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 — BEHAVIORAL
    Intervention 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 Usual
    Treatment as Usual
  • Experimental: STARRS-PC
    Intervention 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

Locations (15)

FacilityCityStateZIPSite coordinators
AxessPointe Community Health Centers/Health QuartersAkronOhio44303
Terah Omaits, LPN
Signature HealthAshtabulaOhio44004
Libbie Stansifer, MD
(440) 992-8552
Holzer Health SystemAthensOhio45701
Jonathan Mathis, MD
(740) 589-3100
Nationwide Children's HospitalColumbusOhio43205
Cynthia Fontanella, PhD
(614) 938-0323
Priyanka Desirazu, MSE
(614) 938-1113
Jeffrey Bridge, PhD (PRINCIPAL_INVESTIGATOR)
Alex Kemper, MD, MPH, MS (PRINCIPAL_INVESTIGATOR)
Jennifer Hughes, PhD, MPH (PRINCIPAL_INVESTIGATOR)
Dayton Children's Hospital - Hope CenterDaytonOhio45404
Shipla Sangvai, MD, MPH
Dayton Children's Hospital - MainDaytonOhio45404
Shipla Sangvai, MD,MPH
Holzer Health SystemGallipolisOhio45613
Jonathan Mathis, MD
(740) 446-5937
Hilliard PediatricsHilliardOhio43026
Cathy Homick
(614) 777-1800
Holzer Health SystemJacksonOhio45640
Jonathan Mathis, MD
(740) 395-8801
Maumee Pediatric AssociatesMaumeeOhio43537
Iris Castillo, MD
4193891444
Cornerstone PediatricsMiamisburgOhio45342-
Signature HealthPainesvilleOhio44077
Libbie Stansifer, MD
(440) 853-1501
Village Square Primary Care CenterPerrysburgOhio43551
Franklin Avenue Primary Care CenterToledoOhio43620-
Signature HealthWilloughbyOhio44094
Libbie Stansifer, MD
(440) 953-9999

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