Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477848
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-06
Brief Title:
Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 SUDOUD lack of training resources and support to deliver SUDOUD 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 effectivenessreach 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 httpshealnihgov
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 effectivenessreach 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 httpshealnihgov
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 eg 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 SUDOUD 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 SUDOUD 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 SUDOUD 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 SUDOUD 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 SUDOUD
The research team will capitalize on the infrastructure of three statewide initiatives to improve behavioral healthcare for adolescents 1 IU Healths Pediatric Integrated Behavioral Health IBH Project which is in the process of embedding behavioral healthcare providersprocedures 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 SUDOUD 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 SUDOUD 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 effectivenessreach outcomes delivery of integrated primary care-based OUDSUD 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 SUDOUD
This project is supported by the HEAL Initiative httpshealnihgov
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 SUDOUD 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 SUDOUD 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 SUDOUD 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 SUDOUD 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 SUDOUD
The research team will capitalize on the infrastructure of three statewide initiatives to improve behavioral healthcare for adolescents 1 IU Healths Pediatric Integrated Behavioral Health IBH Project which is in the process of embedding behavioral healthcare providersprocedures 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 SUDOUD 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 SUDOUD 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 effectivenessreach outcomes delivery of integrated primary care-based OUDSUD 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 SUDOUD
This project is supported by the HEAL Initiative httpshealnihgov
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R61DA059948-01 | NIH | None | None |