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Using mHealth Technology to Identify and Refer Surgical Site Infections in Rwanda

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Not Applicable
Locations
Rwanda
Study Type
Interventional
Intervention
SSI Screening Tool used in home visits by CHWs
SSI Screening Tool used via phone call follow-up
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Surgical Site Infection focused on measuring Surgical Site Infection, mHealth, Cesarean Section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Kirehe District Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Home Visit

Phone Call

Standard of Care

Arm Description

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"

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"

Individuals in Arm 3 will not have any additional contact beyond standard of care.

Outcomes

Primary Outcome Measures

Number of patients with SSI returning to care
The number of patients in each study arm who return to care with a surgical site infection.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2017
Last Updated
January 15, 2019
Sponsor
Brigham and Women's Hospital
Collaborators
Harvard Medical School (HMS and HSDM), Partners in Health
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1. Study Identification

Unique Protocol Identification Number
NCT03311399
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
October 4, 2018 (Actual)
Study Completion Date
October 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Harvard Medical School (HMS and HSDM), Partners in Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Surgical Site Infection, mHealth, Cesarean Section

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
653 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home Visit
Arm Type
Experimental
Arm Description
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"
Arm Title
Phone Call
Arm Type
Experimental
Arm Description
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"
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Individuals in Arm 3 will not have any additional contact beyond standard of care.
Intervention Type
Other
Intervention Name(s)
SSI Screening Tool used in home visits by CHWs
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
SSI Screening Tool used via phone call follow-up
Intervention Description
Individuals in Arm 2 will be phoned by the sCHW who will administer the SSI protocol over the phone.
Primary Outcome Measure Information:
Title
Number of patients with SSI returning to care
Description
The number of patients in each study arm who return to care with a surgical site infection.
Time Frame
by 20 days post-surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany Hedt-Gauthier, PhD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kirehe District Hospital
City
Kirehe District
ZIP/Postal Code
0000
Country
Rwanda

12. IPD Sharing Statement

Plan to Share IPD
No
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Using mHealth Technology to Identify and Refer Surgical Site Infections in Rwanda

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