Trial Outcomes & Findings for Adolescent and Child Suicide Prevention in Routine Clinical Encounters (NCT NCT04844021)
NCT ID: NCT04844021
Last Updated: 2024-07-25
Results Overview
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.
COMPLETED
NA
47307 participants
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)
2024-07-25
Participant Flow
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).
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.
Unit of analysis: clinics
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24989 15
|
22318 15
|
|
Overall Study
COMPLETED
|
24989 15
|
22318 14
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adolescent and Child Suicide Prevention in Routine Clinical Encounters
Baseline characteristics by cohort
| Measure |
Nudge
n=24989 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.
|
Nudge+
n=22318 Participants
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.
|
Total
n=47307 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.122 years
STANDARD_DEVIATION 3.718 • n=5 Participants
|
11.448 years
STANDARD_DEVIATION 3.703 • n=7 Participants
|
11.276 years
STANDARD_DEVIATION 3.714 • n=5 Participants
|
|
Sex/Gender, Customized
Sex · female
|
12143 Participants
n=5 Participants
|
10948 Participants
n=7 Participants
|
23091 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex · male
|
12843 Participants
n=5 Participants
|
11367 Participants
n=7 Participants
|
24210 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Sex · unknown
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2459 Participants
n=5 Participants
|
3879 Participants
n=7 Participants
|
6338 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19966 Participants
n=5 Participants
|
16580 Participants
n=7 Participants
|
36546 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2564 Participants
n=5 Participants
|
1859 Participants
n=7 Participants
|
4423 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Patient race · White
|
10741 Participants
n=5 Participants
|
11181 Participants
n=7 Participants
|
21922 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Patient race · Black or African American
|
7013 Participants
n=5 Participants
|
3438 Participants
n=7 Participants
|
10451 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Patient race · Asian
|
1154 Participants
n=5 Participants
|
1348 Participants
n=7 Participants
|
2502 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Patient race · Native American or Alaska Native
|
94 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Patient race · Native Hawaiian or Other Pacific Islander
|
33 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Patient race · Other race
|
1471 Participants
n=5 Participants
|
1210 Participants
n=7 Participants
|
2681 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Patient race · More than one race
|
781 Participants
n=5 Participants
|
937 Participants
n=7 Participants
|
1718 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Patient race · Unknown
|
3702 Participants
n=5 Participants
|
4076 Participants
n=7 Participants
|
7778 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Nudge
n=24989 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.
|
Nudge+
n=22318 Participants
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.
|
|---|---|---|
|
Reach
|
0.2735 proportion of visits
Interval 0.268 to 0.279
|
0.4045 proportion of visits
Interval 0.3981 to 0.4109
|
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
Adverse Events
Nudge
Nudge+
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place