Using mHealth Technology to Identify and Refer Surgical Site Infections in Rwanda
NCT ID: NCT03311399
Last Updated: 2019-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
653 participants
INTERVENTIONAL
2017-03-15
2018-10-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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"
SSI Screening Tool used in home visits by CHWs
Individuals in Arm 1 will be visited at home by the sCHW who will administer the optimized SSI protocol via the mHealth device. Following the screening, the sCHWs will use the cell phone to photograph the surgical wound and record the GPS location of the visit.
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"
SSI Screening Tool used via phone call follow-up
Individuals in Arm 2 will be phoned by the sCHW who will administer the SSI protocol over the phone.
Standard of Care
Individuals in Arm 3 will not have any additional contact beyond standard of care.
No interventions assigned to this group
Interventions
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SSI Screening Tool used in home visits by CHWs
Individuals in Arm 1 will be visited at home by the sCHW who will administer the optimized SSI protocol via the mHealth device. Following the screening, the sCHWs will use the cell phone to photograph the surgical wound and record the GPS location of the visit.
SSI Screening Tool used via phone call follow-up
Individuals in Arm 2 will be phoned by the sCHW who will administer the SSI protocol over the phone.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
FEMALE
Yes
Sponsors
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Harvard Medical School (HMS and HSDM)
OTHER
Partners in Health
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Robert Riviello
Associate Surgeon, Division of Trauma, Burns and Surgical Critical Care
Principal Investigators
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Bethany Hedt-Gauthier, PhD
Role: PRINCIPAL_INVESTIGATOR
Harvard Medical School (HMS and HSDM)
Locations
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Kirehe District Hospital
Kirehe District, Kirehe District, Rwanda
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2016P001943
Identifier Type: -
Identifier Source: org_study_id
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