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

Gary 2009.

Study characteristics
Methods The effects of a nurse case manager and a community health worker team on diabetic control, emergency department visits, and hospitalizations among urban African Americans with type 2 diabetes mellitus: a randomized controlled trial
Patient RCT, conducted in university affiliated managed care organisation with five sites in under‐serviced areas of Baltimore, USA
Two arms: 1. Minimal intervention (control arm) and 2. Intensive NCM/CHW intervention (intervention arm)
Participants Control arm N: 273
Intervention arm N: 269
Diabetes type: type 2
Mean age: 58.0 ± 11.0
% Male: 27.0
Longest follow‐up: 36 months
Interventions Control arm:
1) Case management
2) Patient education
3) Patient reminders
Intervention arm:
1) Case management
2) Team changes
3) Clinician reminders
4) Patient education
5) Promotion of self‐management
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 8.0 (2.2), post 7.9 (NR)
Intervention arm: pre 7.7 (2.1), post 7.5 (NR)
Funding source This study was funded by grants from the National Institutes of Health (R01‐DK48117 and R00052). Dr Gary was funded by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (U01‐DK57149‐05S1) and National Heart, Lung, and Blood Institute (K01‐HL084700), and Dr Brancati was funded by a grant from the NIDDK (K24‐ DK6222).
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) High risk The intensive intervention group was slightly older than the minimal group (59 vs 56 years; P = 0.01), otherwise, there were no statistically significant differences between the intervention groups at baseline.
Patient's baseline outcomes (selection bias) Low risk Table 1. The intensive intervention group was slightly older than the minimal group (59 vs 56 years; P = 0.01), otherwise, there were no statistically significant differences between the intervention groups at baseline.
Incomplete outcome data (attrition bias) Low risk The rate of follow‐up was high, with 92% of participants completing the 24‐month visit (488 of 528 (542 patients −14 deaths)).
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk The HbA1c level was measured using high‐pressure liquid chromatography. The lipid profile (total and HDL‐C) was measured using standard techniques. Blood pressure was assessed using a random‐zero sphygmomanometer; the mean of 3 readings at 1 visit was used at baseline and again at follow‐up.
Selective reporting (reporting bias) Unclear risk No reported protocol. Methods match outcomes reported.
Risk of contamination (other bias) Low risk Control group was not managed by nurse; contamination unlikely.
Other bias Low risk None identified