Surgical Site InfectionNCT03311399
Using mHealth Technology to Identify and Refer Surgical Site Infections in Rwanda
A study testing SSI Screening Tool used in home visits by CHWs and SSI Screening Tool used via phone call follow-up in people with Surgical Site Infection, run by Brigham and Women's Hospital at 1 site in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- SSI Screening Tool used in home visits by CHWs and SSI Screening Tool used via phone call follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 653 participants
- Where
- 1 siteRwanda
- Study dates
- 15 Mar 2017to 4 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients that have undergone cesarean-section surgery at Kirehe District Hospital
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Surgical Site Infection
- Being tested
- SSI Screening Tool used in home visits by CHWs, SSI Screening Tool used via phone call follow-up
- Keywords
- Surgical Site Infection, mHealth, Cesarean Section
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSI Screening Tool used in home visits by CHWsOther
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-upOther
Individuals in Arm 2 will be phoned by the sCHW who will administer the SSI protocol over the phone.
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: 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" Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: by 20 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start15 Mar 2017
- Primary completion4 Oct 2018
- Study completion4 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Partners in Health
- Responsible party
- Principal investigator, Robert Riviello, Brigham and Women's Hospital
- Investigators
- Bethany Hedt-Gauthier, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311399
- Sponsor's protocol ID
- 2016P001943
- Status last verified
- Jan 2019
- First submitted
- 11 Oct 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21146207Bagheri 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.
PubMed 22084514Grimes 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.
PubMed 21360305Hsia RY, Mbembati NA, Macfarlane S, Kruk ME. Access to emergency and surgical care in sub-Saharan Africa: the infrastructure gap. Health Policy Plan. 2012 May;27(3):234-44. doi: 10.1093/heapol/czr023. Epub 2011 Mar 26.
PubMed 21441566Bercion R, Gaudeuille A, Mapouka PA, Behounde T, Guetahoun Y. [Surgical site infection survey in the orthopaedic surgery department of the "Hopital communautaire de Bangui," Central African Republic]. Bull Soc Pathol Exot. 2007 Aug;100(3):197-200. French.
PubMed 17824315Gottrup F, Melling A, Hollander DA. An overview of surgical site infections: aetiology, incidence and risk factors. EWMA Journal. 2005.
Lehman U, Sanders D. Community Health Workers: What do we know about them? The State of the Evidence on Programmes, Activities, Costs and Impact on Health Outcomes Using Community Health Workers. Geneva: World Health Organization, 2007.
Mugeni C, Levine AC, Munyaneza RM, Mulindahabi E, Cockrell HC, Glavis-Bloom J, Nutt CT, Wagner CM, Gaju E, Rukundo A, Habimana JP, Karema C, Ngabo F, Binagwaho A. Nationwide implementation of integrated community case management of childhood illness in Rwanda. Glob Health Sci Pract. 2014 Aug 5;2(3):328-41. doi: 10.9745/GHSP-D-14-00080. eCollection 2014 Aug.
PubMed 25276592Rwanda Health Sector Strategic Plan 2012-2018. Government of Rwanda Ministry of Health. Available online at http://www.moh.gov.rw/fileadmin/templates/Docs/HSSP_III_FINAL_VERSION.pdf.
Farmer PE, Nutt CT, Wagner CM, Sekabaraga C, Nuthulaganti T, Weigel JL, Farmer DB, Habinshuti A, Mugeni SD, Karasi JC, Drobac PC. Reduced premature mortality in Rwanda: lessons from success. BMJ. 2013 Jan 18;346:f65. doi: 10.1136/bmj.f65.
PubMed 23335479Rich ML, Miller AC, Niyigena P, Franke MF, Niyonzima JB, Socci A, Drobac PC, Hakizamungu M, Mayfield A, Ruhayisha R, Epino H, Stulac S, Cancedda C, Karamaga A, Niyonzima S, Yarbrough C, Fleming J, Amoroso C, Mukherjee J, Murray M, Farmer P, Binagwaho A. Excellent clinical outcomes and high retention in care among adults in a community-based HIV treatment program in rural Rwanda. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):e35-42. doi: 10.1097/QAI.0b013e31824476c4.
PubMed 22156912Franke MF, Kaigamba F, Socci AR, Hakizamungu M, Patel A, Bagiruwigize E, Niyigena P, Walker KD, Epino H, Binagwaho A, Mukherjee J, Farmer PE, Rich ML. Improved retention associated with community-based accompaniment for antiretroviral therapy delivery in rural Rwanda. Clin Infect Dis. 2013 May;56(9):1319-26. doi: 10.1093/cid/cis1193. Epub 2012 Dec 18.
PubMed 23249611Condo J, Mugeni C, Naughton B, Hall K, Tuazon MA, Omwega A, Nwaigwe F, Drobac P, Hyder Z, Ngabo F, Binagwaho A. Rwanda's evolving community health worker system: a qualitative assessment of client and provider perspectives. Hum Resour Health. 2014 Dec 13;12:71. doi: 10.1186/1478-4491-12-71.
PubMed 25495237Palazuelos D, Ellis K, Im DD, Peckarsky M, Schwarz D, Farmer DB, Dhillon R, Johnson A, Orihuela C, Hackett J, Bazile J, Berman L, Ballard M, Panjabi R, Ternier R, Slavin S, Lee S, Selinsky S, Mitnick CD. 5-SPICE: the application of an original framework for community health worker program design, quality improvement and research agenda setting. Glob Health Action. 2013 Apr 3;6:19658. doi: 10.3402/gha.v6i0.19658.
PubMed 23561023Statistical Yearbook. Kigali: National Institute of Statistics of Rwanda, 2014.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using mHealth Technology to Identify and Refer Surgical Site Infections in Rwanda
- ClinicalTrials.gov ID
- NCT03311399
- Acronym / sponsor ID
- 2016P001943
- Conditions
- Surgical Site Infection
- Keywords
- Surgical Site Infection, mHealth, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Partners in Health
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home Visit | Experimental | Other: SSI Screening Tool used in home visits by CHWsIndividuals 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 | Other: SSI Screening Tool used via phone call follow-upIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients that have undergone cesarean-section surgery at Kirehe District Hospital
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSI Screening Tool used in home visits by CHWsIndividuals 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. | Other | Home Visit |
| SSI Screening Tool used via phone call follow-upIndividuals in Arm 2 will be phoned by the sCHW who will administer the SSI protocol over the phone. | Other | Phone Call |
Primary outcome
Number of patients with SSI returning to care
Time frame: by 20 days post-surgery
The number of patients in each study arm who return to care with a surgical site infection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Background: PubMed 21146207Allegranzi 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.
- Background: PubMed 22084514Bagheri 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.
- Background: PubMed 21360305Grimes 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.
- Background: PubMed 21441566Hsia RY, Mbembati NA, Macfarlane S, Kruk ME. Access to emergency and surgical care in sub-Saharan Africa: the infrastructure gap. Health Policy Plan. 2012 May;27(3):234-44. doi: 10.1093/heapol/czr023. Epub 2011 Mar 26.
- Background: PubMed 17824315Bercion R, Gaudeuille A, Mapouka PA, Behounde T, Guetahoun Y. [Surgical site infection survey in the orthopaedic surgery department of the "Hopital communautaire de Bangui," Central African Republic]. Bull Soc Pathol Exot. 2007 Aug;100(3):197-200. French.
- BackgroundGottrup F, Melling A, Hollander DA. An overview of surgical site infections: aetiology, incidence and risk factors. EWMA Journal. 2005.
- BackgroundLehman U, Sanders D. Community Health Workers: What do we know about them? The State of the Evidence on Programmes, Activities, Costs and Impact on Health Outcomes Using Community Health Workers. Geneva: World Health Organization, 2007.
- Background: PubMed 25276592Mugeni C, Levine AC, Munyaneza RM, Mulindahabi E, Cockrell HC, Glavis-Bloom J, Nutt CT, Wagner CM, Gaju E, Rukundo A, Habimana JP, Karema C, Ngabo F, Binagwaho A. Nationwide implementation of integrated community case management of childhood illness in Rwanda. Glob Health Sci Pract. 2014 Aug 5;2(3):328-41. doi: 10.9745/GHSP-D-14-00080. eCollection 2014 Aug.
- BackgroundRwanda Health Sector Strategic Plan 2012-2018. Government of Rwanda Ministry of Health. Available online at http://www.moh.gov.rw/fileadmin/templates/Docs/HSSP_III_FINAL_VERSION.pdf.
- Background: PubMed 23335479Farmer PE, Nutt CT, Wagner CM, Sekabaraga C, Nuthulaganti T, Weigel JL, Farmer DB, Habinshuti A, Mugeni SD, Karasi JC, Drobac PC. Reduced premature mortality in Rwanda: lessons from success. BMJ. 2013 Jan 18;346:f65. doi: 10.1136/bmj.f65.
- Background: PubMed 22156912Rich ML, Miller AC, Niyigena P, Franke MF, Niyonzima JB, Socci A, Drobac PC, Hakizamungu M, Mayfield A, Ruhayisha R, Epino H, Stulac S, Cancedda C, Karamaga A, Niyonzima S, Yarbrough C, Fleming J, Amoroso C, Mukherjee J, Murray M, Farmer P, Binagwaho A. Excellent clinical outcomes and high retention in care among adults in a community-based HIV treatment program in rural Rwanda. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):e35-42. doi: 10.1097/QAI.0b013e31824476c4.
- Background: PubMed 23249611Franke MF, Kaigamba F, Socci AR, Hakizamungu M, Patel A, Bagiruwigize E, Niyigena P, Walker KD, Epino H, Binagwaho A, Mukherjee J, Farmer PE, Rich ML. Improved retention associated with community-based accompaniment for antiretroviral therapy delivery in rural Rwanda. Clin Infect Dis. 2013 May;56(9):1319-26. doi: 10.1093/cid/cis1193. Epub 2012 Dec 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bethany Hedt-Gauthier, PhD principal investigator
Harvard Medical School (HMS and HSDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSI Screening Tool used in home visits by CHWs and SSI Screening Tool used via phone call follow-up in people with Surgical Site Infection, run by Brigham and Women's Hospital at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with SSI returning to care (time frame: by 20 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03311399, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.