Opioid Use Disorder
Conditions
Keywords
Stigma, Decision Aid
Brief summary
A major barrier for the uptake of evidence-based interventions to address the ongoing opioid epidemic in the US, especially in rural regions, is stigma, which occurs at many levels, including that of the patient and provider. A shared decision making aid is an evidence-based method for increasing engagement and knowledge of both patients and providers, potentially democratizing treatment decisions, especially in stigmatized conditions. The investigators propose to adapt and pilot a decision aid for opioid use disorder (OUD) treatment and harm reduction in two hospitals in rural Missouri to evaluate whether this reduces stigma in both patients and providers.
Detailed description
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 infections; and HIV and hepatitis C virus (HCV) outbreaks in multiple regions. Rural communities have had an especially disproportionate burden from the impact of opioid use disorder (OUD). Treatment of OUD with pharmacotherapy is one of the most effective strategies for reducing OUD-related mortality and morbidity. But while there has been increasing will for expanding pharmacotherapy, stigma - from community, providers and patients-remains a significant barrier to uptake pharmacotherapy and harm reduction. The approach to substance use has historically favored abstinence strategies that are often without evidence, influenced by punitive, stigmatizing framework. This stigma may be even more prevalent in rural communities. To date there have been very few effective interventions to address inter- and intrapersonal stigma, and none with sustained effectiveness. The investigators propose adapting and piloting a shared decision-making aid for patients presenting to the emergency department or are being admitted at two hospitals in rural Missouri, where there is a high prevalence of OUD and its complications. The decision-aid is an evidence-based intervention show to increase knowledge, engagement and decision-making concordant with patient values in a variety of medical conditions. It is feasible that by democratizing treatment and standardizing decision-making counseling, the decision aid can mediate attitudes and reduce stigma. The investigators hypothesize by delivering standardized, high-quality knowledge to both provider and patient, that stigma can be reduced in both parties. In Aim 1 the investigators will adapt an existing decision aid for OUD treatment to the specific context of rural hospital care. This decision aid will be a part of an existing bundled care program for OUD and related infections that the investigators have implemented in these hospitals. In Aim 2 the investigators will conduct a randomized pilot comparing the decision aid intervention with counseling as usual without decision aid to assess feasibility, acceptability and preliminary effectiveness for reducing stigma in substance use, HIV, OUD pharmacotherapy and harm reduction. The investigators will measure these around the time of the intervention and in longitudinal follow up. The findings could potentially identify a novel intervention and methodology for treatment expansion and stigma reduction that has not been previously explored, especially in the rural context, where need is high. Following the successful completion of this pilot trial, the investigators will develop an expanded multi-site comparative effectiveness trial of the decision aid, implementation studies, and cost-effectiveness analysis.
Interventions
BEHAVIORALShared Decision Making Aid - Patients
Patients will be randomized to the shared decision making aid intervention.
BEHAVIORALShared Decision Making Aid - Providers
Providers of patients randomized o the shared decision making aid intervention.
