Trial Outcomes & Findings for Stigma and a Shared Decision Aid (NCT NCT05352412)

NCT ID: NCT05352412

Last Updated: 2025-06-24

Results Overview

Sum of 6 5-point Likert scale questions that determines self-reported stigma on taking MOUDs. This was compromised of 6 separate questions with a scale of 1-5 with 1 having the lowest stigma and 5 having the highest stigma. The range is thus 6 - 30.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2025-06-24

Participant Flow

Participant milestones

Measure	Baseline Counseling As Usual - Patient Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.	Baseline Counseling As Usual - Provider Providers of patients randomized to the baseline counseling as usual arm will will be asked to participate in a survey to assess their stigma in regards to taking care of patients with opioid use disorder.	Shared Decision Making Aid - Provider Providers of patients randomized to the decision aid arm will will be asked to participate in a survey to assess their stigma in regards to taking care of patients with opioid use disorder.
Overall Study STARTED	23	23	7	9
Overall Study COMPLETED	23	23	7	9
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stigma and a Shared Decision Aid

Baseline characteristics by cohort

Measure	Baseline Counseling As Usual - Patient n=23 Participants Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient n=23 Participants Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.	Baseline Counseling As Usual - Provider n=7 Participants Providers of patients randomized to the baseline counseling as usual arm will will be asked to participate in a survey to assess their stigma in regards to taking care of patients with opioid use disorder.	Shared Decision Making Aid - Provider n=9 Participants Providers of patients randomized to the decision aid arm will will be asked to participate in a survey to assess their stigma in regards to taking care of patients with opioid use disorder.	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	23 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	62 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	35 years n=5 Participants	35 years n=7 Participants	34 years n=5 Participants	38 years n=4 Participants	35 years n=21 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	40 Participants n=21 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	22 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	18 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	50 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Region of Enrollment United States	23 Participants n=5 Participants	23 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	62 Participants n=21 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Number of participants recruited and enrolled

Sum of 6 5-point Likert scale questions that determines self-reported stigma on taking MOUDs. This was compromised of 6 separate questions with a scale of 1-5 with 1 having the lowest stigma and 5 having the highest stigma. The range is thus 6 - 30.

Outcome measures

Measure	Baseline Counseling As Usual - Patient n=23 Participants Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient n=23 Participants Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.
Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project Baseline	15 score on a scale Interval 6.0 to 25.0	11 score on a scale Interval 6.0 to 27.0
Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project Immediate follow-up	14 score on a scale Interval 6.0 to 29.0	8 score on a scale Interval 6.0 to 24.0
Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project 2 week post-discharge	8 score on a scale Interval 6.0 to 21.0	7 score on a scale Interval 6.0 to 23.0
Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project 90 days post-discharge	8 score on a scale Interval 6.0 to 25.0	9 score on a scale Interval 6.0 to 17.0

SECONDARY outcome

Timeframe: 3 months

Population: The Mann-Whitney U test was used to analyze anticipated MOUD stigma.

This 5-point Likert scale was compromised of 7 questions of a range of 7-35. The lower score denotes the lower stigma and the higher score denotes the higher stigma.

Outcome measures

Measure	Baseline Counseling As Usual - Patient n=23 Participants Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient n=23 Participants Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.
Patient Anticipated MOUD Stigma Baseline	20 score on a scale Interval 7.0 to 34.0	21 score on a scale Interval 7.0 to 32.0
Patient Anticipated MOUD Stigma Immediate follow-up	19 score on a scale Interval 7.0 to 32.0	17 score on a scale Interval 7.0 to 35.0
Patient Anticipated MOUD Stigma 2 weeks post-discharge	18 score on a scale Interval 10.0 to 25.0	13 score on a scale Interval 7.0 to 29.0
Patient Anticipated MOUD Stigma 90 days post-discharge	11 score on a scale Interval 7.0 to 30.0	14 score on a scale Interval 7.0 to 30.0

SECONDARY outcome

Timeframe: Immediate post-baseline survey

Population: Mann-Whitney U

Likert scale from 1-4 with 1 being the best and 4 being the worst. There is no statistical analysis for this secondary outcome as patients who did not receive the decision aid cannot provide satisfaction regarding clarity of shared decision aid.

Outcome measures

Measure	Baseline Counseling As Usual - Patient n=18 Participants Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.
Patient Satisfaction With Clarity of Shared Decision Aid	1.33 score on a scale Interval 1.0 to 2.0	—

SECONDARY outcome

Timeframe: Immediate post-baseline survey

Population: Mann-Whitney U

Likert scale from 1-4 with 1 being the best and 4 being the worst

Outcome measures

Measure	Baseline Counseling As Usual - Patient n=18 Participants Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.
Patient Satisfaction With Helpfulness of Shared Decision Aid	1.44 score on a scale Interval 1.0 to 3.0	—

SECONDARY outcome

Timeframe: Immediate post-baseline survey

"I like the decision aid", "The decision aid is appealing", "The decision aid is easy to use", and "The decision aid is doable". The scale range is 1 to 2 with a score of 1 being a better outcome.

