Adolescent and Child Suicide Prevention in Routine Clinical Encounters (ASPIRE)

A Comparative Effectiveness Trial of Strategies to Implement Firearm Safety Promotion as a Universal Suicide Prevention Strategy in Pediatric Primary Care

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Suicide
• Intervention / Treatment: Behavioral: Nudge; Behavioral: Nudge+

Detailed Description

The investigators will conduct a hybrid type III effectiveness-implementation trial using a longitudinal cluster randomized design to test the most effective way to implement S.A.F.E. Firearm among 30 clinics, 158 clinicians, and 48,475 youth nested in two Mental Health Research Network (MHRN) health systems in Michigan and Colorado. Clinics will be randomized to receive either the EHR implementation strategy (Nudge) or the EHR implementation strategy plus 1 year of facilitation to target implementation barriers (Nudge+).

Aim 1: Examine the effects of Nudge vs. Nudge+ on implementation outcomes.

• Reach: The investigators hypothesize that clinician-documented program delivery in the EHR (reach; primary outcome) will be superior in the Nudge+ condition compared to Nudge in the active and sustainment periods.
• Fidelity: The investigators hypothesize that parent-reported clinician fidelity to the program will be superior in the Nudge+ condition compared to Nudge in the active and sustainment periods.
• Cost: The investigators will also assess implementation strategy cost.
• Cable Locks/Acceptability: The investigators hypothesize that the Nudge+ condition will result in increased rates of cable lock distribution and higher acceptability compared with Nudge in both the active and sustainment periods.

Aim 2: Use mixed methods to identify implementation strategy mechanisms. The investigators hypothesize that Nudge+ will have a stronger effect because it will improve clinic adaptive reserve (i.e., the ability to make and sustain change). The investigators will also investigate the role of clinician motivation. The investigators hypothesize that clinician attitudes towards firearm counseling, clinician burnout, and clinician demographics will moderate implementation strategy effectiveness.

Aim 3: Examine the effects of the adapted intervention on clinical outcomes. The investigators hypothesize that Nudge+ will result in a greater proportion of parents reporting that they made firearm(s) less accessible to their child(ren) compared with Nudge. The investigators will explore rates of youth suicide attempts, deaths, and unintentional firearm injury and mortality by implementation condition and across time.

• Study Type: Interventional
• Enrollment (Estimated): 48475
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Kaiser Permanente Colorado
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Parents

• 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.

Exclusion Criteria: Parents

• 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.

Inclusion Criteria: Clinicians and leaders

• 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.

Exclusion criteria: Clinicians and leaders

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nudge; 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; EHR-based "nudge"
Experimental: Nudge+; 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+; EHR-based "nudge" plus facilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	Number of parent-youth dyads who receive the S.A.F.E. firearm program divided by number of eligible parent-youth dyads (extracted from EHR)	EHR data on reach will be extracted for the time period: the beginning of the active implementation period through the sustainment period (24 months total)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity	Whether the clinician followed the two S.A.F.E. Firearm steps (counseling and offering cable lock), measured via parent-report	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-report of acceptability of the S.A.F.E. Firearm program. Parents will be asked to answer questions pertaining to the acceptability of program components. Specifically, they will answer yes/no questions developed by the research team which ask whether they found the component acceptable.	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-report of acceptability of the S.A.F.E. Firearm program. Acceptability of the implementation strategies - EHR nudge and facilitation - will be collected from clinicians as well. Clinicians will be asked questions developed by the research team about whether they found various components of the program and implementation strategies acceptable, and will answer each question with a Likert-scaled answer.	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 of the implementation strategies (EHR nudge, facilitation) and the S.A.F.E. Firearm program delivery. Data on the cost of implementing the program (e.g., costs for printing program materials and distributing firearm locks) and the implementation strategies (e.g., facilitator full-time equivalent [FTE] time) will be collected to estimate the overall cost of the program and implementation strategy delivery.	Cost data will be collected from pre-implementation through sustainment (30 months total)
Distribution of cable locks	Number of cable locks distributed by each clinic will be collected	Cable lock distribution data will be collected from active implementation through sustainment (24 months total)

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Mental Health (NIMH); University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): March 20, 2023
• Study Completion (Estimated): May 8, 2024

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: implementation; fidelity; facilitation; firearm
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide Prevention
• Other Study ID Numbers: R01MH123491 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No