Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Suicide
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The investigators will randomize clinics to the active implementation conditions (Nudge [k = 16] or Nudge+ [k = 16]). Clinicians in clinics assigned to both conditions will deliver the safe 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

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 SAFE Firearm among 32 clinics, 151 clinicians, and 38,989 youth nested in two Mental Health Research Network (MHRN) health sy...

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 SAFE Firearm among 32 clinics, 151 clinicians, and 38,989 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+). The investigators will collect implementation outcomes for 6 months before exposure to condition (i.e., pre-implementation or pre-exposure) and for 1 year following (i.e., sustainment) to allow for comparisons between (a) the active and pre-exposure periods and (b) the active and sustainment periods. Aim 1: Examine the effects of Nudge vs. Nudge+ on implementation outcomes. The investigators hypothesize that in both active conditions, parent-reported clinician fidelity (primary outcome) will be superior to the pre-exposure period and that Nudge+ will be superior to Nudge in the active period. The investigators will assess implementation strategy cost. The investigators will also examine parent-reported clinician fidelity during a follow-up period to evaluate sustainment, and the investigators hypothesize that Nudge and Nudge+ will be equivalent after the interventions are removed but that both will remain superior to the pre-exposure period with respect to fidelity. The investigators also hypothesize that Nudge+ will result in greater patient reach (i.e., EHR-documented program delivery), cable lock distribution, and acceptability compared with Nudge (secondary outcomes) 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 intrinsic and extrinsic motivation. The investigators hypothesize that clinician attitudes towards suicide prevention, implementation climate, and leadership will moderate implementation strategy effectiveness. Aim 3: Examine the effects of the adapted intervention on clinical outcomes. The investigators hypothesize that in both active conditions, parent-reported firearm storage will be superior to the pre-exposure period. Nudge+ will result in greater safe storage 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.

Tracking Information

NCT #
NCT04844021
Collaborators
National Institute of Mental Health (NIMH)
Investigators
Not Provided