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SuicideASPIRENCT04844021

Adolescent and Child Suicide Prevention in Routine Clinical Encounters

A study testing Nudge and Nudge+ in people with Suicide, run by Northwestern University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Suicide
What is being tested?
Nudge and Nudge+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47,307 participants
Where
2 sitesUnited States
Study dates
14 Mar 2022to 8 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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.
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Kaiser Permanente Colorado

    Aurora, Colorado, 80014

  • Henry Ford Health System

    Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Suicide
Being tested
Nudge, Nudge+
Keywords
implementation, fidelity, facilitation, firearm
Medical subject headings
Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NudgeBehavioural

    EHR-based "nudge"

  • Nudge+Behavioural

    EHR-based "nudge" plus facilitation

Study groups in NCT04844021
Study groupRoleWhat they receive
NudgeExperimentalClinics 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.
Receives: Behavioral: Nudge
Nudge+ExperimentalThis 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.
Receives: Behavioral: Nudge+

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Fidelity

    Whether the clinician followed the two S.A.F.E. Firearm steps (counseling and offering cable lock), measured via parent-report

    Measured: 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)

  2. 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.

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

  3. 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.

    Measured: 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)

  4. 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.

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

  5. Distribution of Cable Locks

    Number of cable locks distributed by each clinic will be collected

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start14 Mar 2022
  3. Primary completion20 Mar 2023
  4. Study completion8 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
47,307 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04844021
Sponsor's protocol ID
R01MH123491
Other IDs
R01MH123491
Acronym
ASPIRE
Status last verified
Jul 2024
First submitted
18 Nov 2020
Last updated
25 Jul 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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, Benjamin Wolk C, Wright LA, Williams NJ, Ahmedani BK, Beidas RS. Pediatric healthcare worker perspectives on implementation of a secure firearm storage program: a qualitative study. BMC Pediatr. 2026 May 20;26(1):653. doi: 10.1186/s12887-026-06985-2.

    PubMed 42163187

  • 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.

    PubMed 41282060

  • 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.

    PubMed 39226027

  • 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.

    PubMed 34551811

Questions about this trial

What is this clinical trial studying?

A study testing Nudge and Nudge+ in people with Suicide, run by Northwestern University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reach (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04844021, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.

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