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Table 3 RE-AIM outcome measures

From: Comparing enhancements to well-child visits in the prevention of obesity: ENCIRCLE cluster-randomized controlled trial

RE-AIM Dimension

and Description

Measures

Data sources

Reach

Degree to which target population is exposed to intervention

• Number of eligible caregivers/children

• % of caregivers/children who consent to participate

• % of caregivers/children who complete study follow-up

• Representativeness of caregivers/children who enrolled compared to overall population of screened and eligible caregivers/children

• Reasons why caregivers/children decline participation

• Study database derived from EHR clinical data and study records

• Caregiver questionnaire implemented via REDCap at baseline

• Brief non-participant survey administered via phone or online for caregivers who decline participation

Effectiveness

Intervention success in changing patient outcomes

• Improvement in primary and secondary outcomes by study arm

• Heterogeneity of effects across caregiver/children subgroups

• Attrition by study arm and by caregiver/children subgroups

• Analytic plan for the primary and secondary outcomes is discussed in Statistical Analyses

Adoption

Degree to which interventions are taken up by decision makers (e.g., clinics, providers)

• % of PCPs adopting the intervention by study arm

• Representativeness of PCPs who adopt the Intervention compared to the overall population of providers eligible to participate

• PCP attendance at a virtual study training at baseline

• Clinic leaders via interview

Implementation

Degree to which intervention was delivered as intended, adaptations, and drivers of adaptations

Across Implementation Agents

•Implementation input and processes, including challenges to implementation noted by study team and stakeholders

• Adaptations to intervention components and study protocol

• Decision-maker who initiated adaptation and reasons for adaptation

Agent Implementation

• PCPs’ and health coach’s self-reported barriers to completing intervention components

• % and characteristics of participating PCPs who utilize FNPA (arms 2 and 3)

Caregiver Receipt of Intervention

• Caregivers’ self-reported barriers to participating in intervention components

• % and characteristics of participating caregivers who complete FNPA (arms 2 and 3)

• % and characteristics of participating caregivers who complete Food Care sessions and who attend the virtual grocery store tour (arm 3)

• Study records such as meeting minutes

• Adaptation tracking spreadsheet

• PCP study questionnaires implemented via REDCap

• Health coach questionnaire implement via REDCap

• Caregiver questionnaires implemented via REDCap

Maintenance

Degree to which the intervention is sustained across settings and patients

• Plan and commitment from health system and community partners to continue or expand intervention

• % of PCPs maintaining use of FNPA in 12 months following intervention completion

• % of participating caregivers who return to the clinic for a 12-month follow-up WCV

• % of caregivers completing FNPA at 12 months (arms 2 and 3)

• Study database derived from EHR clinical data and study records

• Stakeholder discussions with health system leaders and community partners