Table 3 Summary of outcomes, measures, data sources, and timing of collection for PATHWEIGH study
Construct | Metric/measure | Method of collection | Timing |
|---|---|---|---|
Patient-specific outcomes | |||
 Weight-related outcomes | Weight (kg), height (cm), weight loss maintenance (weight increase ≤ 10%) | EMR | Collected during routine care |
 Clinical and laboratory values | Thyroid-stimulating hormone (TSH), lipid panel, liver function tests, A1c, blood pressure | EMR | Collected during routine care |
 Patient characteristics | Demographics (age, gender, race/ethnicity, insurance, comorbidities, medications) | EMR | Collected during routine care |
Clinician and clinic staff-specific outcomes | |||
 Clinic characteristics | # and characteristics of clinicians and patients empaneled to the clinic | Survey to practice leadership | Baseline |
 Practice culture | Survey to providers and staff | Baseline and 1-year post-intervention | |
 Implementation climate | Survey to providers and staff | Baseline and 1-year post-intervention | |
 History of practice improvement | # and type of practice improvement in the past year | Survey to providers and staff | Baseline and 1-year post-intervention |
 Self-efficacy and satisfaction | One item assessment of perceived confidence in ability to provide weight management, one item assessment of perceived satisfaction | Survey to providers and staff | Baseline and 1-year post-intervention |
RE-AIM Outcomes | |||
 Reach – The absolute number, proportion, and representativeness of individuals who participate | #/characteristics of patients in PATHWEIGH out of weight-prioritized and eligible per clinic | EMR | Baseline (patient characteristics) and at each 1-year step (patient participation) |
Barriers, facilitators to participation and outcomes | Interviews with selected patients | 6-month post-intervention start for the patient | |
 Effectiveness – The impact of an intervention on important patient outcomes | Evaluated using weight-related outcomes described above. | ||
 Adoption – The absolute number, proportion, and representativeness of settings and providers who initiate the intervention | Use of PATHWEIGH by any provider in a clinic (setting level) and each provider (provider level) | Survey to practice leadership (practice characteristics), EMR (provider use of PATHWEIGH) | Baseline and at each 1-year step |
Factors influencing adoption/implementation | Interviews with selected providers and staff | Baseline and 1- year post-intervention start for each sequence | |
 Implementation – The intervention agents’ fidelity to the various elements of the intervention’s protocol including consistency of delivery as intended and the time and cost of the intervention | Fidelity to PATHWEIGH functional core components and SOC in control clinics; use of implementation strategies; Clinician use of PATHWEIGH for > 50% weight-prioritized visits; e-learning module completion per clinician; use of consultation; participation in PF trainings | EMR | Ongoing collection; review at 6-month post-intervention start and study end; completion of implementation strategies |
Acceptability of PATHWEIGH; adaptations | Survey to all providers, some staff, and selected patients | 6- month post-intervention start for that cohort | |
Barriers, facilitators to implementation | Interviews with selected providers, clinic leaders, and staff | 1-year post-intervention start for each cohort | |
Cost and resources for implementation | Cost/resources interviews with practice managers and selected provider/staff by research assistant | Control condition and 1-year post-intervention start for each cohort | |
 Maintenance - The extent to which the intervention becomes part of practice | Plans to continue/adapt PATHWEIGH past study | Survey and interviews with practice managers and selected providers and staff | 1-year post-intervention start for each cohort; and study end |