOT, defined as >90 days’ supply in the past 180 days with 
a mean daily dose of40 mg morphine equivalent dosing (MED) or greater in the past 
90 days, as first identified via KPW’s pharmacy dispensing data and opioid use 
subsequently validated by patient self-report during screening for the trial (from 
VDW) 
• 
who can consent to participate in the study arm to which they are randomly assigned 
(from eligibility screening) 
• 
who are able to read, speak, and write English adequate for outcome measures 
(from eligibility screening) 

 
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Revised 6/21/2018 
• 
enrolled in KPW for at least 6 months prior and no plans to disenroll over the next 
year (from eligibility screening) 
 
Exclusion criteria  
We will exclude participants who:  
• 
are receiving treatment for cancer (from VDW and eligibility screening) 
• 
are enrolled in palliative or hospice care (from VDW and eligibility screening) 
• 
have use in past month of parenteral, transdermal, or transmucosal opioids (from VDW) 
• 
are residing in nursing home or assisted living (from VDW and eligibility screening) 
• 
are using any implanted device for pain control (from VDW and eligibility screening) 
• 
are taking buprenorphine formulations (Suboxone) used to treat OUD, (from VDW, self-
report and eligibility screening) 
• 
have psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year 
(from VDW and pre-randomization screening) 
• 
have current suicidal ideation with plan or intent (from VDW and pre-randomization 
screening) 
• 
psychiatric hospitalization or suicide attempt in the past year (from pre-randomization 
screening) 
• 
have cognitive impairment (from VDW) 
• 
do not have regular access to a phone (from eligibility screen) 
• 
are pregnant (from VDW or self-report) 
• 
KPWA employees and members who are on the “do not contact” list 
• 
are enrolled in the KPWA COMET initiative; a pharmacy based initiatve to lower opioid 
dosing  
 
 
Secondary data sources used to identify potentially eligible subjects are listed in the table below. This 
data will be collected from the VDW on potential subjects at each sample pull (every 2 weeks). 
Sources (specify) 
 
(I.e., from KPWA, from an approved or previous 
study, from another site, etc.) 
 
List any electronic data that 
will be used to identify 
potential subjects 
 
Date Range 
KPWHRI Virtual Data Warehouse (VDW) 
Demographics such as 
age, sex, race, ethnicity, 
marital status, education 
2017-2021 
KPWHRI Virtual Data Warehouse (VDW) 
Enrollment 
2017-2021 
KPWHRI Virtual Data Warehouse (VDW) 
Primary care clinic location: 
e.g., Everett, Capital Hill, 
Olympia) 
2017-2021 
KPWHRI Virtual Data Warehouse (VDW) 
Diagnoses (ICD 
2017-2021 
KPWHRI Virtual Data Warehouse (VDW) 
Medications 
2017-2021 
KPWHRI Virtual Data Warehouse (VDW) 
Health care utilization 
including:  outpatient, 
inpatient, hospice care, 
palliative care, emergency 
department 
2017-2021 
KPWHRI Virtual Data Warehouse (VDW) 
Procedures 
2017-2021 
 

 
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NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 9 of 46 
 
Revised 6/21/2018 
 
 
After potential subjects are identified using the electronic data in the VDW listed above, there are two 
steps for screening participants into the study: 
1. Recruitment screening where the Survey Research Program interviewers call to recruit 
participants and screen them into the study with simple screening questions. 
2. Pre-randomization screening where a research specialist will screen for sensitive ineligibility 
criteria such as psychiatric hospitalization and recent suicidal ideation.  
 
Both screening scripts and screening questions are included in this packet.  
 
All participant contact information (name, address, telephone number) and their study disposition 
(non-responder, refuser, or ineligibility reason) remains in the study recruitment database for the 
duration of the study to ensure that the participant isn’t contacted for recruitment again. 
 
The aggregate table below will be populated each time a potentially eligible sample is pulled from the 
VDW (twice per month) and prior to attempting any contact (i.e., mailing of letters and phone calls) 
with subjects. This table will be used for sample monitoring and a future non-reponder bias analysis. 
The table will be updated twice a month with potentially eligible subjects moving into columns of 
enrolled, non-responder, active refuser, or ineligible.    
 
Table 1. Characteristics to  be summarized and updated every two weeks when new potentially eligible 
subjects are identified from the KPWHRI Virtual Data Warehouse (VDW). 
 
 
Potential 
eligible 
(VDW data 
only) 
Enrolled 
Not 
enrolled 
(active and 
passive 
refusers)* 
( 
n= 
n= 
n= 
 
% 
Mean age (SD), years 
 
% Male 
 
  
Race 
 
White 
 
Black 
 
Asian 
 
Other 
 
Missing 
 
Hispanic 
 
Prior health plan enrollment, 
years 
 
1-2 
 
3-9 
 

 
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10+ 
 
Mean number (SD) of visits with 
a pain diagnoses, past year 
 
Multifocal pain (pain arising 
from >1 location) 
 
Mean daily opioid dose, past 90 
days (MEQ - morphine 
equivalent dose) 
 
<40 MEQ 
 
40-49 MEQ   
 
50-89 MEQ 
 
90-119 MEQ 
 
120+ MEQ 
 
Primary Care Clinic 
 
Clinic 1 
 
Clinic 2 
 
Clinic 3 
 
Etc. 
 
Charlson co-morbidity index, 
past year 
 
 
 
0 
 
1 
 
2+ 
 
Depression diagnosis, past year 
 
Anxiety diagnosis, past year 
 
Substance use disorder, past 
year 
 
 
 
Smoking status, past year 
 
Current 
 
Past 
 
Non-smoker 
 
 
 
 
c. Vulnerable Populations 
Indicate whether you will include or exclude each of the following special populations.  This 
refers to subjects who are known members of these populations upon enrollment or at any time 
during the study. Justify the inclusion of any of these populations. Describe additional 
safeguards to protect the rights and welfare of these subjects.  
• 
Children 
• 
Pregnant Women 
• 
Neonates of uncertain viability or nonviable neonates (up to 28 days post birth) 

 
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• 
Prisoners (NOTE: The KP IRB does not have the appropriate membership to review 
research involving prisoners. Consultation with KFRI will be required.) 
We are not including children, pregnant women, neonates or prisoners. 
 
 
Pregnancy is an exclusion criteria (VDW and screening), and a reason for withdrawal from the 
entire study for participants in both arms of the trial (data source: VDW for both arms and EMR 
or patient report for the intervention arm). Data collection and the intervention will stop if the PA 
learns a participant is pregnant (EMR or patient reports). VDW data on diagnosis codes for 
pregnancy will be ascertained on all participants (intervention and control arm) at the end of the 
study and prior to analyses. Pregnant women will be excluded from the analyses. 
 
Pregnancy will be rare in this population. The average age of patients on COT at KPWA is 57 
years. Opioid use during pregnancy issues are complex and need special consideration beyond 
the limits of this study. It also introduces considerable heterogeneity into the study. 
 
IMPORTANT NOTE: Consider whether subjects will be in a vulnerable category at the time of 
data collection or during analysis.  For instance, if you collect data about children who were 
ages 12 – 15 from years 2000 – 2002, you know that now those individuals are no longer 
children. 
d. Identification of Subjects 
Describe how you will identify subjects. If you plan to use private records (EHR, Dept. of 
Licensing) complete 5.e, 5.f., and 5.g below as relevant.   
A KPWHRI research programmer will identify eligible subjects from the KPWHRI Virtual Data 
Warehouse (VDW) using the variables described in Item 5b. At the time of identification (every 2 
weeks), Table 1 will be generated/updated with all potentially eligible subjects. 
 
e. Waiver of Informed Consent for Identification from EHR or Other Private Records 
Provide rationale and justification for the Waiver of Informed Consent for identification of 
subjects, including:  
• 
Does the proposed research present no more than minimal risk to the study 
participants?  
• 
How the waiver of informed consent will not adversely affect the rights and welfare of the 
participants. 
• 
Why this research cannot practically be carried out without a waiver of informed consent. 
• 
Whenever appropriate, the subjects will be provided with additional pertinent information 
after participation. 
We believe that the proposed research presents no more than minimal risk to the study 
participants for the following reasons. Only persons directly involved in the study will have 
access to data. Each KP Washington enrollee will be assigned a unique study identification 
number linked to his or her medical record number at KP Washington. The crosswalk between 
the study identification number and each subject’s medical record number is maintained in 
electronic form, but separate from the analysis files. To create project analytic files the 
crosswalk between the study identification number and each subject’s unique medical record 
number will be re-established by the KP Washington research project programmer. We will use 
existing procedures to ensure that individual patient identifiers are kept separate from analysis 

 
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files. All data necessary to complete this research will be created and stored in secure 
computers to which only project team participants will have access. No participant will be 
identified from any published manuscripts, tables, or reports generated from the proposed 
study. 
 
The waiver will not adversely affect the rights and welfare of the subjects.  Neither care nor 
benefits will be impacted. Furthermore, safeguards are in place to protect the confidentiality of 
all potential research subjects. 
 
We could not practicably identify all potential subjects without identifying them through KP 
Washington Virtual Data Warehouses. We could not practicably approach all participants for 
their consent prior to that data pull.  
 
Subjects will not be provided with additional pertinent information after participation.  
 
 
f. Waiver of HIPAA Privacy Rule Authorization for Identification from EHR 
If you will not obtain a signed HIPAA Privacy Rule Authorization or if you want to eliminate any 
required language from the authorization, provide the following rationale and justification.  
• 
Why the research could not practicably be conducted without the waiver. 
• 
Why access to and use of the PHI is necessary for the research. 
• 
Why the use or disclosure of PHI for the research poses no more than minimal risk to 
the subjects' privacy (must have an adequate plan to protect the PHI from improper use 
or disclosure, a plan to destroy identifiers at the earliest opportunity consistent with the 
purpose of the research, and when applicable, written assurances from collaborators 
that PHI will not be reused or re-disclosed to any other entity). 
We are requesting a waiver of HIPAA authorization of Identification from EHR because we could 
not practicably identify and approach all potential subjects without identifying them through KP 
Washington Data Warehouses.  
 
Access to and the use of PHI for this research is necessary because we need participant 
contact information to approach participants by mail and telephone. We also need dates 
(medication and enrollments) to correctly identify the sample. Finally, once on the phone, we 
need information such as name and birth date to confirm we have the correct person on the 
phone.  
 
The use and disclosures of PHI poses no more than minimal risk to the subject’s privacy 
because of the following protections: Only persons directly involved in the study will have 
access to data. Each KPW enrollee will be assigned a unique study identification number linked 
to his or her medical record number. The crosswalk between the study identification number 
and each subject’s medical record number is maintained in electronic form at each site, but 
separate from the analysis files. To create project analytic files the crosswalk between the study 
identification number and each subject’s unique medical record number will be re-established by 
the project programmer. We will use existing procedures to ensure that individual patient 
identifiers are kept separate from analysis files. All data necessary to complete this research will 

 
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be created and stored in secure computers to which only project team participants will have 
access. When these files are created, the crosswalk will be erased from all files and kept only 
by the programmer. No participant will be identified from any published manuscripts or reports 
generated from the proposed study.   
 
