Suicide
Conditions
Keywords
implementation, fidelity, facilitation, firearm
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.
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.
Interventions
BEHAVIORALNudge
EHR-based nudge
BEHAVIORALNudge+
EHR-based nudge plus facilitation
Sponsors
University of Pennsylvania
National Institute of Mental Health (NIMH)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Whether the clinician followed the two S.A.F.E. Firearm steps (counseling and offering cable lock), measured via parent-report |
| 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) | 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. |
| 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) | 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. |
| Cost | 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. |
| Distribution of Cable Locks | 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 |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24,989 |
| 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. | 22,318 |
| Total | 47,307 |
Baseline characteristics
| Characteristic | Nudge | Nudge+ | Total |
|---|---|---|---|
| Age, Continuous | 11.122 years STANDARD_DEVIATION 3.718 | 11.448 years STANDARD_DEVIATION 3.703 | 11.276 years STANDARD_DEVIATION 3.714 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2459 Participants | 3879 Participants | 6338 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19966 Participants | 16580 Participants | 36546 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2564 Participants | 1859 Participants | 4423 Participants |
| Race/Ethnicity, Customized Patient race Asian | 1154 Participants | 1348 Participants | 2502 Participants |
| Race/Ethnicity, Customized Patient race Black or African American | 7013 Participants | 3438 Participants | 10451 Participants |
| Race/Ethnicity, Customized Patient race More than one race | 781 Participants | 937 Participants | 1718 Participants |
| Race/Ethnicity, Customized Patient race Native American or Alaska Native | 94 Participants | 79 Participants | 173 Participants |
| Race/Ethnicity, Customized Patient race Native Hawaiian or Other Pacific Islander | 33 Participants | 49 Participants | 82 Participants |
| Race/Ethnicity, Customized Patient race Other race | 1471 Participants | 1210 Participants | 2681 Participants |
| Race/Ethnicity, Customized Patient race Unknown | 3702 Participants | 4076 Participants | 7778 Participants |
| Race/Ethnicity, Customized Patient race White | 10741 Participants | 11181 Participants | 21922 Participants |
| Sex/Gender, Customized Sex female | 12143 Participants | 10948 Participants | 23091 Participants |
| Sex/Gender, Customized Sex male | 12843 Participants | 11367 Participants | 24210 Participants |
| Sex/Gender, Customized Sex unknown | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24,989 | 0 / 22,318 |
| other Total, other adverse events | 0 / 24,989 | 0 / 22,318 |
| serious Total, serious adverse events | 0 / 24,989 | 0 / 22,318 |
Outcome results
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.
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)
Population: Participants refers to well-child visits with patients ages 5-17. Data were extracted from the electronic health record (EHR).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nudge | Reach | 0.2735 proportion of visits |
| Nudge+ | Reach | 0.4045 proportion of visits |
Comparison: The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.95% CI: [0.13, 0.31]
Comparison: The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.95% CI: [0.37, 0.61]
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.
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)
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.
Time frame: Cost data will be collected from pre-implementation through sustainment (30 months total)
Secondary
Distribution of Cable Locks
Number of cable locks distributed by each clinic will be collected
Time frame: Cable lock distribution data will be collected from active implementation through sustainment (24 months total)
Secondary
Fidelity
Whether the clinician followed the two S.A.F.E. Firearm steps (counseling and offering cable lock), measured via parent-report
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)
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.
Time frame: Parent surveys will be collected from parents within two weeks of well-child visit from pre-implementation through sustainment (30 months total)