Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care
NCT Number: NCT06477848
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Substance Use Disorder|Opioid Use Disorder|Adolescent
Interventions: OTHER: Integrated Behavioral Health System with SUD Resources
Sponsor: Indiana University
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-08
Locations: Indiana University School of Medicine, Indianapolis, Indiana, 46202, United States

Summary:
This project seeks to address the increasing risk of overdose death, substance use disorder (SUD), and opioid use disorder (OUD) in adolescents. The investigators believe that pediatric primary care providers (PCP) could play an important role in helping youth with SUD because most adolescents see their PCPs for annual wellness visits. However, PCPs have many barriers to treating their young patients with SUD/OUD: lack of training, resources, and support to deliver SUD/OUD services, limited time with patients, and the only available referral options often come with long wait times for an appointment.

Through this project, the investigators will build upon an existing Integrated Behavioral Health (IBH) system by offering stigma-reduction interventions and brief SUD interventions within primary care settings. The goal of this project is to learn if clinics participating in an Integrated Behavioral Healthcare Program with SUD resources will increase delivery of effective adolescent SUD care and ultimately lead to better health outcomes when compared to standard primary care treatment.

During the first project phase, the research team will gather a Parent and Youth Advisory Board, Primary Care Provider Advisory Board, and Integrated Care Expert Panel (Aim 1) to inform the development and refinement of the primary care-based SUD interventions. The investigators will gather input from national experts, local stakeholders, and PCPs to refine our screening to treatment approach (Aim 2), coupled with stigma reduction activities, within pediatric primary care.

During the second project phase, researchers will assess the impact of SUD IBH on PCP behaviors around adolescent SUD intervention. The investigators will interview and survey PCPs, clinic managers, and other clinical staff for willingness to engage in adolescent SUD treatment. The investigators will evaluate implementation outcomes (views toward SUD, stigma attitudes, IBH team dynamics; Aim 3) and effectiveness/reach outcomes (delivery of integrated primary care-based SUD services, the use of brief interventions for adolescents, number of consultation calls, and increased treatment engagement; Aim 4a), along with an exploratory test of local overdose rates for youth (Aim 4b), in order to examine local effects of the new intervention.

This project is supported by the HEAL Initiative (https://heal.nih.gov/).

Primary Outcome Measures: Evidence-Based Practice Attitudes Scale, 15 items that gather general attitudes surrounding Evidence-Based Practices will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site., Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.|Primary Care Team Dynamics Survey, 11 items that assess dynamics within Primary Care Clinic teams will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site., Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.|Implementation Leadership and Climate Scale, 6 and 18 items to measure organization climate's support of adopting new innovations will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site., Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.|Attribution Questionnaire - SUD, 18 items to measure adolescent SUD stigma will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site., Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.|Attitudes of Medication Opioid Use Disorder (MOUD) Treatment, 15 items to measure attitudes toward MOUD treatment for adolescents with OUD will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site., Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.|Acceptability of Intervention, Intervention Appropriateness Measure, Feasibility of Intervention Measure, 12 items to assess perceptions of acceptability, feasibility, and appropriateness of IBH will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site., Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.|Confidence, Barriers, and Feedback, 6 items to measure confidence in ability to implement the model, barriers encountered, suggested improvements will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site., Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.|Provider Report of Sustainment Scale, 3 items to measure sustainability or continued sue of IBH program will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site., Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.|Systems Usability Scale, 12 items to measure electronic Health Record usability will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site., Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.|Stages of Implementation Completion (SIC), The SIC is a measure of implementation process fidelity and allows for continuous measurement of implementation success. The SIC is an observation-based assessment tool that qualitatively measures intervention implementation process and fidelity. Assessment of the SIC results will be ongoing across the intervention time period and into sustainment., From baseline through study completion, an average of 5 years|Screening Rates, Percent of youth screened for Substance Use, From clinical trial launch, data will be collected twice a year, for a total of four years.|Referral Rates, Percent of youth referred to SUD treatment, From clinical trial launch, data will be collected twice a year, for a total of four years.|Brief Substance Use Disorder (SUD) Treatment Engagement, Percent of indicated youth who received brief SUD treatment (e.g. Teen Intervene), From clinical trial launch, data will be collected twice a year, for a total of four years.|Comprehensive SUD Treatment Engagement, Percent of indicated youth who received comprehensive SUD treatment (e.g. ENCOMPASS), From clinical trial launch, data will be collected twice a year, for a total of four years.|MOUD Prescription, Prescription fills of MOUD to adolescents, From clinical trial launch, data will be collected twice a year, for a total of four years.|Provider 2 Provider (P2P) Consultation Calls, Number of P2P Consultation Calls, From clinical trial launch, data will be collected twice a year, for a total of four years.
Secondary Outcome Measures: Nonfatal overdose, EMS and ED records indicating OD, From clinical trial launch, data will be collected twice a year, for a total of four years.|Fatal overdose, Accidental OD death, vital records, From clinical trial launch, data will be collected twice a year, for a total of four years.