None listed
Conditions
Brief summary
AIM: To evaluate the effectiveness and implementation issues involved in the scale-up of oxygen delivery systems to 12 Nigerian hospitals.. BACKGROUND: Oxygen is a life-saving essential medicine that is important for the treatment of respiratory failure in pneumonia, neonatal conditions, and other childhood illnesses. In pneumonia (the largest cause of child deaths globally), hypoxaemia is the biggest risk factor for death in, and occurs in at least 13% of children presenting to hospitals with pneumonia. Better oxygen systems, which includes oxygen therapy using concentrators and pulse oximetry, have been shown to reduce mortality from pneumonia by up to 35% in provincial hospitals. However, significant challenges exist in establishing oxygen systems in small hospitals/health centres – especially in rural areas with unreliable electricity supply and human resource constraints. OBJECTIVES: The project will evaluate implementation issues at a ‘district hospital’ level (i.e. the smallest health facilities that admit children). The issues include technical questions (e.g. power supply, engineering support etc.), clinical questions (e.g. training issues, integration in clinical care, role of nurses/community health workers etc.), and management questions (e.g. program costs, engineering capacity etc.). These issues have not been addressed in a systematic way in developing countries and are impediments to improving children’s access to better care for severe pneumonia. METHODS: This is a health systems and quality improvement project with mixed-methods. Stepped-wedge Cluster Randomised Trial (SWCRT) design and analysis will assess clinical outcomes, quality of care measures, and health system processes and outcomes. Qualitative data will evaluate the impact on clinical care, management, and human resources. PARTICIPANTS: 12 ‘district’ hospitals in south-west Nigeria. Selected on the basis of (i) need for oxygen, and (ii) local and national priorities. TIME FRAME: Three years, including: Needs analysis and participatory planning; Preparatory activities; Oxygen system implementation; Evaluation and dissemination of results. EXPECTED OUTCOMES: This study will have direct benefits in reducing mortality and improving quality of care in implementation health centres as well as broader health system benefits in Nigeria. Learning gained will be of benefit for these countries and other low-resource countries that are seeking to find low-cost solutions to reducing mortality from severe pneumonia and other causes of hypoxaemia.
Interventions
Intervention: Comprehensive oxygen therapy system
We will implement a comprehensive oxygen therapy system in 12 secondary health facilities in south-west Nigeria. This system will include:
- oxygen equipment: oxygen concentrators, pulse oximetry, and oxygen delivery devices. Equipment will be installed using a participatory approach, involving local technicians and management in the procurement, delivery, installation and commissioning. Equipment will be selected and planned with input from an e
Intervention: Comprehensive oxygen therapy system We will implement a comprehensive oxygen therapy system in 12 secondary health facilities in south-west Nigeria. This system will include: - oxygen equipment: oxygen concentrators, pulse oximetry, and oxygen delivery devices. Equipment will be installed using a participatory approach, involving local technicians and management in the procurement, delivery, installation and commissioning. Equipment will be selected and planned with input from an expert biomedical engineer with extensive experience with oxygen systems. - education: practical training for nursing and medical staff on hypoxaemia and the clinical use of oxygen. Training will be delivered using an 'apprentice' model, training trainers on-site and then supervising them to train their colleagues (based on the WHO oxygen guidelines and the WHO Pocketbook of Hospital Care for Children). Training will be developed by paediatricians and educators with experience in oxygen therapy, and delivered by trained clinical educators. Comprehensive half-day training will be led by the coordination team at the start of implementation at each hospital (in conjunction with equipment installation and commissioning) - and will be repeated approximately 2-3 times to capture all relevant staff (depending on the size of the hospital). All training information will be provided to the hospitals to conduct future training as new staff enter the hospital, rotate around wards, or otherwise as needed. - improved power supply: solar power systems and/or dedicated generators with UPS/battery back-up. This will be provided by an experience solar power company. - supportive supervision and feedback: we use an quality improvement approach to involve local stakeholders in the planning, implementation and evaluation of the project. This will involve study nurses working closely with each hospital, and regular visits by the project team (approximately 3 monthly). Study nurses primary role is to coordinate local data collection, but they are also available as a first port of call for practical assistance in using the oxygen equipment correctly, and communicating practical challenges with the use of oxygen to be addressed by the project coordination team. - maintenance and repair process: training for hospital and central technicians on preventive maintenance and repair of oxygen concentrators and other equipment (a single 3-day training for the central engineers and one engineer from each hospital); log-books and repair manuals for documenting maintenance; spare part supply; regular maintenance visits (3 monthly). Training will be developed by a biomedical engineer with expertise in oxygen, with input from clinicians, and delivered by trained engineers and clinicians. In keeping with a quality improvement approach, particular aspects of this intervention may be individualised within each hospital to optimise fidelity of implementation. We will collect data on implementation processes, and be able to report on the fidelity of implementation within different hospitals. The intervention will be stepped out to hospitals over a 12 month period, with a 4 month baseline period (no intervention in all hospitals) and a final 8 month period after all hospitals have received the intervention.
Sponsors
Centre for International Child Health, University of Melbourne and Murdoch Children's Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 15 Years
Healthy volunteers
No
Inclusion criteria
We will select hospitals based on the following criteria: 1. Challenging implementation environment. Implementation previously has generally been conducted in sites that are most conducive to the intervention. To advance the science, we seek to understand implementation constraints in the challenging environments, such as small health facilities with difficult access. 2. High burden of pneumonia and high mortality. This intervention should target the areas currently facing the most significant burden of disease. This is important for maximising impact, enabling measurement of effect, and to address the biggest needs of participating communities. 3. Fit with state/national health priorities. This should be done in real-life settings, and be compatible with the priorities set out by state and national administrative bodies. This is important for ongoing sustainability, maximising whole-of-system impact, and in answering the most relevant questions for decision-makers. We will collect data on all children and neonates admitted to these hospitals.
Exclusion criteria
No exclusion criteria, as there is no specific recruitment to the study. It is an implementation effectiveness evaluation based on normal health facility functioning.
Outcome results
None listed