Emerson 2016.
Study characteristics | ||
Methods |
A multidisciplinary intervention utilizing virtual communication tools to reduce health disparities: a pilot randomized controlled trial RCT (NA clusters and NA providers), conducted in 1) Two Carolinas Healthcare System (CHS) safety‐net clinics in Mecklenburg County, NC. 2) The intervention involved multidisciplinary primary care (consisting of a primary care physician, social worker, pharmacist and behavioural therapist) utilising health coach‐facilitated virtual visits and cloud‐based glucose monitoring, called Carolinas Partners. In United States of America. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (Carolinas Partners with virtual communication tools) (intervention arm) |
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Participants | Control arm N: 5 Intervention arm N: 5, NA, NA Diabetes type: 4 Mean age: 48.2 ± 8.4 % Male: 60 Longest follow‐up: 3 months |
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Interventions |
Control arm: (usual care) Intervention arm: (Carolinas Partners with virtual communication tools) 1) Case management 2) Team change 3) Electronic patient registry 4) Facilitated relay of clinical information 5) Promotion of self‐management |
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Outcomes | Glycated haemoglobin | |
Funding source | Unfunded pilot study. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. All patients meeting the initial inclusion criteria after a query of the data available through the electronic medical record data warehouse underwent pre‐consent randomisation to either control or intervention groups. These groups were then stratified into 4 geographically‐defined regions within Mecklenburg County. Randomisation was completed by the data analytics department at Carolinas Healthcare System, and study personnel were not involved in the randomisation process. Regions were included in the randomisation to demonstrate the method of tailoring future interventions aimed at health disparities at the neighbourhood level, a component that would be vital in a larger study. |
Allocation concealment (selection bias) | Low risk | "Randomization was completed by the data analytics department at Carolinas Healthcare System and study personnel were not involved in the randomization process." |
Patient's baseline characteristics (selection bias) | Low risk | No P value reported. Nothing mentioned in text. Only 5 patients per arm; relatively balanced |
Patient's baseline outcomes (selection bias) | Low risk | No P value reported. Nothing mentioned in text. Only 5 patients per arm; relatively balanced |
Incomplete outcome data (attrition bias) | High risk | Four out of 5 patients completed the follow‐up in each arm (20% loss). |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Our outcome of interest is objective (HbA1c). |
Selective reporting (reporting bias) | High risk | No registered protocol or previously published protocol. They measured blood pressure but they do not report the results (quote: All participants attended an initial and final in‐person visit to measure haemoglobin A1C, blood pressure and psychosocial parameters through survey. Blood pressures were recorded as the average of the 3 readings on an automated cuff). |
Risk of contamination (other bias) | Low risk | Patients were followed by a multidisciplinary team only seeing patients in the intervention arm. |
Other bias | Low risk | No evidence of other bias. |