Clinical trial NCT03311399: Using mHealth Technology to Identify and Refer Surgical Site Infections in Rwanda
Official title: Using mHealth Technology to Identify and Refer Surgical Site Infections in Rwanda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: Surgical Site Infection
mHealth
Cesarean Section
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Partners in Health
First posted: 2017-10-17
Enrollment: 653
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients that have undergone cesarean-section surgery at Kirehe District Hospital

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Number of patients with SSI returning to care
timeFrame: by 20 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kirehe District
country: Rwanda
facility: Kirehe District Hospital
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Bethany Hedt-Gauthier, PhD
role: PRINCIPAL_INVESTIGATOR
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