A pragmatic cluster randomised controlled trial to evaluate the effectiveness of the EMPOWER-PAR intervention in improving primary care provides' adherence to T2DM CPG and medication adherence in T2DM patients / Maryam Hannah Daud

Background: Numerous local studies have shown that there were poor adherence to T2DM clinical practice guideline (CPG) recommendations among primary care providers (PCP) and poor medication adherence among T2DM patients in primary care. The Chronic Care Model (CCM) had been proven to be effective in improving providers' adherence to CPG and medication adherence among T2DM patients in developed countries. However, evidence in developing countries is still lacking. Objectives: The first objective of this study was to design a pragmatic intervention based on the CCM i.e. EMPOWER-PAR intervention. The second objective was to evaluate the effectiveness of this intervention in improving the PCPs' adherence to T2DM CPG, medication adherence level and clinical outcomes among T2DM patients in the Malaysian public primary care setting. Methods: This is a sub study of a larger pragmatic cluster randomized controlled trial - participatory action research which was conducted in 10 public primary care clinics in Selangor and Kuala Lumpur. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another 5 clinics continued with usual care. The PCPs' adherence to T2DM CPG was measured using the 'Process of Care Questionnaire', which includes the indicators of care as recommended by the Malaysian CPG on the Management of T2DM. Data were collected from the patients' medical records, retrospectively at baseline and at 1-year follow-up. Medication adherence levels among T2DM patients were measured using the previously validated Malay version of the Morisky Medication Adherence Scale - 8 (MMAS-8). Data were collected using face-to-face interview by trained interviewers, at baseline and at 1-year follow-up. Clinical outcome data were collected at baseline and at 1-year follow-up. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for the baseline differences and the clustering effect. Results: A total of 888 patients were recruited at baseline; 471 were in the intervention and 417 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 percent change of the level of PCPs' adherence in the intervention compared to the control group at 1-year follow-up in several indicators of care. The intervention improved medication adherence levels twice more likely compared to usual care (adjusted OR 2.18, 95% CI 1.55 - 3.06, p-value<0.001). The proportion of patients achieving HbAlc target in the intervention group was significantly higher compared to the control groups (18.0% vs. 12.5%, p-value=0.022). The intervention also improved the proportion of T2DM patients achieving HbAlc target twice more likely compared to usual care (adjusted OR 2.34, 95% CI 1.22 - 4.51, p-value<0.011). Conclusions: The EMPOWER-PAR intervention has been proven to be effective in improving the PCPs' adherence to T2DM CPG in several indicators of care, patients' medication adherence levels and the proportion of patients achieving HbAlc target. Findings from this study provided objective evidence of the effectiveness of this intervention in the Malaysian public primary care setting

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&lt;0.001); performing foot examination (2.4% vs. 0.6%, p&lt;0.001); performing funduscopy/fundus photography (1.5% vs. 0.3%, p&lt;0.001); monitoring renal profile (0.9% vs. −0.6%, p=0.001); measuring urine protein (1.2% vs. 0.6%, p&lt;0.001), and giving lifestyle modification and self-management advice (1.2% vs. −0.3%, p&lt;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

Impact of opioid-free analgesia on pain severity and patient satisfaction after discharge from surgery: multispecialty, prospective cohort study in 25 countries

Background: Balancing opioid stewardship and the need for adequate analgesia following discharge after surgery is challenging. This study aimed to compare the outcomes for patients discharged with opioid versus opioid-free analgesia after common surgical procedures.Methods: This international, multicentre, prospective cohort study collected data from patients undergoing common acute and elective general surgical, urological, gynaecological, and orthopaedic procedures. The primary outcomes were patient-reported time in severe pain measured on a numerical analogue scale from 0 to 100% and patient-reported satisfaction with pain relief during the first week following discharge. Data were collected by in-hospital chart review and patient telephone interview 1 week after discharge.Results: The study recruited 4273 patients from 144 centres in 25 countries; 1311 patients (30.7%) were prescribed opioid analgesia at discharge. Patients reported being in severe pain for 10 (i.q.r. 1-30)% of the first week after discharge and rated satisfaction with analgesia as 90 (i.q.r. 80-100) of 100. After adjustment for confounders, opioid analgesia on discharge was independently associated with increased pain severity (risk ratio 1.52, 95% c.i. 1.31 to 1.76; P &lt; 0.001) and re-presentation to healthcare providers owing to side-effects of medication (OR 2.38, 95% c.i. 1.36 to 4.17; P = 0.004), but not with satisfaction with analgesia (beta coefficient 0.92, 95% c.i. -1.52 to 3.36; P = 0.468) compared with opioid-free analgesia. Although opioid prescribing varied greatly between high-income and low- and middle-income countries, patient-reported outcomes did not.Conclusion: Opioid analgesia prescription on surgical discharge is associated with a higher risk of re-presentation owing to side-effects of medication and increased patient-reported pain, but not with changes in patient-reported satisfaction. Opioid-free discharge analgesia should be adopted routinely

Design, development, utility and usability testing of the EMPOWER-SUSTAIN Self-Management Mobile App among primary care physicians and patients with metabolic syndrome

Objective This study aimed to design, develop, assess and refine the EMPOWER-SUSTAIN Self-Management Mobile App © among primary care physicians (PCP) and patients with metabolic syndrome (MetS) in primary care. Methodology Using the software-development-life-cycle (SDLC) iterative model, storyboard and wireframe were drafted; and a mock prototype was designed to illustrate the content and function graphically. Subsequently, a working prototype was developed. Qualitative studies using the ‘think-aloud’ and cognitive-task-analysis methods were conducted for the utility and usability testing. Topic guide was based on the 10-Nielsen's-Heuristic-Principles. Utility testing was conducted among PCP in which they ‘thought-aloud’ while performing tasks using the mobile app. Usability testing was conducted among MetS patients after they were given the app for 3 weeks. They ‘thought-aloud’ while performing tasks using the app. Interviews were audio- and video-recorded, and transcribed verbatim. Thematic content analysis was performed. Result Seven PCP and nine patients participated in the utility and usability testing, respectively. Six themes (efficiency of use, user control and freedom, appearance and aesthetic features, clinical content, error prevention, and help and documentation) emerged. PCP found the mobile app attractive and relevant sections were easy to find. They suggested adding ‘zoom/swipe’ functions and some parts needed bigger fonts. Patients commented that the app was user-friendly, has nice interface, and straightforward language. It helped them understand their health better. Based on these findings, the mobile app was refined. Conclusion This app was produced using a robust SDLC method to increase users’ satisfaction and sustainability of its use. It could potentially improve self-management behaviour among MetS patients in primary care

Additional file 1 of Factors associated with usability of the EMPOWER-SUSTAIN Global Cardiovascular Risks Self-Management Booklet© among individuals with metabolic syndrome in primary care: a cross-sectional study

Additional file 1. The EMPOWER-SUSTAIN Usability Questionnaire (E-SUQ©) Malay Version

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