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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04844021
Recruitment Status : Enrolling by invitation
First Posted : April 14, 2021
Last Update Posted : March 22, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Suicide Behavioral: Nudge Behavioral: Nudge+ Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Comparative Effectiveness Trial of Strategies to Implement Firearm Safety Promotion as a Universal Suicide Prevention Strategy in Pediatric Primary Care
Actual Study Start Date : March 14, 2022
Estimated Primary Completion Date : March 14, 2024
Estimated Study Completion Date : March 14, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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




Primary Outcome Measures :
  1. Reach [ Time Frame: 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) ]
    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)


Secondary Outcome Measures :
  1. Fidelity [ Time Frame: 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) ]
    Whether the clinician followed the two S.A.F.E. Firearm steps (counseling and offering cable lock), measured via parent-report

  2. Parent-reported acceptability [ Time Frame: Parent surveys will be collected from parents within two weeks of well-child visit from pre-implementation through sustainment (30 months total) ]
    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.

  3. Clinician-reported acceptability [ Time Frame: 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) ]
    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.

  4. Cost [ Time Frame: Cost data will be collected from pre-implementation through sustainment (30 months total) ]
    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.

  5. Distribution of cable locks [ Time Frame: Cable lock distribution data will be collected from active implementation through sustainment (24 months total) ]
    Number of cable locks distributed by each clinic will be collected



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844021


Locations
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United States, Colorado
Kaiser Permanente Colorado
Aurora, Colorado, United States, 80014
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04844021    
Other Study ID Numbers: R01MH123491 ( U.S. NIH Grant/Contract )
R01MH123491 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
implementation
fidelity
facilitation
firearm
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms