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) |
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| 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 |
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| 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 |
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| 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) |
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| 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 |