Once all data has been collected for this study, the crosswalk between the study identification 
number and each subject’s unique medical record number will be erased from all analysis files 
and stored in a file kept by each site’s project programmer. The project manager maintains a 
calendar that tracks destruction date information and will notify the programmer prior to the 
scheduled date for destruction. 
 
All linkages will be destroyed as early as is consistent with the research and no later than 
December 31, 2026 
 
 
 
g. RCW 70.02 Requirements to Access HIPAA Covered Data without Consent for 
Identification from EHR (WA State Law)  
If you will not obtain written HIPAA Authorization provide the following rationale and justification. 
Explain how the research: 
• 
Is of sufficient importance to outweigh the intrusion into the privacy of the patient that 
would result from the disclosure; 
• 
Is impracticable without the use or disclosure of the health care information in 
individually identifiable form; 
• 
Contains reasonable safeguards to protect the information from redisclosure; 
• 
Contains reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research project; and 
• 
Contains procedures to remove or destroy at the earliest opportunity, consistent with the 
purposes of the project, information that would enable the patient to be identified, unless 
an institutional review board authorizes retention of identifying information for purposes 
of another research project. 
 
 This research is of sufficient importance to outweigh the intrusion into the privacy of the 
participant that would result from the disclosure because although some study participants may 
not benefit directly from this study, their participation may eventually be of help in understanding 
whether pain self-management training and optional taper support helps patients reduce their 
prescribed opioid medications, which is currently an important public health priority. 
 
We could not practicably identify potentially eligible patients or approach participants for their 
written authorization prior to the automated data (i.e., VDW) pull. 
 
Access to and the use of PHI for this research is necessary because we need participant 
contact information to approach participants by mail and telephone. We also need dates 
(medication and enrollments) to correctly identify the sample. Finally, once on the phone, we 
need information such as name and birth date to confirm we have the correct person on the 
phone.  

 
Protocol Template 
(Use with Core Data Form) 
Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 14 of 46 
 
Revised 6/21/2018 
 
The use and disclosures of PHI poses no more than minimal risk to the subject’s privacy. Only 
persons directly involved in the study will have access to data. Each KPWA enrollee will be 
assigned a unique study identification number linked to his or her medical record number. The 
crosswalk between the study identification number and each subject’s medical record number is 
maintained in electronic form at each site, but separate from the analysis files. To create project 
analytic files the crosswalk between the study identification number and each subject’s unique 
medical record number will be re-established by the project programmer. We will use existing 
procedures to ensure that individual patient identifiers are kept separate from analysis files. All 
data necessary to complete this research will be created and stored in secure computers to 
which only project team participants will have access. When these files are created, the 
crosswalk will be erased from all files and kept only by the programmer. No participant will be 
identified from any published manuscripts or reports generated from the proposed study.   
 
Once all data has been collected for this study, the crosswalk between the study identification 
number and each subject’s unique medical record number will be erased from all analysis files 
and stored in a file kept by each site’s project programmer. The project manager maintains a 
calendar that tracks destruction date information and will notify the programmer prior to the 
scheduled date for destruction. All linkages will be destroyed as early as is consistent with the 
research and no later than December 31, 2026 
 
 
 
 
h.  Decisionally Impaired Adults   
State whether decisionally impaired adults will be included and explain the extent of cognitive 
impairment (complete, fluctuating, progressive, or temporary).  Justify their inclusion, and 
explain any protections to mitigate risk (such as the involvement of a caregiver or authorized 
representative).  Describe consent/assent procedures. 
N/A we will not include decisionally impaired adults.   
 
 
i. 
Other Populations Targeted for Recruitment 
If you are targeting a population that may be vulnerable to coercion or undue influence based on 
the specific circumstances of the study, describe how you will ensure that participation is 
voluntary and minimize any added risk. (Common examples include employees, students, 
people of low socioeconomic status, etc.) 
N/A we will not be targeting or including vulnerable populations. We will not actively be 
excluding KPWA employees, but we will exclude patients including KPWA employees, who 
have pro-actively requested to not be included in research. 
 
 
j. 
Setting 
Describe the sites or locations where your research team will conduct the research. 
 
We will sample participants from KPWA clinics that have high the highest proportion of high 
dose LtOT users.  Preliminary data exploration suggests that Olympia, Capitol Hill and Everett 

 
Protocol Template 
(Use with Core Data Form) 
Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 15 of 46 
 
Revised 6/21/2018 
Medical Centers have the highest counts of LtOT users but we are working with leaders in the 
delivery system (Sarah Levy and Melissa Sturgis) to determine the best clinics to target.  
 
We will recruit participants by mail and telephone. All study visits will be conducted on the 
telephone.  
 
 
k. Recruitment Methods 
Describe how study participants will be recruited and enrolled. Indicate whether you will openly 
recruit using advertisements, websites, or brochures. Indicate if you plan to do targeted 
recruitment using existing records or referral. (Upload all recruitment materials to your 
submission to the IRB.) 
 
Describe, by position/title, who will be recruiting and enrolling participants (providing the specific 
names of research team members is not necessary). 
 
Describe any plans for the participants in the currently proposed study to be re-contacted or 
recruited for future follow-up studies. (Note that participants should be informed of this potential 
for re-recruitment during the current study’s consent process.) 
 
Potential participants will be identified using the KPWHRI VDW (see inclusion/exclusion 
criteria). Survey Research Program staff will then mail potential participants an advance 
invitation letter describing the study along with an information sheet, study insert and $2 pre-
incentive.  
 
Approximately 5 business days after sending the invitation packet, the Survey Research 
Program phone room staff will call participant to conduct the first round of eligibility screening 
and, for subjects who remain eligible, schedule the pre-randomization screening with the study 
research specialist.  After the call, we will send these potentially eligible participants a cover 
letter and a copy of the consent form for the next round of screening. 
 
At the pre-randomization, second round of screening, the study research specialist with further 
screen potential participants with two more screening questions. If eligible, the participant will 
then be consented, enrolled, and asked to take the baseline survey by phone or web.   
 
Once the baseline survey is complete (by phone or web), the participant will receive a thank you 
letter (including $20 incentive) with their randomization status (PSMOT intervention arm or 
control arm) and next steps. Participants in the intervention arm will also receive a welcome 
cover letter with the materials needed for the training sessions. Their provider will also receive a 
letter informing them of their patient’s enrollment into the intervention arm of the trial (see letter 
to PCP that informs them of their patient’s participation in the intervention arm of the trial). 
 
Participants may be recruited for future supplements to this study. Drs. Sullivan and Boudreau 
are exploring the feasibility of conducting a supplement to this project where participants 

 
Protocol Template 
(Use with Core Data Form) 
Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 16 of 46 
 
Revised 6/21/2018 
enrolled in the intervention arm would be offered the opportunity to participate in two (one at 
baseline and one at 12 month) 2 hour, in-person, neuropsychology tests to examine the 
cognitive and social aspects of patients as they taper down their opioid dosage. While all 
intervention arm participants would/could take the baseline assessment, only those who chose 
to taper would be approached to do a 12 month assessment. At this time, Dr. Sullivan is merely 
exploring the feasibility of doing this type of supplement and no definitive plans are in place for 
moving this research forward. We would like to request permission at this time to contact the 
intervention arm participants for this potential, future research if it comes to fruition.  
 
 
Description of Recruitment Methods, Randomization and Mailings 
 
When 
Task 
Who 
Description 
Day 0 
Send Invitation Packet 
Survey Research Program 
Mail hardcopy invitation letter, study 
insert, information sheet and $2 bill 
Day 5 
Call to recruit and first 
eligibility screen  
Survey Research Program 
Eligibility screen 
Day 5 
Mail Consent Packet 
Survey Research Program 
Mail cover letter and copy of consent 
form 
Day 10 
Pre-randomization screen 
and consent 
Study Research Specialist 
2nd eligibility screen, obtain oral 
consent, confirm PCP information, 
obtain web survey mode preference 
Day ~10-
28 
Baseline survey 
Participant/ Survey 
Research Program 
Participant takes baseline survey by 
web or phone 
Day ~10-
28 
Randomization 
Study Programmer 
Study team randomizes participants 
who complete their survey to either 
the intervention arm or the control 
arm 
Day ~14-
32 
Thank you letter 
Survey Research Program 
Mail thank you letter with 
randomization status and $20 
incentive 
Day ~14-
32 
Letter to PCP 
Study Team 
Mail letter to intervention participant’s 
PCP informing them of enrollment into 
intervention arm of STRIPE study 

 
Protocol Template 
(Use with Core Data Form) 
Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 17 of 46 
 
Revised 6/21/2018 
Day ~14-
32 
Intervention Welcome 
Study Team 
Mail intervention packet containing 
cover letter, participant workbook with 
appendices, audio files on CD and "The 
Pain Survival Guide."  
 
l. 
Informed Consent Process 
 
Describe how you will obtain and document consent, including: 
• 
Where, when and how the consent process will take place. 
• 
A process to ensure ongoing consent. 
• 
Steps that will be taken to minimize the possibility of coercion or undue influence. 
• 
Any steps that will be taken to ensure the subjects’ understanding. 
• 
If you will conduct screening or any other research procedures before obtaining full 
informed consent, describe this. 
For this study we will be collecting data and requesting different forms of consent and a waiver of 
HIPAA authorization for the following data collection activities. 
 
 
OVERVIEW OF CONSENT PROCESS: 
 
Please see the table below for an overview of the proposed consent and waiver of informed 
consent for this study. 
Data collection 
timepoint 
Informed Consent 
HIPAA Authorization 
 
Informed 
Consent 
Waiver of 
documentation of 
informed consent 
Waiver of 
informed 
consent 
HIPAA 
authorization 
Waiver of 
HIPAA 
authorization 
Sample 
identification via 
VDW 
 
 
X 
 
X 
Recruitment 
screening 
 
X 
 
 
No EMR data if 
ineligible 
Pre-randomization 
screening 
 
X 
 
 
No EMR data if 
ineligible 
Study enrollment 
 
X 
 
 
X 
 
All project activities are conducted through the mail, on the telephone or using a web-link for 
survey data collection. There are no in-person study activities, therefore this project is 
requesting a waiver of documentation of informed consent to: 
• 
Screen potential participants in two rounds for eligibility during recruitment. VDW data 
will be used to identify the potentially eligible sample.   
• 
Enroll participants into our study by sending a copy of the consent form and obtaining 
verbal consent (instead of signed consent) 

 
Protocol Template 
(Use with Core Data Form) 
Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 18 of 46 
 
Revised 6/21/2018 
 
For the screening steps (both for eligibility during recruitment calling and pre-randomization 
screening) the consent process will be as follows: 
• 
The study team will send potential participants a single invitation letter and an 
information sheet that describes both screening activities   
• 
For each screening telephone call, the study team will confirm the participant’s 
identity, provide an opportunity to answer any questions and obtain oral consent 
 
    For study enrollment the consent process will be as follows: 
• 
Consent will occur during the pre-randomized second screening telephone call  
o Prior to the call, the study team will send the participant a paper copy of 
the consent form and a cover letter  
o After and if the participant has screened eligible, the study research 
specialist will go over the consent form with the participant (using a script 
which will highlight all the key points) and obtain: 
 
Oral consent to participate in the study 
 
Approval/disapproval to allow the use of email for study 
communication 
 
Approval/disapproval to allow the study team to audio record 
telephone sessions (if the participant is chosen to be in the 
intervention arm) 
o The study team will track the consent outcomes (consented yes/no, use 
of email yes/no, and audio recording yes/no) in the project tracking 
database 
 
m. Waiver of Informed Consent  
Provide rationale and justification for the Waiver of Informed Consent for this study, including:  
• 
Does the proposed research present no more than minimal risk to the study 
participants?  
• 
How the waiver of informed consent will not adversely affect the rights and welfare of the 
participants. 
• 
Why this research cannot practically be carried out without a waiver of informed consent. 
• 
Whenever appropriate, the subjects will be provided with additional pertinent information 
after participation. 
 
