Table 2 Outcomes, timeline, and data sources
Pilot outcomes | |||
Process measures of recruitment, retention, and program participation | Data source | ||
Proportion of family practices that participated | Response via paper patient list | ||
Number of patients generated in EMR query | EMR Query output (Excel document) | ||
Number of patients excluded based on inclusion and exclusion criteria (with reasons for exclusion) | Research files—data from provider exclusion, chart audit exclusion, or exclusion based on phone conversation with patient | ||
Number of participants recruited | Research files | ||
Appropriateness of randomization process | Research files | ||
Number of participants who withdrew (with reasons for withdrawal) | Research files—data from clients | ||
Number of participants who completed the intervention | Research files | ||
Proportion of participants who completed each Healthy Lifestyle App survey | Healthy Lifestyle App | ||
Questions missed in completed Healthy Lifestyle App surveys | Healthy Lifestyle App | ||
Number of volunteers recruited | Volunteer agency files | ||
Number of volunteers trained | Volunteer agency files | ||
Number of client encounters made by volunteers, and type | Healthy Lifestyle App | ||
Number of reports sent to the clinic and seen by the interprofessional huddle team | Research tracking based on reports created from Healthy Lifestyle App data and sent to EMR | ||
Other pilot outcomes | Data source | ||
Perceived program feasibility | Qualitative interviews | ||
Risks or safety issues arising from this pilot | Qualitative interviews | ||
Trial outcome assessment | |||
Outcome | Outcome measure | Time collected | Data source |
Diabetes self-efficacy | Stanford Diabetes Self-Efficacy Scale [28] | T0, T4 | In-person sessions with research staff |
Eight items, ranges from 1 to 10, higher scores indicate better self-efficacy for managing diabetes | |||
Self-efficacy in managing chronic disease | Stanford self-efficacy for managing chronic disease [29] | T0, T4 | In-person sessions with research staff |
6 items, score ranges from 1 to 10, higher scores indicate better self-efficacy for managing chronic diseases | |||
Readiness to change | Readiness to change questionnaire (based on a cardiovascular version [30]) | T0, T4 | In-person sessions with research staff |
3 items, score ranges from 1 to 5, lower scores indicate higher readiness to change | |||
Physical activity | Rapid Assessment of Physical Activity (RAPA)—Aerobic Sub-scale [31] | T0, T4 | For T0 baseline intervention: Healthy Lifestyle app |
7 items, score ranges from 1 to 7, higher scores indicate more physical activity (< 6 indicates suboptimal activity) | For control group and T4: in-person sessions with research staff | ||
HbA1c | EMR Chart Audit | T−12, T0, T4, T10* | EMR |
Perceived patient empowerment | Patient Empowerment [32] | T0, T4 | In-person sessions with research staff |
5 items, score ranges from 1 to 4, higher scores represent perceiving more empowerment from the health care team | |||
Patient-centeredness that participants perceive of their primary care clinic | Patient-centeredness [32] | T0, T4 | In-person sessions with research staff |
6 items, score ranges from 1 to 4, higher scores represent perceiving the health care team as more patient-centered | |||
Satisfaction with healthcare | Patient Assessment of Chronic Illness Care (PACIC) [33] | T0, T4 | In-person sessions with research staff |
20 items, score ranges from 1 to 10, higher scores represent more positive assessment of care | |||
Attainment of health goals | Goal attainment scaling | T4 | In-person sessions with research staff |
Score ranges from − 10 to 110, with higher scores indicating better perception of goal attainment | |||
Qualitative data | |||
Measure | Time collected | Data source | |
Qualitative patient interviews | T4 | In-person interview with research staff | |