An evaluation of the impact of standards-based audit and healthcare provider training on the availability and quality of antenatal (ANC) and postnatal care (PNC) in Togo
| ISRCTN | ISRCTN12212410 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12212410 |
- Submission date
- 17/07/2019
- Registration date
- 25/07/2019
- Last edited
- 03/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Maternal and perinatal deaths and morbidities remain a challenge, especially in Togo. Antenatal and postnatal care (ANC-PNC) offered in healthcare facilities (HCFs) by trained healthcare providers (HCPs) is a useful platform for addressing the health needs of women and babies at the time of pregnancy and the immediate period after the baby is born. In practice, however, many women do not receive all the necessary components of care. Both the content and the quality of care are at times insufficient, at least to a degree, because of a lack of knowledge, skills and confidence among HCPs. To improve the quality and availability of care, a common strategy in LMIC is to provide HCPs with in-service competency-based practical training workshops. It may also be beneficial to introduce a process for improving the quality of care called standards-based audit. This improves compliance with agreed standards of care and helps HCP make changes to their practice if compliance is poor. Standards-based audit can be done in 3-month cycles. Once standards of care are agreed, the compliance with one or more agreed standards are measured, HCPs review what could be done to improve compliance, take the appropriate action, and, this should result in improved compliance and thus a measurably improved quality of that aspect of care. The aim of this study is to find out whether training of HCPs will improve the availability and quality of integrated ANC and PNC, and whether the introduction of standards-based audit will improve the quality and availability of integrated ANC and PNC.
Who can participate?
Women who have received ANC or PNC and healthcare providers involved in ANC and PNC
What does the study involve?
Participating HCFs are randomly allocated to receive the two interventions (standards-based audit and training in ANC and PNC) at different times. Monthly measurements of the availability of ANC-PNC before training of the HCPS are compared to monthly measurements after training. Compliance to standards is also measured before and after action is taken for improvement.
What are the possible benefits and risks of participating?
In addition to training being provided for healthcare providers, the benefits of the assessment include making available to the facility data on the quality of care provided, including recommendations for improvement. There are no immediate risks to healthcare facilities and healthcare providers in participating, except for the potential increase in workload related to data collection for the study. The assessment will generate data on quality of care and highlight areas of care that may need to improve. However, none of the findings will be linked to individual staff and there will be no negative repercussions for the staff in the facility.
There are no direct benefits to patients, but the information provided will help to identify what aspects of care need to improve and the intention is that the facility will then make improvements to the quality of care provided; this means other women and their babies, would benefit in the future. There are no immediate risks to patients from taking part; however, exit interviews may stir up distressing memories of poor care being recalled as part of the assessment.
Where is the study run from?
18 healthcare facilities from the 3 regions Lomé, Plateaux and Savanes in Togo ; all work is coordinated by the Centre for Maternal and Newborn Care at the Liverpool School of Tropical Medicine, in partnership with the Ministry of Health in Togo and the University of Lomé.
When is study starting and how long is it expected to run for?
May 2019 to November 2020
Who is the main contact?
1. Dr Charles Ameh
charles.ameh@lstmed.ac.uk
2. Dr Marion Ravit
marion.ravit@lstmed.ac.uk
Contact information
Scientific
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
 ORCID ID |
0000-0002-2341-7605 |
|---|---|
| Phone | +44 (0)7714 75 3844 |
| charles.ameh@lstmed.ac.uk |
Scientific
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
| ORCID ID |
0000-0003-4440-0260 |
|---|---|
| Phone | +44 (0)151 832 1687 |
| marion.ravit@lstmed.ac.uk |
Study information
| Study design | Interventional multi-centre crossed randomised stepped-wedge clustered controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | Crossed randomised stepped wedge trial to assess the effectiveness of standards-based audit and healthcare provider training on the availability and quality of Antenatal (ANC) and Postnatal Care (PNC) in Togo |
| Study objectives | For this implementation research study there are two hypotheses: 1. Training of HCPs will improve the availability and quality of integrated ANC and PNC 2. The introduction of standards-based audit will improve the quality and availability of integrated ANC and PNC |
| Ethics approval(s) | 1. Approved 16/05/2019, Bioethics Committee for Health Research (Comité Bioéthique pour la Recherche en Santé – CBRS, Togo; Tel: +228(0) 22 21 38 01; Email: cbrstogo@gmail.com), ref: 021/2019/CBRS 2. Approved 13/08/2019, Research Governance and Ethics Office (Room 221, 2nd Floor LLSA, Daulby Street, Liverpool; Tel: +44 (0)151 705 9396; Email: lstmrec@lstmed.ac.uk) |
| Health condition(s) or problem(s) studied | Maternal and neonatal health and quality of care |
