Stepped Approach to Reducing Risk of Suicide in Primary Care
Part of paid clinical trials in Akron, Ohio.
- Sponsor
- Cynthia Fontanella
- Study ID
- NCT06018285
- Status
- Recruiting
Conditions
- Suicidal Ideation
- Suicide Prevention
- Suicide, Attempted
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Stepped Approach to Reducing Risk of Suicide in Primary Care — BEHAVIORALIntervention consists of implementation of clinical pathway for youth suicide risk
Study Details
Suicide is the second leading cause of death among young people aged 12-17 years in the United States, yet many youth at risk for suicide are not identified or go untreated. Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings, including primary care. The goal of this hybrid I stepped wedge effectiveness-implementation study is to test the effectiveness of a population-based quality improvement (QI) intervention, entitled STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) compared to treatment as usual (TAU), in reducing the risk of suicidal behavior among youth in the pediatric primary care setting. STARRS-PC implements a clinical pathway for youth at elevated risk for suicide in pediatric primary care clinics. Clinical pathways are tools used by health professionals to guide evidence-informed practice. The STARRS-PC pathway consists of three evidence-based suicide clinical care processes: risk detection, assessment and triage, and, if needed, follow-up transitional care. STARRS-PC is guided by the Practical, Robust Implementation, and Sustainability Model (PRISM), which allows for the study of factors that influence effective implementation of the suicide prevention clinical pathway and is focused on scalability. The main questions the study aims to answer are: * Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12 months post-baseline (primary outcome)? * Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal self-injury, and improving family satisfaction at 12 months post-baseline (secondary outcomes)? * What are the barriers and facilitators of effective implementation and sustainability of STARRS-PC?
Key Dates
- Start date
- Aug 8, 2023
- Status verified
- May 2025
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 2,572 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- PREVENTION
Arms
- No Intervention: Treatment As UsualTreatment as Usual
- Experimental: STARRS-PCIntervention consists of implementation of clinical pathway for youth suicide risk
Primary Outcome Measure
Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt] [ Time Frame: Baseline, 3, 6, 12 Months ]
Central Contacts
- Cynthia Fontanella, PhD(614) 938-0323
- Priyanka Desirazu, MSE(614) 938-1113
Locations (15)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| AxessPointe Community Health Centers/Health Quarters | Akron | Ohio | 44303 | Terah Omaits, LPN |
| Signature Health | Ashtabula | Ohio | 44004 | |
| Holzer Health System | Athens | Ohio | 45701 | |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | Jeffrey Bridge, PhD (PRINCIPAL_INVESTIGATOR) Alex Kemper, MD, MPH, MS (PRINCIPAL_INVESTIGATOR) Jennifer Hughes, PhD, MPH (PRINCIPAL_INVESTIGATOR) |
| Dayton Children's Hospital - Hope Center | Dayton | Ohio | 45404 | Shipla Sangvai, MD, MPH |
| Dayton Children's Hospital - Main | Dayton | Ohio | 45404 | Shipla Sangvai, MD,MPH |
| Holzer Health System | Gallipolis | Ohio | 45613 | |
| Hilliard Pediatrics | Hilliard | Ohio | 43026 | |
| Holzer Health System | Jackson | Ohio | 45640 | |
| Maumee Pediatric Associates | Maumee | Ohio | 43537 | Amy Hardy |
| Cornerstone Pediatrics | Miamisburg | Ohio | 45342 | - |
| Signature Health | Painesville | Ohio | 44077 | |
| Village Square Primary Care Center | Perrysburg | Ohio | 43551 | Amy Hardy |
| Franklin Avenue Primary Care Center | Toledo | Ohio | 43620 | - |
| Signature Health | Willoughby | Ohio | 44094 |
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