Implementation and Evaluation of Home-based Care and Hand Hygiene Interventions in Honduras
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 1,821
- Locations
- 1
- Primary Endpoint
- Duration of hospitalization
Study Overview
Brief Summary
This study aims to enroll patients with acute infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) who do not meet criteria for hospital admission according to protocols developed by the Honduras Ministry of Health (MOH). Patients who are triaged to home must also be over the age of 60 years or have one high risk comorbidity and be over 45 years in order to meet inclusion criteria. These patients will be randomly assigned to one of four home-based care strategies, which may or may not include regular blood oxygenation monitoring and provision of alcohol-based hand-rub. Patients will be followed until resolution of their acute illness, and data will be collected on feasibility, impact and acceptance of the intervention. Some patients will be followed for up to one year to monitor for post-Coronavirus Disease 2019 (COVID-19) symptoms.
Detailed Description
Rationale:
This project is intended to enhance the existing MOH home-based care approach by providing additional resources and monitoring for patients with COVID-19 that are triaged to Home-based care (HBC) by MOH triage clinicians. In addition, given limited data on which home-based care strategies most effectively and efficiently minimize poor outcomes, we aim to monitor four discrete home-based care approaches. Assignment to home-based care approach will be randomized. Given the primary goal of the project is to reduce morbidity and mortality due to the COVID-19 pandemic, we will not include a control arm.
Setting:
The project location will be the designated municipalities in Honduras. Activities will be conducted in the existing MOH triage (known by the Spanish acronym for Temporary Triage and Stabilization Centers: "CETTE's") and other health centers. Selection of target centers will be performed in collaboration with the Honduras MOH and based on criteria including current and projected COVID-19 hotspots, mortality data and logistical considerations including access and security.
Project Population:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Duration of hospitalization
Time Frame: 90 days
Duration of hospitalization (days) for those who are admitted
Disposition after referral
Time Frame: 28 days
Disposition (home, admission, other) for those referred to a higher level of care
Duration of ICU and/or ventilator requirement
Time Frame: 90 days
Duration of ICU and/or ventilator requirement (days) for those requiring critical care
Mortality
Time Frame: 90 days
Death prior to discharge from acute COVID-19 monitoring
Secondary Outcomes
No secondary outcomes reported
Investigators
Eric J. Nilles, M.D.,M.S.C.
Assistant Professor
Brigham and Women's Hospital