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| Name | Class |
|---|---|
| Harvard Medical School (HMS and HSDM) | OTHER |
| Partners in Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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" |
|
| 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" |
|
| Standard of Care | No Intervention | Individuals in Arm 3 will not have any additional contact beyond standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bethany Hedt-Gauthier, PhD | Harvard Medical School (HMS and HSDM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kirehe District Hospital | Kirehe District | Kirehe District | 0000 | Rwanda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21146207 | Background | Allegranzi B, Bagheri Nejad S, Combescure C, Graafmans W, Attar H, Donaldson L, Pittet D. Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis. Lancet. 2011 Jan 15;377(9761):228-41. doi: 10.1016/S0140-6736(10)61458-4. Epub 2010 Dec 9. | |
| 22084514 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2017 | Sep 26, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2017 | Oct 4, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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|
| 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. |
|
| Bagheri Nejad S, Allegranzi B, Syed SB, Ellis B, Pittet D. Health-care-associated infection in Africa: a systematic review. Bull World Health Organ. 2011 Oct 1;89(10):757-65. doi: 10.2471/BLT.11.088179. Epub 2011 Jul 20. |
| 21360305 | Background | Grimes CE, Bowman KG, Dodgion CM, Lavy CB. Systematic review of barriers to surgical care in low-income and middle-income countries. World J Surg. 2011 May;35(5):941-50. doi: 10.1007/s00268-011-1010-1. |
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| 35675108 | Derived | Kateera F, Riviello R, Goodman A, Nkurunziza T, Cherian T, Bikorimana L, Nkurunziza J, Nahimana E, Habiyakare C, Ntakiyiruta G, Matousek A, Gaju E, Gruendl M, Powell B, Sonderman K, Koch R, Hedt-Gauthier B. The Effect and Feasibility of mHealth-Supported Surgical Site Infection Diagnosis by Community Health Workers After Cesarean Section in Rural Rwanda: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Jun 8;10(6):e35155. doi: 10.2196/35155. |
| 29739786 | Derived | Sonderman KA, Nkurunziza T, Kateera F, Gruendl M, Koch R, Gaju E, Habiyakare C, Matousek A, Nahimana E, Ntakiyiruta G, Riviello R, Hedt-Gauthier BL. Using mobile health technology and community health workers to identify and refer caesarean-related surgical site infections in rural Rwanda: a randomised controlled trial protocol. BMJ Open. 2018 May 8;8(5):e022214. doi: 10.1136/bmjopen-2018-022214. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |