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Clinical Trials/NCT06200012
NCT06200012
Completed
Not Applicable

Multi-Level Stigma Intervention to Improve Access to Substance Use Care With Prescribing Providers in Mental Health Settings

Wayne State University1 site in 1 country12 target enrollmentNovember 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Social Stigma
Sponsor
Wayne State University
Enrollment
12
Locations
1
Primary Endpoint
Number of patients in the provider panel (new or old) diagnosed with OUD or AUD who initiated OUD or AUD pharmacotherapy
Status
Completed
Last Updated
6 months ago

Overview

Brief Summary

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.

Detailed Description

Substance use is commonly stigmatized, even in health settings. Stigma toward people who use drugs (PWUD) arises from multiple sources, including policies and individuals who carry out policies ("structural stigma") and health professionals ("provider-based stigma"). This study seeks to answer the question of whether addressing organizational-level structural stigma toward PWUD enhances the behavioral effects of stigma training among professionals providing mental health (MH) services. This study will have two intervention groups: A MH clinic where the providers receive only the educational intervention and a MH clinic where the providers receive both the educational intervention and an organizational policy change. 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 PWUD compared to a site where providers receive training alone. Only a small body of research develops and evaluates interventions seeking to reduce structural and provider-based stigma toward PWUD in healthcare settings or investigates the impact of such interventions on provision of evidence-based interventions like substance use disorder (SUD) pharmacotherapy. Little is known about substance use stigma in MH settings in particular, although some research suggests psychiatrist stigma toward dual diagnosis patients is greater than toward patients with either a SUD or MH diagnosis alone. Extant studies on stigma toward PWUD in healthcare found educational interventions incorporating critical reflection techniques and contact with PWUD significantly reduced provider-based stigma. But most provider-based stigma intervention studies have two major weaknesses: 1) failing to address structural drivers of stigma, such as organizational policies motivating attitudes and behaviors, and 2) falling short of practical application because they largely focus on professional attitudes without measuring changes to service provision. The investigators propose to pilot test a multi-level stigma intervention that leverages what existing research suggests works in professional stigma education, and adds a novel component of organizational policy change within a MH clinic. Because so little research exists on organizational-level stigma interventions, the investigators will use an inductive approach to identify a promising feasible policy that may reduce stigma toward PWUD. Our pilot testing will assess the extent to which combining interventions that modify structural/organizational and individual/professional-level drivers of stigma in outpatient MH services may improve not only attitudes but also health service provision to PWUD.

Registry
clinicaltrials.gov
Start Date
November 6, 2023
End Date
February 8, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erin F. Madden

Assistant Professor

Wayne State University

Eligibility Criteria

Inclusion Criteria

  • Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study.
  • Site inclusion:
  • The sites will be selected using convenience sampling.
  • The inclusion criterion will be sites with at least 4 providers.
  • 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.
  • 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.

Exclusion Criteria

  • All individuals meeting any of the exclusion criteria will be excluded from study participation.
  • 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.
  • 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.

Outcomes

Primary Outcomes

Number of patients in the provider panel (new or old) diagnosed with OUD or AUD who initiated OUD or AUD pharmacotherapy

Time Frame: 3-months prior to intervention vs. 3-months after intervention

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)

Number of patients where substance use was addressed during a MH visit among new intakes and documented in EHR

Time Frame: 3-months prior to intervention vs. 3-months after intervention

Identified ICD-10s or notes among participating providers in electronic health records (EHR)

Three-month retention in MH services for new patients whose EHR indicate substance use or SUD

Time Frame: 3-months prior to intervention vs. 3-months after intervention

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

Secondary Outcomes

  • Training intervention feasibility(up to 14 days after training)
  • Training intervention appropriateness(up to 14 days after training)
  • Professional Stigma measured with Medical Condition Regard Scale (MCRS)(up to 14 days before training, up to 14 days after training, and 6-weeks after training)
  • Patient-reported stigma measured with Internalized Stigma of Mental Illness Inventory (ISMI)(6-week post-training survey)
  • Professional Stigma measured with Social Distance Scale (SDS)(up to 14 days before training, up to 14 days after training, and 6-weeks after training)
  • Training intervention acceptability(up to 14 days after training)
  • Professional Stigma measured with Perceived Dangerousness Scale(up to 14 days before training, up to 14 days after training, and 6-weeks after training)

Study Sites (1)

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