Piloting a Shared Decision-Making Aid for Reducing Stigma in Drug Use and HIV Harm Reduction in a Rural Setting
Phase: NA
Conditions: Opioid Use Disorder
Sponsor: Washington University School of Medicine

Cover Page 
Study Title 
“ImplementaƟon of a Shared Decision-Making Aid for Reducing SƟgma against Drug Use and HIV Harm 
ReducƟon in a Rural Seƫng” 
IdenƟﬁers: NCT05352412 
Unique Protocol ID: 202107155 
Date: March 25, 2022

Study Protocol 
Project Title: 
ImplementaƟon of a Shared Decision-Making Aid for Reducing SƟgma against Drug Use and Harm 
ReducƟon in a Rural Seƫng 
Select how you plan to obtain consent: 
•  
Let er or informaƟon sheet with no signature 
•  
Script for use either in person or over the phone with no signature 
Summary: 
Patients who inject drugs are at high risk for invasive bacterial and fungal infections related 
to contaminated needles. These patients should be treated with a combination of antibiotics 
and addiction treatment. Our team has demonstrated that medications for opioid use 
disorder (MOUDS; e.g., methadone, suboxone), improve patient outcomes. However, there 
is substantial stigma associated with these medications. Both patients and healthcare 
providers view them as drugs for "addicts." The goal of this proposal is to determine if a 
shared decision aid to help patients select the most appropriate MOUD will reduce internal 
stigma by the patient (reluctance to start on MOUDs) and stigma from the healthcare 
provider to offer a prescription for MOUDs. We propose to use serial stigma survey 
assessments before, directly after, and weeks after use of the tool. 
 
Specify your research quesƟon(s), study aims or hypotheses: 
We hypothesize that the use of the tool will reduce healthcare and paƟent sƟgma about use of MOUDs. 
Background and signiﬁcance and/or Preliminary studies related to this project: 
In the past decade, the US opioid crisis has emerged as a leading cause of death among adults. It has 
also led to an increase in invasive bacterial and fungal infecƟons; and HIV and HCV outbreaks in mulƟple 
regions. Rural communiƟes have had an especially disproporƟonate burden from the impact of opioid 
use disorder (OUD). Treatment of OUD with pharmacotherapy is one of the most eﬀecƟve strategies for 
reducing OUD related mortality and morbidity. But while there has been increasing will for expanding 
pharmacotherapy, sƟgma – from community, providers and paƟents—remains a signiﬁcant barrier to 
uptake pharmacotherapy and harm reducƟon. The approach to substance use has historically favored 
absƟnence strategies that are oŌen without evidence, inﬂuenced by puniƟve, sƟgmaƟzing framework. 
This sƟgma may be even more prevalent in rural communiƟes. To date there have been very few 
eﬀecƟve intervenƟons to address inter- and intrapersonal sƟgma, and none with sustained eﬀecƟveness.  
Describe EACH of your parƟcipant populaƟons 
We will have 2 paƟent populaƟons. 
1) Healthcare providers. 
Inclusion criteria: 
-physician, nurse pracƟƟoner, or physician assistant with a DEA X waiver to prescribe MOUDs 

-provides care to paƟents at Barnes-Jewish Hospital 
-must be able to complete electronic survey writ en in English 
2) PaƟent inclusion criteria 
-paƟent from a rural community currently admit ed or recently admit ed to Barnes-Jewish Hospital 
-Admission must be for an infecƟon associated with intravenous drug use 
-PaƟent must be willing to speak with healthcare provider about MOUDs 
-paƟent must be over 18 years old 
-must be able to complete electronic survey writ en in English 
 
 
Describe where the consent discussion will occur (check all that apply): 
•  
Private room or area 
•  
By phone 
ParƟcipants and/or their legally authorized representaƟve will have (check all that apply to the 
consent process and explain process in QuesƟon 1.12 below): 
•  
As much Ɵme as they desire to consider enrolling in the study, including: 
An opportunity to thoroughly review the consent materials with knowledgeable members of the 
research team, and with family and/or friends as appropriate 
• 
Suﬃcient Ɵme to have all of their quesƟons answered 
Provide a description of the enrollment and consent process in sequential order 
and address EACH of the bulleted points below: 
 
Study populaƟon: We will have 2 study populaƟons. PaƟents who receive MOUDs and healthcare 
providers who prescribe MOUDs. These populaƟons will be randomized to either receipt or no receipt of 
the shared decision tool. 
 
