McDermott 2015.

Study characteristics
Methods	Community health workers improve diabetes care in remote Australian Indigenous communities: results of a pragmatic cluster randomized controlled trial Clustered RCT (12 clusters and 12 providers), conducted in 1) The study setting was 12 small remote communities (Indigenous population range 260 to 3000) in far north Queensland where the majority of the population was Aboriginal or Torres Strait Islander, served by a single provider. Primary health care is provided by either a community‐controlled service (n = 4) or the Queensland Government (n = 8). 2) Intervention provided by community‐based Indigenous health worker supported by a clinical outreach team. In Australia 2 arms: 1. Control (usual care/wait‐list) (control arm) and 2. Intervention (community health workers management) (intervention arm)
Participants	Control arm N: 113 Intervention arm N: 100, NA, NA Diabetes type: 2 Mean age: 47.9 ± 10.9 % Male: 37.6 Longest follow‐up: 18 months
Interventions	Control arm: (usual care/wait‐list) Intervention arm: (community health workers management) 1) Case management 2) Team change 3) Patient education 4) Promotion of self‐management
Outcomes	Lipid‐lowering drugs Antihypertensive drug Retinopathy screening Foot screening Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein Smoking status
Funding source	Support from the peak Aboriginal and Torres Strait Islander Health Councils. RM is supported by NHMRC and QH Practitioner Fellowship and Barbara Schmidt and Sean Taylor are supported in part by a Fellowship funded under the Australian Primary Health Care Research Institute. This study was funded by NHMRC and the Queensland Government, Partnership Grant No. 570149, and the Centre for Research Excellence in Primary Health Care.
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The 12 services were randomly allocated (names out of a hat) to either the intervention (n = 6) or wait‐list group (n = 6).
Allocation concealment (selection bias)	Low risk	Clustered RCT (unit of allocation was community health centre).
Provider's baseline characteristics (selection bias)	Unclear risk	12 remote communities served by a single provider. The unit of randomisation was the community health service. No data on community health services' characteristics are reported in each arm at baseline.
Patient's baseline characteristics (selection bias)	Low risk	At baseline, there were no significant differences between allocation groups in age (mean age 47.9 years), sex ratio (62% women), employment status, years of schooling, median household income, self‐reported food insecurity, household size and median AQoL score on the mental health scale (Table 1, P value higher than 0.05).
Patient's baseline outcomes (selection bias)	Low risk	At baseline, there were no significant differences between allocation groups in smoking prevalence (Table 1), HbA1c (10.7%, Table 3) and mean BMI (32.5, Table 1). P values higher than 0.05.
Incomplete outcome data (attrition bias)	Unclear risk	Over the study period, 22 patients (10.3%) were lost to follow‐up: 6 died, 15 moved away from the community permanently and one withdrew. More patients in the intervention group than the wait‐list group were lost to follow‐up (16.0% vs 5.3%) (Figure 1).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	Our outcomes of interest are all objective: HbA1c, blood pressure, statins, LDL, ACEi or ARB drugs, eyes and foot check. Self‐reported outcome: current smoking (subjective but secondary outcome). The study was not blinded as the allocation arm was known following recruitment and baseline data collection and the study was designed as a pragmatic trial reflecting effectiveness in real world practice.
Selective reporting (reporting bias)	Low risk	Prospectively registered protocol (protocol submitted on September 2010, enrolment occurred between December 2011 and July 2012). All outcomes of interest are reported.
Risk of contamination (other bias)	Low risk	Clustered RCT (allocation by health centre).
Other bias	Low risk	None identified.