Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Change in one year systolic blood pressure as measured in clinic
研究概览
简要总结
"STRENGTHS" is a transdisciplinary implementation research study, guided by the PRECEDE-PROCEED framework, to address the challenge of improving hypertension control in low-resource settings. The investigators propose to test the hypothesis that referral networks strengthened by an integrated health information technology and peer support intervention will be effective and cost-effective in improving hypertension control among patients in western Kenya. The investigators hypothesise that the integrated Health information Technology and Peer Support intervention will facilitate seamless referral of hypertensive patients across the different levels of the health system compared to usual care, leading to improvement in blood pressure. If proven to be successful, STRENGTHS can serve as a model for improving referral of patients upstream and downstream in health systems worldwide.
详细描述
Hypertension is a major risk factor for cardiovascular disease, and 80% of global mortality due to cardiovascular diseases occurs in low- and middle-income countries. In low income countries, lack of coordination between different levels of the health system threatens the ability to provide the care necessary to control hypertension and prevent cardiovascular disease related morbidity. Strong referral networks have improved health outcomes for chronic disease in a variety of settings. Health information technology and peer-based support are two strategies that have improved care coordination and clinical outcomes. However, their effectiveness in strengthening referral networks to improve blood pressure control and reduce cardiovascular disease risk in low-resource settings is unknown.
The Academic Model Providing Access to Healthcare (AMPATH) partners with the Kenya Ministry of Health to provide care for non-communicable chronic diseases (NCDs), including hypertension at all levels of the health system. The Kenya Ministry of Health Sector Referral Strategy 2014-2018 calls for improving the referral system at every level of the health system. AMPATH has piloted both health information technology and peer support for NCDs, and both strategies are feasible in this setting. However, the impact of integrating Health information technology and peer support to strengthen referral networks for hypertension control is unknown.
The proposal's objective is to utilise the PRECEDE-PROCEED framework to conduct trans-disciplinary, translational implementation research focused on strengthening referral networks for hypertension control. The central hypothesis is "Health Information Technology integrated with peer support will be effective and cost-effective in strengthening referral networks, improving blood pressure control, and reducing cardiovascular risk among hypertensive patients in western Kenya." The investigators hypothesise that Health information technology(HIT) and peer support(PS) will synergistically address barriers to hypertension control at the patient, provider and health system levels. The investigators further hypothesise that changes in referral network characteristics may mediate the impact of the intervention on the primary outcome, and that baseline referral net-work characteristics may moderate the impact of the intervention. To test these hypotheses and achieve the overall objective, STRENGTHS has the following specific aims:
Aim 1: Conduct a baseline needs and contextual assessment for implementing and integrating HIT and PS to strengthen referral networks for hypertension control, using a mixed-methods approach, including: observational process mapping and gap assessment; baseline referral network analysis; and qualitative methods to identify facilitators, barriers, contextual factors, and readiness for change.
Sub-Aim 1.1: Use data from the aim 1 to develop a contextually and culturally appropriate intervention to strengthen referral networks for hypertension control using a participatory, iterative design process. Conduct pilot acceptability and feasibility testing 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
- Treatment
- 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
- •>= 18 yrs
- •Enrolled in AMPATH CDM Program
- •meet criteria for referral up or down the network
- •Patients with complicated hypertension meet criteria for referral up the network, defined as patients with hypertension who remain uncontrolled (SBP >= 140 or DBP >= 90) on 3 or more anti-hypertensive medications, who have signs or symptoms of end-organ damage, or who have suspected secondary causes of hypertension (age <35 years, HIV, or pregnancy)
- •Patients with stable, uncomplicated hypertension meet criteria for referral down the network, defined as controlled BP (SBP < 140 and DBP < 90) for 3 or more consecutive visits and no evidence of new end-organ damage
排除标准
- •acute illness requiring immediate medical attention
- •terminal illness
- •inability to provide informed consent
结局指标
主要结局
Change in one year systolic blood pressure as measured in clinic
时间窗: 1 year
The systolic blood pressure at baseline will be compared to systolic blood after 1 year of follow up. Blood pressure measurements will be averaged from three successive readings taken every 5 minutes in clinic
次要结局
- Mortality(1 year follow up)
- Change in one year overall Cardiovascular disease (CVD) QRISK2 score(1 year)
- Hospitalisation(1 year of follow up)
- Change in number of CVD risk factors and behaviors as assessed using a standardised screening questionnaire(1 year)
- Cardiovascular disease complications(1 year follow up)
- Self reported adherence to hypertension medication as assessed using the Morisky Medication adherence questionnaire(1 year)