We are requesting a waiver of documention of informed consent to screen and enroll subjects 
into the study. See below.   
 
 
 
 
n. Waiver of Documentation of Informed Consent  
Provide rationale and justification for the Waiver of Documentation of Informed Consent by 
identifying which of these two conditions applies and how.  

 
Protocol Template 
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Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 19 of 46 
 
Revised 6/21/2018 
1) The research involves no more than minimal risk to participants AND involves no 
procedures for which written consent is normally required outside of the research 
context.    
2) The signed consent document would be the only record linking the participants to the 
research, and the principal risk to participants would be potential harm resulting from a 
breach of confidentiality. 
We are requesting a waiver of documentation of informed consent to: 
 
• 
Screen potential participants for two rounds of eligibility during recruitment by sending an 
information sheet and obtaining verbal consent  
• 
Enroll participants into our study by sending a copy of the consent form prior to the pre-
randomization screening call and obtaining verbal consent (instead of signed consent) 
during that pre-randomization screening call after the participant has screened eligible.  
 
 
We believe that the proposed research presents no more than minimal risk to the study 
participants. Only persons directly involved in the study will have access to data. Each KPWA 
enrollee will be assigned a unique study identification number linked to his or her medical record 
number at KPWA. The crosswalk between the study identification number and each subject’s 
medical record number is maintained in electronic form, but separate from the analysis files. To 
create project analytic files the crosswalk between the study identification number and each 
subject’s unique medical record number will be re-established by the KP Washington research 
project programmer. We will use existing procedures to ensure that individual patient identifiers 
are kept separate from analysis files. All data necessary to complete this research will be 
created and stored in secure computers to which only project team participants will have 
access. No participant will be identified from any published manuscripts or reports generated 
from the proposed study. 
 
Additionally, all study activities are being conducted on the telephone and written consent 
cannot be obtained, we will do the following:  For eligibility screenings, we will send an 
information sheet and obtain verbal consent.  For enrollment into the study, we will send a copy 
of the consent form for participant’s review, obtain oral consent and track documentation of 
consent in our project tracking database.  
 
 
 
 
o. Alteration of Informed Consent  
Identify the required elements of informed consent that you wish to remove or alter. Provide 
justification for their removal or alteration. 
N/A 
 
p. Non-English-Speaking Subjects  
If subjects who do not speak English will be enrolled, describe how the consent discussion will 
take place and indicate if translated consent forms or short forms will be used. Confirm that an 
interpreter will assist with the initial consent process and subsequent study visits. 
N/A 

 
Protocol Template 
(Use with Core Data Form) 
Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 20 of 46 
 
Revised 6/21/2018 
 
 
 
q. Assent of Children and Parent Permission 
IMPORTANT NOTE: Consent may be obtained in certain situations.  For example, conducting 
family planning or sexually transmitted disease (STD) research.  In addition, for older children 
ages 16 and up who participate in an adult study, the consent document can be used in place of 
the assent document.   
 
Describe how you will obtain and document assent/parental permission, including: 
• 
Describe your plan for obtaining parent permission.  The permission of one parent is 
generally sufficient for minimal risk research, or for greater than minimal risk research if 
there is the potential for direct benefit to the child. 
• 
Note that for studies involving greater than minimal risk with no prospect of direct benefit 
to the child, permission of both parents is required unless one parent is deceased, 
unknown, incompetent, or not reasonably available, or when only one parent has legal 
responsibility for the care and custody of the child. 
• 
Describe whether permission will be obtained from individuals other than parents, and if 
so, who will be allowed to provide permission.  
• 
Indicate whether assent will be obtained and documented from all, some, or none of the 
children. If assent will only be obtained from some children (because of very young age, 
severe cognitive impairment, etc.), indicate which children will be required to assent and 
which will not. 
• 
When assent of children is obtained, describe whether and how it will be documented. 
• 
When subjects might reach the age of majority during the study, describe the plan to 
obtain consent from these subjects at that time using an adult consent form. 
N/A 
 
 
r. Adults Unable to Consent/Decisionally Impaired  
Describe the consent/assent process for Adults Unable to Consent/Decisionally Impaired, 
including: 
• 
Describe the process to determine whether an individual is capable of consent. 
• 
List the individuals from whom permission will be obtained in order of priority. (E.g., 
durable power of attorney for health care, court appointed guardian for health care 
decisions, spouse, and adult child.   
• 
Describe the process for assent of the subjects. Address the following: 
o Whether assent will be required of all, some, or none of the subjects. If assent 
will be obtained from some subjects, indicate which subjects will be required to 
assent and which will not. 
o If assent will not be obtained from some or all subjects, an explanation of why 
not. 
o When assent is obtained, describe how it will be documented.  
• 
Describe the plan to obtain consent if subjects might regain capacity to consent during 
the study. 
N/A 
 

 
Protocol Template 
(Use with Core Data Form) 
Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 21 of 46 
 
Revised 6/21/2018 
 
s. HIPAA Privacy Rule Authorization – if study will use or disclose Protected Health Information 
(PHI) 
Describe the plan to obtain a signed Privacy Rule Authorization from each subject. 
All participant contact will occur by mail, telephone or web (for those who elect to take their 
surveys on the internet) and we will not have the opportunity to obtain a signed HIPAA 
authorization form from each subject. We are requesting a waiver of HIPAA authorization.      
 
t. Waiver of HIPAA Privacy Rule Authorization  
If you will not obtain a signed HIPAA Privacy Rule Authorization, or include HIPAA authorization 
in the consent form, or if you want to eliminate any required language from the authorization, 
provide the following rationale and justification.  
• 
Why the research could not practicably be conducted without the waiver. 
• 
Why access to and use of the PHI is necessary for the research. 
• 
Why the use or disclosure of PHI for the research poses no more than minimal risk to 
the subjects' privacy (must have an adequate plan to protect the PHI from improper use 
or disclosure, a plan to destroy identifiers at the earliest opportunity consistent with the 
purpose of the research, and when applicable, written assurances from collaborators 
that PHI will not be reused or re-disclosed to any other entity). 
All study activities will take place over the telephone, mail or internet and we will not be able to 
obtain signed HIPAA authorization.  
 
For the following activities we are requesting a waiver of HIPAA authorization to: 
• 
Enrolling participants into the study by sending a copy of the consent form which contains 
the required HIPAA authorization language 
 
 
For the above activities, research could not practicably be conducted without a waiver because 
there are no plans for contacting participants in person.  Additionally, we cannot practicably 
identify the sample without a waiver. 
 
Access to and the use of PHI for this research is necessary because we need participant 
contact information to approach participants by mail and telephone. We also need dates 
(medication and enrollments) to correctly identify the sample. Finally, once on the phone, we 
need information such as name and birth date to confirm we have the correct person on the 
phone.  
 
The use and disclosures of PHI poses no more than minimal risk to the subject’s privacy. Only 
persons directly involved in the study will have access to data. Each KPW enrollee will be 
assigned a unique study identification number linked to his or her medical record number. The 
crosswalk between the study identification number and each subject’s medical record number is 
maintained in electronic form at each site, but separate from the analysis files. To create project 
analytic files the crosswalk between the study identification number and each subject’s unique 
medical record number will be re-established by the project programmer. We will use existing 
procedures to ensure that individual patient identifiers are kept separate from analysis files. All 
data necessary to complete this research will be created and stored in secure computers to 
which only project team participants will have access. When these files are created, the 

 
Protocol Template 
(Use with Core Data Form) 
Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 22 of 46 
 
Revised 6/21/2018 
crosswalk will be erased from all files and kept only by the programmer. No participant will be 
identified from any published manuscripts or reports generated from the proposed study.   
 
Once all data has been collected for this study, the crosswalk between the study identification 
number and each subject’s unique medical record number will be erased from all analysis files 
and stored in a file kept by each site’s project programmer. The project manager maintains a 
calendar that tracks destruction date information and will notify the programmer prior to the 
scheduled date for destruction. 
 
All linkages will be destroyed as early as is consistent with the research and no later than 
December 31, 2026 
 
 
 
 
 
 
u. RCW 70.02-Requirments to Access HIPAA Covered Data without Consent  
If you will not obtain HIPAA Authorization or Consent provide the following rationale and 
justification. Explain how the research: 
 
• 
Is of sufficient importance to outweigh the intrusion into the privacy of the patient that 
would result from the disclosure; 
• 
Is impracticable without the use or disclosure of the health care information in 
individually identifiable form; 
• 
Contains reasonable safeguards to protect the information from redisclosure; 
• 
Contains reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research project; and 
• 
Contains procedures to remove or destroy at the earliest opportunity, consistent with the 
purposes of the project, information that would enable the patient to be identified, unless 
an institutional review board authorizes retention of identifying information for purposes 
of another research project. 
 
 
This research is of sufficient importance to outweigh the intrusion into the privacy of the 
participant that would result from the disclosure because although some study participants may 
not benefit directly from this study, their participation may eventually be of help in understanding 
whether taper support helps patients taper their prescribed opioid medications, which is 
currently an important public health priority. 
 
