Evaluation of a Multi-country Medical Oxygen Program — REAL-MOXY  

Sepsis Clinical Trial

Official title: Realist Evaluation and Learning in a Multi-country Medical OXYgen Program (REAL-MOXY)

Status Recruiting

Clinical Trial Summary

REAL-MOXY is a set of 5 mixed methods studies designed to understand how oxygen and pulse oximetry are used (or not used) at a facility level, to identify opportunities and barriers for strengthening oxygen systems for beneficiaries, users and managers.

Clinical Trial Description

Medical oxygen is an essential medicine. Hypoxaemia is deadly, and increases the risk of death by 5-8 fold, requiring prompt recognition and oxygen therapy. Oxygen services are currently inequitable within and between countries, and this has been exacerbated by the COVID19 pandemic. Children are especially vulnerable: in many contexts, fewer than 20% of children admitted to district hospitals with severe hypoxaemia receive oxygen. There are many barriers, at all levels, to ensuring that people who need oxygen will receive it- from delayed care-seeking and referral barriers to facility under-preparedness and over-burdened healthcare workers, to deficiencies in maintenance services, and community misconceptions and fears. Reliable access in rural and remote facilities poses even more challenges.

The Clinton Health Access Initiatives (CHAI), on the back of pre-existing close collaborations with Ministries of Health (MoH) has supported countries in tackling the oxygen access crises of the pandemic. Emerging from this, CHAI and MoH in 9 countries have amalgamated these efforts into a program targeted at improved access to oxygen in each country (the 'MOXY' program). The specific approaches are different in each country but broadly include efforts to: (1) strengthening policies, strategies, and governance of medical oxygen production, distribution, maintenance, and use; (2) building capacity of healthcare workers and technicians to use and maintain oxygen well, and (3) strengthening oxygen-related data acquisition and use for forecasting, budgeting, and monitoring.

MOXY provides the first opportunity to learn from interventions specifically directed at addressing the oxygen problem at large scale, and across different settings (between and within countries). REAL-MOXY is a series of embedded mixed methods studies that aim to better understand the contexts into which oxygen interventions are being introduced; identify and interrogate mechanisms of how these systems work (or not work) to improve health outcomes, and their interaction with different contexts; and synthesise these findings to test and develop theories that can guide policy makers and clinicians in delivering more effective approaches to improve oxygen access.

We will adopt a mixed methods design, with an iterative approach, and co-design to adapt the study methodology to the specific context of each country and facility. We have planned for 5 embedded sub-studies:

The findings of sub-study 1 identifies the facilities that will contribute data (i.e., sequential); and then data collection and integration is concurrent in sub-studies 2-5.

Sub-study 1 aims to identify facilities with high and low functioning oxygen systems, based on current pulse oximetry and oxygen-related clinical practices and facility oxygen readiness. We will use the results of a cross-sectional study already being conducted involving all health facilities in the MOXY catchment areas (part of the MOXY baseline assessment for which ethical approval is already in place). Results will inform facility selection for the subsequent mixed-methods studies.

Sub-study 2 aims to map care pathways (as they are intended) for children (<15 years) with 4 hypothetical clinical scenarios in each participating facility. Data sources include direct observation of patient and equipment flow, and discussions with senior clinicians and managers. Maps to study questions i, ii, and iv.

Sub-study 3 aims to follow patient journeys from arrival through the first 4 hours of care, to understand the sequence of care for acutely unwell children, including how pulse oximetry and oxygen are integrated with other aspects of emergency care. Data sources include direct observation of patients and health workers, patient/caregiver interviews and medical documentation. This sub-study is based in the initial assessment areas of facilities (e.g., emergency or outpatient units). Maps to study questions i, ii, and iv.

Sub-study 4 aims to understand how pulse oximetry and oxygen are used by nurses and medical officers, why, and how this impacts on patient care. Data sources include direct observation of nursing practice, ward rounds, and medical documentation. This sub-study is based in an inpatient unit caring for children. Maps to study questions i, ii and iii.

Sub-study 5 aims to understand the perspectives of a) patients/caregivers, b) healthcare workers, managers and biomedical engineers/technicians. Data sources include focus group discussions and in-depth interviews. Maps to study questions i, ii, iii and iv. ;

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia
• Infant, Newborn, Diseases
• Morality
• Neonatal Disease
• Pneumonia
• Sepsis

• NCT number: NCT06087315
• Study type: Observational
• Source: Murdoch Childrens Research Institute
• Contact: Rami Subhi, FRACP
• Phone: +61403151186
• Email: rami.subhi@mcri.edu.au
• Status: Recruiting
• Start date: November 27, 2023
• Completion date: December 2027