Clinical trial NCT06018285: Stepped Approach to Reducing Risk of Suicide in Primary Care
Official title: Stepped Approach to Reducing Risk of Suicide in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Suicide, Attempted
Suicide Prevention
Keywords: Suicide
STARRS-PC
Adolescent
Risk Assessment
Triage
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Ohio State University
name: Holzer Athens
name: Signature Health Ashtabula
name: Signature Health Willoughby
name: Signature Health Painesville
name: AxessPointe - Arlington
name: Dayton Children's Pediatrics - Main Campus
name: Dayton Children's Pediatrics - Hope Center
name: Cornerstone Pediatrics
name: Village Square Primary Care Center
name: Maumee Pediatric Associates
name: Holzer Jackson
name: Holzer Gallipolis
name: AxessPointe - Health Quarters
First posted: 2023-08-30
Enrollment: 5244
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge Design
Primary purpose: PREVENTION

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?

Detailed description: This five-year multi-site study consists of the following essential elements: (1) recruitment of 2,572 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 14 pediatric primary care practices.

The study consists of three phases of data collection: TAU, intervention, and sustainability. Eight hundred forty-nine suicidal youth will be enrolled during the TAU phase, and 1,723 suicidal youth will be enrolled during the intervention phase (total number of youth participants = 2,572). 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.

Eligibility criteria: 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 14 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.

Primary outcomes:
measure: Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt]
timeFrame: Baseline, 3, 6, 12 Months
measure: Suicidal Ideation Questionnaire-JR [Suicidal ideation]
timeFrame: Baseline, 3, 6, 12 Months
Secondary outcomes:
measure: Non-Suicidal Self-Injury (NSSI) [NSSI]
timeFrame: 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.
measure: Client Satisfaction Questionnaire-8 (CSQ-8) [Family satisfaction]
timeFrame: Baseline ONLY, Parent and Child receive survey independently.
measure: AIM (Acceptability of Intervention Measure) [Family satisfaction]
timeFrame: Baseline ONLY, Parent and Child receive survey independently.
measure: Service Assessment Child and Adolescent
timeFrame: Baseline, 3, 6, & 12 Month Follow-ups. Parent ONLY receives this measure.
measure: Social Determinants of Health
timeFrame: Baseline. Parent ONLY Assessment
Other outcomes:
measure: The DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure
timeFrame: Baseline, 3, 6, & 12 Month Follow-ups. Parent & youth receive this independently from each other.
measure: The RCADS-25 Assessment
timeFrame: Baseline appointment ONLY. Parent & youth will complete independently from each other.
Locations:
city: Akron
country: United States
facility: AxessPointe Community Health Centers/Health Quarters
state: Ohio
city: Ashtabula
country: United States
facility: Signature Health
state: Ohio
city: Athens
country: United States
facility: Holzer Health System
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Dayton
country: United States
facility: Dayton Children's Hospital - Hope Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Children's Hospital - Main
state: Ohio
city: Gallipolis
country: United States
facility: Holzer Health System
state: Ohio
city: Hilliard
country: United States
facility: Hilliard Pediatrics
state: Ohio
city: Jackson
country: United States
facility: Holzer Health System
state: Ohio
city: Maumee
country: United States
facility: Maumee Pediatric Associates
state: Ohio
city: Miamisburg
country: United States
facility: Cornerstone Pediatrics
state: Ohio
city: Painesville
country: United States
facility: Signature Health
state: Ohio
city: Perrysburg
country: United States
facility: Village Square Primary Care Center
state: Ohio
city: Toledo
country: United States
facility: Franklin Avenue Primary Care Center
state: Ohio
city: Willoughby
country: United States
facility: Signature Health
state: Ohio
Study officials:
affiliation: Abigail Wexner Research Institute at NCH
name: Jeffrey Bridge, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abigail Wexner Research Institute at NCH
name: Alex Kemper, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Abigail Wexner Research Institute at NCH
name: Cynthia Fontanella, PhD
role: STUDY_DIRECTOR
affiliation: Abigail Wexner Research Institue at NCH
name: Jennifer Hughes, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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