Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06087315 |
Other study ID # |
HREC97817 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 27, 2023 |
Est. completion date |
December 2027 |
Study information
Verified date |
May 2024 |
Source |
Murdoch Childrens Research Institute |
Contact |
Rami Subhi, FRACP |
Phone |
+61403151186 |
Email |
rami.subhi[@]mcri.edu.au |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
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.
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.