Sponsors
National Institute on Drug Abuse (NIDA)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients from a rural community currently admitted or recently admitted to Barnes-Jewish Hospital * Admission must be for an infection associated with intravenous drug use * Patient must be willing to speak with healthcare provider about medications for opioid use disorder (MOUDs) * patient must be over 18 years old * must be able to complete electronic survey written in English
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Clarity of Shared Decision Aid | Immediate post-baseline survey | 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. |
| Patient Satisfaction With Helpfulness of Shared Decision Aid | Immediate post-baseline survey | Likert scale from 1-4 with 1 being the best and 4 being the worst |
| Overall Patient Satisfaction With the Shared Decision Aid | 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. |
| Patient Anticipated MOUD Stigma | 3 months | 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. |
| Hospital Policy Stigma Towards Patients With Opioid Use Disorder | 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. |
| Provider Comfort Treating Patients With Opioid Use Disorder | Immediate post-intervention | 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. |
| Provider Stigma Towards Patients With Opioid Use Order | Immediate | 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. |
| Provider Willingness To Work With Patients With Opioid Use Disorder | Immediately post-intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Counseling As Usual - Patient Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder. | 23 |
| 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. | 23 |
| 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. | 7 |
| 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. | 9 |
| Total | 62 |
Baseline characteristics
| Characteristic | Shared Decision Making Aid - Patient | Baseline Counseling As Usual - Provider | Shared Decision Making Aid - Provider | Baseline Counseling As Usual - Patient | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 7 Participants | 9 Participants | 23 Participants | 62 Participants |
| Age, Continuous | 35 years | 34 years | 38 years | 35 years | 35 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 2 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) White | 18 Participants | 4 Participants | 6 Participants | 22 Participants | 50 Participants |
| Region of Enrollment United States | 23 Participants | 7 Participants | 9 Participants | 23 Participants | 62 Participants |
| Sex: Female, Male Female | 14 Participants | 7 Participants | 6 Participants | 13 Participants | 40 Participants |
| Sex: Female, Male Male | 9 Participants | 0 Participants | 3 Participants | 10 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 23 | 1 / 23 | 0 / 7 | 0 / 9 |
| other Total, other adverse events | 0 / 23 | 0 / 23 | 0 / 7 | 0 / 9 |
| serious Total, serious adverse events | 1 / 23 | 2 / 23 | 0 / 7 | 0 / 9 |
Outcome results
Primary
Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project
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.
Time frame: 3 months
Population: Number of participants recruited and enrolled
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Baseline Counseling As Usual - Patient | Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project | Baseline | 15 score on a scale |
| Baseline Counseling As Usual - Patient | Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project | Immediate follow-up | 14 score on a scale |
| Baseline Counseling As Usual - Patient | 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 |
| Baseline Counseling As Usual - Patient | 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 |
| Shared Decision Making Aid - Patient | Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project | 90 days post-discharge | 9 score on a scale |
| Shared Decision Making Aid - Patient | Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project | Baseline | 11 score on a scale |
| Shared Decision Making Aid - Patient | Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project | 2 week post-discharge | 7 score on a scale |
| Shared Decision Making Aid - Patient | Patient Internalized Stigma Towards Medicaid for Opioid Use Disorder (MOUDs) Over the Course of the Project | Immediate follow-up | 8 score on a scale |
p-value: 0.32Wilcoxon (Mann-Whitney)
Comparison: Baseline survey compared with immediate follow-up surveyp-value: 0.39Wilcoxon (Mann-Whitney)
Comparison: 2 weeks post-discharge compared with baseline surveyp-value: 0.21Wilcoxon (Mann-Whitney)
Comparison: 90 days post-discharge compared with baseline surveyp-value: 0.19Wilcoxon (Mann-Whitney)
Comparison: Baseline survey versus immediate follow-upp-value: 0.38Wilcoxon (Mann-Whitney)
Comparison: 2 weeks post-discharge compared with baseline surveyp-value: 0.25Wilcoxon (Mann-Whitney)
Comparison: 90 days post-discharge compared with baseline surveyp-value: 0.07Wilcoxon (Mann-Whitney)
Comparison: Immediate follow-up between the two armsp-value: 0.03Wilcoxon (Mann-Whitney)
Comparison: 2 weeks post-discharge comparison between the 2 armsp-value: 0.65Wilcoxon (Mann-Whitney)
Comparison: 90-days post discharge compared between the 2 armsp-value: 0.97Wilcoxon (Mann-Whitney)
Secondary
Hospital Policy Stigma Towards Patients With Opioid Use Disorder
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.
