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Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial.

ABSTRACT: Diabetes mellitus (DM) group clinics can effectively control hypertension, but data to support glycemic control are equivocal. This study evaluated the comparative effectiveness of 2 DM group clinic interventions on glycosylated hemoglobin (HbA(1c)) levels in primary care.Eighty-seven participants were recruited from a DM registry of a single regional Veterans Affairs medical center to participate in an open, randomized comparative effectiveness study. Two primary care-based DM group interventions of 3 months' duration were compared. Empowering Patients in Care (EPIC) was a clinician-led, patient-centered group clinic consisting of 4 sessions on setting self-management action plans (diet, exercise, home monitoring, medications, etc) and communicating about progress with action plans. The comparison intervention consisted of group education sessions with a DM educator and dietician followed by an additional visit with one's primary care provider. Hemoglobin A(1c) levels were compared after intervention and at the 1-year follow-up.Participants in the EPIC intervention had significantly greater improvements in HbA(1c) levels immediately following the active intervention (8.86%-8.04% vs 8.74%-8.70% of total hemoglobin; mean [SD] between-group difference 0.67% [1.3%]; P=.03), and these differences persisted at the 1 year follow-up (0.59% [1.4%], P=.05). A repeated-measures analysis using all study time points found a significant time-by-treatment interaction effect on HbA(1c) levels favoring the EPIC intervention (F(2,85)=3.55; P=.03). The effect of the time-by-treatment interaction seems to be partially mediated by DM self-efficacy (F(1,85)=10.39; P=.002).Primary care-based DM group clinics that include structured goal-setting approaches to self-management can significantly improve HbA(1c) levels after intervention and maintain improvements for 1 year. Trial Registration clinicaltrials.gov Identifier: NCT00481286.

SUBMITTER: Naik AD

PROVIDER: S-EPMC3132209 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature

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Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial.

Naik Aanand D AD Palmer Nynikka N Petersen Nancy J NJ Street Richard L RL Rao Radha R Suarez-Almazor Maria M Haidet Paul P

Archives of internal medicine 20110301 5

<h4>Background</h4>Diabetes mellitus (DM) group clinics can effectively control hypertension, but data to support glycemic control are equivocal. This study evaluated the comparative effectiveness of 2 DM group clinic interventions on glycosylated hemoglobin (HbA(1c)) levels in primary care.<h4>Methods</h4>Eighty-seven participants were recruited from a DM registry of a single regional Veterans Affairs medical center to participate in an open, randomized comparative effectiveness study. Two prim ...[more]

PMID: 21403042

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Project description:Background: Despite being the first Indian state with a dedicated Non-Communicable Disease (NCD) program, glycemic control among a large proportion of patients is low in Kerala. This study tries to find evidence for a standardized non-pharmacological strategy delivered through Junior Public Health Nurses (JPHNs) in achieving and maintaining glycemic control among diabetic patients registered with NCD clinics of primary health care settings. Design: A cluster randomized controlled trial was conducted among adult patients with Diabetes Mellitus attending NCD clinics of primary care settings of South Kerala, India. JPHNs of the intervention group received additional module-based training while standard management continued in the control group. Sequence generation was done by random permuted blocks method and a cluster of 12 patients was selected from each of the 11 settings by computer-generated random numbers. Patients were followed up for 6 months with monthly monitoring of Fasting Blood Sugar (FBS), Post-Prandial Blood Sugar (PPBS), blood pressure, Body Mass Index (BMI), and health-related behaviors. Knowledge and skills/practice of JPHNs were also evaluated. Analysis of Covariance was done to study the final outcome adjusting for the baseline values and a model for glycemic control was predicted using multilevel modeling. Results: We analyzed 72 participants in the intervention group and 60 participants in the control group according to the intention-to-treat principle. The intervention was associated with a significant reduction in FBS (p < 0.001) and PPBS (p < 0.001) adjusting for the baseline values. The achievement of glycemic control was 1.5 (95% CI: 1.05-2.3) times better with intervention and they showed a better trend of maintenance of glycemic control (FBS, p = 0.003 and PPBS, p = 0.039). Adjusting for clustering and the baseline values, the intervention showed a significant effect on FBS (B = -3.1, SE = 0.57; p < 0.001) and PPBS (B = -0.81, SE = 0.3; p < 0.001) with time. Drug adherence score (p < 0.001), hours of physical activity (p < 0.001), BMI (p = 0.002), fruit intake (p = 0.004), and green leafy vegetable intake (p = 0.01) were the major predictors of FBS control. The practice/skills score of the JPHNs significantly improved with intervention (p < 0.001) adjusting for baseline values. Conclusion: A well-designed health worker intervention package incorporated into the existing health system can translate into attitude change and skill development in the health workers which can reflect in the improvement of glycemic control among the patients. Trial registration: [URL: http://www.ctri.nic.in], identifier [CTRI/2017/11/010622].

