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 hypertension outcomes in primary care

Abstract

BackgroundChronic 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/DesignA 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.DiscussionResults 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.Trial RegistrationClinicalTrials.gov NCT01545401

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

“…The pragmatic study design was chosen to maximise external validity to ensure that the results can be generalised to the public primary care system in Malaysia [21]. The study protocol was registered with the clinicaltrial.gov (NCT01545401) and was published in 2014 [22]. This paper reports the findings from the T2DM arm of the study and the reporting is done in accordance with the extension of CONSORT Statements on reporting pragmatic trials and cluster randomised trials [23, 24].…”

“…The details of its development have been described in the study protocol [22]. It consisted of three obligatory components and two optional components utilising readily available and existing resources in the Malaysian public primary care setting.…”

“…It consisted of three obligatory components and two optional components utilising readily available and existing resources in the Malaysian public primary care setting. The aim was to have a productive interaction between the empowered CDM team and the informed, empowered T2DM patients [22]. Table 1 summarised the components of the EMPOWER-PAR intervention according to their respective CCM elements.…”

Chronic care model and cost reduction in initial health: a new approach for satisfaction and improvement of chronicity

“…Cross-site evaluation of the Alliance to Reduce Disparities in Diabetes: clinical and patient-reported outcomes 22 2014, USA Evaluation Studies 5. Study protocol of EMPOWER participatory action research (EMPOWER-PAR): a pragmatic cluster randomised controlled trial of 2014, Malaysia multifaceted chronic disease management strategies to improve diabetes and hypertension outcomes in primary care 23 Randomized Controlled Trial 6. Implementing community-based diabetes programs: the scripps whittier diabetes institute experience 24 2014, California (USA) Research Support, N.I.H., Extramural 7.…”

“…Subsequently, the following limits were imposed: i) text availability: free full text; ii) publication dates: 5 years; and iii) species: human, with the exclusion of 94 studies, for a total of 14 studies useful for the revision (Table 2). [19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] …”