We will have the following safeguards in place to protect the information from re-disclosure: 
 
Physical Controls: KPWA policies and procedures ensure controlled access to computers and 
physical space for secure storage of data and confidentiality information. Access to the 
KPWHRI building is restricted by locked doors and requires a key card to enter KPWHIR facility 

 
Protocol Template 
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Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 23 of 46 
 
Revised 6/21/2018 
always.  Any paper files with identifiers are required to be kept in locked filing cabinets. Keys are 
only provided to study staff once they are approved by the facilities and project managers. 
Technical Controls: Administrative, physical, and technical safeguards are employed to ensure 
the confidentiality, integrity, and security of electronic health information (45 CFR Part 160 and 
Subparts A and C of Part 164; 44 U.S.C. § 3541, et seq). At KPWA data will be stored on 
password protected computers in a network folder where only authorized study personnel are 
granted access. All access by staff person, date and time is logged. All computers are loaded 
with anti-virus software and security patches are deployed to staff computers automatically. 
Data will never be transferred to laptops, memory sticks or other mobile devices; our policy does 
not permit the storage of PHI on these devices.  
Administrative Controls: At KPWA, files are backed up on an hourly basis to a disk system and 
are not encrypted. Backup media are stored within KPWA data centers in Tukwila, Quincy and 
Liberty Lake (all within Washington State) to which only authorized staff have access. Data will 
be accessed via KPWA desktop computers which require staff to log on using their password. 
Data will be stored on KPWA’s SAN system, secured using NTFS file permissions. members. 
The data will be kept in a dedicated secure folder, separate from administrative 
datasets/records and will only be accessed by study team members. Collected data will be used 
only for this IRB approved study and will not be combined with any non-study administrative 
datasets/records. At project completion, the data will be archived with an automated, mandatory 
deletion date the sooner of 5 years from receipt of the data or December 31, 2026. Published 
data will not contain any individual identifiers.  
 
We could not practicably approach all participants for their written authorization because we are 
not conducting any study visits in-person.   
 
While aggregate data can be appropriate for certain study questions, collecting individual level 
data is necessary to conduct analyses that look at the relationship among variables. 
 
The use and disclosures of PHI poses no more than minimal risk to the subject’s privacy. Only 
persons directly involved in the study will have access to data. Each KPW enrollee will be 
assigned a unique study identification number linked to his or her medical record number. The 
crosswalk between the study identification number and each subject’s medical record number is 
maintained in electronic form at each site, but separate from the analysis files. To create project 
analytic files the crosswalk between the study identification number and each subject’s unique 
medical record number will be re-established by the project programmer. We will use existing 
procedures to ensure that individual patient identifiers are kept separate from analysis files. All 
data necessary to complete this research will be created and stored in secure computers to 
which only project team participants will have access. When these files are created, the 
crosswalk will be erased from all files and kept only by the programmer. No participant will be 
identified from any published manuscripts or reports generated from the proposed study.   
 
Once all data has been collected for this study, the crosswalk between the study identification 
number and each subject’s unique medical record number will be erased from all analysis files 
and stored in a file kept by each site’s project programmer. The project manager maintains a 

 
Protocol Template 
(Use with Core Data Form) 
Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 24 of 46 
 
Revised 6/21/2018 
calendar that tracks destruction date information and will notify the programmer prior to the 
scheduled date for destruction.  
All linkages will be destroyed as early as is consistent with the research and no later than 
December 31, 2026 
 
 
 
6. Study Procedures 
Describe and explain the study design, including: 
• 
Procedures to monitor subjects for safety, including who will review the data and at what 
frequency for safety issues. 
• 
Procedures performed to lessen the probability or magnitude of risks. 
• 
All drugs and devices used in the research and the purpose of their use, and their 
regulatory approval status. 
• 
The source records that will be used to collect data about subjects. (Attach all surveys, 
scripts, and data collection forms.) 
• 
What data will be collected including long-term follow-up. 
• 
The duration of an individual subject’s participation in the study. 
• 
The duration anticipated to enroll all study subjects. 
• 
The estimated date for the investigators to complete this study (complete primary 
analyses) 
NOTE:  It should be clear exactly which procedures will be conducted for the research as 
opposed to procedures the subjects would undergo (in the exact manner described in the 
protocol) even if they were not participating in the study. 
 
Describe procedures that will be followed when subjects withdraw from the research, including 
withdrawal from intervention but continued data collection. 
 
Describe any anticipated circumstances under which subjects could be withdrawn from the 
research without their consent.   
 
Describe any procedures for orderly termination. 
 
If the study involves genetic testing or collection of genetic information, describe this. 
 
 
 
Study Procedures – Intervention Arm and  Control Arm 
Sequential description 
 
 
As described in the recruitment section of this application, potential research participants are identified 
via the KPWHRI VDW by the KPWA programmer and sent a letter of invitation, a study information 
sheet, study insert, and a $2 incentive.  Five days after the invite letter is sent, the KPWA survey team 
calls subjects for the first screening.  Participants will be screened twice. First, they will be screened on 
basic eligibility criteria when the survey research program calls them to recruit. (See STRIPE screening 

 
Protocol Template 
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Form  
NCRSP HRP FORM KP-202, Version 1.0  
     KP WA Implementation Date: 07/23/2018 
Page 25 of 46 
 
Revised 6/21/2018 
script for screening questions.)  If the participant passes the first round of screening and is still 
interested, they will be scheduled for a second round of screening with a study research specialist.  
 
Prior to the call, the study team will mail the participant a copy of the consent form and a cover letter. 
During the second screening call, the research specialist will ask sensitive eligibility questions regarding 
recent intent to harm and recent psychiatric hospitalization. (see ”Pre-randomization script”  for 
sensitive eligibility screening script and questions).  If the participant passes this round of screening, the 
research specialist will administer and obtain oral consent. The participant will then be offered the 
baseline survey via phone or web. If phone is chosen, the participant will be asked if they would like to 
do the baseline survey now or schedule a time to complete it. If web is chosen, the research specialist 
will confirm the participants email address and email them a link to the survey. Reminder emails and/or 
phone follow-up will occur if subjects do not complete the baseline survey.   
 
Once the baseline survey is complete, we will randomize the participant into the intervention arm or the 
control arm. The study team wants participants to be randomized after the baseline survey out of 
concern that knowledge of status could affect a subject’s responses to questions and participation in 
the baseline assessment. We will send participants a thank you letter with their incentive upon 
completion of the baseline assessment that details which arm they were assigned to and next steps. 
 
 We anticipate the time from the letter being mailed to time of enrollment to be between 2-4 weeks. All 
invitation materials, consent forms, HIPAA authorization forms and scripts are attached in this package. 
 
 
 
 
After the baseline assessment and randomization, all participants will be asked to take two more 
surveys; 6 months after enrollment and 12 months after enrollment. The survey can be taken either in 
web form or on the telephone, administered by a survey research program telephone interviewer. With 
the 12 month phone or web survey reminder letter, all participants wil receive a $2 pre-incentive.  The 
survey will ask questions about physical health (including any experience with pain), mental health 
(depression and anxiety), and medication use.  All baseline, 6-month, and 12-month surveys including 
script are included in this packet. See Master Survey document for a list of the surveys to be 
administered at the three-time points. 
 
Additionally, all subjects enrolled in the intervention who choose to taper their opioids  arm will be 
asked to complete the two item Graded Chronic Pain Scale (GCPS) and the fourteen item Hospital 
Anxiety and Depression Scale (HADS) before each intervention telephone session. (See Measures for 
Intervention Arm only doc.). Surveys are attached in this package. The pre-visit GCPS and HADS will 
be completed  on paper (mailed with intervention packet materials) prior to the visit and read their score 
to the research interventionist at the beginning of the session.  
 
 
Activity  
Time Commitment 

 
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Read invitation packet 
 5 minutes 
1st screening call 
10 minutes 
Read consent packet and 
answer any questions 
10 minutes 
2nd screening call including 
consent and randomization 
20 minutes 
Baseline survey 
30 minutes 
Pre-visit GCPS and HADS for 
particpants who choose to 
taper 
5 minutes each visit 5-18 
Intervention arm study visit 1-
18 
30-60 minutes each visit 
6 month survey 
20 minutes 
12 month survey 
20 minutes 
 
We anticipate it will take 18 months to enroll all 250 study participants. Each participant will be followed 
for 12-months post randomization. 
 
Device/drug information 
N/A 
 
Secondary data: data, sources, and date range  
 
In addition to the primary data described above, secondary data to be collected on participants enrolled 
in both arms of the study are listed in the table below.  
 
Data from KP Washington  
 
Source (specify) 
(i.e., from KPWA, or from an 
existing or previous study) 
Key Information/Description of 
Variables 
Date Range 
 
 
 
 
 
 
KPWA data sources (VDW) 
Diagnoses via ICD codes and dates of 
code: Comorbidities (comorbidity indices 
and the individual constituent diseases), 
mental health disorders (e.g. depression, 
anxiety), substance use disorders (e.g. 
opioid use disorder, alcohol use 
disorder, tobacco use disorder, cannabis 
use disorder, stimulant use disorder), 
2016-2022 

 
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Revised 6/21/2018 
 
 
 
 
DIRECT IDENTIFERS 
 Names 
 Dates 
 Postal address  
 Geocode  
 Phone numbers 
 Fax numbers 
 Email address 
 Social Security Numbers 
 Medical record numbers 
 Health plan numbers 
 Account numbers 
 License/Certificate numbers 
 Vehicle ID numbers 
 Device identifiers/Serial numbers 
 Web URLs 
 IP address numbers 
 Biometric identifiers (e.g., 
finger prints, voice prints, 
retina scans) 
 Facial Photos/Images 
 CHS ID 
 Other unique identifier(s): 
 
Alternative treatment(s) and/or denied treatment 
N/A 
Deception/incomplete disclosure 
N/A 
Incidental findings 
N/A 
 
Procedures to monitor, lessen or mitigate risk 
There are several study design features that lessen or mitigate risk: 
cancer, suicidal ideation, and pain 
including site of pain 
KPWA data sources (VDW) 
Social history table variables for alcohol 
use and tobacco use 
2016-2022 
KPWA data sources  (VDW) 
Health plan enrollment information  
(start and stop dates) 
2016-2022 
KPWA data sources (VDW) 
Health care utilization including:  
outpatient, inpatient,, emergency 
department 
2016-2022 
KPWA data sources (VDW) 
Medication orders and pharmacy 
dispensings including dates  
2016-2022 
KPWA data sources (VDW) 
Laboratory tests and results  
2016-2022 

 
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Revised 6/21/2018 
• 
Participants assigned to the control group may be disappointed with their assignment. 
We are providing incentives for completing 6 and 12 months surveys for both groups to 
improve retention in the trial. 
• 
Participants may be embarrassed or psychologically distressed at the survey questions, 
they are told that they can skip any questions they do not want to answer 
• 
Breach of confidentiality is a potential risk. See section 5u for a description of the various 
controls set in place to safeguard data security.  Additionally, staff are trained on best 
practice privacy and confidentiality measures.  
• 
The study will have a plan in place to handle Critical Incidents, when a participant 
endorses intent to harm themselves or others. Although, we anticipate this to be rare, we 
would like to be prepared in the event that a participant spontaneously endorses intent 
to harm. The research specialist and research interventionist  will administer the 
Columbia Suicidality Severity Rating Scale. After determining the score, the research 
interventionist will take the appropriate steps to triage the participant per the study 
protocol.  (see CI procedures for Columbia Suicidality Severity Rating Scale and general 
CI procedures). Additionally, the research specialist and research interventionist will be 
supervised by a KPW licensed clinical psychologist. Dr. Ben Balderson is KPWA mental 
health provider. All critical incidents will be reviewed by the study psychologist.  
• 
A data use agreement will be in place to share study data with investigators at the 
University of Washington 
 
 
Subject drop out or withdrawal procedures 
If a subject drops out or we withdraw them from the study, the study team will: 
• 
Update the tracking database to indicate that no further patient-self report data collection 
or participant contact will occur. They will not be asked to complete any more surveys. If 
we withdraw the participant from the study, we will send them a letter notifying them that 
they are no longer enrolled in the study.  
• 
We will continue to use the data they have already contributed/agreed to allow us to use 
per their consent for analyses 
• 
 All participants using buprenorphine for treatment of OUD will be withdrawn from the 
entire study. We may learn about buprenorphine use from the screening survey or as 
indicated in VDW medication dispensing data ascertained prior to the analyses. Primary 
data collection will cease and they will not be included in analyses. This is an exclusion 
criteria.  
• 
All pregnant women will be withdrawn from the study entirely. Primary data collection will 
cease and they will not be included in analyses. Pregnancy status will be determined via 
a screening question and diagnosis codes from the VDW for subjects in both study arm 
prior to analyses. We expect very few young women to be in the study due to the 
average age of chronic high dose opioid users at KP. 
 