Project description:World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders.This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. orStandard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (?7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients.Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.[ClinicalTrials.gov: Identifier NCT00945204].

Project description:BackgroundThe effectiveness of an intervention in clinical practice is often reduced compared to the efficacy demonstrated in a randomised controlled trial (RCT). In this comparative effectiveness study, the RCT-proven efficacy of a diabetes education programme for type 1 diabetic patients (PRIMAS) was compared to the effectiveness observed in an implementation trial (IT) under routine care conditions.Methods75 patients with type 1 diabetes received PRIMAS through an RCT, whereas 179 patients were observed in an implementation trial. Baseline characteristics and treatment outcomes at the 6-month follow-up (improvement of HbA1c, hypoglycaemia problems, and diabetes-related distress) were compared.ResultsAt baseline, the type 1 diabetic patients in the RCT had a significant longer diabetes duration (18.7 ± 12.3 vs. 13.8 ± 12.7 yrs., p = .005), lower self-efficacy scores (21.9 ± 4.7 vs. 23.7 ± 6.1, p = .02) and a greater number of diabetes complications (0.8 ± 1.3 vs. 0.4 ± 0.9, p = .02). After 6 months, PRIMAS achieved comparable effects under RCT and implementation trial conditions, as demonstrated by improvement in HbA1c (-0.36% ± 1.1 vs. -0.37 ± 1.2; Δ -0.01, 95% CI -0.33 to 0.31) and hypoglycaemia unawareness (-0.5 ± 1.4 vs. -0.3 ± 1.4; Δ 0.18, 95% CI -0.21 to 0.57). The likelihood of clinical improvement did not depend on the trial setting (RCT vs. IT: OR 1.18, 95% CI 0.60 to 2.33). The participants with worse glycaemic control (OR 1.40, 95% CI 1.02 to 1.92), hypoglycaemia problems (OR 2.13, 95% CI 1.53 to 2.97) or elevated diabetes distress (OR 1.40, 95% CI 1.03 to 1.89) had a better chance of clinical improvement.ConclusionsThe effectiveness of PRIMAS under routine care conditions was comparable to the efficacy demonstrated in the RCT. Clinical improvement was independent of the setting in which PRIMAS was evaluated. The PRIMAS education programme for type 1 diabetes can be delivered under conditions of routine care without a loss of effectiveness, compared to its original evaluation in an RCT.

Project description:Audit and feedback to physicians is a commonly used quality improvement strategy, but its optimal design is unknown. This trial tested the effects of a theory-informed worksheet to facilitate goal setting and action planning, appended to feedback reports on chronic disease management, compared to feedback reports provided without these worksheets.A two-arm pragmatic cluster randomized trial was conducted, with allocation at the level of primary care clinics. Participants were family physicians who contributed data from their electronic medical records. The 'usual feedback' arm received feedback every six months for two years regarding the proportion of their patients meeting quality targets for diabetes and/or ischemic heart disease. The intervention arm received these same reports plus a worksheet designed to facilitate goal setting and action plan development in response to the feedback reports. Blood pressure (BP) and low-density lipoprotein cholesterol (LDL) values were compared after two years as the primary outcomes. Process outcomes measured the proportion of guideline-recommended actions (e.g., testing and prescribing) conducted within the appropriate timeframe. Intention-to-treat analysis was performed.Outcomes were similar across groups at baseline. Final analysis included 20 physicians from seven clinics and 1,832 patients in the intervention arm (15% loss to follow up) and 29 physicians from seven clinics and 2,223 patients in the usual feedback arm (10% loss to follow up). Ten of 20 physicians completed the worksheet at least once during the study. Mean BP was 128/72 in the feedback plus worksheet arm and 128/73 in the feedback alone arm, while LDL was 2.1 and 2.0, respectively. Thus, no significant differences were observed across groups in the primary outcomes, but mean haemoglobin A1c was lower in the feedback plus worksheet arm (7.2% versus 7.4%, p<0.001). Improvements in both arms were noted over time for one-half of the process outcomes.Appending a theory-informed goal setting and action planning worksheet to an externally produced audit and feedback intervention did not lead to improvements in patient outcomes. The results may be explained in part by passive dissemination of the worksheet leading to inadequate engagement with the intervention.ClinicalTrials.gov NCT00996645.

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Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial.

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Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial.

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