Plain English Summary
Background and study aims
Every year 303,000 women die due to pregnancy-related complications, 2.6 million babies are stillborn and a further 2.7 million die in the first month of life. Many of these deaths occur in low and middle-income countries and can be prevented if effective and good quality of care is available. Malawi is one of the countries in sub-Saharan Africa with high maternal and newborn deaths. The maternal mortality ratio is 634 deaths per 100,000 live births, representing about 15% of all deaths of women in the reproductive age group (15-49 years). The Malawi demographic survey for 2015-2016 reported a newborn mortality rate of 27 deaths per 1,000 live births, infant mortality of 42 deaths per 1,000 live births, and perinatal mortality at 35 deaths per 1,000 pregnancies. About 43% of all deaths occur during the first month of life. Poor quality of care is one of the major contributors to the unacceptably high death rates for mothers and newborns in Malawi. With the transition from Millennium Development Goals to the new global Sustainable Development Goals, absolute targets have been set to reduce maternal deaths, stillbirth and newborn mortality and there is still more to be done. Improving quality of care for mothers and babies is of the utmost urgency. The aim of this study is to assess the impact of using a standards-based audit on compliance with defined standards for emergency obstetric and newborn care to improve quality of maternal and newborn health care in Malawi.
Who can participate?
Women and their newborns who attend 43 healthcare facilities providing emergency obstetric and newborn care within five districts in Malawi
What does the study involve?
The intervention is the adoption by a healthcare facility of standards-based audits for standards of emergency obstetric and newborn care. The aim of the study is to estimate the improvement in compliance with the standard of care when adopting standards-based audits. Training in the conduct of standards-based audit for maternal and newborn health is provided before starting any audit cycle at each facility. For each defined standard the intervention is the action taken in the second month of an audit cycle (the ‘action month’) within the facility to address any deficiencies in care identified during the first month of the audit cycle. Within each facility there are two consecutive audit cycle periods, i.e. the study period is six months in total. For the participating facilities the study period starts in one of three consecutive months, which have been randomly allocated, thus the study period for the entire study is eight calendar months.
What are the possible benefits and risks of participating?
There are no direct benefits for a participant in the study. Staff may benefit from training which increases their ability to deliver quality care to mothers and babies. Compliance to standard is expected to improve service delivery and subsequently improve women and newborn outcomes (reduce morbidities and mortalities) and contribute to client satisfaction with care. There are no risks of taking part in the study.
Where is the study run from?
Liverpool School of Tropical Medicine (UK)
When is the study starting and how long is it expected to run for?
March 2018 to February 2019
Who is funding the study?
UNICEF
Who is the main contact?
1. Prof. Florence Mgawadere
2. Prof. Nynke van den Broek
Trial website
Contact information
Type
Scientific
Primary contact
Prof Florence Mgawadere
ORCID ID
http://orcid.org/0000-0003-3341-9118
Contact details
Centre for Maternal and Newborn Health
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
Type
Scientific
Additional contact
Prof Nynke van den Broek
ORCID ID
http://orcid.org/0000-0001-8523-2684
Contact details
Centre for Maternal and Newborn Health
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LRPS-2017-9136548
Study information
Scientific title
Using standard based audit to improve the quality of maternal and newborn health in a low resource setting
Acronym
Study hypothesis
Introducing the practice of conducting standards-based audits within facilities providing emergency obstetric and newborn care in Malawi will improve compliance to standards of care.
Ethics approval
1. Ethics committee of Liverpool School of Tropical Medicine e_Research Protocol, 21/06/2018, ref: 18-028
2. Study granted ethics review exemption by the Malawi Ministry of Health, 20/06/2018, ref: QMD/10
Study design
Cluster randomized incomplete stepped wedge trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Recipient of obstetric or newborn care
Intervention
The intervention is the adoption by a healthcare facility of standards-based audits for standards of emergency obstetric and newborn care. Using the stepped wedge design each participating health care facility (cluster) acts as their own control, providing data for standards audited within the facility both prior to and subsequent to the action phase of the audit cycle.