Outcome measures

Measure	Baseline Counseling As Usual - Patient n=18 Participants Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.
Overall Patient Satisfaction With the Shared Decision Aid I like the decision aid	1.06 score on a scale Interval 1.0 to 2.0	—
Overall Patient Satisfaction With the Shared Decision Aid The decision aid is appealing	1.06 score on a scale Interval 1.0 to 2.0	—
Overall Patient Satisfaction With the Shared Decision Aid The decision aid is easy to use	1.06 score on a scale Interval 1.0 to 2.0	—
Overall Patient Satisfaction With the Shared Decision Aid The decision aid is doable	1 score on a scale Interval 1.0 to 1.0	—

SECONDARY outcome

Timeframe: Immediately post-intervention

Population: Healthcare providers taking care of patients with Opioid Use Disorder

5-point Likert scale where score of 1 is the most stigma and 5 is the least stigma. The overall number is a sum of 4 questions with a theoretical range of 4 - 20.

Outcome measures

Measure	Baseline Counseling As Usual - Patient n=9 Participants Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient n=7 Participants Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.
Provider Willingness To Work With Patients With Opioid Use Disorder Baseline	20 score on a scale Interval 5.0 to 20.0	20 score on a scale Interval 17.0 to 20.0
Provider Willingness To Work With Patients With Opioid Use Disorder Immediate follow-up post randomization of patient	20 score on a scale Interval 5.0 to 20.0	20 score on a scale Interval 20.0 to 20.0

SECONDARY outcome

Timeframe: Immediate

5-point Likert scale where score of 1 least stigma towards patients with opioid use disorder and 5 is the highest stigma towards patients with opioid use disorder. The overall number is a sum of 4 questions with a theoretical range of 4 - 20.

Outcome measures

Measure	Baseline Counseling As Usual - Patient n=9 Participants Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient n=7 Participants Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.
Hospital Policy Stigma Towards Patients With Opioid Use Disorder Baseline	8 score on a scale Interval 4.0 to 10.0	7 score on a scale Interval 5.0 to 9.0
Hospital Policy Stigma Towards Patients With Opioid Use Disorder Immediate follow-up post patient randomization	7 score on a scale Interval 4.0 to 13.0	7 score on a scale Interval 4.0 to 8.0

SECONDARY outcome

Timeframe: Immediate post-intervention

Population: Healthcare providers who care of patients with opioid use disorder

A 6 question 5-point Likert scale with a scale of 1= least stigma and 5=most stigma. A total of 6 questions were asked. Thus the range is 6 - 30.

Outcome measures

Measure	Baseline Counseling As Usual - Patient n=9 Participants Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient n=7 Participants Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.
Provider Comfort Treating Patients With Opioid Use Disorder Baseline	17 score on a scale Interval 15.0 to 20.0	17 score on a scale Interval 16.0 to 20.0
Provider Comfort Treating Patients With Opioid Use Disorder Immediate follow-up post patient randomization	18 score on a scale Interval 15.0 to 30.0	18 score on a scale Interval 15.0 to 19.0

SECONDARY outcome

Timeframe: Immediate

Population: Healthcare providers who treat patients with opioid use disorder

A 6 question 5-point Likert scale with a scale of 1= least stigma and 5=most stigma. A total of 6 questions were asked. Thus the range is 6 - 30.

Outcome measures

Measure	Baseline Counseling As Usual - Patient n=9 Participants Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient n=7 Participants Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.
Provider Stigma Towards Patients With Opioid Use Order Baseline	14 score on a scale Interval 11.0 to 16.0	14 score on a scale Interval 12.0 to 15.0
Provider Stigma Towards Patients With Opioid Use Order Immediate follow-up post patient randomization	14 score on a scale Interval 12.0 to 19.0	13 score on a scale Interval 12.0 to 14.0

Adverse Events

Baseline Counseling As Usual - Patient

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Shared Decision Making Aid - Patient

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Baseline Counseling As Usual - Provider

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Shared Decision Making Aid - Provider

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Baseline Counseling As Usual - Patient n=23 participants at risk Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder.	Shared Decision Making Aid - Patient n=23 participants at risk Patients randomized to the decision aid arm will receive all of the above as well as a shared decision making aid. This will be a 10-minute survey that takes into account their priorities and preferences around medications for opioid use disorder.	Baseline Counseling As Usual - Provider n=7 participants at risk Providers of patients randomized to the baseline counseling as usual arm will will be asked to participate in a survey to assess their stigma in regards to taking care of patients with opioid use disorder.	Shared Decision Making Aid - Provider n=9 participants at risk Providers of patients randomized to the decision aid arm will will be asked to participate in a survey to assess their stigma in regards to taking care of patients with opioid use disorder.
Respiratory, thoracic and mediastinal disorders Overdose	4.3% 1/23 • Number of events 1 • Participants were followed for 3 months for any adverse events.	4.3% 1/23 • Number of events 1 • Participants were followed for 3 months for any adverse events.	0.00% 0/7 • Participants were followed for 3 months for any adverse events.	0.00% 0/9 • Participants were followed for 3 months for any adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/23 • Participants were followed for 3 months for any adverse events.	4.3% 1/23 • Number of events 1 • Participants were followed for 3 months for any adverse events.	0.00% 0/7 • Participants were followed for 3 months for any adverse events.	0.00% 0/9 • Participants were followed for 3 months for any adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael J. Durkin, Principal Investigator

Washington University School of Medicine

Phone: 314-454-8225

Email: mdurkin@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place