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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Piatt 2010.

Study characteristics
Methods 3‐year follow‐up of clinical and behavioral improvements following a multifaceted diabetes care intervention: results of a randomized controlled trial
Clustered RCT (11 clusters and 24 providers), conducted in 1) This study took place in an underserved suburb of Pittsburgh, Pennsylvania. 11 primary care practices, and their patients, were randomised. 2) Intervention delivered by an endocrinologist and certified diabetes educators. In United States of America.
3 arms: 1. Control (usual care ‐ UC group) (control arm) and 2. Intervention 1 (provider intervention ‐ PROV group) (intervention arm), 3. Intervention 2 (chronic care model intervention ‐ CCM group) (other arm)
Participants Control arm N: 51
Intervention arm N: 38, 30, NA
Diabetes type: 4
Mean age: 67.54 ± 9.39
% Male: 50.42
Longest follow‐up: 36 months
Interventions Control arm: (usual care)
1) Audit and feedback
2) Team change
3) Electronic patient registry
4) Clinician education
Intervention arm: (provider intervention ‐ PROV group)
1) Audit and feedback
2) Team change
3) Electronic patient registry
4) Clinician education
Intervention arm: (chronic care model intervention ‐ CCM group)
1) Audit and feedback
2) Case management
3) Team change
4) Electronic patient registry
5) Clinician education
6) Patient education
Promotion of self‐management
Outcomes Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Funding source "We acknowledge the University of Pittsburgh Diabetes Institute, the University of Michigan DRTC, the Lions District 14B and 14E, the local hospital foundation, and the UPMC Division of Community Health Services. Portions of this research were sponsored by funding from the United States Air Force administered by the US Army Medical Research Acquisition Activity, Fort Detrick, Maryland, Award Number W81XWH‐04‐2‐003. Review of material does not imply Department of the Air Force endorsement of factual accuracy or opinion. This work utilized the Behavioral, Clinical, Health Services (BCHS) Core of the Michigan Diabetes Research and Training Center funded by Grant No. NIH5P60DK020572 from the National Institute of Diabetes and Digestive and Kidney Diseases."
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported. Upon completion of the chart audit, practices were randomised into 1 of 3 study groups (Figure 1). A block randomisation procedure was used with practice size (determined by the number of people with diabetes in each practice) as the blocking factor. Three practices received the CCM intervention; 3 practices received only provider education (PROV), and 5 practices received usual care (UC).
Allocation concealment (selection bias) Low risk Clustered RCT.
Provider's baseline characteristics (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Table 2 in reference 14. Age has a P value of 0.04 (patients are older in the CCM group).
Patient's baseline outcomes (selection bias) Low risk Table 3 in reference 14. Data appear balanced.
Incomplete outcome data (attrition bias) High risk For HbA1c, SBP and DBP, there are data for 57 patients out of 119 randomised (52% lost).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk All our outcomes of interest were objectively measured (HbA1c, SBP and DBP).
Selective reporting (reporting bias) Unclear risk No registered protocol, but reference 14 is cited as the protocol. No data about diabetes knowledge and empowerment (secondary outcomes) in the paper.
Risk of contamination (other bias) Low risk Clustered RCT.
Other bias Low risk No evidence of other bias.