The aim of the study is to estimate the improvement in compliance with the standard of care when adopting standards-based audits. Training in the conduct of standards-based audit for maternal and newborn health will be provided prior to commencing any audit cycle at each facility.
For each defined standard the intervention will be the action taken in the second month of an audit cycle (the ‘action month’) within the facility to address any deficiencies in care identified during the first month of the audit cycle. Within each facility there will be two consecutive audit cycle periods, i.e. the study period will be six months in total. (For the participating facilities the study period starts in one of three consecutive months, which have been randomly assigned, thus the study period for the entire study will be eight calendar months).
Intervention type
Other
Phase
Drug names
Primary outcome measure
Compliance with defined standard of care aggregated for all emergency obstetric and newborn care standards audited. This will be defined as the mean across all facilities and standards, with each standard audited by each facility carrying equal weight. (Thus, at facility level the means for CEmOC facilities which audit twice as many standards will carry twice the weight of the BEmOC facilities). Standards will be weighted by the number of facilities which audit the standard). Data collected in the following months for a facility will be used for each facility: months 1 and 6 for all standards; month 3 for the standard(s) audited in the first cycle; and month 4 for the standard(s) audited in the second cycle within the facility. The primary outcome will be derived by appropriate aggregation of estimates for individual standards.
Secondary outcome measures
Compliance with defined standard of care for each of the emergency obstetric and newborn care standards audited in the study. Measurements will be made within months 1 and 3 of each audit cycle. Additionally, in facilities which audit a standard in the first audit cycle there will be a (post-intervention) assessment during month 6 for the facility, i.e. 4 months after the intervention (‘action month’) and in those which audit the standard in the second audit cycle there will be an additional (pre-intervention) assessment during month 1 for the facility, i.e. 4 months before the ‘action month’. A standard-specific tool will be used in each month of data collection at a facility to collect data for 25 clients. The data collected will be used to classify each client as having received/not received care which is compliant with the standard.
Overall trial start date
01/03/2018
Overall trial end date
28/02/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Clusters:
43 healthcare facilities providing emergency obstetric and newborn care within five districts in Malawi
Clients:
Women and their newborns who attend the study facilities for obstetric/newborn care addressed by the standard being assessed that month
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
8,100
Participant exclusion criteria
1. Women who did not give birth at a healthcare facility
2. Facilities not designated to provide emergency obstetric and newborn care services as basic (BEmOC) or comprehensive (CEmOC) level
Recruitment start date
31/07/2018
Recruitment end date
31/12/2018
Locations
Countries of recruitment
Malawi
Trial participating centre
Dedza District Hospital
Dedza district
Dedza
00
Malawi
Trial participating centre
Mayani Health Centre
Dedza district
Dedza
00
Malawi
Trial participating centre
Lobi Health Centre
Dedza district
Dedza
00
Malawi
Trial participating centre
Chitowo Health Centre
Dedza district
Dedza
00
Malawi
Trial participating centre
Mtakataka Health Centre
Dedza district
Dedza
00
Malawi
Trial participating centre
Mtendere Health Centre
Dedza district
Dedza
00
Malawi
Trial participating centre
Chikuse Health Centre
Dedza district
Dedza
00
Malawi
Trial participating centre
Golomoti Health Centre
Dedza district
Dedza
00
Malawi
Trial participating centre
Chimoto Health Centre
Dedza district
Dedza
00
Malawi
Trial participating centre
Mangochi district hospital
