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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06087315




Registration number
NCT06087315
Ethics application status
Date submitted
12/10/2023
Date registered
17/10/2023
Date last updated
30/10/2023

Titles & IDs
Public title
Evaluation of a Multi-country Medical Oxygen Program
Scientific title
Realist Evaluation and Learning in a Multi-country Medical OXYgen Program (REAL-MOXY)
Secondary ID [1] 0 0
HREC97817
Universal Trial Number (UTN)
Trial acronym
REAL-MOXY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoxemia 0 0
Neonatal Disease 0 0
Pneumonia 0 0
Sepsis 0 0
Morality 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Multi-faceted oxygen systems strengthening interventions (different for each country)

Other interventions: Multi-faceted oxygen systems strengthening interventions (different for each country)
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mixed methods
Timepoint [1] 0 0
5 years

Eligibility
Key inclusion 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.
Minimum age
0 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Cambodia
State/province [1] 0 0
Phnom Penh
Country [2] 0 0
Lao People's Democratic Republic
State/province [2] 0 0
Vientiane
Country [3] 0 0
Liberia
State/province [3] 0 0
Monrovia
Country [4] 0 0
Nigeria
State/province [4] 0 0
Ibadan
Country [5] 0 0
Rwanda
State/province [5] 0 0
Kigali
Country [6] 0 0
Uganda
State/province [6] 0 0
Kampala

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Makerere University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Health Sciences Lao PDR
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Health Sciences, Cambodia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Clinton Health Access Initiative, Nigeria
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Clinical and Public Health Services at Ministry of Health Rwanda
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Ibadan
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06087315
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Hamish Graham, PhD
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rami Subhi, FRACP
Address 0 0
Country 0 0
Phone 0 0
+61403151186
Fax 0 0
Email 0 0
rami.subhi@mcri.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06087315