Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care

NCT06477848 | Enrolling By Invitation

• 2 other identifiers: 232081R61DA059948-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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/).

Conditions

Substance Use Disorder; Opioid Use Disorder; Adolescent

Keywords

Opioid Use; Opioid Use Disorder; Substance Use Disorder; Opioid; Treatment; Adolescent

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (2)

• Nonfatal overdose

  From clinical trial launch, data will be collected twice a year, for a total of four years.

• Fatal overdose

  From clinical trial launch, data will be collected twice a year, for a total of four years.

Study Arms (2)

Primary Care Practice As Usual

NO INTERVENTION

Data are collected regarding standard primary care practice and outcomes before implementation of SUD resources within the Integrated Behavioral Health System.

Integrated Behavioral Health with SUD Resources

EXPERIMENTAL

Participating clinics receive a system-level intervention, an Integrated Behavioral Health System with SUD Resources, designed to improve youth connection to substance use treatment.

Other: Integrated Behavioral Health System with SUD Resources

Interventions

Integrated Behavioral Health System with SUD Resources OTHER

This is a system-level intervention designed to improve collaboration among personnel from primary care clinics and SUD resources.

Integrated Behavioral Health with SUD Resources

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• member of participating pediatric primary care team
• at least 18 years old
• speaks and understanding English.
• patient at one of the participating pediatric primary care team
• years old

You may not qualify if:

• N/A

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Study Officials

• Leslie A Hulvershorn, MD

  Indiana University/Indiana University Health

  PRINCIPAL INVESTIGATOR

• Zachary W Adams, PhD

  Indiana University/Indiana University Health

  PRINCIPAL INVESTIGATOR

• Matthew C Aalsma, PhD

  Indiana University/Indiana University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: The investigators will conduct a cluster-randomized stepped-wedge trial to compare the effects of SUD IBH on PCP willingness to engage in adolescent SUD treatment.

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 27, 2024
• Study Start: February 21, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 17, 2025

Record last verified: 2025-04

Locations

US (1)