Mangochi District
Mangochi
00
Malawi
Trial participating centre
Monkeybay Community Hospital
Mangochi district
Mangochi
00
Malawi
Trial participating centre
Makanjira Health Centre
Mangochi district
Mangochi
00
Malawi
Trial participating centre
Koche Community Hospital
Mangochi district
Mangochi
00
Malawi
Trial participating centre
Namwera Health cente
Mangochi district
Mangochi
00
Malawi
Trial participating centre
Ndirande Health Centre
Blantyre District
BlantyreM
00
Malawi
Trial participating centre
Phirilongwe Health Centre
Mangochi district
Mangochi
00
Malawi
Trial participating centre
Lungwena Health Centre
Mangochi district
Mangochi
00
Malawi
Trial participating centre
Chilipa Health Centre
Mangochi district
Mangochi
00
Malawi
Trial participating centre
Chilonga Health Centre
Mangochi district
Mangochi
00
Malawi
Trial participating centre
Nankumba Health Centre
Mangochi district
Mangochi
00
Malawi
Trial participating centre
Mkumba Health Centre
Mangochi district
Mangochi
00
Malawi
Trial participating centre
Limbe Health Centre
Blantyre district
Blantyre
00
Malawi
Trial participating centre
South Lunzu Health Centre
Blantyre district
Blantyre
00
Malawi
Trial participating centre
Mlambe Hospital
Blanytre district
Blantyre
00
Malawi
Trial participating centre
Mdeka Health Centre
Blantyre district
Blantyre
00
Malawi
Trial participating centre
Bangwe Health Centre
Blantyre district
Blantyre
00
Malawi
Trial participating centre
Lundu Health Centre
Blantyre district
Blantyre
00
Malawi
Trial participating centre
Zingwangwa Health Centre
Blantyre district
Blanytre
00
Malawi
Trial participating centre
Chilomoni Health Centre
Blantyre district
Blanytre
00
Malawi
Trial participating centre
Thyolo District Hospital
Thyolo district
Thyolo
00
Malawi
Trial participating centre
Malamulo Hospital
Thyolo district
Thyolo
00
Malawi
Trial participating centre
Khonjeni
Thyolo district
Thyolo
00
Malawi
Trial participating centre
Thekerani Health Centre
Thyolo district
Thyolo
00
Malawi
Trial participating centre
Mikolongwe Health Centre
Thyolo district
Thyolo
00
Malawi
Trial participating centre
Chimaliro Health Centre
Thyolo district
Thyolo
00
Malawi
Trial participating centre
Bvumbwe
Thyolo district
Thyolo
00
Malawi
Trial participating centre
Chisoka
Thyolo
Thyolo
00
Malawi
Trial participating centre
Nkhatabay district hospital
Nhkatabay district
Nkhatabay
oo
Malawi
Trial participating centre
Chintheche Community Hospital
Nkhatabay district
Nkhatabay
00
Malawi
Trial participating centre
Mpamba Health Centre
Nkhatabay district
Nkatabay
00
Malawi
Trial participating centre
Liuzi Health Centre
Nkhatabay District
Nkhatabay
00
Malawi
Trial participating centre
Bula Health Centre
Nkkatabay District
Nkhatabay
00
Malawi
Trial participating centre
Mzenga Health Centre
Nkhatabay district
Nkhatabay
oo
Malawi
Trial participating centre
Liverpool School of Tropical Medicine, Malawi office
Private Bag B425
Lilongwe
00
Malawi
Trial participating centre
Mua Hospital
Dedza district
Dedza
00
Malawi
Sponsor information
Organisation
Liverpool School of Tropical Medicine
Sponsor details
Pembroke Place
Liverpool
L3 5QA
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
UNICEF
Alternative name(s)
United Nations Children's Emergency Fund
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal by mid-2019. Additional documents such as study protocol, statistical analysis plan, other will be available upon request. The protocol is not yet published.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Florence Mgawadere and Prof. Nynke van den Broek. The protocol and the dataset for the standards to be audited will be available from September. The current institutional policy requires that data is kept for 5 years after publication. The anonymised data can be shared for any analysis required upon request through the following institutional email address: CMNH@lstmed.ac.uk. All data will be anonymised and consent will obtained for all the data to be collected and there are no ethical nor legal restrictions at present.
Intention to publish date
30/06/2019
Participant level data
Available on request
Basic results (scientific)
Publication list