Article Text
Abstract
Introduction Front-line health workers in remote health facilities are the first contact of the formal health sector and are confronted with life-saving decisions. Health information systems (HIS) support the collection and use of health related data. However, HIS focus on reporting and are unfit to support decisions. Since data tools are paper-based in most primary healthcare settings, we have produced an innovative Paper-based Health Information System in Comprehensive Care (PHISICC) using a human-centred design approach. We are carrying out a cluster randomised controlled trial in three African countries to assess the effects of PHISICC compared with the current systems.
Methods and analysis Study areas are in rural zones of Côte d’Ivoire, Mozambique and Nigeria. Seventy health facilities in each country have been randomly allocated to using PHISICC tools or to continuing to use the regular HIS tools. We have randomly selected households in the catchment areas of each health facility to collect outcomes’ data (household surveys have been carried out in two of the three countries and the end-line data collection is planned for mid-2021). Primary outcomes include data quality and use, coverage of health services and health workers satisfaction; secondary outcomes are additional data quality and use parameters, childhood mortality and additional health workers and clients experience with the system. Just prior to the implementation of the trial, we had to relocate the study site in Mozambique due to unforeseen logistical issues. The effects of the intervention will be estimated using regression models and accounting for clustering using random effects.
Ethics and dissemination Ethics committees in Côte d’Ivoire, Mozambique and Nigeria approved the trials. We plan to disseminate our findings, data and research materials among researchers and policy-makers. We aim at having our findings included in systematic reviews on health systems interventions and future guidance development on HIS.
Trial registration number PACTR201904664660639; Pre-results.
- human resource management
- Organisation of health services
- protocols & guidelines
- quality in health care
- statistics & research methods
- primary care
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Footnotes
Contributors XB-C, AO-I, AMM, RBY and CA prepared the proposal for the funding agency, conceived the study and produced the data collection tools. SG ensured the regulatory, ethical and trial monitoring components. AR developed the analytical approaches and made the sample size calculations. RBY, MS and SB adapted the protocol to the context of Côte d’Ivoire and managed the administrative and ethical approvals in the country; AO-I, NE, ON, ANN and ABG likewise in Nigeria; AMM, SML and GM, in Nampula province (Mozambique); JS and TM adapted the protocol and acquired ethical and administrative clearances for Inhambane province (Mozambique). DWB is chair of the PHISICC Technical Advisory Group (TAG) and has coordinated multiple formal and informal inputs. LKK and DWB have advised on the adequacy of the study protocol within the overall PHISICC proposal and TAG advices. All country teams participated in PHISICC workshops and ensured that the protocol was suitable to countries realities; developed data collection tools and training materials. They are responsible for the implementation of the trial in each country. XB-C drafted the first version of the manuscript. All authors commented on several versions of the manuscript.
Funding This study was funded by the Bill & Melinda Gates Foundation, grant number INV-010193/OPP1135947.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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