The DIPLOMATIC project is composed of eight interlocking Work Packages, with cross cutting capacity building in clinical trial methodology, database design and analysis, improvement science, and education in Malawi and Zambia.
An outline of the design of each of the work packages is described below. We anticipate all work packages will begin in Malawi, and will then be undertaken in Zambia as the project progresses.
Work Package 1
Work package 1 will concentrate on Evidence Based Practices (EBPs), crafted from existing reviews and guidelines by colleagues in Malawi and Zambia, and involving the patient voice as much as possible. We recognise that a variety of strategies could be used to reduce preterm birth and stillbirth but, to provide focus, we will choose EBPs which can be delivered or provided from a hospital facility to women who are already pregnant plus identify strategies to increase adoption. A country specific guideline will be generated, assisted by colleagues at the Scottish Intercollegiate Guideline Network (SIGN).
Work Package 2
We will define a core dataset to measure outcomes of preterm birth and stillbirth care (prevention diagnosis and treatment) at a hospital level. Our aim is also to include measures which will describe key individual components of care (e.g., whether or not prenatal corticosteroids were administered). The primary purpose of this dataset is to support and inform routine clinical practice.
Work Package 3
We will style a trial using a rigorous high quality design (adaptive [multi-arm, multi-stage], randomised stepped wedge or interrupted time series, appropriate for the chosen EBP) with a formal sample size calculation to determine health impact, fidelity to the evidence-based practice and barriers and facilitators to implementation. Quality improvement techniques will be used during the trial to continuously improve health outcomes and fidelity to the intervention.
Work Package 4
The purpose of this work package is to generate a platform, likely to be web based but using readily available tools (e.g. Microsoft Excel) that can be easily adapted by colleagues in the future. The database will be hosted in the relevant country (Malawi or Zambia) and anonymised extracts of the database with summary statistics will be made available to clinicians in each institution.
Work Package 5
Early ultrasound scanning is recommended unequivocally and certainty of gestational age is required to facilitate optimal timing of interventions and for accurate data collection. We will develop and test a training programme which will be used to train a cadre of midwives and health care workers who can then train others in basic early pregnancy ultrasound scanning.
Work Package 6
Work package 6 is the conduct and evaluation of the study designed in work package 3.
Work Package 7
We will identify and evaluate barriers and facilitators from the perspectives of individual women and their families, and in the wider social context, individual healthcare workers, hospital systems and Ministry of Health. This will be done through a review of extant literature and new empirical research in selected sites (e.g. interviews, focus groups and ethnographic observations).
Work Package 8
In two phases, work package 8 will design a trial to determine the effectiveness of an intervention and pilot the trial.