Time frame: Immediate
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Baseline Counseling As Usual - Patient | Hospital Policy Stigma Towards Patients With Opioid Use Disorder | Baseline | 8 score on a scale |
| Baseline Counseling As Usual - Patient | Hospital Policy Stigma Towards Patients With Opioid Use Disorder | Immediate follow-up post patient randomization | 7 score on a scale |
| Shared Decision Making Aid - Patient | Hospital Policy Stigma Towards Patients With Opioid Use Disorder | Baseline | 7 score on a scale |
| Shared Decision Making Aid - Patient | Hospital Policy Stigma Towards Patients With Opioid Use Disorder | Immediate follow-up post patient randomization | 7 score on a scale |
p-value: 0.48Wilcoxon (Mann-Whitney)
p-value: 1Wilcoxon (Mann-Whitney)
p-value: 0.17Wilcoxon (Mann-Whitney)
Comparison: Immediate follow-upp-value: 0.42Wilcoxon (Mann-Whitney)
Secondary
Overall Patient Satisfaction With the Shared Decision Aid
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.
Time frame: Immediate post-baseline survey
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Baseline Counseling As Usual - Patient | Overall Patient Satisfaction With the Shared Decision Aid | I like the decision aid | 1.06 score on a scale |
| Baseline Counseling As Usual - Patient | Overall Patient Satisfaction With the Shared Decision Aid | The decision aid is appealing | 1.06 score on a scale |
| Baseline Counseling As Usual - Patient | Overall Patient Satisfaction With the Shared Decision Aid | The decision aid is easy to use | 1.06 score on a scale |
| Baseline Counseling As Usual - Patient | Overall Patient Satisfaction With the Shared Decision Aid | The decision aid is doable | 1 score on a scale |
Secondary
Patient 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.
Time frame: 3 months
Population: The Mann-Whitney U test was used to analyze anticipated MOUD stigma.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Baseline Counseling As Usual - Patient | Patient Anticipated MOUD Stigma | Immediate follow-up | 19 score on a scale |
| Baseline Counseling As Usual - Patient | Patient Anticipated MOUD Stigma | Baseline | 20 score on a scale |
| Baseline Counseling As Usual - Patient | Patient Anticipated MOUD Stigma | 2 weeks post-discharge | 18 score on a scale |
| Baseline Counseling As Usual - Patient | Patient Anticipated MOUD Stigma | 90 days post-discharge | 11 score on a scale |
| Shared Decision Making Aid - Patient | Patient Anticipated MOUD Stigma | 90 days post-discharge | 14 score on a scale |
| Shared Decision Making Aid - Patient | Patient Anticipated MOUD Stigma | Baseline | 21 score on a scale |
| Shared Decision Making Aid - Patient | Patient Anticipated MOUD Stigma | Immediate follow-up | 17 score on a scale |
| Shared Decision Making Aid - Patient | Patient Anticipated MOUD Stigma | 2 weeks post-discharge | 13 score on a scale |
Comparison: Baseline comparison between the 2 armsp-value: 0.77Wilcoxon (Mann-Whitney)
Comparison: Immediate follow-up compared with baseline surveyp-value: 0.85Wilcoxon (Mann-Whitney)
Comparison: 2-week post-discharge compared with baseline surveyp-value: 0.38Wilcoxon (Mann-Whitney)
Comparison: 90-day post discharge compared with baseline surveyp-value: 0.21Wilcoxon (Mann-Whitney)
Comparison: Immediate follow-up compared with baseline surveyp-value: 0.32Wilcoxon (Mann-Whitney)
Comparison: 2 week post-discharge compared with baseline surveyp-value: 0.09Wilcoxon (Mann-Whitney)
Comparison: 90-day post-discharge compared with baseline surveyp-value: 0.07Wilcoxon (Mann-Whitney)
Comparison: 2 weeks post-discharge compared between the 2 armsp-value: 0.26Wilcoxon (Mann-Whitney)
Comparison: Immediate follow-up compared between the 2 armsp-value: 0.69Wilcoxon (Mann-Whitney)
Comparison: 90-day post-discharge compared between the 2 armsp-value: 0.32Wilcoxon (Mann-Whitney)
Secondary
Patient Satisfaction With Clarity of Shared Decision Aid
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.
