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

NCT03311399 | Completed DMC

• 1 other identifier: 2016P001943
• Study Type: interventional
• Target: 653
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Keywords

Surgical Site Infection; mHealth; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• 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.

  by 20 days post-surgery

Study Arms (3)

Home Visit

EXPERIMENTAL

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"

Other: SSI Screening Tool used in home visits by CHWs

Phone Call

EXPERIMENTAL

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"

Other: SSI Screening Tool used via phone call follow-up

Standard of Care

NO INTERVENTION

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

Interventions

SSI Screening Tool used in home visits by CHWs OTHER

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.

Home Visit

SSI Screening Tool used via phone call follow-up OTHER

Individuals in Arm 2 will be phoned by the sCHW who will administer the SSI protocol over the phone.

Phone Call

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator
• Partners in Health: collaborator

Study Sites (1)

Kirehe District Hospital

Kirehe District, Kirehe District, 0000, Rwanda

Location

Related Publications (25)

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MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bethany Hedt-Gauthier, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Surgeon, Division of Trauma, Burns and Surgical Critical Care

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 17, 2017
• Study Start: March 15, 2017
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)