Empowering Primary Care Providers and Patients to Improve Chronic Disease Outcomes: The EMPOWER Participatory Action Research (EMPOWER - PAR)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 1,545
- 试验地点
- 2
- 主要终点
- Change in the proportion of patients achieving glycaemic and BP control
研究概览
简要总结
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.
详细描述
HYPOTHESES
The primary hypothesis for T2DM patients is that the proportion achieving target HbA1c of <6.5% would improve with the EMPOWER-PAR intervention. The primary hypothesis for HPT patients without T2DM is that the proportion achieving target BP of <140/90 mmHg would improve with the EMPOWER-PAR intervention.
The secondary hypothesis for T2DM patients is that the proportion achieving target blood pressure (BP) of <130/80 mmHg would improve with the EMPOWER-PAR intervention. The secondary hypotheses for both groups of patients (T2DM and HPT without T2DM) are that the proportions achieving target fasting serum lipid, body mass index (BMI) and waist circumference (WC) would improve with the intervention. Medication adherence levels and patients' perceptions of their experience in receiving chronic disease care are also expected to improve with the intervention. Secondary hypotheses are also made at the primary care providers' level in terms of the process of care and prescribing pattern which are expected to improve with the intervention. Cost-effectiveness analysis and primary care providers' perception, attitude, experience and perceived barriers in implementing the intervention are also explored.
METHODS
- Pragmatic cluster-randomised parallel controlled trial -participatory action research conducted in 10 public primary care clinics from two states in Malaysia which are Wilayah Persekutuan Kuala Lumpur (WPKL) and Selangor (SEL).
- The overall duration of the study is 2 years while the duration of intervention is 1 year.
- Blinding is not possible due to the nature and complexity of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
EMPOWER-PAR Intervention
The intervention arm receives the EMPOWER-PAR intervention package consisting of:
- Chronic Disease Management (CDM) Training Workshops for the staff in the respective clinics
- The Global CV Risks Self-Management Booklet (patient self-management tool) to empower patients to self-manage their CV risk factors
- Facilitation and support of the staff in these clinics so that they may implement the interventions
干预措施: EMPOWER-PAR Intervention (Other)
Control
The control arm continues with usual care.
The EMPOWER-PAR intervention package will be made available after the trial ends.
结局指标
主要结局
Change in the proportion of patients achieving glycaemic and BP control
时间窗: 1 year
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.
次要结局
- Change in the proportion of patients achieving clinical targets:(1 year)
- Other secondary outcome measures(1 year)
研究者
Sharmila MKL
Dr
Ministry of Health, Malaysia