  
Anticipated study end date 
The anticipated study end date for the completion of primary analyses will be on or before December 
31, 2021 
 
 

 
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Study Procedures – Intervention Arm  
 
Sequential description  
 
 
 
After subjects are randomized into the intervention arm, they will receive a letter with their 
randomization status, intervention packet, and then begin having telephone visits with the study 
research interventionist . The study team will send a letter to the participants PCP noting their 
participation in the pain self-management training arm of the trial. Prior to their first telephone call we 
will send participants a packet containing, “The Pain Survival Guide” https://www.amazon.com/Pain-
Survival-Guide-Reclaim-LifeTools-ebook/dp/B0029KHTK8, a CD containing audio files of relaxation  
techniques and participant workbook that includes the various exercises for each visit along with  
GCPS and HADS questionnaires to administer before each telephone visit.  Participants can opt to 
receive and take the GCPS and HADS questionnaires on the web if they choose.  The workbook, CD 
and questionnaires are included in this package. Additionally, we are working on creating a study 
website that will host the audio files. 
 
A description of each telephone visit, the timing of the visit and the duration of the visit is described in 
the following table. See the “Clinician Manual” for details on the content for each session. 
 
Session 
number 
Week 
(from 
random-
ization) 
Session content 
Duration 
1 
1 
Overview of intervention and sessions, education regarding benefits of pain coping skills 
training and collaborative nature of treatment.  
Identification of treatment goals. Instruction and practice in diaphragmatic breathing.  
Personal action plan introduction.  
Review of study team contacts  
Review pre-visit GCPS and HADS assessments to be done prior to each subsequent 
session  
60 mi 
2 
2 
 Diaphragmatic breathing review and practice. Education regarding rationale for and 
benefits of relaxation techniques, introduction to 7-muscle group tense-release 
progressive muscle relaxation.  
30 min 
3 
3 
Pain neuroscience education and rationale for cognitive and behavioral techniques for 
managing pain.  Education about and discussion of harm and fear-avoidance beliefs. 
Home assignment: watch two videos and read article about patient opioid taper 
experiences. 
30 min 
4 
4 
Motivational interviewing: elicit history of opioid use and views about tapering, provide 
education about long-term opioid therapy risks and scientific evidence for benefits, 
discuss and problem-solve barriers to tapering. Education about withdrawal symptoms. 
--debriefing of subject after viewing videos at home of patient experiences tapering off 
opioids. 
--If interested in taper, subject instructed to make appointment with primary care provider 
at the time of their next opioid refill to discuss taper and subject informed interventionist  
will communicate with PCP about this, as well as with the study PI, a psychiatrist with 
expertise in pain, who will review their medications and may make suggestions about their 
medications. To be asked at subsequent sessions if patient is not interested in tapering 
starting at session 4.  
-- If pt interested in taper, interventionist  provides to Study PI information on EHR 
diagnoses, pain rating (graded chronic pain scale - GCPS), anxiety and depression score 
45 min 

 
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(HADS). After consultation with Study PI Dr. Sullivan, interventionist  provides guidance to 
primary care provider about taper discussion, opioid taper plan, and initiation or 
adjustment of non-opioid medications to relieve pain, anxiety, depression, insomnia. See 
Taper Guidelines for details. 
--If not interested, interventionist  will ask about interest at subsequent sessions as 
deemed appropriate. 
5 
5 
Education about relationship between sleep and pain, sleep hygiene, and cognitive and 
behavioral strategies for improving sleep.  
30 min 
6 
6 
Review of cognitive and behavioral skills taught to date, and application to daily life to 
manage pain and stress. Concept that hurt ≠ harm.  
30 min 
7 
8 
Education about benefits of activity pacing. Development of individual activity pacing plan 
for the participant.  
30 min 
8 
10 
Coping with pain flare-ups: development of personal pain coping plan.  
30 min 
9 
12 
Instruction and practice in 4-muscle group tense-release progressive muscle relaxation 
30 min 
10 
14 
Instruction in and practice of 4-muscle group progressive muscle relaxation without 
tensing. 
30 min 
11 
18 
Education about coping self-statements and identification of helpful coping self-
statements for the individual participant.   
30 min 
12 
22 
 Distraction as a pain coping skill.  
30 min 
13 
26 
Instruction and practice in body scan technique. 
30 min 
14 
30 
Instruction and practice in mini-relaxations. 
30 min 
15 
34 
Review and practice of mini-relaxation, and application to daily situations of increased 
pain or stress.   
30 min 
16 
38 
Education about importance of pleasurable activities, identification of pleasurable and 
meaningful activities for the individual participant, education about goal setting, 
pleasurable activity goal-setting. Review of daily plan and pain coping flare-ups plan; 
refinement and revision as necessary. Pain coping skills review.  
30 min 
17 
42 
Review of pain coping skills learned in this program. Education about maintenance of 
gains and relapse prevention. 
30 min 
18 
46 
Skills summary, final plan for maintaining gains and managing setbacks and pain flare-
ups. Discussion of participant’s thoughts about this being the last session, and reminders 
of next steps in the research. 
30 min 
 
Note: The first 6 sessions are weekly. The next 4 sessions are biweekly. The remaining sessions are 
monthly. For participants who are tapering their opioid dose, each session will include discussion of 
how that is going and how the pain coping skills might be used to manage pain and any other 
symptoms experienced. Each session includes home activity assignments for reading (The Pain 
Survival Guide and participant workbook) and coping skills practice (personal action plan) and review of 
experiences with the previous week’s assignments. Each session also includes identification of 
obstacles or challenges to completing the home activity assignments and problem-solving ways to 
overcome these. Intervention participants will be provided a workbook, The Pain Survival Guide, 
access to audio files of relaxation exercises, and access to two videos of patient interviews. 
 
Primary Data Collected on the Intervention  
During each telephone session, the research interventionist will track the phone sessions into the 
project REDCap tracking data base hosted at KPWA. The information captured at the visits includes: 
• 
Date of the phone visit 

 
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• 
Whether or not the participant attended their scheduled appointment 
• 
Check boxes for session content that was covered during the visit 
• 
Any critical incidents (intent to harm oneself or other) 
• 
Any adverse events 
• 
Detailed notes on the visit 
• 
Amount of time spent on each visit 
• 
HADS and GCPS score ( score read to interventionist and entered into REDCap at the 
beginning of each session for participants who choose to taper) 
At the fourth study visit, the research interventionist will ask participants if they want to taper their opioid 
dosing.  If the participant declines to taper, they will proceed with the rest of their pain self-management 
sessions and follow-up surveys. If a participant expresses interest in tapering, the interventionist will 
recommend medication taper suggestion to the participant’s PCP using Epic Telephone Encounters. 
We will provide taper support at a later date if they prefer to delay the taper or resume paused tapers. 
Patients will be allowed to pause tapers (i.e., put the taper on hold) for any reason including the need to 
escalate opioid dose (e.g., surgery requiring additional pain management). Patients delaying or pausing 
tapers will still continue to receive the pain self-management training. Participants will be informed of 
the risk of stock-piling opiates during the taper process. The research interventionist may need to 
consult with Dr. Sullivan, the study research physician on complicated tapering scenarios. Dr. Sullivan 
will have Epic read only access to review the medical records of any difficult tapering sessions to 
provide guidance to the research interventionist. The guideline for tapering was developed by Dr. 
Sullivan (UW psychiatrist and Principal Investigator),and is attached. The guidelines were reviewed by 
Dr. Sarah Levy (KP Medical Director, Continuum of Care), Dr. Angela Sparks (Family Medicine 
Physician and Medical Director, Clinical Knowledge Development and Support), Dr. Khushboo Mehta 
(Family Medicine provider, Program Chief of Family Medicine, study Co-Investigator) and Melissa 
Sturgis, PharmD, BCACP (Pharmacy Clinical Coordinator, Quality and Clinical Operations).  This taper 
guideline is consistent with KPWA guidelines for COT tapering.   
Prior to opioid tapering, the research interventionist  will follow the Communication Plan for points to 
cover with both the patient and provider.  
A random sample of the intervention visits will be chosen for quality assurance activities. We will send 
audio files of the visit to Dr. Turner at the University of Washington using the KPW secure file transfer 
site. The purpose of the QA is to ensure the research interventionist  is conducting the telephone visits 
correctly according to protocol.  During the telephone visit, the research interventionist will inform the 
participant that they will not use the participant’s full name in session and the recordings will be labeled 
with a study id and date; not their name.  
Primary Data Collected on Opioid Tapering for a Subgroup of Patients Electing to Taper 
During the opioid taper, Dr. Sullivan will be responsible for managing the tapering plan.  
The research interventionist will meet with Dr. Sullivan weekly and  together they will track specifics 
about the taper into the project REDCap tracking data base hosted at KPWA. This data will come from 
the patient and provider interactions and the electronic medical record. The information captured in 
REDCap at the visits that are specific to tapering includes: 
• 
Details on the taper each week 

 
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o Taper start date 
o Current opioid medication(s) name and dose per day in morphine equivalents 
o Taper recommendations: opioid taper plan, specific opioid taper recommendations (see 
Taper Guidelines)  
o Other medication recommendations:  drug name and dose (see Taper Guidelines and 
KPWA guidelines) 
o Provider implemented recommendations for taper: yes, no, no response 
o Provider implemented recommendations for supportive medications for the taper: yes, 
no, no response 
o Taper paused (i.e., put on hold) (yes, no) 
 
Reason for pause (dose escalation, patient preference, provider preference, 
pain, other symptoms, etc.) 
o Taper resumed (yes, no, date) 
Device/drug information 
N/A 
 
Secondary data: data, sources, and date range  
 
Additional secondary data other than what is described in the “Study Procedures – Intervention Arm 
and Control Arm” will be collected and entered into REDCap on participants enrolled in the intervention 
arm as outlined in the table below. 
 