Recruitment: We will send an email to healthcare providers who prescribe MOUDs in the hospital. This 
will likely include addicƟon medicine services, internists, emergency medicine providers, psychiatrists, 
and infecƟous diseases physicians. We will send the email to people in these divisions. We will also 
noƟfy staﬀ in the Washington University Bridge to Health Program via email. These individuals include a 
case manager and 2 health coaches who care for persons who inject drugs as part of a quality 
improvement project. If these individuals idenƟfy a suitable candidate, they will contact our study 
coordinator or the PI that it is acceptable to approach the healthcare provider and/or paƟent for study 
recruitment. The study coordinator will discuss the study either in person or over the phone with the 
healthcare provider and in person with the paƟent. The study coordinator will discuss the risks and 
beneﬁts of enrolling in the study and consent the paƟent. 

 
Time to consider parƟcipaƟon: paƟents and healthcare providers will have as much Ɵme as they need to 
consider parƟcipaƟon. However, ideally, they should start this intervenƟon prior to iniƟaƟng a MOUD in 
the hospital. 
 
Minimize coercion: our study coordinator is a trained staﬀ therapist who will inform the parƟcipant that 
the study is completely voluntary and parƟcipaƟon will not impact clinical care. 
 
Provide a detailed description in sequential order of the study procedures 
following the consent process - DO NOT cut and paste from the Consent Document. 
 
This decision aid is a web-based survey that is presented on a tablet. It includes ﬁve secƟons: (D1) 
Provide an overview of both the disease and treatment. (D2) Assess the paƟent’s eligibility for 
pharmacotherapy. (D3) Compare the current medicaƟon opƟons (methadone, buprenorphine, and long-
acƟng naltrexone), examining demand characterisƟcs, such as side eﬀects, route of administraƟon, and 
cost. (D4) Describe expectaƟons for treatment duraƟon and eﬀects if the medicaƟon is self-disconƟnued. 
(D5) Complete a brief values clariﬁcaƟon exercise. 
 
AŌer Alpha and beta tesƟng are completed in Aim 1 of this project: AŌer the paƟent meets with a 
member of the Bridge To Health team, they will be referred to a member of the research team. The 
research team member will approach the paƟent and their provider of medicaƟon-assisted treatment 
once the paƟent has been stabilized to determine the paƟent's interest in treatment for their opioid use 
disorder, but prior to discharge from the hospital. This will usually occur within 2 weeks of the paƟent 
being discharged from the hospital. If a paƟent is interested in parƟcipaƟng, consent will be obtained 
from the paƟent and their healthcare provider will be approached for consent as well. Once consent 
from both parƟes, paƟent and provider, is obtained the paƟent will be randomized to either receive the 
shared decision aid or standard of care. If randomized to receive the shared decision aid, the paƟent and 
provider will take the survey on separate devices but at the same Ɵme. The decision aid survey 
integrates a values clariﬁcaƟon exercise and summarizes paƟent concerns/preferences to guide shared 
decision-making with clinicians. We will measure sƟgma and other outcomes prior to discharge, 2 weeks 
post-discharge, and 3 months post-discharge to assess the feasibility and preliminary eﬀecƟveness of the 
decision aid. If the paƟent is not randomized to receive the decision aid tool, they will complete the 
survey and receive standard of care. We will measure sƟgma and other outcomes prior to discharge, 2 
weeks post-discharge, and 3 months post-discharge to assess the feasibility and preliminary eﬀecƟveness 
of standard of care. 
 
We will implement a method to create a unique paƟent ID code to link parƟcipant data and informaƟon 
to rather than their name, and that the study team will not collect or record any idenƟﬁable health 
informaƟon in order to protect parƟcipants' conﬁdenƟality 
 
 
What have you done to minimize any risks? 
•  
Adverse event monitoring 

What are the potenƟal beneﬁts related to this project for: 
The paƟent will have more input on what type of MOUD they will receive. This might increase 
adherence. 
The tool may help reduce sƟgma and improve long-term MOUD acceptance, which will reduce overdose 
rates among persons who inject drugs. 
 
Provide a summary of the analysis methods you will use, including, if applicable, the data points or 
outcomes you will analyze. 
We will use likert scale quesƟons to assess sƟgma immediately before and aŌer the survey. We will also 
measure long-term sƟgma changes compared to baseline at 2 weeks and 3 months. These results will be 
compared to the baseline tesƟng results in a paired manner. We will use non-parametric tests to 
evaluate for staƟsƟcal signiﬁcance. We will also compare overall response rates between those who did 
vs. did not receive the clinical decision tool. 
Provide the raƟonale or power analysis to support the number of parƟcipants proposed to complete 
this study. 
This is a pilot study. No power analyses needed. 
ParƟcipants 
18 years old. No age limit. We will not recruit non-English speaking people. Must have diagnosis of 
opioid use disorder and come from a rural locaƟon. 
Sites: 
Barnes-Jewish Hospital 
Privacy and ConﬁdenƟality:  
Only minimum necessary informaƟon to be collected. Recruit in a private seƫng when possible. 
Materials will be stored in a secured environment and team members will be the only ones with access.