Adolescent and Child Suicide Prevention in Routine Clinical Encounters

NCT04844021 | Completed Results DMC

• 1 other identifier: R01MH123491
• Study Type: interventional
• Target: 47,307
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to compare two approaches to implement an evidence-based firearm safety promotion program, S.A.F.E. Firearm, in pediatric primary care as a universal suicide prevention strategy. The first implementation approach is a prompt in the electronic health record (EHR; Nudge) reminding clinicians to a) discuss firearm storage and b) offer a free cable firearm lock during the pediatric well visit. The second implementation approach (Nudge+) includes both the EHR Nudge described above plus one year of support to the clinics in deploying the program (i.e., practice facilitation). The study also aims to identify how these strategies work and whether the S.A.F.E. Firearm program results in reduced unauthorized access to firearms by young people. The investigators hypothesize that a greater proportion of well-visits will have S.A.F.E. Firearm delivery documented in the electronic health record in Nudge+ clinics vs. Nudge clinics.

Conditions

Suicide

Keywords

implementation; fidelity; facilitation; firearm

Outcome Measures

Primary Outcomes (1)

• Reach

  Reach is the proportion of eligible well-child visits who received the S.A.F.E. Firearm program. "Participants" refers to well-child visits. For each well-child visit, data regarding S.A.F.E. Firearm delivery were available in the form of binary indicators, with 1 indicating S.A.F.E. Firearm was delivered during the visit and 0 indicating S.A.F.E. Firearm was not delivered during the visit. Reach outcomes presented below are means of the binary indicators, which were calculated across all eligible well-child visits.

  EHR data on reach will be extracted for the time period: the beginning of the active implementation period through the end of the active implementation period (12 months total)

Secondary Outcomes (5)

• Fidelity

  surveys collected from parents within two weeks of well-child visit. Surveys will be collected during the duration of the pre-implementation, active implementation, and sustainment phases (30 months total)

• Parent-reported Acceptability

  Parent surveys will be collected from parents within two weeks of well-child visit from pre-implementation through sustainment (30 months total)

• Clinician-reported Acceptability

  Clinician surveys will be collected at two time points during the study period: during pre-implementation (surveys will be administered for approximately 1 month) and during active implementation (surveys will be administered for approximately 1 month)

• Cost

  Cost data will be collected from pre-implementation through sustainment (30 months total)

• Distribution of Cable Locks

  Cable lock distribution data will be collected from active implementation through sustainment (24 months total)

Study Arms (2)

Nudge

EXPERIMENTAL

Clinics randomized to the Nudge condition will receive the EHR prompt only. The investigators will add default language to the standard Well Child Visit workflow to serve as a reminder and allow for tracking of S.A.F.E. Firearm implementation. The clinician will be asked to denote whether the program was delivered (e.g., whether conversation around firearm storage was conducted, whether cable firearm lock was offered) to the parent during the visit. This EHR prompt will remain turned "on" from active implementation through the sustainment period.

Behavioral: Nudge

Nudge+

EXPERIMENTAL

This arm consists of Nudge as described above, as well as facilitation. Facilitation (i.e., external support delivered by health system employees not employed within the clinic site) will be offered for 12 months to each clinic, in keeping with other implementation trials. The investigators will use a train-the-trainer model to train facilitators at both health systems to ensure they achieve facilitator core competencies with an eye toward implementation of S.A.F.E. Firearm. The role of the facilitator is to engage with study clinics, to assist each clinic in setting change and performance goals around the implementation of S.A.F.E. Firearm, and to troubleshoot implementation barriers.

Behavioral: Nudge+

Interventions

Nudge+ BEHAVIORAL

EHR-based "nudge" plus facilitation

Nudge+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents and/or legal guardians (hereafter referred to as parents) at participating pediatric clinics who have a child age 5-17 who attends a well visit. At least one parent must attend the well visit to be eligible. The parent must be at least 18 years old to participate.

You may not qualify if:

• Due to translation costs and challenges of recruiting non-US resident participants, respectively, non-English speaking parents and non-US resident parents will not be eligible to participate at Henry Ford Health System.
• Pediatric physicians and non-physician clinicians (hereafter referred to as clinicians) employed within the participating pediatric clinics, as well as health system leaders employed within the two health systems, are eligible to participate. Family medicine clinicians who see pediatric patients in participating clinics at Kaiser Permanente Colorado will also be eligible.
• At Kaiser Permanente Colorado, family medicine clinicians whose patient panel is comprised of fewer than 5% pediatric patients will be excluded.
• Family medicine clinicians who see pediatric patients in participating clinics at Henry Ford Health System will be excluded.

Sponsors & Collaborators

• Northwestern University: lead
• University of Pennsylvania: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Kaiser Permanente Colorado

Aurora, Colorado, 80014, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (3)

• Waller CR, Pandey M, Boggs JM, Beck A, Bedoy RP, Buttenheim AM, Elias ME, Hoskins K, Jager-Hyman S, Johnson C, Maye M, McArdle B, Pappas C, Small DS, Quintana LM, Wolk CB, Wright LA, Williams NJ, Ahmedani BK, Beidas RS. Pediatric Healthcare Worker Perspectives on Implementation of a Secure Firearm Storage Program: A Qualitative Study. Res Sq [Preprint]. 2025 Oct 8:rs.3.rs-7437500. doi: 10.21203/rs.3.rs-7437500/v1.

  PMID: 41282060 DERIVED

• Beidas RS, Linn KA, Boggs JM, Marcus SC, Hoskins K, Jager-Hyman S, Johnson C, Maye M, Quintana L, Wolk CB, Wright L, Pappas C, Beck A, Bedjeti K, Buttenheim AM, Daley MF, Elias M, Lyons J, Martin ML, McArdle B, Ritzwoller DP, Small DS, Williams NJ, Zhang S, Ahmedani BK. Implementation of a Secure Firearm Storage Program in Pediatric Primary Care: A Cluster Randomized Trial. JAMA Pediatr. 2024 Nov 1;178(11):1104-1113. doi: 10.1001/jamapediatrics.2024.3274.

  PMID: 39226027 DERIVED

• Beidas RS, Ahmedani BK, Linn KA, Marcus SC, Johnson C, Maye M, Westphal J, Wright L, Beck AL, Buttenheim AM, Daley MF, Davis M, Elias ME, Jager-Hyman S, Hoskins K, Lieberman A, McArdle B, Ritzwoller DP, Small DS, Wolk CB, Williams NJ, Boggs JM. Study protocol for a type III hybrid effectiveness-implementation trial of strategies to implement firearm safety promotion as a universal suicide prevention strategy in pediatric primary care. Implement Sci. 2021 Sep 22;16(1):89. doi: 10.1186/s13012-021-01154-8.

  PMID: 34551811 DERIVED

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Rinad Beidas
• Organization: Northwestern University

rinad.beidas@northwestern.edu

312-503-0546

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ralph Seal Paffenbarger Professor and Chair, Department of Medical Social Sciences

Model Details: The investigators will randomize clinics to the active implementation conditions (Nudge \[k = 15\] or Nudge+ \[k = 15\]). Clinicians in clinics assigned to both conditions will deliver the S.A.F.E. Firearm storage program to patients during well-child visits. Clinicians from all participating clinics, regardless of study arm, will be invited to participate in surveys and interviews.

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: April 14, 2021
• Study Start: March 14, 2022
• Primary Completion: March 20, 2023
• Study Completion: May 8, 2024
• Last Updated: July 25, 2024
• Results First Posted: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)