Data from KP Washington  
 
 
 
DIRECT IDENTIFERS 
Source (specify) 
(i.e., from KPWA, or from an 
existing or previous study) 
Key Information/Description of 
Variables 
Date Range 
KPWA data sources (Epic) 
Current problem list  
2018-2021 
KPWA data sources (Epic) 
Current medication list  
2018-2021 

 
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 Names 
 Dates 
 Postal address  
 Geocode  
 Phone numbers 
 Fax numbers 
 Email address 
 Social Security Numbers 
 Medical record numbers 
 Health plan numbers 
 Account numbers 
 License/Certificate numbers 
 Vehicle ID numbers 
 Device identifiers/Serial numbers 
 Web URLs 
 IP address numbers 
 Biometric identifiers (e.g., 
finger prints, voice prints, 
retina scans) 
 Facial Photos/Images 
 CHS ID 
 Other unique identifier(s): 
 
 
 
Alternative treatment(s) and/or denied treatment 
N/A 
Deception/incomplete disclosure 
N/A 
Incidental findings 
N/A 
 
Procedures to monitor, lessen or mitigate risk 
There are several study design features that lessen or mitigate risk: 
• 
Participants may be embarrassed or psychologically distressed at some of the survey 
questions, they are told that they can skip any questions they do not want to answer 
• 
Breach of confidentiality is a potential risk. See section 5u for a description of the various 
controls set in place to safeguard data security.  Additionally, staff are trained on best 
practice privacy and confidentiality measures.  
• 
Participants may feel increased pain while they are tapering.  If the participant 
experiences increased pain due to the condition for which they are on COT, the research 
interventionist may consult with Dr. Sullivan and the participant’s PCP to evaluate and 
provide assistance.   
• 
While very unlikely with the planned gradual taper, participants may experience opioid 
withdrawal and can call the research interventionist  to discuss these symptoms. The 
research interventionist  will consult with Dr. Sullivan (PI) and work closely with the 
participant’s PCP to recommend medications to provide comfort from withdrawal 
symptoms.  
• 
The study will have a plan in place to handle Critical Incidents, when a participant 
endorses intent to harm themselves.  The research interventionist (PA) will administer 
the Columbia Suicidality Severity Rating Scale.  After determining the score, the 
research interventionist will take the appropriate steps to triage the participant per the 
study protocol and KPWA guidelines.  Additionally, the research interventionist will be 
supervised by a KPW licensed clinical psychologist.  All critical incidents will be reviewed 
by the study psychologist.  The protocol for handling critical incidents is including in this 
package.  
• 
A data use agreement will be in place to share study data with investigators at the 
University of Washington 

 
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Revised 6/21/2018 
 
 
Subject drop out or withdrawal procedures 
If a subject drops out or we withdraw them from the study, the study team will: 
• 
Update the tracking database to indicate that no further patient-self report data collection 
or participant contact will occur.  
• 
We will continue to use the data they have already contributed/agreed to allow us to use 
per their consent for analyses 
• 
We will not ask them to complete any additional surveys or attend study visits (if 
applicable) 
 
In rare instances, the study PI’s may decide to withdraw a participant from the study and analyses. The 
reasons for removing participants from the study and analyses would be:  
• 
Concern about data validity. Examples of the types of scenarios are when a participant’s 
behavior indicates that they may not be answering questions truthfully either due to 
deceit, they are high on drugs during their scheduled visit or there is a medical condition 
like narcolepsy that makes it difficult for them stay awake during their scheduled 
appointment. 
o The research interventionist  would bring concerns about data validity to the 
study team and the PI would make the determination on whether to withdraw or 
not. The study team will send them a letter informing them of their withdrawal. 
 
• 
 All participants using buprenorphine for treatment of OUD will be withdrawn from the 
entire study. Primary data collection will cease and they will not be included in analyses. 
While buprenorphine is a partial opioid, it is indicated for the treatment of opioid use 
disorder and rarely if ever used to treat pain at KPWA. Patients treated with 
buprenorphine for OUD are complicated and are either no longer on other opioids or 
being tapered off other opioids by the provider treating their OUD. They are not part of 
our study population of interest and thus buprenorphine use is both an exclusion criteria 
and reason for being withdrawn from the study.  
o If the research interventionist  learns that the participant is taking buprenorphine 
for OUD, they would bring that information to the study team and the PI would 
withdraw the participant from the study. The study team will send them a letter 
informing them of their withdrawal.  
o Similarly, patients in both the intervention and control arm will be removed from 
the entire study and analyses if they are using buprenorphine as indicated in 
VDW medication dispensing data ascertained prior to the analyses. 
• 
All pregnant women will be withdrawn from the study entirely. Primary data collection will 
cease and they will not be included in analyses. Pregnancy status will be determined via 
diagnosis codes from the VDW for subjects in both study arm prior to analyses.  The 
research interventionist  may also learn of pregnancy through the EMR, PCP, or self-
report from the participant. We expect very few young women to be in the study due to 
the average age of chronic high dose opioid users at KP. 
 
 
 
Anticipated study end date 

 
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The anticipated study end date for the completion of primary analyses will be on or before December 
31, 2021 
 
Study Procedures –Control Arm 
 
Sequential description  
Participants randomized to the control arm (i.e. usual care only) will not receive any intervention visits. 
They will only complete the three surveys described above in the “Study Procedures – Intervention Arm 
and Control Arm” section.  
 
Device/drug information 
N/A 
 
Secondary data: data, sources, and date range  
N/A – no additional data other than what is described in the “Study Procedures – Intervention Arm and 
Control Arm” will be collected.  
 
Alternative treatment(s) and/or denied treatment 
N/A 
Deception/incomplete disclosure 
N/A 
Incidental findings 
N/A 
Procedures to monitor, lessen or mitigate risk 
N/A 
Subject drop out or withdrawal procedures 
If a subject drops out or we withdraw them from the study, the study team will: 
• 
Update the tracking database to indicate that no further patient-self report data collection 
or participant contact will occur. 
 
Anticipated study end date 
The anticipated study end date for the completion of primary analyses will be on or before December 
31, 2021 
 
a. Data Analysis  
Describe the data analysis plan, including: 
• 
Statistical procedures.  
• 
When applicable, the power analysis.  
• 
Any procedures that will be used for quality control of collected data. 
We will use descriptive statistics to characterize the sample at baseline. To address the trial’s 
effectiveness aims, we will use an intent-to-treat approach (i.e., individuals will be analyzed 
according to randomized group regardless of participation in any opioid taper support sessions). 
We will also use a complete case analysis (i.e., that includes those participants who have 
observed follow-up outcome data) since we expect at least 85% follow-up at 12 months (primary 
time-point).  

 
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To compare each of the primary outcome measures (opioid dose and PEG score) between 
intervention groups the following linear regression model will be constructed: 𝐸𝐸൫𝑌𝑌𝑖𝑖𝑖𝑖൯= 𝛽𝛽0 +
𝛽𝛽1𝑇𝑇𝑇𝑇𝑇𝑇𝑖𝑖+ 𝛽𝛽2𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑗𝑗+ 𝛽𝛽3𝑇𝑇𝑇𝑇𝑇𝑇𝑖𝑖𝑥𝑥𝑥𝑥𝑥𝑥𝑥𝑥𝑥𝑥𝑗𝑗+ 𝛼𝛼𝑧𝑧𝒁𝒁𝑖𝑖, where 𝑌𝑌𝑖𝑖𝑖𝑖 is the outcome for person i at time j (j=6 or 
12 months), 𝑇𝑇𝑇𝑇𝑇𝑇𝑖𝑖 is the dichotomous intervention effect of interest (with control arm as the 
referent group), 𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑗𝑗 is the dichotomous variable indicating the 6- or 12-month time point, 
𝑇𝑇𝑇𝑇𝑇𝑇𝑖𝑖𝑥𝑥𝑥𝑥𝑥𝑥𝑥𝑥𝑥𝑥𝑗𝑗 is the interaction between the treatment and time point indicators and 𝒁𝒁𝑖𝑖 is a vector 
of baseline covariates that we a priori plan to adjust for including age, gender, baseline opioid 
dose group, whether they were referred to COMET, and KPWA clinic. We will include both 6- 
and 12-month time-points in a single model to improve statistical efficiency, but the12-month 
time point is considered primary.  We will fit the linear regression model using GEE with robust 
standard errors to account for the multiple time points in a single model. We will use two-sided 
tests at the 0.05 level. Arguments against adjusting for multiple comparisons for two co-primary 
outcomes have been made by Rothman and others.( Rothman KJ. No adjustments are needed 
for multiple comparisons. Epidemiology. 1990;1:43–46) For each outcome, we will report the 
adjusted mean difference between treatment groups and its 95% confidence interval.  
 
A set of comparable linear regression models will be fit for continuous secondary outcomes. For 
dichotomous secondary outcomes, similar models will be built using a modified Poisson 
regression framework with a robust sandwich estimator to estimate adjusted relative risks and 
95% confidence intervals. In addition, for each outcome, we will conduct a sensitivity analysis 
that further adjusts for baseline factors that are predictive of the outcomes, predictive of the 
probability of being missing at follow-up, or found to be significantly different between treatment 
groups. If more data are missing than expected (i.e., <85% with follow-up), we will also conduct 
a sensitivity analysis using an imputation method for non-ignorable non-response to evaluate 
whether our results are robust to different missing data assumptions. Selection bias analyses 
will compare demographic and clinical data of non-responders (potentially eligible per VDW and 
unreachable for recruitment) with responders (enrolled) using chi square and t-tests. This will 
allow us to identify factors associated with non-response. Secondary analyses will be conducted 
to assess for subgroup heterogeneity of treatment effects across levels of these pre-specified 
baseline variables: SUD+ vs SUD-, MH+ vs MH-, <90mg. vs >90mg MED, opioids with 
sedatives vs without, and focal pain vs multifocal pain. Heterogeneity will be indicated by a 
significant test of the interaction between treatment and each baseline variable, and subgroup-
specific treatment effects with confidence intervals will be reported. In light of multiplicity and 
reduced power, these results of these analyses will be interpreted cautiously. 
 
Sample Size:  
Our sample size is designed to ensure that we are highly powered to detect a clinically 
meaningful difference in the co-primary outcomes of opioid dose and pain (PEG) at 12 months. 
With 172 participants (86 per intervention arm) we will have >90% power to detect a 20mg 
mean difference in opioid dose between intervention groups assuming a 34 mg SD (based on 
data from KPWHRI participants meeting entry criteria) and a two-sided, two-sample equal-
variance t-test.  Assuming the mean baseline dose in our study population to be 67mg MED, 
this 20mg difference represents a clinically meaningful 30% reduction. Further, given our 

 
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sample size of 172 participants we will have approximately 90% power to detect a 1.2 point 
difference in the PEG between intervention groups, assuming a standard deviation of 2.5.  To 
ensure adequate power given potential loss to follow-up we inflated our final sample size by 
25% yielding a target randomization of 215 participants. This will also allow some pre-specified 
sub-group analyses to look for heterogeneity of treatment effect, as described below. Sample 
and power calculations were conducted using PASS software Version 14. 
 
