Bieszk 2016.

Study characteristics
Methods	Act on threes paradigm for treatment intensification of type 2 diabetes in managed care: results of a randomized controlled study with an educational intervention targeting improved glycaemic control RCT (NA clusters and NA providers), conducted in 1) Patients identified through the analysis of administrative claims data (1 May 2011 to 30 April 30) from the Humana database. High‐risk Medicare Advantage with prescription drug coverage (MAPD) members from US (Northeast, Midwest, South and West). Humana is a for‐profit health insurance company with more than 13 million US‐based customers. 2) For the educational intervention, patients and physicians were simultaneously mailed general and targeted information (educational brochures and cover letters). The materials were developed in association with Humana’s in‐house clinical task force and communications team. In United States of America. 2 arms: 1) Control (standard care alone) (control arm) and 2) Intervention (Act on Threes educational intervention and standard care) (intervention arm)
Participants	Control arm N: 1688 Intervention arm N: 4555, NA, NA Diabetes type: 2 Mean age: 70.41 ± 13.59 % Male: 56.46 Longest follow‐up: 15 months
Interventions	Control arm: (standard care alone) Intervention arm: (Act on Threes educational intervention and standard care) 1) Clinician education 2) Facilitated relay of clinical information 3) Patient education
Outcomes	Glycated haemoglobin
Funding source	This study was funded by Sanofi US
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported. Patients were randomized 3:1.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Patient's baseline characteristics (selection bias)	Low risk	Patient demographics and baseline characteristics were similar for the 2 groups; P values above 0.05; data look balanced.
Patient's baseline outcomes (selection bias)	High risk	Patients in the intervention group had a significantly higher mean A1c level at baseline compared with the control group (8.66% vs 8.53%, respectively; P = 0.043).
Incomplete outcome data (attrition bias)	High risk	A1c levels were examined for a subgroup of patients. They have post‐intervention data for HbA1c outcome for 539/1688 (68.1% lost) in the control arm and 1503/4555 (67.0%) in the intervention arm. High numbers. They excluded 1977/8220 (24.1%) patients after randomisation.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	Our outcome of interest was objectively measured (HbA1c).
Selective reporting (reporting bias)	Unclear risk	No registered or published protocol. Results match methods.
Risk of contamination (other bias)	Unclear risk	Control patients were only enrolled if the treating physician was not involved in the care of any patients in the intervention group. Communications between control and intervention physicians working in the same clinic might have happened.
Other bias	Unclear risk	No external testing or validation of the educational materials was conducted to determine their utility for patients and physicians alike. In this study, the less aggressive treatment goals may have affected patient and physician responses to educational intervention. Both groups improved for proportion of patients with at least 2 A1c tests annually (Figure 2). It is not known what other concomitant interventions the patients received that were not related to this study.