Assessing the Feasibility and Effectiveness of Introducing Pulse Oximetry in IMCI Services
NCT ID: NCT03750747
Last Updated: 2022-03-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
612 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-12-01
Study Completion Date
2022-12-31
Brief Summary
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The purpose of the study is to assess the feasibility, acceptability and operational challenges of introducing Pulse Oximeter (PO) in IMCI services to manage acute respiratory infections at first-level primary care facilities in Bangladesh (phase 1). The investigators will also evaluate the effectiveness and cost-effectiveness of introducing PO in IMCI services at first level primary care health facilities (phase 2).
This study will employ a cluster randomized controlled trial design to evaluate the effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility assessment (phase-1 objective) will be nested within the larger effectiveness trail as internal piloting; which will help in generating evidence for designing a robust phase-2 trial. First-level primary healthcare facilities providing IMCI services will be regarded as clusters and the unit of randomization. Sixteen first level primary care health facilities (UH\&FWC) will be randomly assigned to comparison and intervention facilities.
This study will employ a cluster randomized controlled trial design to evaluate the effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility assessment (phase-1 objective) will be nested within the larger effectiveness trail as internal piloting; which will help in generating evidence for designing a robust phase-2 trial. First-level primary healthcare facilities providing IMCI services will be regarded as clusters and the unit of randomization. Sixteen first level primary care health facilities (UH\&FWC) will be randomly assigned to comparison and intervention facilities.
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Detailed Description
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Background:
1. Burden: Pneumonia is the leading cause of childhood mortality which accounts for 16% of all under-5 deaths in Bangladesh and globally. Most of these deaths happen in the developing countries, where WHO recommends adopting Integrated Management of Childhood Illness (IMCI) as a strategy for outpatient management of common childhood illnesses, including pneumonia, in these poor resource settings.
2. Knowledge gap: As per the IMCI guidelines, 'Pneumonia' can be treated through home-based management with oral antibiotics, whereas 'Severe Pneumonia' should be referred to high-level facilities for inpatient care. Previously, chest indrawing was considered as one of the signs of 'Severe Pneumonia.' In 2014, WHO revised the IMCI guidelines recommending chest indrawing as a sign of 'Pneumonia' instead of 'Severe Pneumonia.' A systematic review of the home-based management of chest indrawing 'Pneumonia' reported a treatment failure rate of 8.5% on day 6. This implies that some of the chest indrawing 'Pneumonia' cases will require special inpatient care in addition to oral antibiotics and home-based management as currently recommended by WHO.
3. Relevance: Hypoxemia (SpO2\<90%) is one of the strongest predictors of mortality due to pneumonia. Many of the chest indrawing 'Pneumonia' cases may have hypoxemia and need specialized inpatient care. In response to this, WHO recommended measuring SpO2 level with pulse oximetry (PO) as a part of IMCI services. As per the updated IMCI guidelines, any sick child (2-59 months) having SpO2 \<90% should be referred for inpatient management, irrespective of its clinical classification. However, most of the primary care facilities are devoid of PO; and there is a paucity of evidence related to the feasibility and effectiveness of introducing of PO in primary care facilities.
Objectives:
* Phase-1: To assess the feasibility, acceptability and operational challenges of introducing PO in IMCI services at first-level primary care health facilities in Bangladesh
* Phase-2: To evaluate the effectiveness and cost-effectiveness of introducing PO in IMCI services at first level primary care health facilities in Bangladesh
Methods:
This study will employ a cluster randomized controlled trial design to evaluate the effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility assessment (phase-1 objective) will be nested within the larger effectiveness trail as an internal piloting; which will help in generating evidence for designing a robust phase-2 trial. First-level primary healthcare facilities providing IMCI services will be regarded as clusters and the unit of randomization. Twenty-four first level primary care health facilities will be randomly assigned to comparison and intervention facilities.
In phase-1, the feasibility, acceptability and operational challenges of introducing PO in IMCI services will be assessed in the intervention facilities. Structured observation of the use of PO in IMCI services and community case tracking will be conducted to address the phase-1 objective. Rigorous process documentation and qualitative method of data collection will be employed to document the process of implementation and assess implementation outcomes.
In phase-2, effectiveness will be assessed through community case tracking in both comparison and intervention facilities. Treatment failure rate will be the primary outcome and the analysis will consider 'intention to treat' approach. In addition, activity-based costing method will be adopted for collecting cost-related data.
Outcome measures/variables:
This study will assess the effectiveness of integrating PO in IMCI services in first-level health facilities in Bangladesh. PO will be able to identify children who are classified as 'Pneumonia' based on history and clinical signs but have hypoxaemia. It will facilitate referral of children with hypoxaemia to higher level facilities.
1. Burden: Pneumonia is the leading cause of childhood mortality which accounts for 16% of all under-5 deaths in Bangladesh and globally. Most of these deaths happen in the developing countries, where WHO recommends adopting Integrated Management of Childhood Illness (IMCI) as a strategy for outpatient management of common childhood illnesses, including pneumonia, in these poor resource settings.
2. Knowledge gap: As per the IMCI guidelines, 'Pneumonia' can be treated through home-based management with oral antibiotics, whereas 'Severe Pneumonia' should be referred to high-level facilities for inpatient care. Previously, chest indrawing was considered as one of the signs of 'Severe Pneumonia.' In 2014, WHO revised the IMCI guidelines recommending chest indrawing as a sign of 'Pneumonia' instead of 'Severe Pneumonia.' A systematic review of the home-based management of chest indrawing 'Pneumonia' reported a treatment failure rate of 8.5% on day 6. This implies that some of the chest indrawing 'Pneumonia' cases will require special inpatient care in addition to oral antibiotics and home-based management as currently recommended by WHO.
3. Relevance: Hypoxemia (SpO2\<90%) is one of the strongest predictors of mortality due to pneumonia. Many of the chest indrawing 'Pneumonia' cases may have hypoxemia and need specialized inpatient care. In response to this, WHO recommended measuring SpO2 level with pulse oximetry (PO) as a part of IMCI services. As per the updated IMCI guidelines, any sick child (2-59 months) having SpO2 \<90% should be referred for inpatient management, irrespective of its clinical classification. However, most of the primary care facilities are devoid of PO; and there is a paucity of evidence related to the feasibility and effectiveness of introducing of PO in primary care facilities.
Objectives:
* Phase-1: To assess the feasibility, acceptability and operational challenges of introducing PO in IMCI services at first-level primary care health facilities in Bangladesh
* Phase-2: To evaluate the effectiveness and cost-effectiveness of introducing PO in IMCI services at first level primary care health facilities in Bangladesh
Methods:
This study will employ a cluster randomized controlled trial design to evaluate the effectiveness of introducing PO in IMCI services (phase-2 objective). The feasibility assessment (phase-1 objective) will be nested within the larger effectiveness trail as an internal piloting; which will help in generating evidence for designing a robust phase-2 trial. First-level primary healthcare facilities providing IMCI services will be regarded as clusters and the unit of randomization. Twenty-four first level primary care health facilities will be randomly assigned to comparison and intervention facilities.
In phase-1, the feasibility, acceptability and operational challenges of introducing PO in IMCI services will be assessed in the intervention facilities. Structured observation of the use of PO in IMCI services and community case tracking will be conducted to address the phase-1 objective. Rigorous process documentation and qualitative method of data collection will be employed to document the process of implementation and assess implementation outcomes.
In phase-2, effectiveness will be assessed through community case tracking in both comparison and intervention facilities. Treatment failure rate will be the primary outcome and the analysis will consider 'intention to treat' approach. In addition, activity-based costing method will be adopted for collecting cost-related data.
Outcome measures/variables:
This study will assess the effectiveness of integrating PO in IMCI services in first-level health facilities in Bangladesh. PO will be able to identify children who are classified as 'Pneumonia' based on history and clinical signs but have hypoxaemia. It will facilitate referral of children with hypoxaemia to higher level facilities.
Conditions
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Childhood Pneumonia
Hypoxemia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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Intervention (Pulse Oximeter)
The intervention facilities will provide IMCI services with PO in addition to following existing IMCI guidelines. The IMCI service providers will classify and treat children presenting with cough and difficult breathing based on history and clinical signs. In addition, they will use PO to measure the SpO2 status of the sick children. Children clinically classified as 'Pneumonia' but having SpO2\<90% will be referred to higher-level facilities for in-patient management. Only the children clinically classified 'Pneumonia' and having SpO2\>90% will be treated through home-based management with oral antibiotics (amoxicillin, twice daily for five day).
Group Type
EXPERIMENTAL
Pulse Oximeter
Intervention Type
DEVICE
SpO2 will be measured using a handheld PO device (selected for this study) applying the low noise cabled sensor. For patients weighing \<10 kg, the sensor will be placed on the big toe. For patients weighing \>10 kg, the sensor will be placed on an index finger. In case of failure in the first attempt, the alternate toe or index finger will be tried (second attempt). First, the sensor will be placed on toe or index finger and then the PO will be powered-on. A stable Sp02 reading will be considered to be obtained if SpO2 reading is stable by ±1 % for at least 10 seconds and the device signal strength is displayed to be adequate (green signal). Second attempt will be warranted if a stable reading is not obtaining within 1-2 minutes.
Comparison
The comparison facilities will continue providing routine IMCI services as per the existing guidelines. In routine IMCI services, IMCI service providers classify and treat children presenting with cough and difficult breathing based on history and clinical signs only. In routine IMCI services in Bangladesh, PO has not been introduced. Therefore, in the comparison facilities all children clinically classified as 'Pneumonia' will be treated through home-based management with oral antibiotics (amoxicillin, twice daily for five day)
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Pulse Oximeter
SpO2 will be measured using a handheld PO device (selected for this study) applying the low noise cabled sensor. For patients weighing \<10 kg, the sensor will be placed on the big toe. For patients weighing \>10 kg, the sensor will be placed on an index finger. In case of failure in the first attempt, the alternate toe or index finger will be tried (second attempt). First, the sensor will be placed on toe or index finger and then the PO will be powered-on. A stable Sp02 reading will be considered to be obtained if SpO2 reading is stable by ±1 % for at least 10 seconds and the device signal strength is displayed to be adequate (green signal). Second attempt will be warranted if a stable reading is not obtaining within 1-2 minutes.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
1. Sick children aged 2 to 59 months
2. Presenting with cough or difficult breathing
3. Receiving IMCI services in the selected facilities will be enrolled
2. Presenting with cough or difficult breathing
3. Receiving IMCI services in the selected facilities will be enrolled
Exclusion Criteria
1. Severely ill children who need to be referred immediately
2. If the parents of the children are unwilling to participate
2. If the parents of the children are unwilling to participate
Minimum Eligible Age
2 Months
Maximum Eligible Age
59 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Edinburgh
OTHER
Sponsor Role
collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ahmed Ehsanur Rahman, MBBS, MPH
Role: PRINCIPAL_INVESTIGATOR
International Centre for Diarrhoeal Disease Research, Bangladesh
Locations
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International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, , Bangladesh
Site Status
RECRUITING
Countries
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Bangladesh
Central Contacts
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References
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Related Links
Access external resources that provide additional context or updates about the study.
http://apps.who.int/iris/bitstream/handle/10665/104772/9789241506823_Chartbook_eng.pdf;jsessionid=45058111AE386D954C19C57B8AD47E13?sequence=16
World Health Organization. Integrated Management of Childhood Illness; Chart Booklet: WHO Library Cataloguin; 2014.
https://www.ncbi.nlm.nih.gov/books/NBK264164/
World Health Organization. Revised WHO classification and treatment of pneumonia in children at health facilities: evidence summaries. 2014.
http://apps.who.int/iris/bitstream/handle/10665/44774/?sequence=1
Recommendations for management of common childhood conditions: evidence for technical update of pocket book recommendations
https://patents.google.com/patent/US5911690A/en
Rall G. Use of a pulse oxymetry sensor device. Google Patents; 1999.
http://uxpajournal.org/usability-studies-and-the-hawthorne-effect/
Macefield R. Usability studies and the Hawthorne Effect. Journal of Usability Studies. 2007;2(3):145-54.
http://researchspace.bathspa.ac.uk/91/
Smith ID, Coombs SJ. The Hawthorne Effect: is it a help or a hindrance in social science research? Change (Sydney, NSW). 2003;6(1):97.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PR-18054
Identifier Type: -
Identifier Source: org_study_id
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