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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06169514
Other study ID # HREC 100143
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2024
Est. completion date December 2027

Study information

Verified date February 2024
Source Murdoch Childrens Research Institute
Contact Rami Subhi, MBBS, FRACS, MD (Res)
Phone +61403151186
Email rami.subhi@mcri.edu.au
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a mixed-methods program evaluation from a health systems and policy perspective, involving (i) stakeholder analysis, (ii) policy-implementation gap analysis, and (iii) comparative country case studies. This study aims to understand how national oxygen strategies achieve impact at national, and subnational level, across country contexts, at what cost. The the investigators seek to: 1. Involve policymakers, implementers (including private sector), and medical oxygen users in identifying challenges and understanding potential solutions to medical oxygen access; 2. Generate new data on how medical oxygen systems work and can be improved from multiple perspectives; 3. Draw lessons on medical oxygen that can directly inform national and global practice and policy. This study will be conducted in 6 of the 9 countries participating in the Clinton Health Access Initiative (CHAI) led Medical Oxygen Implementation (MOXY) program (Uganda, Nigeria, Rwanda, Liberia, Lao PDR, Cambodia). Key informants will be selected representing government, non-governmental agencies, professional associations, private sector, and civil society. This study will be completed over 4 years, with timelines varying between country study sites.


Description:

The investigators will use a concurrent mixed-methods design, with an overarching comparative case study methodology. The investigators will adopt an iterative approach, using co-design to adapt the study methodology to the specific context of each country and annual learning team meetings with stakeholders to refine the final case study topics (sub-study 3) and methodology. Three embedded sub-studies are planned: Sub-study 1 (Stakeholder Analysis) aims to understand the policy environment for medical oxygen services across different country contexts. This will be informed by the MOXY baseline survey, which includes data on oxygen-related facility readiness and clinical practices across the MOXY program areas. Data sources will include stakeholder interviews with participants from different levels (national, provincial, local) and policy perspectives (government, implementing/advising partners, practitioners, beneficiaries). Results will inform sub-study 2 and MOXY program implementation. Sub-study 2 (Policy-Implementation Gap Analysis) aims to critically analyse the gap between policy intentions and actual implementation. This will be informed by the baseline facility readiness and clinical practice data. Data sources will include a desk review of oxygen-related policies, stakeholder in-depth interviews, and program administrative data. Results will inform implementation of country oxygen strategies and feed into prioritization of focus areas for sub-study 3. Sub-study 3 (Comparative Country Case Studies) aims to compare oxygen programs across countries, focusing on particular challenges or unique solutions identified in sub-study 1 and 2. Data sources will include repeated desk review of oxygen-related policies and program administrative data, follow-up stakeholder interviews, and triangulation with quantitative survey results on facility readiness and clinical practices. This research will also draw on national stakeholder dialogues - both to review, refine, and validate preliminary findings of the study team and to draw out feasible solutions/alternatives for both policy and practice and oxygen eco-system. In year 1 the investigators will generate key evidence about how the current strategies and polices are being translated into action, identifying key opportunities for implementing partners to focus support. Over years 2 and 3, the investigators will learn how these activities have affected medical oxygen service coverage, drawing lessons across country contexts and across different implementation approaches.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Key informants will be selected representing government, non-governmental agencies, professional associations, private sector, and civil society.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
Cambodia Cambodia Phnom Penh
Lao People's Democratic Republic Lao PDR Vientiane
Liberia Liberia Monrovia
Nigeria Nigeria Ibadan
Rwanda Rwanda Kigali
Uganda Uganda Kampala

Sponsors (8)

Lead Sponsor Collaborator
Murdoch Childrens Research Institute Karolinska Institutet, Makerere University, Ministry of Health, Liberia, Ministry of Health, Rwanda, University of Health Sciences, Cambodia, University of Health Sciences, Lao People's Democratic Republic (PDR), University of Ibadan

Countries where clinical trial is conducted

Cambodia,  Lao People's Democratic Republic,  Liberia,  Nigeria,  Rwanda,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary In-depth stakeholder interviews on national medical oxygen strategies In depth stakeholder interviews covering perspectives on policies, oversight, implementation, and related support towards the particular domain (e.g. measurement and indicators, health workforce capacity building, etc.) 4 years
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