Carter 2009.
Study characteristics | ||
Methods |
Physician and pharmacist collaboration to improve blood pressure control Clustered RCT (6 clusters and 165 providers), conducted in 1) 6 community‐based family medicine residency programs in Davenport, Des Moines (2 offices), Mason City, Sioux City and Waterloo, Iowa. All study visits with intervention pharmacists occurred in the medical office. 2) Intervention delivered to patients by physician and pharmacist. Clinician education provided by Barry L. Carter. Physicians and pharmacists underwent team‐building exercises conducted by Barry L. Carter and William R. Doucette. In United States of America. 2 arms: 1) Control (usual care: control office) (control arm) and 2) Intervention (physician and pharmacist collaborative model) (intervention arm) |
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Participants | Control arm N: 80 Intervention arm N: 38, NA, NA Diabetes type: 4 Mean age: 58.29 ± 8.5 % Male: 41.05 Longest follow‐up: 6 months |
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Interventions |
Control arm: (usual care: control office) 1) Patient education Intervention arm: (physician and pharmacist collaborative model) 1) Case management 2) Team change 3) Clinician education 4) Patient education 5) Patient reminders 6) Continuous quality improvement |
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Outcomes | Hypertension control | |
Funding source | This study was supported by grant R01 HL070740 from the National Heart, Lung, and Blood Institute. Drs Carter, Doucette and Chrischilles are supported by co‐operative agreement 5U18 HS016094 from the Agency for Healthcare Research and Quality Centers for Education and Research on Therapeutics. Dr Carter and Ms Franciscus are supported by grant HFP 04‐149 from the Center for Research in Implementation in Innovative Strategies in Practice, Department of Veterans Affairs, Veterans Health Administration, Health Services Research and Development Service. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 6 community‐based family medicine residency programmes in Davenport, Des Moines (2 offices), Mason City, Sioux City and Waterloo, Iowa, randomised to a control group (n = 3) or to an intervention group (n = 3) using a table of random numbers. |
Allocation concealment (selection bias) | Low risk | Cluster‐RCT. |
Provider's baseline characteristics (selection bias) | Low risk | Table 1 summarises the demographics and staffing at the participating clinics. The general operations of all 6 sites were similar, and the office served as the model office for a distinct family medicine residency. All 6 programmes met the institutional requirements of the Accreditation Committee for Graduate Medical Education and the programme requirements for family practice set out by the Accreditation Committee for Graduate Medical Education and its Residency Review Committee. All faculty physicians were board certified in family practice. |
Patient's baseline characteristics (selection bias) | High risk | Table 2. Characteristics not provided for diabetic subsample only. At baseline, patients in the control group were significantly less likely to be married (P = 0.001) and were more likely to have diabetes mellitus (P = 0.001, more than double the number of diabetics in the control group versus the intervention, 80 vs 38 respectively), self‐pay for their care (P = 0.001), have more co‐existing conditions (P = 0.001), have an annual household income below USD $25,000 (P = 0.001), take more antihypertensive medications (P = 0.001) and have a history of myocardial infarction (P = 0.002) or angina (P = 0.003) (Table 2). |
Patient's baseline outcomes (selection bias) | High risk | Table 3. Baseline outcomes not reported only for diabetic patients. Before the study, there was a wide range of BP control rates (28.6% to 70.0%), higher at the control sites (55.7%) than at the intervention sites (41.9%). |
Incomplete outcome data (attrition bias) | High risk | They lost 36/210 (17%) patients in the control clinics and 34/192 (18%) patients in the intervention clinics. High but balanced numbers of lost in each group. Quote: "Also, this study had a higher dropout rate than a previous efficacy study". Not specific to diabetic population. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | BP objectively measured. |
Selective reporting (reporting bias) | Unclear risk | Retrospectively registered protocol. They do not report physician knowledge and physician‐pharmacist relationship in the paper. They do not report data for the passive observation group. |
Risk of contamination (other bias) | Low risk | Cluster‐RCT. Randomisation at the clinic level. |
Other bias | Unclear risk | Physicians and pharmacists in the intervention offices decided how to best implement the intervention, and they were not required to perform the suggested intervention visits for this pragmatic trial. Few randomised clinics. |