Article Text

Protocol
Does an innovative paper-based health information system (PHISICC) improve data quality and use in primary healthcare? Protocol of a multicountry, cluster randomised controlled trial in sub-Saharan African rural settings
  1. Xavier Bosch-Capblanch1,2,
  2. Angela Oyo-Ita3,
  3. Artur Manuel Muloliwa4,
  4. Richard B Yapi5,
  5. Christian Auer1,2,
  6. Mamadou Samba6,
  7. Suzanne Gajewski1,2,
  8. Amanda Ross1,2,
  9. L Kendall Krause7,
  10. Nnette Ekpenyong3,
  11. Ogonna Nwankwo3,
  12. Anthonia Ngozi Njepuome8,
  13. Sofia Mandjate Lee9,
  14. Jahit Sacarlal10,
  15. Tavares Madede10,
  16. Salimata Berté5,
  17. Graça Matsinhe11,
  18. Abdullahi Bulama Garba12,
  19. David W Brown13
  1. 1Swiss Tropical and Public Health Institute, Basel, Basel-Stadt, Switzerland
  2. 2University of Basel, Basel, Basel-Stadt, Switzerland
  3. 3Department of Community Medicine, University of Calabar Teaching Hospital, Calabar, Cross River, Nigeria
  4. 4Lurio University Faculty of Health Sciences, Nampula, Nampula, Mozambique
  5. 5Centre Suisse de Recherches Scientifiques en Côte d'Ivoire, Abidjan, Lagunes, Côte d'Ivoire
  6. 6Ministère de la Santé et de l'Hygiène Publique, Abidjan, Lagunes, Côte d'Ivoire
  7. 7Bill & Melinda Gates Foundation, Seattle, Washington, USA
  8. 8Swiss Tropical and Public Health Institute, Abuja, Nigeria
  9. 9Swiss Tropical and Public Health Institute, Maputo, Mozambique
  10. 10Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique
  11. 11Expanded Program on Immunization, Ministério da Saúde, Maputo, Mozambique
  12. 12Planning, Research and Statistics, National Primary Healthcare Development Agency, Abuja, Nigeria
  13. 13BCGI LLC / pivot-23.5°, Chapel Hill, North Carolina, USA
  1. Correspondence to Dr Xavier Bosch-Capblanch; x.bosch{at}unibas.ch

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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Supplementary materials

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.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.