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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline Counseling As Usual - Patient | No Intervention | Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder. | |
| Shared Decision Making Aid - Patient | Active Comparator | 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 | No Intervention | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared Decision Making Aid - Patients | Behavioral | Patients will be randomized to the shared decision making aid intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Patient Satisfaction With Clarity of Shared Decision Aid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J. Durkin, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Baseline Counseling As Usual - Patient | Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Counseling As Usual - Patient | Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder. |
| BG001 | Shared Decision Making Aid - Patient |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants recruited and enrolled | Posted | Median | Full Range | score on a scale | 3 months |
|
Participants were followed for 3 months for any adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline Counseling As Usual - Patient | Patients randomized to the baseline counseling from their healthcare provider regarding medications for opioid use disorder. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overdose | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Drug overdose unrelated to survey |
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Our preliminary findings included patients who were hospitalized. Anecdotally ,our team needed time to screen, recruit, and consent participants. On average, this ended up taking about 2 days. Our findings were biased more towards individuals who were hospitalized for a prolonged period of time and for individuals with a long history of opioid use disorder. If or how this would work in outpatient settings needs to be evaluated. The shared decision aid was somewhat time consuming to complete.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael J. Durkin, Principal Investigator | Washington University School of Medicine | 314-454-8225 | mdurkin@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 25, 2022 | May 9, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient Letter of Consent | Mar 25, 2022 | May 9, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Provider Letter of Consent | Apr 4, 2022 | May 9, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Shared Decision Making Aid - Providers | Behavioral | Providers of patients randomized o the shared decision making aid intervention. |
|
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. |
| Immediate post-baseline survey |
| Patient Satisfaction With Helpfulness of Shared Decision Aid | Likert scale from 1-4 with 1 being the best and 4 being the worst | Immediate post-baseline survey |
| 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. | Immediate post-baseline survey |
| 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. | Immediately post-intervention |
| 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. | Immediate |
| 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. | Immediate post-intervention |
| 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. | Immediate |
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.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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.
|
|
|
| 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. | The Mann-Whitney U test was used to analyze anticipated MOUD stigma. | Posted | Median | Full Range | score on a scale | 3 months |
|
|
|
|
| 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. | Mann-Whitney U | Posted | Mean | Full Range | score on a scale | Immediate post-baseline survey |
|
|
|
| Secondary | Patient Satisfaction With Helpfulness of Shared Decision Aid | Likert scale from 1-4 with 1 being the best and 4 being the worst | Mann-Whitney U | Posted | Mean | Full Range | score on a scale | Immediate post-baseline survey |
|
|
|
| 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. | Posted | Mean | Full Range | score on a scale | Immediate post-baseline survey |
|
|
|
| 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. | Healthcare providers taking care of patients with Opioid Use Disorder | Posted | Median | Full Range | score on a scale | Immediately post-intervention |
|
|
|
|
| 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. | Posted | Median | Full Range | score on a scale | Immediate |
|
|
|
|
| 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. | Healthcare providers who care of patients with opioid use disorder | Posted | Median | Full Range | score on a scale | Immediate post-intervention |
|
|
|
|
| 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. | Healthcare providers who treat patients with opioid use disorder | Posted | Median | Full Range | score on a scale | Immediate |
|
|
|
|
| 1 |
| 23 |
| 1 |
| 23 |
| 0 |
| 23 |
| EG001 | 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. | 1 | 23 | 2 | 23 | 0 | 23 |
| EG002 | 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. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG003 | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Pneumonia unrelated to survey |
|
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| D012919 | Social Behavior |
| D001519 | Behavior |
| 2 weeks post-discharge |
|
| 90 days post-discharge |
|
| 0.85 |
| Mann-Whitney U |
| 0.85 |
| 2-Sided |
| Other |
| 2-week post-discharge compared with baseline survey | Wilcoxon (Mann-Whitney) | 0.38 | Mann-Whitney U | 0.38 | 2-Sided | Other |
| 90-day post discharge compared with baseline survey | Wilcoxon (Mann-Whitney) | 0.21 | Mann-Whitney U | 0.21 | 2-Sided | Other |
| Immediate follow-up compared with baseline survey | Wilcoxon (Mann-Whitney) | 0.32 | Mann-Whitney U | 0.32 | 2-Sided | Other |
| 2 week post-discharge compared with baseline survey | Wilcoxon (Mann-Whitney) | 0.09 | Mann-Whitney U | 0.09 | 2-Sided | Other |
| 90-day post-discharge compared with baseline survey | Wilcoxon (Mann-Whitney) | 0.07 | Mann-Whitney U | 0.07 | 2-Sided | Other |
| 2 weeks post-discharge compared between the 2 arms | Wilcoxon (Mann-Whitney) | 0.26 | Mann-Whitney U | 0.26 | 2-Sided | Other |
| Immediate follow-up compared between the 2 arms | Wilcoxon (Mann-Whitney) | 0.69 | Mann-Whitney U | 0.69 | 2-Sided | Other |
| 90-day post-discharge compared between the 2 arms | Wilcoxon (Mann-Whitney) | 0.32 | Mann-Whitney U | 0.32 | 2-Sided | Other |
|
| The decision aid is doable |
|
| Mann-Whitney U |
| 1.00 |
| 2-Sided |
| Other |
Mann-Whitney U |
| Wilcoxon (Mann-Whitney) | 0.12 | Mann-Whitney U | 0.12 | 2-Sided | Other | Mann-Whitney U |
| Immediate follow-up | Wilcoxon (Mann-Whitney) | 0.12 | Mann-Whitney U | 0.12 | 2-Sided | Other | Mann-Whitney U |
| Mann-Whitney U |
| 1.00 |
| 2-Sided |
| Other |
Mann-Whitney U |
| Wilcoxon (Mann-Whitney) | 0.17 | Mann-Whitney U | 0.17 | 2-Sided | Other | Mann-Whitney U |
| Immediate follow-up | Wilcoxon (Mann-Whitney) | 0.42 | Mann-Whitney U | 0.42 | 2-Sided | Other | Mann-Whitney U |
| 0.11 |
| Mann-Whitney U |
| 0.11 |
| 2-Sided |
| Other |
Mann-Whitney U |
| Baseline versus immediate follow-up | Wilcoxon (Mann-Whitney) | 0.89 | Mann-Whitney U | 0.89 | 2-Sided | Other | Mann-Whitney U |
| Immediate follow-up | Wilcoxon (Mann-Whitney) | 0.55 | Mann-Whitney U | 0.55 | 2-Sided | Other | Mann-Whitney U |
| Wilcoxon (Mann-Whitney) |
| 0.20 |
| Mann-Whitney U |
| 0.20 |
| 2-Sided |
| Other |
Mann-Whitney U |
| Baseline versus immediate follow-up post randomization | Wilcoxon (Mann-Whitney) | 0.85 | Mann-Whitney U | 0.85 | 2-Sided | Other | Mann-Whitney U |
| Immediate follow-up post randomization | Wilcoxon (Mann-Whitney) | 0.07 | Mann-Whitney U | 0.07 | 2-Sided | Other | Mann-Whitney U |