Understanding the Impact of a Randomized Controlled Trial of High Flow Oxygen on Clinical Care in Five Hospitals in Sub-saharan Africa

Abstract Rationale: We explored the impact of a multicenter, randomized controlled trial (RCT) on clinical care in five hospitals in Sub-Saharan Africa from the perspective of study staff and hospital clinicians. Describing these impacts will facilitate improved research design and increased equity in clinical research. Methods: We conducted a qualitative analysis of the Building Respiratory Support in East Africa Through High-Flow versus Standard Flow Oxygen Evaluation (BREATHE) trial, an RCT comparing high-flow oxygen with usual care across four public and one faith-based hospital in Kenya, Malawi, and Rwanda (ClinicalTrials.gov, NCT05754034). Guided by the Consolidated Framework for Implementation Research (CFIR), we performed a rapid inductive analysis of 50 staff meetings and 9 clinician interviews to identify trial-related facilitators of and barriers to quality care. Results: We identified several facilitators of improved clinical practice from the perspective of trial staff and clinicians. Patients in both arms received increased monitoring, diagnostics (lung ultrasound), and emotional support from study staff, a significant benefit in settings with low clinician-to-patient ratios. Trial-related monitoring helped identify existing clinical gaps. Leadership at some sites were eager to incorporate aspects of trial protocols, such as oxygen titration guidelines, into hospital-wide practice. Trial staff conducted educational sessions for clinical staff, which were well-attended and appreciated. Many felt the trial fostered a culture of academic inquiry and cross-site networking for future clinical trials, for which planning is already underway. One clinician suggested further locally-driven research “would be very good because we can use the effective data which is local..the real population and the real conditions.” Negative impacts (barriers) were also identified. Early in enrollment, adapting to trial activities was burdensome for busy clinicians. Patients were worried about randomization and parallel care pathways. Later, clinicians expressed concern about a vacuum of knowledge and resources that may occur when the trial concludes-"If they left them [HFO devices] without training they cannot benefit us.” These are preliminary results pending further interviews with clinical staff, patients, and caregivers. Conclusion: CFIR-guided analysis of a multicenter RCT in sub-Saharan Africa uncovered impacts of RCT implementation at participating hospitals including increased monitoring and support for patients, identification of care gaps, education for clinical staff, and fostering a culture of inquiry, but also extra clinician burden, patient concerns around randomization, and worries about reduced resources after trial completion. Future researchers should consider these factors during study design and implementation to account for the impact of research on clinical practice.