Empowering Primary Care Providers and Patients to Improve Chronic Disease Outcomes: The EMPOWER Participatory Action Research (EMPOWER - PAR)

Summary

BACKGROUND

Chronic disease management (CDM) presents enormous challenges to the primary care workforce due to the rising epidemic of cardiovascular risk factors. The Chronic Care Model (CCM) was proven effective in improving chronic disease outcomes in developed countries. Evidence that this model works in developing countries is still scarce. Therefore, the aim of this study is to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted CDM strategies based on the CCM) in managing type 2 diabetes mellitus (T2DM) and hypertension (HPT), using readily available resources in the Malaysian public primary care setting.

METHODS

This is a pragmatic cluster randomised controlled trial - participatory action research which is currently being conducted in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics are randomly selected to provide the EMPOWER-PAR intervention for 1 year, while the other 5 clinics continued with usual care. Each clinic recruits consecutive T2DM and HPT patients who fulfil the inclusion and exclusion criteria over a 2-week period.

The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary CDM Team; and training the team to utilise the Global CV Risks Self-Management Booklet to support patient care and reinforcing them to utilise relevant clinical practice guidelines to aid management and prescribing.

For T2DM, primary outcome is the change in the proportion of patients achieving target HbA1c of \<6.5%. For HPT without T2DM, primary outcome is the change in the proportion of patients achieving target blood pressure of \<140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets 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, providers' perception, attitude and perceived barriers in delivering the care and cost-effectiveness of the intervention are also evaluated.

CONCLUSION

Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the CCM in resource constraint public primary care setting. It is hoped that the evidence will instigate the much needed primary care system change in Malaysia.

Conditions

• Type 2 Diabetes Mellitus
• Hypertension (Without Type 2 Diabetes Mellitus)

Interventions

OTHER

EMPOWER-PAR Intervention

Implementation process is conducted in 3 phases: I. Phase 1: Formation and training of the CDM team II. Phase 2: Distributions of the intervention tools * Global CV Risks Self-Management Booklets * CPG to aid clinical decision making III. Phase 3: Facilitation and support to implement the intervention

Sponsors & Collaborators

• Ministry of Education, Malaysia

  collaborator OTHER_GOV

• Universiti Teknologi Mara

  collaborator OTHER

• Ministry of Health, Malaysia

  lead OTHER_GOV

Principal Investigators

• Assoc. Prof. Dr. Anis Safura Ramli, MRCGP (UK) · University Teknologi MARA, Malaysia

• Dr. Jamaiyah Haniff, MPH · Clinical Research Centre

• Dr. Sharmila Lakshmanan, MBBS · Clinical Research Centre

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2014-06-30

Completion

2014-06-30

Countries

• Malaysia

Study Locations