Clincosm LogoSign in Get a demo

STARRS-PC: Stepped Approach to Reducing Risk of Suicide in Primary Care

Sponsor
Cynthia Fontanella (Other)
Overall Status
Recruiting
CT.gov ID
NCT06018285
Collaborator
National Institute of Mental Health (NIMH) (NIH), Ohio State University (Other), Holzer Gallipolis (Other), Holzer Jackson (Other), Holzer Athens (Other), Eastglen Pediatrics (Other), Signature Health Ashtabula (Other), Signature Health Willoughby (Other), Signature Health Painesville (Other), AxessPointe - Arlington (Other), Dayton Children's - Main Campus (Other), Dayton Children's - Northwest Campus (Other), Cornerstone Pediatrics (Other), Kettering Pediatric and Family Care (Other), Franklin Avenue Primary Care Center (Other), Village Square Primary Care Center (Other), Spring Valley Primary Care Center (Other)
4,648
Enrollment
17
Locations
2
Arms
47.7
Anticipated Duration (Months)
273.4
Patients Per Site
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Stepped Approach to Reducing Risk of Suicide in Primary Care
 N/A

Detailed Description

This five-year multi-site study consists of the following essential elements: (1) recruitment of 2,324 adolescents ages 12-17 years inclusive at baseline, and their parent/guardian; (2) initial assessment of youth and parent/guardian participants using direct interviews and standardized questionnaires; and (3) follow-up assessments of all participants at 3-months, 6-months, and 1-year post-baseline. To achieve the study objectives, the project will be conducted in 16 pediatric primary care practices.

The study consists of three phases of data collection: TAU, intervention, and sustainability. One thousand thirty-three suicidal youth will be enrolled during the TAU phase, and 1,291 suicidal youth will be enrolled during the intervention phase (total number of youth participants = 2,324). Youth and parent participants enrolled in the study will complete multiple questionnaires at four time points (baseline, 3-months, 6-months, and 12-months). Medical record reviews of youth participant files will occur throughout the study and be reviewed by research staff. The intervention phase is followed by a 6-month sustainability phase during which the participating practices will work on maintaining or further improving upon the anticipated gains made during the intervention phase.

Phase 1: TAU

TAU immediately precedes the intervention phase and ranges in length from 6 to 26 months. During TAU, participants will be treated according to usual and customary care, thus establishing each site's baseline rate of suicide risk screening and detection. Usual care at each participating practice involves screening for depression and suicide risk with the PHQ-9. This baseline rate will serve as the control for subsequent study phases.

Phase 2: Intervention

The intervention phase will range from 11 to 30 months. During this phase, each site will implement the clinical pathway, which includes universal screening for suicide risk using the Ask Suicide-Screening Questions (ASQ), a four-item questionnaire. Those who screen positive will then be evaluated using the Brief Suicide Safety Assessment (BSSA). The BSSA allows the clinician to assess the level of suicide risk to then choose how to proceed with clinical next steps. Clinicians will triage care based on three categories of risk: low-risk, further evaluation needed, and imminent-risk. The risk assessment will determine the type of care the individual then receives (e.g., mental health referrals, mental health evaluation and safety plan, tele-psychiatry crisis intervention consultation, send to ED).

We will also conduct in-depth qualitative interviews with a purposive sample of providers (e.g., physicians, nurses, social workers) at each of the participating sites. Purposive sampling is a way to identify and recruit participants that are especially experienced with or knowledgeable about a phenomenon of interest. Provider participants will complete a series of questionnaires at three separate times: 1) prior to clinical pathway training, 2) after training, and 3) 6 months after training. Provider participants will also be trained on the quality improvement process for implementing the intervention strategy. Some provider participants will be asked to complete up to four qualitative interviews that will focus on the implementation process, barriers and facilitators to successful implementation of the clinical pathway, and lessons learned.

