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Table 3 Summary of outcomes, measures, data sources and data collection timing for Invested in Diabetes

From: The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments

Outcome domain

Construct

Source

Metric/Measure

Timing

Patient reach

Service acceptance

Tracking spreadsheet

Attendance at initial SMA session among all invited

Initial SMA session

Participation

Tracking spreadsheet

n/% and types of sessions attended

Monthly

Interviews

Patient reasons for participation/non-participation

Within 3 weeks of last session

Characteristics of participants

EHR

Demographics (age, gender, insurance, race/ethnicity) and clinical status (co-morbidity index [40]; insulin dependence, mental illness)

Collected during routine care

Patient-level effectiveness outcomes

Diabetes distress

Survey

DDS-17

1st and last SMA session

Autonomy support

Survey

Health Care Climate Questionnaire

1st and last SMA session

Perceived competence

Survey

Perceived Competence Scale

1st and last SMA session

Self-care behaviors

Survey

Summary of Diabetes Self-Care Activities [41]

1st and last SMA session

Health literacy (moderator)

Survey

Limited Health Literacy

1st SMA session

Clinical outcomes

EHR

HbA1c, blood pressure, BMI

Collected during routine care (per 3–6 months)

Patient experience and out-of-pocket costs

Interviews

Interview guide

≥ 3 weeks of last SMA session

Practice-level effectiveness

Team-based care

Survey

Relational coordination survey [42]

Baseline, midpoint, end of implementation

Quality of care

Survey

Assessment of Chronic Illness Care [43]

Baseline, midpoint, end of implementation

Practice-level adoption, implementation, maintenance

Intervention fidelity and adaptations

Tracking spreadsheet, observation

Fidelity and adaptations observation guide

1 session observed per quarter per practice

Practice culture

Survey

Practice Culture Assessment

Baseline, midpoint, end of implementation

Practice motivations for adoption, perceived value and sustainability SMAs

Qualitative Interviews

Interview guide

Baseline, midpoint, end of implementation

Implementation cost of SMAs

Survey

Time-Driven Activity-Based Costing framework [44]

Baseline, midpoint, end of implementation

  1. BMI body mass index, DDS-17 Diabetes Distress Scale-17, EHR Electronic Health Record, SMA shared medical appointment