Substance Use Disorders Clinical Trial
Official title:
Multi-Level Stigma Intervention to Improve Access to Substance Use Care With Prescribing Providers in Mental Health Settings
Verified date | April 2024 |
Source | Wayne State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This cluster randomized trial develops and pilot tests a multi-level substance use stigma intervention that leverages organizational policy and professional education to address structural and professional drivers of stigma in outpatient mental health (MH) services. The investigators will generate preliminary data to determine whether adding an organizational policy to a professional stigma training may reduce measures of provider-based stigma towards substance use and improve care quality and patient outcomes to a greater degree than simply conducting training alone. The investigators hypothesize that providers at a MH site implementing an organizational policy change in addition to providing professional training will demonstrate greater improvement to health services for people who use drugs compared to a site where providers receive training alone.
Status | Active, not recruiting |
Enrollment | 12 |
Est. completion date | February 8, 2025 |
Est. primary completion date | February 8, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study. 1. Site inclusion: - The sites will be selected using convenience sampling. - The inclusion criterion will be sites with at least 4 providers. 2. Provider inclusion: - Providers at participating sites will also be recruited using convenience sampling. - Any psychiatrists or psychiatric NPs are eligible to participate as long as they are employed at the participating LSH site. 3. Patient EHR inclusion: - All new patients entering mental health services during the 3-months prior and 3- months after the intervention will be included in the EHR data sample to assess whether substance use was addressed during their first visit and subsequent 3-month retention in care. - Existing and new patients with alcohol use disorder (AUD)/opioid use disorder (OUD) will be identified through the EHR to assess pharmacotherapy initiation. 4. Patient survey inclusion: - Half of the survey sample (n=20) will include patients without a substance use disorder (SUD) documented in their chart at the time of data collection - The other half of the survey sample (n=20) will include patients who do have an ICD-10 code for SUD in their chart. - Patient stratification rationale: the intention is to compare experiences and perceptions of stigma among patients who have SUD noted in their EHR and those who do not. This is also to assess stigma among patients who may not have their substance use addressed during a MH visit but who have substance use related health risks and substance use disorders (assessed through the ASSIST questionnaire). Exclusion Criteria: All individuals meeting any of the exclusion criteria will be excluded from study participation. 1. Provider exclusion: - Providers may be excluded if they were not employed by LSH and seeing patients for the past three months at the time of enrollment. 2. Patient exclusion: - Patients may be excluded from the SUD-stratified portion of the survey sample if their SUD diagnosis is only for a tobacco use disorder. - Patients may also be excluded if they are unable or unwilling to give written informed consent. - Patients who are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities will also be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | LifeStance Health | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
Wayne State University | LifeStance Health, Loyola University Chicago, University of New Mexico |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients where substance use was addressed during a MH visit among new intakes and documented in EHR | Identified ICD-10s or notes among participating providers in electronic health records (EHR) | 3-months prior to intervention vs. 3-months after intervention | |
Primary | Number of patients in the provider panel (new or old) diagnosed with OUD or AUD who initiated OUD or AUD pharmacotherapy | Whether pharmacotherapy for opioid use disorders (OUD) or alcohol use disorders (AUD) was initiated for patients with ICD-10s for OUD or AUD, as indicated in electronic health records (EHR) | 3-months prior to intervention vs. 3-months after intervention | |
Primary | Three-month retention in MH services for new patients whose EHR indicate substance use or SUD | Measured as any return visit for mental health (MH) services, as documented in electronic health records (EHR) for patients with ICD-10s for substance use disorders (SUD) or any indication of substance use in provider notes | 3-months prior to intervention vs. 3-months after intervention | |
Secondary | Training intervention feasibility | Assessed among professionals in training using Feasibility of Intervention Measure (FIM) in post-training surveys | up to 14 days after training | |
Secondary | Training intervention acceptability | Assessed among professionals in training using Acceptability of Intervention Measure (AIM) in post-training surveys | up to 14 days after training | |
Secondary | Training intervention appropriateness | Assessed among professionals in training using Intervention Appropriateness Measure (IAM) in post-training surveys | up to 14 days after training | |
Secondary | Professional Stigma measured with Social Distance Scale (SDS) | Measures willingness to have several kinds of social relationships among professionals in training, and adapted for three populations: relationships with people who actively use drugs, with people who used to use drugs, and with people treated with opioid agonist treatment. Assessed in longitudinal surveys (within 14 days pre-training, within 14 days post-training, and 6-weeks post-training). Lower score indicates greater stigma, min=12 and max=60. | up to 14 days before training, up to 14 days after training, and 6-weeks after training | |
Secondary | Professional Stigma measured with Medical Condition Regard Scale (MCRS) | Measures endorsed provider-based stigma toward patients with a specific diagnosis among professionals in training. Assessed in longitudinal surveys (within 14 days pre-training, within 14 days post-training, and 6-weeks post-training). Lower score indicates greater stigma, min=7 and max=35. | up to 14 days before training, up to 14 days after training, and 6-weeks after training | |
Secondary | Professional Stigma measured with Perceived Dangerousness Scale | Measures perceptions of the dangerousness of a stigmatized group among professionals in training. Assessed in longitudinal surveys (within 14 days pre-training, within 14 days post-training, and 6-weeks post-training). Lower score indicates greater stigma, min=5 and max=25. | up to 14 days before training, up to 14 days after training, and 6-weeks after training | |
Secondary | Patient-reported stigma measured with Internalized Stigma of Mental Illness Inventory (ISMI) | This measure is for patients and includes questions about anticipated stigma and internalized/self-stigma. This will be asked of a stratified random sample of patients of participating providers (n=20 with a SUD and n=20 not diagnosed with an SUD). Lower score indicates less stigma, min=29 and max=116. | 6-week post-training survey |
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