Evaluation of a multi-country medical oxygen program

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

This study is trying to see how medical oxygen is used in hospitals across nine countries to find ways to make it easier for patients, especially children with low oxygen levels, to get the help they need.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 0 Years to 15 Years
• Sex: All
• Sponsor: Murdoch Childrens Research Institute (other)
• Locations: 3 sites (Phnom Penh and 2 other locations)
• Trial ID: NCT06087315 on ClinicalTrials.gov

What this trial studies

This study aims to assess the use of medical oxygen and pulse oximetry in healthcare facilities across nine countries, focusing on identifying barriers and opportunities to improve oxygen access for patients. It involves a series of mixed-methods assessments to evaluate current practices and institutional readiness for oxygen service delivery, particularly for children suffering from severe hypoxemia. The program seeks to strengthen oxygen systems through tailored interventions that address local challenges in healthcare delivery. By collaborating with Ministries of Health and local institutions, the study aims to enhance the capacity of healthcare workers and improve oxygen service governance.

Who should consider this trial

Good fit: Ideal candidates for this study include children admitted to healthcare facilities in the participating countries who are at risk of hypoxemia or related conditions.

Not a fit: Patients who are not admitted to the participating healthcare facilities or those who do not require oxygen therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve access to life-saving oxygen therapy for vulnerable populations, particularly children with severe respiratory conditions.

How similar studies have performed: Other studies have shown success in improving oxygen access and management in similar low-resource settings, indicating that this approach has potential for positive outcomes.

Eligibility criteria

Sub-study 1:

Research Question: What are the baseline pulse oximetry and oxygen practices for children admitted to participating health facilities, and what is the level of institutional readiness for oxygen service delivery? Which facilities, representative of high- and low-performing facilities and different levels of care and facility types, can be selected for additional investigation to understand current functioning of oxygen systems?

Setting and Population: The broader MOXY program baseline cross-sectional assessments involve 9 countries. We have selected 6 MOXY countries for the mixed methods studies outlined in this protocol - Nigeria, Uganda, Liberia, Rwanda, Cambodia and Lao PDR - based on pre-existing research collaborations, and with the aim of representing broadly different geographical contexts.

Baseline assessments are being conducted in all facilities participating in the MOXY program in each of the 6 study countries. From this data set, we will analyse primary and secondary outcomes for wards caring for children \<15 years (including neonatal wards where relevant).

Analysis/outcomes: Primary - proportion of admitted children (\<15 years, including neonates) screened with pulse oximetry. Secondary - proportion of admitted children with hypoxaemia (\<15 years, including neonates) treated with oxygen. For Real-Moxy the secondary outcome will inform identification of facilities for inclusion.

Sub-study 2:

Research question: Where and how are patients managed from arrival to admission and discharge (or transfer), and how does oxygen equipment move within and between clinical areas? How do process maps vary for different clinical scenarios representing different patient groups: i) pneumonia with and without hypoxaemia; ii) severe, acute illness syndrome with WHO emergency signs (e.g., shock, multi-trauma, seizures); iii) surgical condition and iv) neonatal illness (inborn and outborn)?

Setting and Population: This will be conducted in 10 health facilities in each of the 6 countries (Nigeria, Uganda, Liberia, Rwanda, Lao PDR, Cambodia), selected to represent high and low functioning facility oxygen systems and include secondary and tertiary health facilities from government and non-governmental sectors (identified in sub-study 1). We will focus on admitted children (\<15 years, including neonates) with (i) pneumonia, (ii) other acute illness with WHO emergency signs, (iii) surgical conditions, and (iv) neonatal illness. We have chosen these conditions to represent diagnoses with a high prevalence of hypoxaemia, and to capture the nuances of how pulse oximetry and oxygen practices are adapted (or not adapted) to clinical scenarios (e.g., having a lower threshold to provide oxygen to a patient in shock; or targeting safe oxygen saturations in neonates).

Analysis/outcomes: Facility maps of patient and equipment flow.

Sub-study 3:

Research question: What is the sequence of emergency care for an unwell child in the first 4 hours, and how are decisions made - particularly relating to oxygen (when to start, stop, how much, what delivery modality, etc.)? What are the points of delays to appropriate care (including pulse oximetry and oxygen) and at what points in time and location could pulse oximetry and oxygen be used better for emergency care of children?

Setting and Population: facilities are same as sub-study 2). Children (\<15 years, including neonates) presenting with each of 4 acute illness syndromes: (i) pneumonia, (ii) other acute illness with WHO emergency signs, (iii) surgical conditions, and (iv) neonatal illness.

Analysis/outcomes: Patient journey maps.

Sub-study 4:

Research question: How do healthcare workers use pulse oximetry and oxygen for admitted patients, and how does this change over time and vary between patient groups, facility type, and location? How do practices compare with treatment guidelines and where are the priority areas for improving oxygen care?

Population and setting: Facilities are same as sub-studies 2\&3.

Analysis/outcomes: Narrative descriptions of handover, ward rounds, and nursing rounds, with specific emphasis on how pulse oximetry is used, and decision making for oxygen therapy.

Sub-study 5: Indepth interviews and focus group discussions Research questions: 5a) How do patients/caregivers perceive pulse oximetry and oxygen therapy within their broader care experience? 5b) How do healthcare workers, managers and technicians perceive oxygen therapy and the provision of oxygen-related care within the broader care provision experience?

Population:

* Patients and caregivers enrolled in sub-study 3 (patient journey mapping).
* Healthcare workers (bedside), managers (including clinical and non-clinical managers) and technicians in each health facility. We will select staff with direct responsibility for wards caring for children \<15 years.

Analysis/outcomes: Reflexive thematic analysis of interviews and focus group discussions.

Where this trial is running

Phnom Penh and 2 other locations

• 10 Facilities to Be Selected — Phnom Penh, Cambodia (RECRUITING)
• 10 Facilities to Be Selected — Ibadan, Nigeria (ACTIVE_NOT_RECRUITING)
• 10 Facilities to Be Selected — Kampala, Uganda (ACTIVE_NOT_RECRUITING)

Study contacts

• Principal investigator: Hamish Graham, PhD — Murdoch Childrens Research Institute
• Study coordinator: Rami Subhi, FRACP

Conditions: Hypoxemia, Neonatal Disease, Pneumonia, Sepsis, Morality, Oxygen systems, Pulse oximetry, Low middle income countries