Clinical trial NCT06477848: Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care
Official title: Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Substance Use Disorder
Opioid Use Disorder
Adolescent
Keywords: Opioid Use
Opioid Use Disorder
Substance Use Disorder
Opioid
Treatment
Adolescent
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-06-27
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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/).

Detailed description: Adolescents are at increasing risk of overdose death. Since 2020, the overdose crisis has expanded most rapidly among younger populations, largely because of the recent reality that any illicit substance (e.g., counterfeit pharmaceuticals, methamphetamines) used by adolescents has the potential to contain lethal amounts of fentanyl. Preventing overdose deaths, therefore, necessitates identifying and treating youth - not only with opioid use disorder (OUD) - but any substance use disorder (SUD).

The investigators seek to ensure a robust workforce is available and equipped to deliver interventions to youth with SUD. The investigators will do so by implementing a multifaceted intervention to change the cultural and procedural norms of pediatric primary care settings regarding adolescent SUD treatment. The investigators will take advantage of a large-scale roll out of integrated behavioral health (IBH) to improve assessment and treatment of adolescents with substance use and SUDs. Intervention components for this adolescent SUD IBH program consist of task-shifting within primary care settings to facilitate delivery of brief SUD intervention, case management, provider-to-provider (P2P) consultation regarding adolescent OUD pharmacology, telehealth SUD/OUD service delivery (when indicated) and stigma-reduction interventions.

The investigators argue that pediatric primary care providers (PCPs) could play a critical role in clinical management of adolescent SUD/OUD, since most youth attend annual well-child visits and PCPs already regularly engage around management of mental health disorders. However, current primary care norms present barriers to expanding the availability of effective SUD care for youth. First, most adolescent PCPs fail to sufficiently screen or inquire about SUD treatment needs, especially emergent needs associated with disorders like OUD. Relatedly, PCPs have notoriously limited time with patients, rendering appropriate SUD assessment and delivery of even brief interventions challenging to implement and sustain within primary care. While effective treatments and specialists are theoretically available for youth with SUD/OUD, stark workforce gaps in community-based behavioral healthcare prevent PCPs from being able to make meaningful referrals to services. For instance, of the Indiana buprenorphine prescribers surveyed by our team, less than 9% were willing to accept patients under age 18. Without viable referral options, PCPs face a conundrum about how best to care for their patients as they often lack formal SUD-related training, leaving them feeling unqualified to diagnose, discuss, and treat SUD/OUD in youth independently. Lastly, PCPs and their staff commonly hold high levels of stigmatizing attitudes toward people who use illicit substances and people treated for SUD, particularly OUD; PCP stigma is associated with less willingness to provide needed care. Empirically supported team-based solutions are needed to shift primary care norms, address stigma, and expand the workforce to meet the needs of adolescents with SUD/OUD.

The research team will capitalize on the infrastructure of three statewide initiatives to improve behavioral healthcare for adolescents: 1) IU Health's Pediatric Integrated Behavioral Health (IBH) Project, which is in the process of embedding behavioral healthcare providers/procedures in primary care practices across Indiana; 2) the Indiana Adolescent Addiction Access Program (AAA), a statewide provider to provider (P2P) consultation program focused on adolescent SUD/OUD; and 3) ENCOMPASS, an established hybrid telehealth outpatient dual diagnosis treatment program for adolescents with more severe SUD, including OUD. The primary purpose of the proposed intervention is to formally combine, build on, and increase uptake of the resources available through these initiatives to shift primary care practice toward delivering effective adolescent SUD care.

R61 Specific Aims: Convene 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 proposed primary care-based SUD interventions. The investigators will apply a person-centered research design approach with the expert panel to refine our screening to treatment approach (Aim 2), coupled with stigma reduction activities, within pediatric primary care.

R33 Specific Aims: Assess the impact of SUD IBH on PCP behaviors around adolescent SUD/OUD intervention. 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. The investigators will evaluate implementation outcomes (views toward MOUD, stigma attitudes, IBH team dynamics; Aim 3) and effectiveness/reach outcomes (delivery of integrated primary care-based OUD/SUD services, the use of MOUD for adolescents, number of P2P consultation calls to AAA, 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.

Here, the research team of clinician-scientists with expertise in etiology and treatment of adolescent SUDs, implementation science, and stigma reduction will study novel efforts to improve workforce capacity and willingness to deliver SUD services for youth. The research team is ideally situated in Indiana, where investigators can leverage the upcoming roll out of funded statewide behavioral health initiatives to rigorously evaluate how to best provide timely, evidence-based treatment for youth with SUD/OUD.

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

Eligibility criteria: Inclusion Criteria for providers and staff recruited to complete surveys, focus groups, and/or interviews:

1. member of participating pediatric primary care team
2. at least 18 years old
3. speaks and understanding English.

Inclusion Criteria for administrative data:

1. patient at one of the participating pediatric primary care team
2. 12-18 years old

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Evidence-Based Practice Attitudes Scale
timeFrame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
measure: Primary Care Team Dynamics Survey
timeFrame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
measure: Implementation Leadership and Climate Scale
timeFrame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
measure: Attribution Questionnaire - SUD
timeFrame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
measure: Attitudes of Medication Opioid Use Disorder (MOUD) Treatment
timeFrame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
measure: Acceptability of Intervention, Intervention Appropriateness Measure, Feasibility of Intervention Measure
timeFrame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
measure: Confidence, Barriers, and Feedback
timeFrame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
measure: Provider Report of Sustainment Scale
timeFrame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
measure: Systems Usability Scale
timeFrame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
measure: Stages of Implementation Completion (SIC)
timeFrame: From baseline through study completion, an average of 5 years
measure: Screening Rates
timeFrame: From clinical trial launch, data will be collected twice a year, for a total of four years.
measure: Referral Rates
timeFrame: From clinical trial launch, data will be collected twice a year, for a total of four years.
measure: Brief Substance Use Disorder (SUD) Treatment Engagement
timeFrame: From clinical trial launch, data will be collected twice a year, for a total of four years.
measure: Comprehensive SUD Treatment Engagement
timeFrame: From clinical trial launch, data will be collected twice a year, for a total of four years.
measure: MOUD Prescription
timeFrame: From clinical trial launch, data will be collected twice a year, for a total of four years.
measure: Provider 2 Provider (P2P) Consultation Calls
timeFrame: From clinical trial launch, data will be collected twice a year, for a total of four years.
Secondary outcomes:
measure: Nonfatal overdose
timeFrame: From clinical trial launch, data will be collected twice a year, for a total of four years.
measure: Fatal overdose
timeFrame: From clinical trial launch, data will be collected twice a year, for a total of four years.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University/Indiana University Health
name: Leslie A Hulvershorn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University/Indiana University Health
name: Zachary W Adams, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University/Indiana University Health
name: Matthew C Aalsma, PhD
role: PRINCIPAL_INVESTIGATOR
References: