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Trial registered on ANZCTR

Registration number

ACTRN12617000341325

Ethics application status

Approved

Date submitted

1/03/2017

Date registered

6/03/2017

Date last updated

6/03/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Improving oxygen therapy for children in 12 Nigerian hospitals: a stepped-wedge cluster randomised field trial

Scientific title

Evaluating the effectiveness of an improved oxygen system using pulse-oximetry and supplemental oxygen for the treatment of infants and children: a large-scale multi-center stepped-wedge cluster randomised implementation trial in 12 Nigerian hospitals

Secondary ID [1]

None

Universal Trial Number (UTN)

1111-1193-6364

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

quality of care

hypoxaemia

pneumonia

neonatal conditions

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Respiratory

Other respiratory disorders / diseases

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Other

Comparator / control treatment

We use a stepped-wedge cluster randomised design, with randomisation at the hospital level. Thus, all hospitals will start as controls, then proceed into intervention at defined time points.

In the control situation, all hospitals will be provided with pulse oximeters and basic training to encourage their use on all children and neonates admitted to hospital. This is important for obtaining accurate pre-intervention assessment of hypoxaemia prevalence. The basic pulse oximetry training will be developed by a paediatrician educator and delivered by trained clinicians. It will consist of a 1 hour practical session on the importance of detecting hypoxaemia, and the use of pulse oximetry. It will be delivered as a single session to a convenience sample of paediatric doctors and nurses available on the day, and senior staff are encouraged to share the training with their colleagues. Study nurses will be available as a first port of call for practical assistance in using the pulse oximeters correctly, and communicating practical challenges with pulse oximetry to be addressed by the project coordination team.

All hospitals will start as 'control' 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.

Control group

Active

Outcomes

Primary outcome [1]

Neonatal case fatality rate, assessed from data systematically extracted from routine clinical records

Timepoint [1]

2 years, according to stepped wedge design:
- Clinical data extracted from routine clinical records, for 2 years retrospectively, then for 2 years throughout the period of the main study (4 months all hospitals control, 12 month stepped period, 8 month all hospitals intervention).

Primary outcome [2]

Pneumonia case fatality rate, assessed from data systematically extracted from routine clinical records

Timepoint [2]

Primary outcome [3]

Evaluation of implementation success, including comparison between different hospitals. This will involve mixed-methods evaluation using data systematically extracted from routine clinical records, data from maintenance and equipment use logs, interviews with project personnel and hospital staff, and records of costs. Important implementation questions include:
- how to implement pulse oximetry and oxygen therapy in hospitals
- how to achieve sustainable maintenance and repair in hot, humid, dusty environments
- how to achieve adequate power supply for equipment in difficult environments
- how to scale up oxygen at a state and regional scale

Timepoint [3]

We will collect quantitative and qualitative data from site visits, formal data collection, and interviews at various time points:
- Clinical data extracted from routine clinical records, for 2 years retrospectively, then for 2 years throughout the period of the main study (4 months all hospitals control, 12 month stepped period, 8 month all hospitals intervention).
- Equipment evaluation at baseline, and every 3 months for the duration of the intervention period. Log books completed on a weekly basis by hospital staff.
- Interviews conducted with staff at mid-point and end of intervention period.
- Knowledge and skill tests conducted on those who participate in training (before and immediately after training), developed for study.
- Facility and equipment assessment, conducted at baseline and end of study period.
- Continuous program monitoring and feedback from study nurses in hospitals.

Secondary outcome [1]

Malaria case fatality rate, assessed from data systematically extracted from routine clinical records

Timepoint [1]

Secondary outcome [2]

Preterm neonatal case fatality rate, assessed from data systematically extracted from routine clinical records

Timepoint [2]

Secondary outcome [3]

Quality of care measures (clinical care practices for hypoxaemia, pneumonia, malaria, prematurity), using composite measures derived from the WHO Pocketbook of Hospital Care for Children guidelines. The focus here is on the quality of care 'processes' (rather than the 'structural' and 'impact' aspects of quality of care).

Timepoint [3]

2 years, according to stepped wedge design:
- Clinical practice data extracted from routine clinical records, for 2 years retrospectively, then for 2 years throughout the period of the main study (4 months all hospitals control, 12 month stepped period, 8 month all hospitals intervention). Quality of care measures are derived from a composite of the data on actual clinical practice, and will be analysed using appropriate stepped-wedge cluster randomised trial approaches to determine intervention effect and describe trends in various quality of care components pre-intervention and post-intervention. These quality of care 'processes' outcomes will be reported with reference to the broader 'structural' and 'impact' aspects of quality of care - but the focus is on the actual quality of care practices.

