Effectiveness of the EMPOWER-PAR Intervention on Primary Care Providers’ Adherence to Clinical Practice Guideline on the Management of Type 2 Diabetes Mellitus: A Pragmatic Cluster Randomised Controlled Trial

AIM: The objective of this study was to evaluate the effectiveness of the EMPOWER- participatory action research (PAR) intervention, a multifaceted strategy based on the chronic care model (CCM) on primary care providers (PCP)’ adherence to type 2 diabetes mellitus (T2DM) clinical practice guideline (CPG) in the Malaysian primary care setting. METHODS: This was a pragmatic cluster randomized controlled trial –PAR conducted in ten public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. The outcome measure was the absolute change in the proportion of PCP’s adherence to T2DM CPG captured using the “Indicators of Care Pro forma,” based on the recommendation by the Malaysian CPG on the Management of T2DM. Data were collected from the patients’ medical records, at baseline and at 1-year follow-up; and were analyzed using mixed method model. RESULTS: A total of 888 patients were recruited at baseline; 471 were in the intervention and 417 were in the control group. There was no significant demographic difference between the two groups at baseline except for ethnicity. At 1-year, 455 (96.6%) and 406 (97.3%) patients in the intervention and control groups completed the study, respectively. There were significant improvements in the absolute change in the proportion of PCPs’ adherence to T2DM CPG in the intervention group compared to the control group at 1-year follow-up in several indicators of care. These included the recording of BMI (0.6% vs. −1.8%, p<0.001); performing foot examination (2.4% vs. 0.6%, p<0.001); performing funduscopy/fundus photography (1.5% vs. 0.3%, p<0.001); monitoring renal profile (0.9% vs. −0.6%, p=0.001); measuring urine protein (1.2% vs. 0.6%, p<0.001), and giving lifestyle modification and self-management advice (1.2% vs. −0.3%, p<0.001) in the intervention versus control groups, respectively. CONCLUSION: The EMPOWER-PAR intervention has been proven to be effective in improving the PCPs’ adherence to T2DM CPG in several indicators of care. Findings from this study provided objective evidence of the effectiveness of multifaceted intervention based on the CCM in the Malaysian public primary care setting. TRIAL REGISTRATION: Registered with: ClinicalTrials.gov: NCT01545401. Date of registration: 1st March 2012

Study protocol of EMPOWER Participatory Action Research (EMPOWER-PAR): a pragmatic cluster randomised controlled trial of multifaceted chronic disease management strategies to improve diabetes and hyp

Background Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors. The chronic care model was proven effective in improving chronic disease outcomes in developed countries, but there is little evidence of its effectiveness in developing countries. The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted chronic disease management strategies based on the chronic care model) in improving outcomes for type 2 diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting. This paper presents the study protocol. Methods/Design A pragmatic cluster randomised controlled trial using participatory action research is underway in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Each clinic consecutively recruits type 2 diabetes mellitus and hypertension patients fulfilling the inclusion and exclusion criteria over a 2-week period. The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary chronic disease management team, training the team to use the Global Cardiovascular Risks Self-Management Booklet to support patient care and reinforcing the use of relevant clinical practice guidelines for management and prescribing. For type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving HbA1c < 6.5%. For hypertension without type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving blood pressure < 140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets for serum lipid profile, body mass index and waist circumference. Other outcome measures include medication adherence levels, process of care and prescribing patterns. Patients’ assessment of their chronic disease care and providers’ perceptions, attitudes and perceived barriers in care delivery and cost-effectiveness of the intervention are also evaluated. Discussion Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the chronic care model in resource-constrained public primary care settings. The evidence should instigate crucial primary care system change in Malaysia

Effectiveness of the EMPOWER-PAR intervention in improving clinical outcomes of type 2 diabetes mellitus in primary care: a pragmatic cluster randomised controlled trial

Background: The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. Methods: This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect. Results: A total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs. control: 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. control: −4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34–3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes. Conclusions: This study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting

Additional file 2: of Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial

Definition of outcome categories at 1-year follow-up (PDF 230 kb