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

NCT01545401 | Completed Early Phase 1 DMC

• 1 other identifier: NMRR-11-250-8769
• Study Type: interventional
• Target: 1,545
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

chronic disease management; Chronic Care Model; multifaceted intervention; primary care; type 2 diabetes mellitus; hypertension

Outcome Measures

Primary Outcomes (1)

• Change in the proportion of patients achieving glycaemic and BP control

  Outcome measures are obtained from both intervention and control clinics at baseline and at 1-year after the commencement of intervention. Primary Outcomes For T2DM patients, primary outcome is measured by the change in the proportion of patients achieving glycaemic target of HbA1c \< 6.5%. For HPT patients without T2DM, primary outcome is measured by the change in the proportion of patients achieving BP target of \< 140/90 mmHg.

  1 year

Secondary Outcomes (2)

• Change in the proportion of patients achieving clinical targets:

  1 year

• Other secondary outcome measures

  1 year

Study Arms (2)

EMPOWER-PAR Intervention

EXPERIMENTAL

The intervention arm receives the EMPOWER-PAR intervention package consisting of: 1. Chronic Disease Management (CDM) Training Workshops for the staff in the respective clinics 2. The Global CV Risks Self-Management Booklet (patient self-management tool) to empower patients to self-manage their CV risk factors 3. Facilitation and support of the staff in these clinics so that they may implement the interventions

Other: EMPOWER-PAR Intervention

Control

NO INTERVENTION

The control arm continues with usual care. The EMPOWER-PAR intervention package will be made available after the trial ends.

Interventions

EMPOWER-PAR Intervention OTHER

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

EMPOWER-PAR Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged ≥ 18 years who are diagnosed with:
• T2DM or HPT or both
• Seen at least once in the last one year at the primary care clinic for the above conditions

You may not qualify if:

• Type 1 Diabetes Mellitus
• Receiving renal dialysis
• Presenting with severe HPT (Systolic BP \>180mmHg and/or Diastolic BP \>110 mmHg)
• Diagnosed with conditions resulting in secondary hypertension
• Diagnosed to have circulatory disorders needing referral to secondary care over the last 1 year e.g. unstable angina, heart attack, stroke, transient ischaemic attacks
• Receiving shared care between primary and secondary care for complications of T2DM and/or HPT
• Pregnancy
• Enrolled in another study
• All patients in the intervention arm are required to be seen at least twice by the CDM team of each clinic during the 1-year intervention period. Those who do not comply are considered as lost to follow-up. There is no limit to the number of clinic visits a patient is allowed to make in either arm during the course of the study.

Sponsors & Collaborators

• Ministry of Health, Malaysia: lead
• Ministry of Education, Malaysia: collaborator
• Universiti Teknologi Mara: collaborator

Study Sites (1)

Universiti Teknologi MARA

Batu Caves, Selangor, 68100, Malaysia

Location

Related Publications (2)

• Ramli AS, Selvarajah S, Daud MH, Haniff J, Abdul-Razak S, Tg-Abu-Bakar-Sidik TM, Bujang MA, Chew BH, Rahman T, Tong SF, Shafie AA, Lee VK, Ng KK, Ariffin F, Abdul-Hamid H, Mazapuspavina MY, Mat-Nasir N, Chan CW, Yong-Rafidah AR, Ismail M, Lakshmanan S, Low WH; EMPOWER-PAR Investigators. Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial. BMC Fam Pract. 2016 Nov 14;17(1):157. doi: 10.1186/s12875-016-0557-1.

  PMID: 27842495 DERIVED

• Ramli AS, Lakshmanan S, Haniff J, Selvarajah S, Tong SF, Bujang MA, Abdul-Razak S, Shafie AA, Lee VK, Abdul-Rahman TH, Daud MH, Ng KK, Ariffin F, Abdul-Hamid H, Mazapuspavina MY, Mat-Nasir N, Miskan M, Stanley-Ponniah JP, Ismail M, Chan CW, Abdul-Rahman YR, Chew BH, Low WH. 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. BMC Fam Pract. 2014 Sep 13;15:151. doi: 10.1186/1471-2296-15-151.

  PMID: 25218689 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Assoc. Prof. Dr. Anis Safura Ramli, MRCGP (UK)

  University Teknologi MARA, Malaysia

  PRINCIPAL INVESTIGATOR

• Dr. Jamaiyah Haniff, MPH

  Clinical Research Centre

  PRINCIPAL INVESTIGATOR

• Dr. Sharmila Lakshmanan, MBBS

  Clinical Research Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 6, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

MY (1)