Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care

A Pragmatic Cluster Randomised Controlled Trial

Anis Safura Ramli, Sharmini Selvarajah, Maryam Hannah Daud, Jamaiyah Haniff, Suraya Abdul-Razak, Tg Mohd Ikhwan Tg-Abu-Bakar-Sidik, Mohamad Adam Bujang, Boon How Chew, Thuhairah Rahman, Tong Seng Fah, Asrul Akmal Shafie, Verna K M Lee, Kien Keat Ng, Farnaza Ariffin, Hasidah Abdul-Hamid, Md Yasin Mazapuspavina, Nafiza Mat-Nasir, Chun W. Chan, Abdul Rahman Yong-Rafidah, Mastura Ismail & 2 others Sharmila Lakshmanan, Wilson H H Low

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

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. Trial registration: Registered with: ClinicalTrials.gov.: NCT01545401. Date of registration: 1st March 2012.

Original languageEnglish
Pages (from-to)1-18
Number of pages18
JournalBMC Family Practice
Volume17
Issue number1
DOIs
Publication statusPublished - 14 Nov 2016

Fingerprint

Type 2 Diabetes Mellitus
Primary Health Care
Randomized Controlled Trials
Control Groups
Intention to Treat Analysis
Health Services Research
Malaysia
Waist Circumference
Self Care
Developed Countries
Developing Countries
Cluster Analysis
Body Mass Index
Demography
Outcome Assessment (Health Care)
Organizations
Blood Pressure
Delivery of Health Care
Lipids

Keywords

  • Chronic care model
  • Chronic disease management
  • Clinical outcomes
  • Family medicine
  • Multifaceted intervention
  • Primary care
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Family Practice

Cite this

Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care : A Pragmatic Cluster Randomised Controlled Trial. / Ramli, Anis Safura; Selvarajah, Sharmini; Daud, Maryam Hannah; Haniff, Jamaiyah; Abdul-Razak, Suraya; Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan; Bujang, Mohamad Adam; Chew, Boon How; Rahman, Thuhairah; Seng Fah, Tong; Shafie, Asrul Akmal; Lee, Verna K M; Ng, Kien Keat; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md Yasin; Mat-Nasir, Nafiza; Chan, Chun W.; Yong-Rafidah, Abdul Rahman; Ismail, Mastura; Lakshmanan, Sharmila; Low, Wilson H H.

In: BMC Family Practice, Vol. 17, No. 1, 14.11.2016, p. 1-18.

Research output: Contribution to journalArticle

Ramli, AS, Selvarajah, S, Daud, MH, Haniff, J, Abdul-Razak, S, Tg-Abu-Bakar-Sidik, TMI, Bujang, MA, Chew, BH, Rahman, T, Seng Fah, T, Shafie, AA, Lee, VKM, Ng, KK, Ariffin, F, Abdul-Hamid, H, Mazapuspavina, MY, Mat-Nasir, N, Chan, CW, Yong-Rafidah, AR, Ismail, M, Lakshmanan, S & Low, WHH 2016, '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 Family Practice, vol. 17, no. 1, pp. 1-18. https://doi.org/10.1186/s12875-016-0557-1
Ramli, Anis Safura ; Selvarajah, Sharmini ; Daud, Maryam Hannah ; Haniff, Jamaiyah ; Abdul-Razak, Suraya ; Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan ; Bujang, Mohamad Adam ; Chew, Boon How ; Rahman, Thuhairah ; Seng Fah, Tong ; Shafie, Asrul Akmal ; Lee, Verna K M ; Ng, Kien Keat ; Ariffin, Farnaza ; Abdul-Hamid, Hasidah ; Mazapuspavina, Md Yasin ; Mat-Nasir, Nafiza ; Chan, Chun W. ; Yong-Rafidah, Abdul Rahman ; Ismail, Mastura ; Lakshmanan, Sharmila ; Low, Wilson H H. / Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care : A Pragmatic Cluster Randomised Controlled Trial. In: BMC Family Practice. 2016 ; Vol. 17, No. 1. pp. 1-18.
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T1 - Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care

T2 - A Pragmatic Cluster Randomised Controlled Trial

AU - Ramli, Anis Safura

AU - Selvarajah, Sharmini

AU - Daud, Maryam Hannah

AU - Haniff, Jamaiyah

AU - Abdul-Razak, Suraya

AU - Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan

AU - Bujang, Mohamad Adam

AU - Chew, Boon How

AU - Rahman, Thuhairah

AU - Seng Fah, Tong

AU - Shafie, Asrul Akmal

AU - Lee, Verna K M

AU - Ng, Kien Keat

AU - Ariffin, Farnaza

AU - Abdul-Hamid, Hasidah

AU - Mazapuspavina, Md Yasin

AU - Mat-Nasir, Nafiza

AU - Chan, Chun W.

AU - Yong-Rafidah, Abdul Rahman

AU - Ismail, Mastura

AU - Lakshmanan, Sharmila

AU - Low, Wilson H H

PY - 2016/11/14

Y1 - 2016/11/14

N2 - 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. Trial registration: Registered with: ClinicalTrials.gov.: NCT01545401. Date of registration: 1st March 2012.

AB - 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. Trial registration: Registered with: ClinicalTrials.gov.: NCT01545401. Date of registration: 1st March 2012.

KW - Chronic care model

KW - Chronic disease management

KW - Clinical outcomes

KW - Family medicine

KW - Multifaceted intervention

KW - Primary care

KW - Type 2 diabetes mellitus

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