Condition category
Pregnancy and Childbirth
Date applied
17/07/2019
Date assigned
25/07/2019
Last edited
16/08/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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?
Prof. Nynke van den Broek
nynke.vandenbroek@lstmed.ac.uk

Trial website

Contact information

Type

Scientific

Primary 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
+44 (0)151 705 3154
nynke.vandenbroek@lstmed.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

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

Acronym

Study hypothesis

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

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)

Study design

Interventional multi-centre crossed randomised stepped-wedge clustered controlled study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

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

Phase

Drug names

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 trial start date

20/05/2019

Overall trial end date

30/11/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Mixed

Gender

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.

Participant exclusion criteria

1. Women from non-selected facilities
2. Women that do not consent to be interviewed for audits measurements

Recruitment start date

05/08/2019

Recruitment end date

30/11/2019

Locations

Countries of recruitment

Togo

Trial participating centre

Centre De Sante Lomé
Lomé
-
Togo

Trial participating centre

CHR Lomé
Lomé
-
Togo

Trial participating centre

Hospital de District (HD) de Be
Lomé
-
Togo

Trial participating centre

Polyclinique Be Kpota / Hopital D2, Lomé Region
Lomé
-
Togo

Trial participating centre

CMS UTB Circulaire
Lomé
-
Togo

Trial participating centre

CMS Cacaveli
Lomé
-
Togo

Trial participating centre

CHP Kpalime
Kpalimé
-
Togo

Trial participating centre

CHR Atakpame
Atakpamé
-
Togo

Trial participating centre

CMS notre dame de misericorde
Kloto
-
Togo

Trial participating centre

USP Akpare
Akparé
-
Togo

Trial participating centre

CMS Anna Maria,
Ogou
-
Togo

Trial participating centre

USP Homagan
Homagan
-
Togo

Trial participating centre

CHP Mango
Mango
-
Togo

Trial participating centre

Hopital De L'esperance / Hopital Baptiste De Mango
Mango
-
Togo

Trial participating centre

CHR Dapaong
Dapaong
-
Togo

Trial participating centre

Polyclinique Dapaong
Dapaong
-
Togo

Trial participating centre

CMS Gando
Gando
-
Togo

Trial participating centre

CMS Barkoissi
Barkoissi
-
Togo

Sponsor information

Organisation

Liverpool School of Tropical Medicine

Sponsor details

Pembroke Place
Liverpool
Liverpool
L3 5QA
United Kingdom
+44 (0)151 705 3100
info@lstmed.ac.uk

Sponsor type

University/education

Website

https://www.lstmed.ac.uk/

Funders

Funder type

Research organisation

Funder name

Global Fund to Fight AIDS, Tuberculosis and Malaria

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

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

Results and Publications

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 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.

Intention to publish date

01/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/08/2019: Ethics approval details updated. 25/07/2019: Trial's existence confirmed by ethics board.