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

Anis S. Ramli, Sharmila Lakshmanan, Jamaiyah Haniff, Sharmini Selvarajah, Tong Seng Fah, Mohamad Adam Bujang, Suraya Abdul-Razak, Asrul A. Shafie, Verna K M Lee, Thuhairah H. Abdul-Rahman, Maryam H. Daud, Kien K. Ng, Farnaza Ariffin, Hasidah Abdul-Hamid, Md Yasin Mazapuspavina, Nafiza Mat-Nasir, Maizatullifah Miskan, Jaya P. Stanley-Ponniah, Mastura Ismail, Chun W. ChanYong R. Abdul-Rahman, Boon How Chew, Wilson H H Low

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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. Trial Registration: ClinicalTrials.gov NCT01545401.

Original languageEnglish
Article number151
JournalBMC Family Practice
Volume15
Issue number1
DOIs
Publication statusPublished - 13 Sep 2014

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Health Services Research
Disease Management
Primary Health Care
Chronic Disease
Randomized Controlled Trials
Type 2 Diabetes Mellitus
Hypertension
Malaysia
Cost-Benefit Analysis
Pamphlets
Medication Adherence
Practice Management
Risk Management
Waist Circumference
Self Care
Practice Guidelines
Developed Countries
Developing Countries
Patient Care
Body Mass Index

Keywords

  • Chronic care model
  • Chronic disease management
  • Hypertension
  • Multifaceted intervention
  • Primary care
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Family Practice

Cite this

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. / Ramli, Anis S.; Lakshmanan, Sharmila; Haniff, Jamaiyah; Selvarajah, Sharmini; Seng Fah, Tong; Bujang, Mohamad Adam; Abdul-Razak, Suraya; Shafie, Asrul A.; Lee, Verna K M; Abdul-Rahman, Thuhairah H.; Daud, Maryam H.; Ng, Kien K.; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md Yasin; Mat-Nasir, Nafiza; Miskan, Maizatullifah; Stanley-Ponniah, Jaya P.; Ismail, Mastura; Chan, Chun W.; Abdul-Rahman, Yong R.; Chew, Boon How; Low, Wilson H H.

In: BMC Family Practice, Vol. 15, No. 1, 151, 13.09.2014.

Research output: Contribution to journalArticle

Ramli, AS, Lakshmanan, S, Haniff, J, Selvarajah, S, Seng Fah, T, Bujang, MA, Abdul-Razak, S, Shafie, AA, Lee, VKM, 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, WHH 2014, '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 Family Practice, vol. 15, no. 1, 151. https://doi.org/10.1186/1471-2296-15-151
Ramli, Anis S. ; Lakshmanan, Sharmila ; Haniff, Jamaiyah ; Selvarajah, Sharmini ; Seng Fah, Tong ; Bujang, Mohamad Adam ; Abdul-Razak, Suraya ; Shafie, Asrul A. ; Lee, Verna K M ; Abdul-Rahman, Thuhairah H. ; Daud, Maryam H. ; Ng, Kien K. ; Ariffin, Farnaza ; Abdul-Hamid, Hasidah ; Mazapuspavina, Md Yasin ; Mat-Nasir, Nafiza ; Miskan, Maizatullifah ; Stanley-Ponniah, Jaya P. ; Ismail, Mastura ; Chan, Chun W. ; Abdul-Rahman, Yong R. ; Chew, Boon How ; Low, Wilson H H. / 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. In: BMC Family Practice. 2014 ; Vol. 15, No. 1.
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T2 - A pragmatic cluster randomised controlled trial of multifaceted chronic disease management strategies to improve diabetes and hypertension outcomes in primary care

AU - Ramli, Anis S.

AU - Lakshmanan, Sharmila

AU - Haniff, Jamaiyah

AU - Selvarajah, Sharmini

AU - Seng Fah, Tong

AU - Bujang, Mohamad Adam

AU - Abdul-Razak, Suraya

AU - Shafie, Asrul A.

AU - Lee, Verna K M

AU - Abdul-Rahman, Thuhairah H.

AU - Daud, Maryam H.

AU - Ng, Kien K.

AU - Ariffin, Farnaza

AU - Abdul-Hamid, Hasidah

AU - Mazapuspavina, Md Yasin

AU - Mat-Nasir, Nafiza

AU - Miskan, Maizatullifah

AU - Stanley-Ponniah, Jaya P.

AU - Ismail, Mastura

AU - Chan, Chun W.

AU - Abdul-Rahman, Yong R.

AU - Chew, Boon How

AU - Low, Wilson H H

PY - 2014/9/13

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N2 - 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. Trial Registration: ClinicalTrials.gov NCT01545401.

AB - 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. Trial Registration: ClinicalTrials.gov NCT01545401.

KW - Chronic care model

KW - Chronic disease management

KW - Hypertension

KW - Multifaceted intervention

KW - Primary care

KW - Type 2 diabetes mellitus

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