Taveira 2011.
Methods | Randomised trial | |
Participants | 88 participants with diabetes (intervention 44: control 44) Eligible patients were identified by a combination of review of the Providence VAMC electronic medical record system and referral by primary care providers. USA Year of study: December 2006 to not stated. |
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Interventions | A multidisciplinary education and pharmacist‐led intensive behavioural and pharmacological group intervention. Intervention patients attended 4 once‐weekly sessions of 2 hours, followed by 5 monthly booster sessions with approximately 4 to 6 participants in each session. Each session consisted of 2 parts: i) education and ii) behavioural and pharmacological interventions for hypertension, hyperlipidaemia, hyperglycaemia and tobacco use. The education portion included interactive lectures provided by a nurse, nutritionist, or the clinical pharmacists who were certified in diabetes education. Each session focused on 1 or 2 self‐care behaviours, such as goal setting, to promote health and problem‐solving for daily living or integration of psychosocial adjustment to daily life. At each session, food logs were reviewed by the pharmacist and participants were reminded of their nutrition goals. Participants prepared healthy food choices during these sessions and were advised of the availability of nutrition programmes. The pharmacological and behavioural intervention was conducted by a clinical pharmacist certified in diabetes education who performed a group assessment to determine the degree to which patients felt they could manage the daily aspects of diabetes care through discussion and use of the Perceived Competence for Diabetes Scale. Each participant was provided with a cardiovascular risk report card containing medical history, current medications, vital signs, and laboratory test results. Medications for blood pressure, cholesterol, diabetes, and tobacco cessation were initiated or titrated based on previously established treatment algorithms. Each group member was provided with individualised homework for medication changes and a behaviour change goal, such as exercise recommendations, dietary modifications, and blood glucose or blood pressure monitoring. A clinical pharmacist used theory‐based counselling and reinforcement to change outcome expectations and to increase behaviours that would improve diabetes self‐care behaviours such as increasing physical activity and healthy eating. Demonstration and coaching to increase self‐efficacy for self‐care skills, such as monitoring of blood glucose and logging daily dietary intake, were also performed. Number of Interventions: 4 once‐weekly sessions of 2 hours, followed by 5 monthly booster sessions held in a classroom with approximately 4 to 6 participants in each session. |
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Outcomes | HbA1C Systolic BP Low density lipoprotein‐cholesterol (LDL‐C) |
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Notes | Funding source: American College of Clinical Pharmacy Astra‐Zeneca Health Outcomes Research Award (Dr. Taveira), American Society of Health System Pharmacists and Education Foundation Federal Services Research Grant Program (Dr. Cohen), and VA HSR&D Merit Review Award IAB 06‐269 (Drs. Taveira, Cohen, and Wu). Conflict of interest: None stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were assigned to the intervention arm or standard care arm using simple coin toss randomisation. |
Allocation concealment (selection bias) | Unclear risk | No relevant information |
Blinding of participants and personnel (performance bias) All Outcomes/Outcome 1 | Unclear risk | Unclear if participants were blinded |
Blinding of outcome assessment (detection bias) All Outcomes/Outcome 1 | Low risk | Unclear if assessors were blinded, but HbA1C is an objective measure. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Between group attrition < 10%. |
Selective reporting (reporting bias) | Unclear risk | Most outcomes were reported |
Other bias | Low risk | None |