Vinicor 1987.
Methods | RCT (incomplete block design, randomised by resident clinic team)
Randomisation concealment: NOT CLEAR
Follow up:
‐ providers: NOT CLEAR
‐ patients: NOT DONE
Blinded assessment: DONE for fasting plasma glucose, A1Hgb, post‐prandial plasma glucose, process measures
NOT DONE for weight, blood pressure
Baseline: DONE for fasting plasma glucose, A1Hgb, weight , blood pressure, process measures
NOT DONE for post‐prandial plasma glucose
Reliable outcomes: DONE for fasting plasma glucose, A1Hgb, post‐prandial plasma glucose and the process measures fasting blood glucose and random blood glucose
NOT CLEAR for weight, blood pressure and other process measures
Protection against contamination: NOT CLEAR unit of analysis error |
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Participants | General medicine clinic at Wishard Memorial hospital, Indiana University Medical Center (US). Physicians (residents) responsible for care of patients with diabetes. 994 patients were contacted, 728 agreed to participate, 532 completed baseline and 275 were reassessed post intervention for patient outcomes and 323 were reassessed for process measures (Mazzuca) (Type 1 and Type 2 diabetes). Provider‐ 86 residents patients ‐ 532 practices ‐ 1 general medicine clinic | |
Interventions | Intervention group:
Professional intervention (distribution of educational materials + educational meetings + local consensus processes + audit and feedback + reminders) + organisational intervention (communication and case discussion between distant health professionals) + patient education Control group: usual care Length of intervention: 11 months Follow up period for reassessment patients: Average of 26 months (patient education began 13 months after baseline assessment) |
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Outcomes | PROCESS:
% of total clinic visits for monitoring metabolic control:
Fasting blood glucose
Random blood glucose
Urine test record
History of hypoglycaemia % of patients for whom dietary management recommendations were followed: Diet prescription Calories per formula Teach patient caloric limit: Advise patient to minimise concentrated CHO Negotiate a target weight with obese patients Refer to diet clinic % of patients for whom recommendations for monitoring chronic complications were followed on at least an annual basis Visual symptoms Visual acuity Fundus examination BUN or Creatinine Foot examination Discuss foot care Neurologic examination History of peripheral pain History of urinary symptoms Postural hypotension Impotence (males only) Blood pressure Baseline electrocardiography Smoking history Cholesterol or triglycerides Carotid and femoral bruits PATIENT: fasting plasma glucose A1Hgb 2 hour postprandial weight systolic blood pressure diastolic blood pressure |
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Notes | Protocols evolved from discussions with general internists as well as review of patient baseline data ‐directed at treatment and diagnostics ‐targets: obesity, hyperglycemia, retinopathy, foot disease, neuropathy, and risk factors for cardiac, renal and vascular disease | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |