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

Stroebel 2002.

Study characteristics
Methods A randomized trial of three diabetes registry implementation strategies in a community internal medicine practice
Clustered RCT (29 clusters and 29 providers), conducted in 1) The Mayo Clinic is a large multispecialty group practice in Rochester, Minnesota. The Division of Community Internal Medicine (CIM) has 35 general internists providing primary care for the local adult population. The practice is organised into practice care teams, which are typically composed of 3 or 4 physicians (MDs), 2 licensed practical nurses, 1 registered nurse (RN) and 1 appointment secretary. All physicians are salaried. The majority of patients has either fee‐for‐service or Medicare coverage. Each physician is responsible for a patient age‐ and gender‐adjusted panel of approximately 1600 patients. 2) Intervention delivered by registered nurses and physicians (RN/MD) care teams (1 RN with 3 or 4 MDs). Hot lists were generated by each team’s appointment secretary and distributed to the MD and RN. Patients on the Hot List who needed glycosylated Hgb or low‐density lipoprotein cholesterol determination received a letter from the appointment secretary. In United States of America.
3 arms: 1. Control (Group A: registry + hot lists) (control arm) and 2. Intervention 1 (Group B: registry + hot lists + team time) (intervention arm), 3. Intervention 2 (Group C: registry + hot lists + team time + automatic letters) (other arm)
Participants Control arm N: 396
Intervention arm N: 331, 356, NA
Diabetes type: 4
Mean age: 65.73 ± 10.68
% Male: 53.20
Longest follow‐up: 6 months
Interventions Control arm: (Group A: registery + hot lists)
1) Audit and feedback
2) Electronic patient registry
Intervention arm: (Group B: registery + hot lists + team time)
1) Audit and feedback
2) Team changes
3) Electronic patient registry
Intervention arm: (Group C: registery + hot lists + team time + automatic letters)
1) Audit and feedback
2) Team changes
3) Case management
4) Electronic patient registry
5) Promotion of self‐management
6) Patient reminders
Outcomes Glycated haemoglobin
Low‐density lipoprotein
Hypertension control
Funding source Not reported
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method not reported. In this randomised, prospective trial, clusters of physicians were assigned to one of 3 intervention arms: A, B or C (Table 2, below). Randomisation was based on the RN/MD care teams (one RN with 3 or 4 MDs) to ensure that the RNs in each team participated in only one care model. The randomisation resulted in a total of 9 or 10 participating physicians, each of whose panel of patients was enrolled in each of the 3 intervention arms.
Allocation concealment (selection bias) Low risk Clustered RCT.
Provider's baseline characteristics (selection bias) Unclear risk No comparison of physicians between groups. All physicians are salaried. The majority of patients has either fee‐for‐service or Medicare coverage. Each physician is responsible for a patient age‐ and gender‐adjusted panel of approximately 1600 patients.
Patient's baseline characteristics (selection bias) Low risk Top of Table 1.  Groups seem similar.
 
Patient's baseline outcomes (selection bias) Unclear risk Top of Table 1. Quote: "The baseline mean LDL cholesterol value in Group A was lower than in Group C."
 
Incomplete outcome data (attrition bias) Low risk All patients eligible for inclusion in the registry were continued in the study for the duration. New patients were added to the registry during the study but not included in the analysis. Seems like there was no loss to follow‐up.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Our outcomes of interest were objectively assessed (HbA1c, LDL, blood pressure).
Selective reporting (reporting bias) Unclear risk No registered or published protocol. Results match methods.
Risk of contamination (other bias) Unclear risk Clustered RCT. In this randomised, prospective trial, clusters of physicians were assigned to one of 3 intervention arms: A, B or C (Table 2, below). Randomisation was based on the RN/MD care teams (one RN with 3 or 4 MDs) to ensure that the RNs in each team participated in only one care model. The randomisation resulted in a total of 9 or 10 participating physicians, each of whose panel of patients was enrolled in each of the 3 intervention arms. However, all physicians and RN were working in the same clinic, communication between them might have happen and/or some physicians/RN might have decided to also do team meeting even if they were not assigned to this group.
Other bias Low risk None.