Phase 3: Sustainability

The intervention phase is followed by a 6-month sustainability phase during which the site will work on maintaining or further improving upon the anticipated gains made during the intervention phase. No participants will be recruited during the sustainability phase and this phase will not be used to evaluate intervention effectiveness.

The specific aims include:

Aim 1: To implement, study, and improve through a Plan-Do-Study-Act (PDSA) cycle, the STARRS-PC intervention that includes suicide risk detection, assessment and triage, and care management based on risk profile. PDSA is a systematic way to test a change that is implemented by breaking down the implementation process into specific steps, and then evaluating the outcome, improving on it, and testing again.

Aim 2: Test the effectiveness of STARRS-PC compared to TAU on the primary patient outcome, suicide attempts, secondary patient outcomes (suicidal ideation, non-suicidal self-injury (NSSI), and family satisfaction) at 12 months post-baseline, as well as mediators and moderators, through a stepped wedge design.

  • Hypotheses: STARRS-PC will significantly reduce the rate of: 1) suicide attempts (nonfatal and fatal) and 2) suicidal ideation, NSSI, and improve family satisfaction during the 12-month post-baseline follow-up period compared with TAU.

  • Exploratory Aim 2a: To examine whether increases in provider knowledge, self-efficacy, and buy-in regarding suicide risk screening, assessment, and management will mediate the intervention effect on patient outcomes.

  • Exploratory Aim 2b: To examine whether organization readiness and practice integration will moderate effects of intervention on patient outcomes.

Aim 3: To identify barriers to and facilitators of implementation and sustainability of an intervention designed to improve suicide risk detection and risk management using qualitative interviews and surveys with clinical stakeholders at each study site.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
4648 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Stepped Wedge DesignStepped Wedge Design
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Stepped Approach to Reducing Risk of Suicide in Primary Care
Actual Study Start Date :
Aug 8, 2023
Anticipated Primary Completion Date :
Jul 31, 2027
Anticipated Study Completion Date :
Jul 31, 2027

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Treatment As Usual

Treatment as Usual
Experimental: STARRS-PC

Intervention consists of implementation of clinical pathway for youth suicide risk

Behavioral: Stepped Approach to Reducing Risk of Suicide in Primary Care
Intervention consists of implementation of clinical pathway for youth suicide risk

Outcome Measures

Primary Outcome Measures

  1. Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt] [Baseline, 3, 6, 12 Months]

    Columbia Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview that tracks suicidal ideation and behavior severity over time.

  2. Pierce Suicide Intent Scale (SIS) [suicide attempt] [Based on most recent attempt from CSSRS at baseline, 3, 6 and 12 months]

    Pierce Suicide Intent Scale (SIS) is a questionnaire that assesses behavior and circumstances surrounding the suicide attempt, including plans, preparation, communicative elements, and concept of lethality of the chosen method.

Secondary Outcome Measures

  1. Non-Suicidal Self-Injury (NSSI) [NSSI] [This measure will be administered to youth only at baseline as well as at 3-, 6-, and 12-months after baseline to track NSSI over time. This is a youth only assessment.]

    The Non-Suicidal Self-Injury (NSSI) Assessment measures recent and lifetime NSSI.

  2. Suicidal Ideation Questionnaire-JR [Suicidal ideation] [Baseline, 3, 6, 12 Months]

    Suicidal Ideation Questionnaire-JR is a 15-item modified version of the SIQ, a 30 item self-report measure of suicidal ideation severity in adolescents, that has been tested in a variety of cultural settings and has been used as an outcome measure in several pediatric treatment studies.

  3. Client Satisfaction Questionnaire-8 (CSQ-8) [Family satisfaction] [Baseline ONLY, Parent and Child receive survey independently.]

    Client Satisfaction Questionnaire-8 (CSQ-8) is an 8-item self-report measure with items scored on a 1-4 scale (1=the lowest satisfaction, 4=the highest satisfaction). The CSQ assesses parent and youth perceptions of treatment acceptability and helpfulness.

  4. AIM (Acceptability of Intervention Measure) [Family satisfaction] [Baseline ONLY, Parent and Child receive survey independently.]

    AIM (Acceptability of Intervention Measure) is a 4-item measure used to determine the extent the parent and child finds the intervention pathway acceptable.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria (Youth and Parent):

  • All patients between the ages of 12 - 17 years and their parent/guardian at time of consent who are identified as being at risk for suicide and receive primary care services at one of 16 participating sites are eligible for study inclusion.

  • Youth will be recruited without regard to current or past histories of mental health problems.

  • Youth with comorbid physical illness (e.g., asthma) and those receiving medication treatment for a comorbid physical or psychiatric condition will be eligible to participate provide they otherwise meet study entry criteria.

Inclusion Criteria (Provider):
  • Providers must work with patients at one of the participating PCCs.
Exclusion Criteria (Youth and Parent):
Subjects will be excluded for being:

  • medically or cognitively unable to participate in study procedures

  • without permanent residence or access to a telephone

  • unable to speak English adequately to understand study procedures

Exclusion Criteria (Provider):

  • Unable to give consent

  • Unable to speak English adequately to understand study procedures.

Contacts and Locations

Locations

Site City State Country Postal Code
1 AxessPointe Community Health Centers/Arlington Akron Ohio United States 44333
2 Signature Health Ashtabula Ohio United States 44004
3 Holzer Health System Athens Ohio United States 45701
4 Nationwide Children's Hospital Columbus Ohio United States 43205
5 Eastglen Pediatrics Columbus Ohio United States 43213
6 Dayton Children's Hospital - Main Dayton Ohio United States 45404
7 Dayton Children's Hospital - NW Dayton Ohio United States 45404
8 Holzer Health System Gallipolis Ohio United States 45613
9 Hilliard Pediatrics Hilliard Ohio United States 43026
10 Spring Valley Primary Care Center Holland Ohio United States 43528
11 Holzer Health System Jackson Ohio United States 45640
12 Kettering Pediatric and Family Care Kettering Ohio United States 45429
13 Cornerstone Pediatrics Miamisburg Ohio United States 45342
14 Signature Health Painesville Ohio United States 44077
15 Village Square Primary Care Center Perrysburg Ohio United States 43551
16 Franklin Avenue Primary Care Center Toledo Ohio United States 43620
17 Signature Health Willoughby Ohio United States 44094

Sponsors and Collaborators

  • Cynthia Fontanella
  • National Institute of Mental Health (NIMH)
  • Ohio State University
  • Holzer Gallipolis
  • Holzer Jackson
  • Holzer Athens
  • Eastglen Pediatrics
  • Signature Health Ashtabula
  • Signature Health Willoughby
  • Signature Health Painesville
  • AxessPointe - Arlington
  • Dayton Children's - Main Campus
  • Dayton Children's - Northwest Campus
  • Cornerstone Pediatrics
  • Kettering Pediatric and Family Care
  • Franklin Avenue Primary Care Center
  • Village Square Primary Care Center
  • Spring Valley Primary Care Center

Investigators

  • Principal Investigator: Jeffrey Bridge, PhD, Abigail Wexner Research Institute at NCH
  • Principal Investigator: Alex Kemper, MD, MPH, MS, Abigail Wexner Research Institute at NCH
  • Study Director: Cynthia Fontanella, PhD, Abigail Wexner Research Institute at NCH

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cynthia Fontanella, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT06018285
Other Study ID Numbers:
  • STUDY00002515
  • 1P50MH127476
  • 7956
First Posted:
Aug 30, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cynthia Fontanella, Principal Investigator, Nationwide Children's Hospital
Suicide
STARRS-PC
Adolescent
Risk Assessment
Triage
Additional relevant MeSH terms:
Suicide
Suicidal Ideation
Suicide Prevention
Suicide, Attempted

Study Results

No Results Posted as of Aug 30, 2023