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) |
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| 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 |
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| 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 |
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| Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure |
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| 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. |