 
 
b. Sharing of Results with Subjects 
Describe whether results (study results or individual subject results, such as results of standard 
or research lab tests and genetic tests) will be shared with subjects or their providers. 
 
 
If the study carries a risk of incidental findings, describe your plan for evaluating these and 
determining whether and how subjects or their providers will be given this information. 
 
 
 
If laboratory results will be shared with subjects or their healthcare providers, verify that the 
laboratory conducting the test is Clinical Laboratory Improvement Amendments (CLIA) certified. 
We will not be sharing study results with participants 
 
We will be communicating some study information with providers, however we will not be 
sharing study results with the provider 
• 
If a participant is enrolled in the intervention arm, the provider will be notified of their 
participation by the study team 
• 
The research interventionist  will pass provide a medication recommendation to the PCP 
using Epic Telephone Encounters. Additionally, any study information that is collected as 
part of the telephone visit which the research interventionist feels may be important to 
either support the taper or supplements clinical care may be shared with the provider.  
This will continue through the course of the taper for patients electing to try the taper 
support. 
 
 
c. Data and/or Specimen Banking 
Indicate if specimens may be used for future research and whether that may include genetic 
research.  
 
State if data or specimens will be sent to a separate repository. If data or specimens will be 
banked in a repository for future use as part of this protocol submission address the following 
questions: 
• 
What will be banked and what identifiers will be associated with the data or specimens? 
• 
Where and how will the data or specimens be stored? 
• 
For what purpose will the data or specimens be used? 
• 
How will the data or specimens be accessed, and who will have access? 
• 
Describe the procedures to release data or specimens, including the process to request 
a release, approvals required for release, who can obtain data or specimens, and the 
data to be provided with specimens. 

 
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N/A we will be not banking data or specimens for this project 
 
 
 
7. Privacy, Confidentiality and Data Security 
Describe the steps that will be taken to protect subjects’ privacy during recruitment, consent and 
study procedures. 
Recruitment, Screening and Consent 
During all recruitment, screening and consent telephone calls, the study team will confirm the 
identity of the participant by asking for their full name and DOB.  All recruitment and screening 
calls will take place in the Kaiser Permanente Washington Health Research Institute (KPWHRI) 
offices; this ensures that work computers are secure and assumes that surrounding colleagues 
are trained in standard research privacy and confidentiality procedures.  We will use REDCap 
hosted at KPWA to collect patient reported data and intervention visit data; it is 21 CFR Part 11, 
FISMA, and HIPAA-compliant. 
 
Intervention 
All intervention telephone visit calls will be made at KPWHRI offices (see above). Intervention 
study visit information will be collected using REDCap which is 21 CFR Part 11, FISMA, and 
HIPAA-compliant. 
 
 
a. Describe the plan for storage of data and/or specimens. 
• 
Who will have access and how. 
• 
Where the data/materials will be stored and for how long. 
• 
What identifiers will be included. 
• 
Any other steps that will be taken to ensure security (e.g., training of staff, authorization 
of access, password protection, encryption, physical security, and separation of 
identifiers from data and specimens, certificates of confidentiality). 
• 
Describe the plan to deidentify data, destroy data, or retain/archive data at the end of the 
study. 
Analytic study data will be stored at KPWA indefinitely. The linking file and files with PII needed 
for recruitment and participant contact (names, DOB, address, telephone number, email) will be 
stored at KPWA on the project G: drive and then destroyed by 12/31/2026. Analytic data files 
will be stored on the project G: drive. REDcap will be stored on KPWA servers while data 
collection is ongoing.  When REDCap data collection has been completed, QA’ed and cleaned, 
that data will be exported to the project G: drive and merged with other data sources to create 
the analytic dataset. Data will be accessible to the study team whose access is controlled by the 
study project manager and Dr. Boudreau. 
 
Additional steps to ensure data security include:  
• 
All KPWA staff are required to have current Human Subjects Research Training 
• 
All KPWA staff are required to have privacy and confidentiality training when they 
onboard employment 
• 
All KPWA computers are password protected in secure office building where workspace 
is accessible by key cards 

 
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• 
REDCap access requires a study specific URL to access it and requires a user 
login/password to authenticate and login 
o REDCap is 21 CFR Part 11, FISMA, and HIPAA-compliant. 
• 
The project has a Certificate of Confidentiality from the National Institutes of Health  
 
 
b. Collection of data from subjects electronically 
If you will collect any data from participants electronically (including email, website, etc.), 
explain: 
• 
How the data will be collected. 
• 
How the information will be secured (encryption, password protection, etc.; may require 
consultation with IT department). 
• 
Any risks to the participants’ privacy posed by using these methods (describe in consent, 
as applicable). 
• 
How you will verify the participant’s identity. 
Participants who elect to take their surveys (at baseline, 6 and 12 months) on the internet 
will complete their survey in REDCap.  
 
When the participant’s survey is due (at baseline, 6 and 12 months) the system will trigger 
an email that sends a link that is specific to the individual recipient.   
 
Similarly, in the intervention arm, participants who elect to take their pre-visit GCPS and 
HADS surveys on the internet will be emailed a link to take the surveys online. (See “Master 
Survey Doc”) 
 
There will be no further authentication steps to verify the participant’s identity.  
 
As stated in above sections, there are many technical, physical and administrative 
safeguards in place for both REDCap and the servers that REDCap is stored at KPW.  
 
The consent form adequately explains the risks of using email for study research and asks 
participants to opt-in or out of receiving study emails for web survey administration.  
 
 
 
c. Does this study involve the disclosure of PHI to a collaborator? 
If any data will be sent outside of this site, list each recipient (may list by role or category if the 
information is the same for several different entities).  For each recipient, describe: 
• 
What will be sent. 
• 
Whether the information will be fully identifiable (PHI, if health information), a Limited 
Data Set, de-identified, or aggregate. 
• 
How the data/materials will be transferred securely (for instance, Secure File Transfer). 
This study will disclose PHI to the University of Washington; Drs. Sullivan and  
Turner.  
 
We will send audio files of intervention sessions to Dr. Turner and these files may contain PHI. 
 
 

 
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Additionally, Drs. Sullivan and Turner will receive dates, such as medication dispensing dates, 
intervention visit dates, and diagnosis dates. 
 
The information sent to Drs. Sullivan and Turner will be in the form of 1) a limited data set during 
analyses and 2) the participant tracking database in REDCap, where Dr. Sullivan will be able to 
view the intervention visit information for each participant and PII will not be displayed/made 
visible to him. He can view the data in REDCap, but cannot export it.  
 
Dr. Sullivan will have EPIC read only access. He will access EPIC from the KPWHRI hotel 
stations, inside the KP firewall.  
 
With regard to data transfer security, analytic datasets and audio files will be transferred to Drs. 
Sullivan and Turner using the KPWA secure file transfer site (SFTS). This SFTS is housed on 
KPWA servers. Main analyses will occur at KPWHRI. 
 
When the audio files are transferred to Dr. Tuner at UW, she will store the files on a UW 
network drive on her UW office computer. This resides inside the UW firewall.  Physically, this 
computer resides at Dr. Turner’s personal office which is kept locked when she is not present. 
The computer is password protected and meets all UW Medicine and UW regulations and 
policies.  The UW has security controls in place to prevent the unauthorized access and 
monitors for unauthorized access.  
 
With regard to the participant tracking database, REDCap is also housed on KPWA servers. 
 
 
8. Provisions to Monitor Data to Ensure the Safety of Subjects 
This is required when research involves more than Minimal Risk to subjects. 
 
The plan might include establishing a data monitoring committee and a plan for reporting data 
monitoring committee findings to the IRB and the sponsor. 
Describe: 
• 
Who will monitor the study data for safety? 
• 
The plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe. 
• 
What data are reviewed, including safety data, untoward events, and efficacy data. 
• 
How the safety information will be collected (e.g., with case report forms, at study visits, 
by telephone calls with participants). 
• 
The frequency of data collection, including when safety data collection starts. 
• 
The frequency or periodicity of review of cumulative data. 
• 
Criteria for taking action on monitoring findings (for instance, stopping rules, immediate 
suspension, reporting, protocol changes, changes to monitoring frequency or plan). 
• 
For studies monitored by a DSMB/C, describe the committee membership and structure, 
meeting format, and quorum requirements.  Upload the board/committee charter, if one 
exists. 
 
To monitor risks of the interventions and any need to stop the trial early, we have will create a 
Data Safety Monitoring Committee (DSMC).  This committee will be composed of Dr. David 

 
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Tauben (general internist and Head of the Pain Division of the Department of Anesthesiology 
and Pain Medicine at the University of Washington), Dr. Jane Ballantyne (anesthesiologist and 
pain medicine expert practicing at Harborview Medical Center in Seattle) and Dr. Joan Russo, a 
biostatistician and Associate Professor, Psychiatry and Behavioral Sciences, University of 
Washington, with experience in data analysis and design of RCTs.  Dr. Tauben will serve as the 
chair of the committee while Drs. Ballantyne and Russo will be members. This committee will 
meet during the pre-intervention phase and annually to review the protocol, data collection and 
data completeness.  A quorum is defined as all three members of the committee being present.  
 
The research specialist and research interventionist and project manager will monitor AEs and 
severe adverse events (SAEs) as they interact with study participants. They will be documented 
in the study tracking database.  These will be reviewed with Drs. Sullivan and Boudreau during 
monthly study meetings. AEs and SAEs will be reported to the KPW IRB according to the timing 
summarized above. AEs will be forwarded monthly and SAEs will be forwarded weekly to the 
DSMC.  
 
Progress in enrollment and data collection will be reviewed on a bi-weekly basis using study 
status reports and status report meetings with study personnel.  Any difficulties in enrollment or 
data collection will be discussed by the research team in order to resolve any problems and 
ensure complete data.  
 
The KPWHRI biostatisticians, will review all study data, including AE and CI data, once per year 
to determine if there are substantially more adverse events in one intervention group compared 
to another or if one group demonstrates a markedly superior or more negative effect on the 
outcome variables than the other groups.  The biostatistician will provide a summary report of 
this review to the DSMC. If the DSMC agrees that there is a markedly superior or negative 
effect in one group vs. another or if there are substantially more adverse events in one group vs. 
another, Dr. Sullivan will notify the NIDA Project Officer and the KPW IRB and follow their 
advice about how to proceed.  If the DSMC agrees that such effects are not present, no further 
action will be taken.  
 
The KPW IRB will review the study protocol. The IRB will maintain ongoing oversight of the risks 
and benefits of the study and ensure compliance with institutional and NIH guidelines. Drs. 
Sullivan and Boudreau will be responsible for notifying the KPW IRB of all adverse events. The 
IRB will work with the Drs. Sullivan and Boudreau to ensure additional agencies (e.g., NIDA) are 
notified as required. Temporary or permanent suspension of an NIH funded protocol will be 
reported to the NIH grant program director directly responsible for the grant.  
 