| Intervention | Two randomised stepped wedge trial designs (SWD) will be crossed and used to assess the effects of the two interventions (Standards-based Audit and Training in ANC and PNC). Thus each HCF will receive both of the interventions, and in the case of standards-based audit the impact will be assessed using six different standards. To assess the impact of training in ANC and PNC, an incomplete closed cohort SWD will be used. This means that the participants are the same HCFs, for which assessments are obtained each month. Availability of each signal function will be assessed in each calendar month. To assess the effect of the implementation of standards-based audit, a multi-dimensional incomplete stepped wedge (SW) cluster randomised trial with cross-sectional sampling will be used. Within each participating HCF standards-based audit for one standard will be commenced at two-monthly intervals. |
| Intervention type | Other |
| Primary outcome measure | 1. Percentage compliance with standards (aggregate) measured with standard-specific tool at baseline (month 1 and 2), then every alternate month from month 2 to month 15, or month 3 to 16, depending on stratum, plus at endline at month 15 or 16 depending on stratum 2. Proportion of ANC and PNC signal functions available measured using a standardised tool monthly |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 20/05/2019 |
| Completion date | 30/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target number of participants | There are 18 clusters (healthcare facilities). In total, there will be a maximum of 600 participants per cluster (50 women per cycle for 6 cycle + 150 baseline and 150 for endline). This number could be lower as some standard audited can be measured on cases from facility registers and do not involve participants. |
| Total final enrolment | 7867 |
| Key inclusion criteria | Note: This is a clustered trial where healthcare facilities represent one cluster In consultation with the Ministry of Health districts or regions will be identified and all public or private HCFs that are: 1. Designated to provide ANC and PNC 2. in a state of readiness to provide ANC and PNC (i.e. equipment and consumables in principle in place) 3. Provide ANC to at least 25 women per month will be eligible for inclusion. For objective i) measurements will be done from facility registers and will not need inclusion of participants For objective ii) measurements will be done either from facility registers, either through exit interviews depending on the standard audited. Participants will be women coming for ANC or PNC within the healthcare facility. Eligible women will be those attending ANC-PNC in the selected facilities |
| Key exclusion criteria | 1. Women from non-selected facilities 2. Women that do not consent to be interviewed for audits measurements |
| Date of first enrolment | 05/08/2019 |
| Date of final enrolment | 30/11/2019 |
Locations
Countries of recruitment
- Togo
Study participating centres
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
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Togo
Sponsor information
University/education
Pembroke Place
Liverpool
Liverpool
L3 5QA
England
United Kingdom
| Phone | +44 (0)151 705 3100 |
|---|---|
| info@lstmed.ac.uk | |
| Website | https://www.lstmed.ac.uk/ |
"ROR" |
https://ror.org/03svjbs84 |
Funders
Funder type
Research organisation
Private sector organisation / International organizations
- Alternative name(s)
- Global Fund, Fonds mondial, The Global Fund to Fight AIDS, Tuberculosis and Malaria, Fonds mondial de lutte contre le sida, la tuberculose et le paludisme, The Global Fund, Le Fonds mondial, GFATM
- Location
- Switzerland
Results and Publications
| Intention to publish date | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers intend to have the protocol published in a journal. Planned publication of the results in a high-impact peer-reviewed journal. |
| IPD sharing plan | Current individual participant data (IPD) sharing statement as of 07/07/2022: The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Marion Ravit (marion.ravit@lstmed.ac.uk) or via the unit's email address (gfpu@lstmed.ac.uk). Data will be accessible once the trial publication is published. The data dictionary with information on data available (variables and characteristics of variables) can be reviewed by interested parties. Use of data would need to be agreed in advance, following legal and ethical guidelines. Data in this trial relate to health facilities, not individual people, but the information on healthcare facilities will be suitably anonymised to protect the individual facilities. LSTM require data to be preserved for a minimum of five years, but there is no cap for how long the data would be stored. Previous individual participant data (IPD) sharing statement: The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Barbara Madaj (Barbara.Madaj@lstmed.ac.uk) or via the Centre’s email address (cmnh@lstmed.ac.uk). Data will be accessible once the trial publication is published. The data dictionary with information on data available (variables and characteristics of variables) can be reviewed by interested parties. Use of data would need to be agreed in advance, following legal and ethical guidelines. Data in this trial relate to health facilities, not individual people, but the information on healthcare facilities will be suitably anonymised to protect the individual facilities. LSTM require data to be preserved for a minimum of five years, but there is no cap for how long the data would be stored. |
Editorial Notes
03/03/2023: Internal review.
11/07/2022: A study contact has been added and the plain English summary has been updated accordingly.
07/07/2022: The following changes have been made:
1. The intention to publish date has been changed from 01/12/2021 to 01/12/2022.
2. The individual participant data (IPD) sharing statement has been updated.
3. The total final enrolment number has been added.
4. The study contact has been updated and the plain English summary has been updated accordingly.
16/08/2019: Ethics approval details updated.
25/07/2019: Trial's existence confirmed by ethics board.
