Clinical trial NCT06619782: Practice Facilitation to Enhance Implementation of a Pediatric Suicide Prevention Pathway
Official title: Practice Facilitation to Enhance Implementation of a Pediatric Suicide Prevention Pathway
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide Prevention
Keywords: suicide prevention
pediatric primary care
practice facilitation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-10-01
Enrollment: 360
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention involves training and implementation of the NIMH suicide prevention pathway in pediatric primary care and family medicine practices
Primary purpose: PREVENTION

Brief summary: Suicide in youth is rapidly growing to where it is the second leading cause of death across the United States. Use of available tools have shown the potential to boost primary care providers' (PCPs) detection of suicide risk and confidence and knowledge around addressing it; however, ways that work to address clinic and provider barriers that influence the ongoing implementation of a pathway to manage at-risk patients remain under researched. The proposed study will assess the impact of the investigators Facilitated Suicide Prevention program--which provides support to assist practices in integrating screening, assessment, data analysis and management procedures into routine care through feedback and coaching--on clinic use of the suicide prevention pathway and youth suicide.

The project hypothesizes that compared to PCPs in Training Only (TO) practices, those in TO+Practice Facilitation (PF) may rate the care pathway as more able to be carried out and acceptable; demonstrate greater use of the pathway components (screening, risk assessment, safety planning, lethal means safety counseling, referrals and follow-up); demonstrate higher levels of use of the pathway suicide prevention skills ; and report higher levels of confidence putting the care pathway into use.

Also we predict that, compared to youth who screen positive for suicide risk and are followed by PCPs in TO practices, those who screen positive and are followed by PCPs in TO+PF practices will be less likely to attempt suicide during the next six months; less likely to have suicidal ideation during the next 6 months; more likely to see a behavioral health provider during the next 6 months; and less likely to be sent to Emergency Departments during the next 6 months .

Detailed description: Suicide is a leading cause of death in youth across the United States. Approximately 80% of youth who die by suicide interface with the medical system in the year preceding their death. Primary care practices (PCPs) serving youth are well positioned to detect patients at risk for suicide and intervene, and widely accessible toolkits are available for practices to use. However, effective ways to impact providers' skills in actually carrying out a clinical pathway to manage at-risk patients remain under researched. Indeed, training without applied practice and support is likely not enough to significantly have an effect on these skills in the long term and less likely to improve patient outcomes. Practice facilitation is a powerful way to transform clinical practice, develop provider skills, and improve patient outcomes. The investigators train PCPs in the National Institute of Mental Health (NIMH) youth suicide prevention care pathway and, in addition, assists them in integrating the pathway into routine care with feedback and support through practice facilitation and data collection. However, there is limited evidence for the effects of supports, such as practice facilitation or coaching, on primary care providers' use of and skills in suicide risk assessment and management. Thus, guided by the combined Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability (PRISM) framework, this study will compare the impact of practice facilitation added to suicide prevention training based on the NIMH youth suicide prevention care pathway (TO+PF) versus training only (TO). In this study, Pediatric and Family Medicine practices in collaborating practice-based research networks will be assigned to TO+PF or to TO. Providers in TO+PF clinics will receive practice facilitation for 6 months, involving monthly individual check-ins which include: 1) clinic- and provider-level data review of use data for the five components of the NIMH youth suicide prevention care pathway, 2) clinical coaching around implementing the different components of the pathway, and 3) coaching in identifying barriers to use and strategies to overcome them. At the clinic/provider level, the feasibility, acceptability, effectiveness, adoption, fidelity, use and barriers will be measured. At the patient level, youth assessed at intermediate or high risk and their family will be followed for 6 months following, with data collected on attempted suicides and suicide ideation as well as emergency room and behavioral health provider visits. The outcomes will provide preliminary support for a subsequent larger. study of the suicide prevention pathway, assessing its use, impact, and sustainability, with the goal of promoting broad use in a variety of clinic contexts.

Eligibility criteria: Inclusion Criteria:

Youth

* between the ages of 12 and 24 years
* present to a participating PCP and practice for a well visit
* receive a positive ASQ screen during their well visit. Providers
* All staff in enrolled Primary Care practices (e.g., physicians, physician assistants nurses, administrative staff) will be eligible to participate and complete relevant measures.

Exclusion Criteria:

Youth

* Over 24 years
* Do not receive a positive ASQ screen at well visit.

Primary outcomes:
measure: Ask Suicide Screening Questions
timeFrame: At enrollment (baseline) and 6 months (study completion)
measure: Suicidal Ideation Questionnaire
timeFrame: At enrollment (baseline) and 6 months (study completion)
measure: Patient Health Questionnaire-9
timeFrame: At enrollment (baseline) and 6 months (study completion)
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: At enrollment (baseline) and 6 months (study completion)
Secondary outcomes:
measure: Services Assessment for Children and Adolescents - Brief form (SACA)
timeFrame: At enrollment (baseline) and 6 months (study completion)
Other outcomes:
measure: Feasibility of Intervention Measure (FIM)
timeFrame: At enrollment (baseline) and 6 months following enrollment
measure: Acceptability of Intervention Measure (AIM)
timeFrame: At enrollment (baseline) and 6 months following enrollment
measure: Intervention Appropriateness Measure (IAM)
timeFrame: At enrollment (baseline) and 6 months following enrollment
Locations:
city: Aurora
country: United States
facility: Department of Psychiatry, University of Colorado School of Medicine
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine - Anschutz Medical Campus
name: Bruno J Anthony, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pitts BH, Doyle R, Wood L, Dar R, De Jesus Ayala S, Sharma T, St Pierre M, Anthony B. Brief Interventions for Suicidal Youths in Medical Settings: A Meta-Analysis. Pediatrics. 2024 Mar 1;153(3):e2023061881. doi: 10.1542/peds.2023-061881.