The following events will be reported to the KPW IRB within 10 business days: unanticipated 
medical problem, serious non-compliance, continuing non-compliance, emergency deviation 
from IRB approved procedures, continuation of research after IRB approval has lapsed, 
complaint of a subject that cannot be resolved by the study team, audit or inspection or safety-
related inquiry by a federal agency, new information that indicates a new or increased risk or 
safety issue. 
 
If it becomes necessary to change the proposed study protocol, amendments will be filed with 
the IRB at KPW seeking approval for these. These changes will be made only after receiving 

 
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approval from the IRBs. Following approval and implementation of these changes, the DSMC 
and NIDA program officer will be notified. 
 
The trial may be stopped because the intervention poses unacceptable risk to participants. We 
will not perform interim efficacy analyses or develop related stopping rules because: 1] it is 
highly unlikely that the intervention will have such dramatic positive effects on both opioid dose 
and pain primary outcomes, 2] the comparison group receives usual care and cannot thus be 
harmed relative to usual care, 3] stopping early may preclude analyses of secondary outcomes 
and subgroup effects. The DSMC (Drs. Tauben, Ballantyne, and Russo) will be kept informed of 
AEs and SAEs encountered in the conduct of the study. They will review these yearly to 
determine if the intervention is posing unacceptable risks to participants. Review may occur 
more frequently if there are unexpectedly frequent or severe AEs. If they believe stopping the 
trial is appropriate, they will notify Drs. Sullivan and Boudreau and the NIDA program officer. 
Decisions about stopping the trial will be made in consultation with the NIDA program officer. 
 
 
 
9. Risks and Benefits  
a. Risks to Subjects 
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects 
related the subjects’ participation in the research. Describe the probability, magnitude, duration, 
and reversibility of the risks. Consider physical, psychological, social, legal, and economic risks. 
• 
If applicable, indicate which procedures may have risks to the subjects that are currently 
unforeseeable. 
• 
If applicable, indicate which procedures may have risks to an embryo or fetus should the 
subject be or become pregnant. 
• 
If applicable, describe risks to others who are not subjects and risks to Kaiser 
Permanente 
 
For both intervention arms potential risks to subjects include breach of confidentiality 
and embarrassment from some of the study questions.      
 
 
 
      
 
For the intervention arm, subjects electing to taper may experience withdrawal 
symptoms. These symptoms can include: increase in pain, insomnia, anxiety, restlessness, 
agitation, sweating, diarrhea nausea, vomiting or abdominal pain. However, our study of 
voluntary, self-paced and supported opioid taper will use a very gradual withdrawal schedule 
over a period of 46 weeks. This gradual withdrawal will minimize, if not eliminate, these 
withdrawal symptoms. These symptoms will be closely monitored during and after taper by the 
research interventionist . Subjects will be cautioned not to abruptly discontinue their opioids. 
However, it is still possible that subjects will become impatient with the taper process and 
abruptly stop their opioids on their own. If participants have an AE’s the research 
interventionist  may recommend medications to the participant’s PCP to help alleviate the 
abstinence syndrome symptoms. During the taper, participants may hoard any non-used 
opioids. The study consent form reminds participants that all non-used opioids should be 
disposed of properly. Participants will be informed of the risk of stock-piling opiates during the 
taper process. All medical care treatment and decisions are the responsibility of the primary 
care provider.  

 
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For the control arm, participants may be disappointed with the intervention condition to which 
they are assigned when they are randomized to the control arm. An incentive is being provided 
to both groups to improve retention in the trial.    
 
b. Potential Benefits to Subjects 
Describe the potential benefits that individual subjects may experience from taking part in the 
research. Include as may be useful for the IRB’s consideration, the probability, magnitude, and 
duration of the potential benefits. Indicate if there is no direct benefit. You may include benefits 
to society or others. 
In the intervention arm, some individuals may benefit from reduced dependency on prescription 
opioids and/or decreased pain and improve quality of life.            
 
10. Economic Burden to Subjects  
Describe any costs that subjects may be responsible for because of participation in the research 
study (for example, co-pays; paying for treatment, therapies, or other interventions, or the 
delivery of these) and how you will inform participants of these costs prior to their enrollment in 
this study. 
Subjects will be financially responsible for the treatment of physical injuries resulting from study 
procedures. Recommended (not required) in-person visits with the PCP and medication costs 
will result in standard co-pays, co-insurance and deductibles. This is outlined in the informed 
consent form.  
 
11. Compensation to Participants  
Describe any compensation provided to participants, for example, for time inconvenience, 
discomfort, travel, or in the event of research related injury. If applicable, describe how you will 
inform participants of this prior to their enrollment in the study, including if payment will be 
prorated if the subject withdraws early from the study.  
 
NOTE: payment may not be withheld as an incentive for participants to complete the study. 
Both intervention and control arm will receive: $20 for completion of baseline assessment, $40 
for completion of the 6 month assessment, $50 for completion of the 12 month assessment 
 
 
 
 
12. Resources Available 
Describe any special resources or expertise required to conduct the study. 
Dr. Boudreau, Senior Scientific Investigator at KPWHRI, will spend .20 FTE conducting and 
completing this research. She will oversee all aspects of the study at KPW.  
 
The project will use REDCap to collect data from participants and to track participant progress 
through the study.  
 
Additionally, Dr. Boudreau is working closely with Dr. Kushboo Mehta. Dr. Mehta is a Family 
Medicine provider and Program Chief of Family Medicine at KPW who assisted with developing 
and rolling out KPW’s newest guidelines on chronic opioid therapy. She will serve as the liaison 
between the study team the KPW delivery system and KPW leadership.  She will be the Study 

 
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Clinic Champion directly involved with educating providers, promoting the study, recruitment 
and retention. 
 
Dr. Boudreau meets and touches based regularly with others in the KPWA delivery system 
including Dr. Sarah Levy (Medical Director, Continuum of Care), Dr. Angela Sparks (Family 
Medicine Physician and Medical Director, Clinical Knowledge Development and Support), and 
Melissa Sturgis, PharmD, BCACP (Pharmacy Clinical Coordinator, Quality and Clinical 
Operations). Dr. Boudreau keeps them apprised of the trial aims, design, and methods while 
they provide feedback on trial and keep her up to date on of KPW initiatives around safe opioid 
prescribing and tapering.  
 
Finally, the taper portion of the study functions by working in conjunction with the participant’s 
primary care provider. The research interventionist  use Epic Telephone Encounters to pass on 
medication dosing recommendations to the primary care provider and any other research 
information that may be pertinent for the provision of health care. 
 
 
 
13. Prior Approvals 
Describe any approvals that will be obtained prior to commencing the research. (e.g., school, 
external site. funding agency, laboratory, radiation safety, or biosafety approval.)  
See attached: 
o Systems Engagement Review 
o KPW Delivery System letters of support 
 
14. Drugs or Devices 
NOTE: see the ICH-GCP guidance for a summary of investigator and sponsor responsibilities in 
clinical trials. 
 
a. Drug Studies 
If the research involves drugs and is investigator-initiated, indicate whether there is any 
possibility that the results will be reported to FDA (e.g. as part of a new drug application [NDA]). 
 
• 
If the drug is investigational (has an IND), confirm that you will comply with all applicable 
FDA requirements for investigators.   
• 
Confirm that you will follow applicable KP pharmacy policies and procedures. 
• 
Describe your plan for drug storage, handling, and accountability, including distribution, 
return, and destruction of the drug(s). 
N/A we are not studying any drugs or devices 
 
 
 
 
 
 
 
 

 
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b. Device Studies: 
If this is a device study and you think the device is Non-Significant Risk, include justification 
here or upload it as a separate document along with any available device information 
(instructions for use, etc.). 
 
If the research involves devices and is investigator-initiated, indicate whether there is any 
possibility that the results will be reported to FDA (e.g. as part of a premarket approval 
application [PMA]). 
 
• 
If the device has an IDE or a claim of abbreviated IDE (Non-Significant Risk device), 
confirm that you will comply with all applicable FDA requirements for investigators.   
• 
Describe the device, the manufacturing process, and the device labeling, including 
safety instructions or warnings.  If available, this may be addressed in separately 
uploaded device information (such as instructions for use). 
• 
Describe device storage, handling, and accountability, including how access to the 
device will be limited to appropriate personnel and how you will ensure the device will be 
used only for appropriate study subjects.  
N/A we are not studying any drugs or devices 
 
 
15. Multi-Site Research  
a. If this is a multi-site study and you are the lead investigator or this site will be the 
coordinating center for any activity, describe the processes to ensure communication 
among sites, such as: 
• 
All sites have the most current version of the protocol, consent document, 
and HIPAA authorization. 
• 
All required approvals have been obtained at each site (including approval by 
the site’s IRB of record). 
• 
All modifications have been communicated to sites, and approved (including 
approval by the site’s IRB of record) before the modification is implemented. 
• 
All engaged participating sites will safeguard data as required by local 
information security policies. 
• 
All local site investigators conduct the study appropriately. 
b. Describe the method for communicating to engaged participating sites the following:  
• 
Problems. 
• 
Interim results. 
• 
The closure of a study. 
 
c. Describe any special resources or expertise required to conduct the study. 
This study is a multi-site study consisting of two sites: KPW and the University of Washington. 
All recruitment, participant interaction and data analysis will occur at KPWA. 
 

 
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KPW will be the IRB of record for this project. We have already received confirming from the 
University of Washington that authority of their submission has been granted to KPW’s IRB. 
(see attached letters from UW IRB) 
 
The KPW project manager will communicate to sites, all modifications before the modification is 
implemented.  
 
All data for this study will be stored at KPW. Data safeguards have been explained in detail in 
previous sections. Data will be transferred to UW and all engaged participating sites (KPWA and 
UW) will safeguard data as required by local information security policies.  
 
Dr. Boudreau will be responsible for ensuring that all site investigators and project staff conduct 
the study appropriately.   
 
Problems on this study will be communicated to all sites by email or telephone from any of the 
study investigators or the project manager.  
 
Interim results will be discussed during monthly project team meetings, as results are made 
available.  The KPW/UW study leads meet bi-monthly and can discuss interim results at those 
meetings when results are made available. 
 
When it is time to close the study, the project manager will inform the UW investigators that the 
project is coming to an end and ask them to complete the administrative paperwork/processes 
on their end to close the study.  
 
 
16. Community-Based Participatory Research  
Describe involvement of the community in the design and conduct of the research. 
 
Describe your plan for ensuring that community research partners are appropriately trained in 
human subjects’ protection.  
 
NOTE: “Community-based Participatory Research” is a collaborative approach to research that 
equitably involves all partners in the research process and recognizes the unique strengths that 
each brings. Community-based Participatory Research begins with a research topic of 
importance to the community, has the aim of combining knowledge with action and achieving 
social change to improve health outcomes and eliminate health disparities. 
N/A this is not community-based participatory research