Schillinger 2009.

Study characteristics
Methods	Effects of self‐management support on structure, process, and outcomes among vulnerable patients with diabetes: a three‐arm practical clinical trial RCT (NA clusters and NA providers), conducted in 1) Eligible patients attended a study enrollment visit at the San Francisco General Hospital Clinical Research Center. 2) Intervention involved nurse follow‐up for automated telephone self‐management support, or monthly group medical visits co‐facilitated by a primary care physician and health educator. In United States of America. 3 arms: 1. Control (usual care) (control arm) and 2. Intervention 1 (ATSM‐telephone support with nurse) (intervention arm), 3. Intervention 2 (GMV‐group medical visits) (other arm)
Participants	Control arm N: 114 Intervention arm N: 112, 113, NA Diabetes type: 2 Mean age: 56.1 ± 11.6 % Male: 41 Longest follow‐up: 12 months
Interventions	Control arm: (usual care) Intervention arm: (ATSM‐telephone support with nurse) 1) Case management 2) Electronic patient registry 3) Facilitated relay of clinical information 4) Patient education 5) Promotion of self‐management Intervention arm: (GMV‐group medical visits) 1) Case management 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management
Outcomes	Glycated haemoglobin Systolic blood pressure Diastolic blood pressure
Funding source	This study was supported by The Commonwealth Fund, Agency for Healthcare Research and Quality Grants R21 HS014864 and R18 HS17261, The California Endowment, the San Francisco Department of Public Health, and The California Healthcare Foundation. D.S. was supported by National Institutes of Health Mentored Clinical Scientist Award K‐23 RR16539. Electronic data and resources of the University of California San Francisco—San Francisco General Hospital General Clinical Research Center were made available through National Institutes of Health Grant UL1 RR024131.
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Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported. Patients were allocated using stratified (on languages) blocked randomisation. Reference 10: Randomisation was administered using a blocked randomisation strategy stratified to ensure even distribution of languages.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Patient's baseline characteristics (selection bias)	Low risk	Table 1. All P values above 0.05. There were no statistically significant differences in baseline characteristics across arms.
Patient's baseline outcomes (selection bias)	Low risk	Table 1. All P values above 0.05. There were no statistically significant differences in baseline characteristics across arms.
Incomplete outcome data (attrition bias)	Unclear risk	Of the participants, 305 (90%) completed follow‐up interviews at 1 year (out of 339 randomised). For HbA1c, ATSM, n = 101/112 (9.8% lost); for GMV, n = 96/113 (15.0% lost), and for usual care, n = 103/114 (9.6%). Paired values for A1C were available for 88.2% of the sample, blood pressure for 94.1% and BMI for 92.3%. Three participants died during the study period in each of the 3 arms. Other reasons not reported. Participants lost to follow‐up were younger (51.7 vs 56.5 years, P = 0.02).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	Our outcomes of interest were objectively measured (HbA1c, SBP and DBP).
Selective reporting (reporting bias)	Unclear risk	Retrospectively registered protocol. Results match protocol for our outcomes of interest.
Risk of contamination (other bias)	Unclear risk	Interventions took place in one safety net health system. Same physicians could have followed patients from all groups. They might have changed their approach with patients in the usual care group after receiving patients' goal‐setting records from intervention arms.
Other bias	Low risk	None.