Stepped Approach to Reducing Risk of Suicide in Primary Care

Summary

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?

Conditions

• Suicidal Ideation
• Suicide, Attempted
• Suicide Prevention

Interventions

BEHAVIORAL

Stepped Approach to Reducing Risk of Suicide in Primary Care

Intervention consists of implementation of clinical pathway for youth suicide risk

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Ohio State University

  collaborator OTHER

• Holzer Athens

  collaborator OTHER

• Signature Health Ashtabula

  collaborator OTHER

• Signature Health Willoughby

  collaborator OTHER

• Signature Health Painesville

  collaborator OTHER

• AxessPointe - Arlington

  collaborator OTHER

• Dayton Children's Pediatrics - Main Campus

  collaborator UNKNOWN

• Dayton Children's Pediatrics - Hope Center

  collaborator UNKNOWN

• Cornerstone Pediatrics

  collaborator OTHER

• Village Square Primary Care Center

  collaborator OTHER

• Maumee Pediatric Associates

  collaborator UNKNOWN

• Holzer Jackson

  collaborator OTHER

• Holzer Gallipolis

  collaborator OTHER

• AxessPointe - Health Quarters

  collaborator UNKNOWN

• Cynthia Fontanella

  lead OTHER

Principal Investigators

• Jeffrey Bridge, PhD · Abigail Wexner Research Institute at NCH

• Alex Kemper, MD, MPH, MS · Abigail Wexner Research Institute at NCH

• Cynthia Fontanella, PhD · Abigail Wexner Research Institute at NCH

• Jennifer Hughes, PhD, MPH · Abigail Wexner Research Institue at NCH

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-08

Primary Completion

2027-07-31

Completion

2027-07-31

Countries

• United States

Study Locations