Leveraging Community-to-facility Service Provision to Implement the World Health Organization HEARTS-D Guidelines in Bangladesh for Improving Diabetes Control and Prevention (HEARTS-D for Bangladesh)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 主要终点
- Implementation of the Community-to-Facility Integrated Care Intervention
研究概览
简要总结
Type-2 diabetes (T2D) is rising at an alarming rate in the low- and middle-income countries (LMIC). This rapid increase in the T2D burden has a particular impact on cities, where more than half the LMIC populations currently live and where 3 out of 4 people with T2D reside. In response to this growing global challenge, the World Health Organization (WHO) has emphasized (a) the need for an equitable and sustained improvement in the detection, treatment, and control of T2D, and (b) a rapid implementation of the WHO's evidence-based HEARTS-D module. However, currently, in most LMICs (such as Bangladesh), effective adoption of the WHO HEARTS-D module into routine urban primary care has been limited. These include suboptimal delivery mechanisms, poor uptake, weak monitoring system, and inadequate capacities. To address this, the investigators will evaluate a community-to-facility integrated strategy to implement WHO HEARTS-D module in the existing urban service delivery system in Bangladesh. First, the investigators will develop and optimize a community-to-facility integrated strategy for adopting the WHO HEARTS-D module using Implementation Mapping. Guided by this approach, the investigators will conduct mixed methods assessments to: (a) identify contextual factors, and (b) assess the implementation behavior of providers that may influence T2D care in cities. The investigators will then develop and optimize a suitable implementation strategy that can achieve high coverage, access and utilization of T2D care, specifically for urban poor populations, through iterative cycles of mixed methods qualitative assessments, implementation, and outcome measurements. For this aim, study staff will select the key stakeholders, primary care providers and CHWs as participants, based in 3 wards in Sylhet city of Bangladesh. Second, the investigators will evaluate the impacts of the optimized community-to-facility integrated strategy on implementation outcomes. The investigators will conduct a 2-arm, type 2, hybrid implementation-effectiveness randomized trial. The study will involve 20 municipal wards as clusters from Sylhet city (10 in each arm). This study compare the following strategies: (a) a community-to-facility integrated strategy for implementing the WHO HEARTS-D module and (b) a facility-only usual service delivery. The investigators will evaluate the implementation process by relevant outcomes based on the RE-AIM framework components: reach, effectiveness, implementation, and maintenance. Third, the investigators will compare the effectiveness of this strategy on T2D status. In a study sample of 10,000 randomly selected participants, the investigators will compare improvements in the prevalence of controlled T2D, treatment uptake and adherence to glucose-lowering therapy, T2D complications and awareness among participants in both study arms from baseline to end-line. Our study should guide the policymakers into effective implementation and sustainment of WHO HEARTS-D module that can be: (a) embedded within local organizational structures, and (b) adapted to similar contexts globally.
详细描述
Background Type-2 diabetes (T2D) is rising at an alarming rate in all low- and middle-income countries (LMIC). This rapid acceleration of the T2D burden has a particular impact on cities, where more than half the LMIC populations currently live and where 3 out of 4 people with T2D reside. In response to this growing global challenge, the World Health Organization (WHO) has emphasized the rapid implementation of the WHO's evidence-based HEARTS-Diabetes (HEARTS-D) module in all member states, which aims to improve service delivery for T2D in primary care facilities using highly effective, scalable, and proven strategies.
Currently, in most LMICs, effective adoption of the WHO HEARTS-D module into routine urban primary care has been limited owing to substantial implementation barriers. This also underscores a global unmet need for implementation research, which could help develop strategies to integrate and sustain this evidence-based module into practice. The Government of Bangladesh committed to rolling out the WHO HEARTS-D module as well. However, like the majority of LMICs, it faces implementation challenges regarding an effective strategy to adopt this module - owing to a lack of relevant implementation research data.
Aims and objectives This implementation research study aims to develop an optimized community-to-facility implementation model to strengthen urban healthcare for T2D management in Bangladesh using the WHO HEARTS-D module. The study will also evaluate the optimized implementation model to investigate its impact and effectiveness on T2D care in an urban setting in Bangladesh.
Study design This is an implementation research study, which will use a mixed-methods design, including both qualitative and quantitative research methodologies.
First, a formative research method will be used to identify barriers and facilitators for community-to-facility WHO HEARTS-D module implementation to design and optimize the initial implementation model. Concurrent program learning using qualitative research and outcome measurement while implementing the initial model in routine care settings will be used to improve the model iteratively until a high coverage of T2D care using the WHO HEARTS-D module is achieved. This process will produce the final, optimized WHO HEARTS-D implementation model, developed from the perspective of sustainable scale-up.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult individuals, ≥35 years of age,
- •Of either sex,
- •Long-term residents in the study area (defined by being a homeowner or a resident for at least the past three years), and
- •Willing to provide informed consent for study procedures and follow-up.
排除标准
- •Individuals planning to migrate from the study area before completing the first 12-month follow-up period, and
- •Individuals explicitly requesting exclusion from the study or unable to provide consent.
研究组 & 干预措施
The community-to-facility integrated strategy
The community-to-facility integrated strategy arm will focus on a joined-up T2D care delivery across the primary, secondary, and healthcare facilities, and urban communities. The intervention arm includes community-based care where Community Health Workers (CHWs) visit households to identify eligible individuals and refer them to relevant facilities. This arm will involve (i) 10 randomly chosen ward clusters, and (ii) primary health care centers and Community Health Workers (CHWs) serving these wards.
干预措施: The community-to-facility integrated strategy (Other)
Existing services with no additional involvement of the PHCC-based CHWs
The remaining 10 ward clusters not included in the intervention arm will be considered as the comparison arm. The participants in this arm will receive the existing conventional services for diabetes in the PHCC and other clinical facilities. However, unlike the experimental arm, there will be no additional involvement of the PHCC-based CHWs in community-based screening and referral.
结局指标
主要结局
Implementation of the Community-to-Facility Integrated Care Intervention
时间窗: Baseline; and through study completion, an average of 1 year.
This outcome will measure the extent to which the integrated community-to-facility care intervention has been successfully implemented, based on the RE-AIM framework.
Effectiveness of the Community-to-Facility Integrated Care Intervention on Health Outcome
时间窗: Baseline; and through study completion, an average of 1 year
This outcome will evaluate the effectiveness of the intervention by measuring the percentage of study participants with uncontrolled T2D
次要结局
未报告次要终点