Tiara Calhoun, MD
(She/Her/Hers)
Rank
Fellow or Postdoc
Department
Medicine
Pulmonary and Critical Care
Authors
Tiara Calhoun*, MD, Lauren Onofrey, MD, Valentine Emily Rambula, Felix Limbani, PhD, Mary Adam, MD, PhD, Ndaziona Peter Banda, MBBS, Blaise Gahungu, MD, Dona Fabiola Gashame, MD, Stephen Gordon, MD, Nancy Haff, MD, Wanja Kageche, Nelly Kebeney, Julie Lauffenburger, PhD, Pharm.D, Peter Oduor, MBChB, George Otieno, MBChB, Innocent Sulani, MBBS, Theogene Twagirumugabe, MD, PhD, Doris Uwamahoro, MD, Elisabeth Riviello, MD, Jeanine Condo, MD, PhD
Principal Investigator
Elisabeth Riviello, MD
Twitter / Website
Categories
Building Respiratory support in East Africa Through High flow versus standard flow oxygen Evaluation (BREATHE trial, enrolling) seeks to determine whether protocolized high-flow oxygen will improve outcomes compared to standard flow oxygen in five sub-Saharan African hospitals (NCT05754034). The concurrent process evaluation described here aims to inform clinical trial effectiveness results by helping explain why interventions were or were not effective and assessing applicability to other clinical contexts.
Qualitative data are collected from regular trial team meetings and targeted interviews with hospital clinical staff and patients/caregivers. Insights are coded into barriers and facilitators using Consolidated Framework for Implementation Research (CFIR) constructs. Quantitative data are extracted from a pre-implementation assessment of hospital resources, (Before BREATHE study, data collection completed), trial records of protocol adherence and adverse events, and data quality monitoring reports. Data will be integrated, compared within and across sites, and assessed using Proctor’s Implementation Outcomes Framework.
This process evaluation explores adherence to study protocols and the experiences of study staff, clinical staff, and patients/caregivers involved in BREATHE in order to contextualize trial effectiveness results. It will help us understand factors that can influence implementation of clinical trials, oxygen protocols, and high flow oxygen, especially in resource-limited settings.