Using mHealth Technology to Identify and Refer Surgical Site Infections in Rwanda
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 653
- 试验地点
- 2
- 主要终点
- Number of patients with SSI returning to care
研究概览
简要总结
The present study aims to examine whether or not the use of mobile Health (mHealth) by community health workers (CHWs) can improve the identification of surgical site infection (SSI) and a timely return to care among patients who undergo cesarean-section surgery at a rural hospital in Rwanda.
详细描述
Surgical site infections (SSI) are a significant cause of morbidity and mortality worldwide, and particularly in low- and middle-income countries, where geographic and infrastructural barriers often delay or prevent post-operative patients from returning to care. In these settings, rates of SSI can reach 30%. In Rwanda, the current standard of care does not include follow-up of post-operative surgical patients. There, a network of community health workers (CHWs) is employed to provide care and follow-up for pregnant and post-partum women as well as children under five years of age. However, the limited education and existing work load of these workers preclude them from supporting the follow-up of other specialized conditions, such as post-operative patients.
The interventions evaluated in this proposed research seeks to address these gaps. The main aim is to evaluate the impact of the SSI screening protocol, delivered by sCHWs equipped with mHealth support, on the rate of return to care for patients with SSI 10 days post-operation. Two CHW-mHealth interventions will be evaluated. In the first, a sCHW will visit post-operative study participants in their homes to administer the screening protocol prompted by the mobile phone. In the second, a sCHW will call the patient and administer the same screening protocol over the phone. In this phase of the research, 364 patients will be assigned to each of these delivery arms, and the rates of appropriate return to care will be compared to that of 364 patients in a control arm receiving the standard of care (i.e. no additional follow-up). Process indicators also will be reported to describe the feasibility of CHW-mHealth interventions.
Investigators believe that the SSI screening protocol administered via CHW-mHealth interventions can support accurate diagnosis of SSI and refer patients back to the hospital for appropriate follow-up care. The research team's close collaboration with colleagues at the Rwanda Ministry of Health will facilitate the scale-up of the intervention, should it prove efficacious. Results of this study will also inform the development of similar mHealth interventions across other disease areas, allowing CHWs to expand services to other specialized patients in rural African settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult patients that have undergone cesarean-section surgery at Kirehe District Hospital
排除标准
- •Patients from Mahama Refugee Camp will not be asked to participate in follow-up activities due to travel autonomy issues
- •Patients that are not residents of Kirehe District
- •Patients that have surgery other than cesarean delivery
- •Patients that have not been discharged by 7 post-operative days (POD)
研究组 & 干预措施
Home Visit
Individuals in Arm 1 will be visited at home by the sCHW who will administer the optimized SSI protocol via the mHealth device. Intervention: "SSI Screening Tool used in home visits by CHWs"
干预措施: SSI Screening Tool used in home visits by CHWs (Other)
Phone Call
Individuals in Arm 2 will be phoned by the sCHW who will administer the SSI protocol over the phone. Intervention: "SSI Screening Tool used via phone call follow-up"
干预措施: SSI Screening Tool used via phone call follow-up (Other)
Standard of Care
Individuals in Arm 3 will not have any additional contact beyond standard of care.
结局指标
主要结局
Number of patients with SSI returning to care
时间窗: by 20 days post-surgery
The number of patients in each study arm who return to care with a surgical site infection.
次要结局
未报告次要终点
研究者
Robert Riviello
Associate Surgeon, Division of Trauma, Burns and Surgical Critical Care
Brigham and Women's Hospital