Time frame: Immediate post-baseline survey
Population: Mann-Whitney U
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline Counseling As Usual - Patient | Patient Satisfaction With Clarity of Shared Decision Aid | 1.33 score on a scale |
Secondary
Patient Satisfaction With Helpfulness of Shared Decision Aid
Likert scale from 1-4 with 1 being the best and 4 being the worst
Time frame: Immediate post-baseline survey
Population: Mann-Whitney U
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Baseline Counseling As Usual - Patient | Patient Satisfaction With Helpfulness of Shared Decision Aid | 1.44 score on a scale |
Secondary
Provider Comfort Treating 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.
Time frame: Immediate post-intervention
Population: Healthcare providers who care of patients with opioid use disorder
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Baseline Counseling As Usual - Patient | Provider Comfort Treating Patients With Opioid Use Disorder | Baseline | 17 score on a scale |
| Baseline Counseling As Usual - Patient | Provider Comfort Treating Patients With Opioid Use Disorder | Immediate follow-up post patient randomization | 18 score on a scale |
| Shared Decision Making Aid - Patient | Provider Comfort Treating Patients With Opioid Use Disorder | Baseline | 17 score on a scale |
| Shared Decision Making Aid - Patient | Provider Comfort Treating Patients With Opioid Use Disorder | Immediate follow-up post patient randomization | 18 score on a scale |
Comparison: Baselinep-value: 1Wilcoxon (Mann-Whitney)
Comparison: Baseline versus immediate follow-upp-value: 0.11Wilcoxon (Mann-Whitney)
Comparison: Baseline versus immediate follow-upp-value: 0.89Wilcoxon (Mann-Whitney)
Comparison: Immediate follow-upp-value: 0.55Wilcoxon (Mann-Whitney)
Secondary
Provider Stigma Towards Patients With Opioid Use Order
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.
Time frame: Immediate
Population: Healthcare providers who treat patients with opioid use disorder
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Baseline Counseling As Usual - Patient | Provider Stigma Towards Patients With Opioid Use Order | Baseline | 14 score on a scale |
| Baseline Counseling As Usual - Patient | Provider Stigma Towards Patients With Opioid Use Order | Immediate follow-up post patient randomization | 14 score on a scale |
| Shared Decision Making Aid - Patient | Provider Stigma Towards Patients With Opioid Use Order | Baseline | 14 score on a scale |
| Shared Decision Making Aid - Patient | Provider Stigma Towards Patients With Opioid Use Order | Immediate follow-up post patient randomization | 13 score on a scale |
Comparison: Baselinep-value: 0.66Wilcoxon (Mann-Whitney)
Comparison: Baseline versus immediate follow-up post randomizationp-value: 0.2Wilcoxon (Mann-Whitney)
Comparison: Baseline versus immediate follow-up post randomizationp-value: 0.85Wilcoxon (Mann-Whitney)
Comparison: Immediate follow-up post randomizationp-value: 0.07Wilcoxon (Mann-Whitney)
Secondary
Provider Willingness To Work With 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.
Time frame: Immediately post-intervention
Population: Healthcare providers taking care of patients with Opioid Use Disorder
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Baseline Counseling As Usual - Patient | Provider Willingness To Work With Patients With Opioid Use Disorder | Baseline | 20 score on a scale |
| Baseline Counseling As Usual - Patient | Provider Willingness To Work With Patients With Opioid Use Disorder | Immediate follow-up post randomization of patient | 20 score on a scale |
| Shared Decision Making Aid - Patient | Provider Willingness To Work With Patients With Opioid Use Disorder | Baseline | 20 score on a scale |
| Shared Decision Making Aid - Patient | Provider Willingness To Work With Patients With Opioid Use Disorder | Immediate follow-up post randomization of patient | 20 score on a scale |
p-value: 1Wilcoxon (Mann-Whitney)
p-value: 1Wilcoxon (Mann-Whitney)
p-value: 0.12Wilcoxon (Mann-Whitney)
Comparison: Immediate follow-upp-value: 0.12Wilcoxon (Mann-Whitney)