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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH123491 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nudge | Behavioral | EHR-based "nudge" |
| |
| Nudge+ |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
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Inclusion Criteria: Parents
Exclusion Criteria: Parents
Inclusion Criteria: Clinicians and leaders
Exclusion criteria: Clinicians and leaders
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Colorado | Aurora | Colorado | 80014 | United States | ||
| Henry Ford Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42163187 | Derived | 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. doi: 10.1186/s12887-026-06985-2. Online ahead of print. | |
| 41282060 | Derived |
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Randomization was at clinic level. Clinics and all clinicians at them received Nudge or Nudge+. Clinics and clinicians are NOT considered "enrolled participants" in our primary outcomes analysis. Parents attending visits with the child received S.A.F.E. Firearm from clinicians, but are NOT considered "enrolled participants" in our primary outcomes analysis. Units of analysis for the primary outcome are number of visits; thus, "participants" in this participant flow refers to well-child visits.
We included children (ages 5-17) attending an in-person well-child visit at a participating pediatric clinic from March 14, 2022 until March 20, 2023. Demographic information and outcomes were assessed for all eligible visits during the study period (e.g., demographic information for two well-child visits with the same patient are included as two separate "participants" in our demographic descriptive statistics). Data were extracted from the electronic health record (EHR).
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Nudge+ | This arm consists of Nudge as described, 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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"Participants" refers to well-child visits with patients ages 5-17. Data were extracted from the electronic health record (EHR).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patient age in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | "Participants" refers to well-child visits with patients ages 5-17. Data were extracted from the electronic health record (EHR). | Posted | Mean | 95% Confidence Interval | proportion of 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) |
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12 months
Our enrolled participants were well-child visits; "number affected" and "number at risk" refers to well-child visits. Adverse event information is reported for all eligible well-child visits during the study period (e.g., information for two well-child visits with the same patient are included as two separate "at-risk participants" in our demographic descriptive statistics).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rinad Beidas | Northwestern University | 312-503-0546 | rinad.beidas@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 3, 2023 | May 24, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2023 | May 24, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 13, 2022 | May 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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| Behavioral |
EHR-based "nudge" plus facilitation |
|
| 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) |
| Detroit |
| Michigan |
| 48202 |
| United States |
| 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. |
| 39226027 | 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. |
| 34551811 | 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. |
| BG001 | Nudge+ | This arm consists of Nudge as described, 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 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. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Patient sex assigned at birth | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Patient ethnicity | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
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.
| OG001 | Nudge+ | This arm consists of Nudge as described, 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 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. |
|
|
|
| Secondary | Fidelity | Whether the clinician followed the two S.A.F.E. Firearm steps (counseling and offering cable lock), measured via parent-report | Not Posted | 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) | Participants |
| Secondary | 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. | Not Posted | Parent surveys will be collected from parents within two weeks of well-child visit from pre-implementation through sustainment (30 months total) | Participants |
| Secondary | 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. | Not Posted | 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) | Participants |
| Secondary | 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. | Not Posted | Cost data will be collected from pre-implementation through sustainment (30 months total) | Participants |
| Secondary | Distribution of Cable Locks | Number of cable locks distributed by each clinic will be collected | Not Posted | Cable lock distribution data will be collected from active implementation through sustainment (24 months total) | Participants |
| 0 |
| 24,989 |
| 0 |
| 24,989 |
| 0 |
| 24,989 |
| EG001 | Nudge+ | This arm consists of Nudge as described, 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 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. | 0 | 22,318 | 0 | 22,318 | 0 | 22,318 |
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