Eligibility

Key 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.

Minimum age

No limit

Maximum age

15 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is done by central randomisation (by computer) at the hospital level (there is no individual allocation), after determination of all hospital eligibility.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

We have chosen a stepped-wedge cluster randomised trial (SWCRT) design, using methodology described by Hemming et al. (2015). This enables a pragmatic approach to implementation (not requiring all 12 hospitals to be set up simultaneously) and enables hospitals to act both as their own control and as a control to other hospitals.

Our SWCRT design involves:
- all 12 hospitals receiving the intervention at different time points, according to randomisation at the hospital level
- we are using 4 clusters of 3 hospitals (stratified to include 1 large and 2 small hospitals in each cluster), with steps at 4 month intervals

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

We will follow the widely accepted Hussey and Hughes methodology for statistical analysis of SWCRT designs using cross-sectional data(Hussey & Hughes, 2007). This involves analysis of variation within- and between-clusters, and methods of analysis that account both for this variation and for the effects of time – specifically generalised linear mixed model (GLMM) or generalised estimating equations (GEE)(Hemming et al., 2015; Hussey & Hughes, 2007).

There are two unique considerations for SWCRT designs compared to traditional parallel RCTs. Firstly, we need to allow for the confounding effect of time (which typically increases the sample size needed to achieve adequate power). Secondly, each cluster effectively acts as its own control by contributing both exposed and unexposed observations (typically enhancing the precision) .

Characteristics of the individuals and clusters will be summarised by exposure status, to illustrate potential imbalance between exposed and unexposed and allow for discussion of potential biases. Number of observations within each cluster will be expressed by overlaying the summary numbers onto a Step-Wedge diagram. Summary data will include the numbers analysed, the average cluster size, cluster characteristics, and important patient characteristics.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

4/04/2016

Date of last participant enrolment

Anticipated

30/11/2017

Actual

Date of last data collection

Anticipated

30/11/2017

Actual

Sample size

Target

20000

Accrual to date

Final

Recruitment outside Australia

Country [1]

Nigeria

State/province [1]

Oyo, Ondo, Osun, Ogun

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Bill and Melinda Gates Foundation (BMGF)

Address [1]

500 Fifth Avenue North Seattle, WA 98109

Country [1]

United States of America

Primary sponsor type

University

Name

Centre for International Child Health, University of Melbourne and Murdoch Children's Research Institute

Address

Centre for International Child Health
University of Melbourne, Department of Paediatrics, MCRI
50 Flemington Road
Parkville, 3052
Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

University College Hospital Ibadan

Address [1]

University College Hospital Ibadan
Queen Elizabeth Road
Ibadan
Oyo state

Country [1]

Nigeria

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne, Human Research Ethics Committee

Ethics committee address [1]

	Parkville, Victoria, 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/10/2015

Approval date [1]

26/02/2016

Ethics approval number [1]

1543797.1

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/372463-ETHICS_standardproject_02022015.doc

Contacts

Principal investigator

Name

Prof Trevor Duke

Address

Centre for International Child Health
University of Melbourne Department of Paediatrics
50 Flemington Road, Parkville, VIC 3052

Country

Australia

Phone

+61 3 9345 5968

Fax

trevor.duke@rch.org.au

Contact person for public queries

Name

Hamish Graham

Address

Centre for International Child Health
University of Melbourne Department of Paediatrics
50 Flemington Road, Parkville, VIC 3052

Country

Australia

Phone

+61 3 9345 6262

Fax

hamish.graham@rch.org.au

Contact person for scientific queries

Name

Hamish Graham

Address

Centre for International Child Health
University of Melbourne Department of Paediatrics
50 Flemington Road, Parkville, VIC 3052

Country

Australia

Phone

+61 3 9345 6262

Fax

hamish.graham@rch.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		2019	372463-(Uploaded-10-02-2020-11-13-07)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Improving oxygen therapy for children and neonates in secondary hospitals in Nigeria: Study protocol for a stepped-wedge cluster randomised trial.	2017	https://dx.doi.org/10.1186/s13063-017-2241-8
Embase	Oxygen systems to improve clinical care and outcomes for children and neonates: A stepped-wedge cluster-randomised trial in Nigeria.	2019	https://dx.doi.org/10.1371/journal.pmed.1002951
Embase	Oxygen systems and quality of care for children with pneumonia, malaria and diarrhoea: Analysis of a stepped-wedge trial in Nigeria.	2021	https://dx.doi.org/10.1371/journal.pone.0254229

N.B. These documents automatically identified may not have been verified by the study sponsor.

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