Implementing the QUALI-DEC project in Argentina, Burkina Faso, Thailand and Viet Nam: a process delineation and theory-driven process evaluation protocol

ABSTRACT

The project ‘Quality Decision-making by women and providers’ (QUALI-DEC) combines four non-clinical interventions to promote informed decision-making surrounding mode of birth, improve women’s birth experiences, and reduce caesarean sections among low-risk women. QUALI-DEC is currently being implemented in 32 healthcare facilities across Argentina, Burkina Faso, Thailand, and Viet Nam. In this paper, we detail implementation processes and the planned process evaluation, which aims to assess how and for whom QUALI-DEC worked, the mechanisms of change and their interactions with context and setting; adaptations to intervention and implementation strategies, feasibility of scaling-up, and cost-effectiveness of the intervention. We developed a project theory of change illustrating how QUALI-DEC might lead to impact. The theory of change, together with on the ground observations of implementation processes, guided the process evaluation strategy including what research questions and perspectives to prioritise. Main data sources will include: 1) regular monitoring visits in healthcare facilities, 2) quantitative process and output indicators, 3) a before and after cross-sectional survey among post-partum women, 4) qualitative interviews with all opinion leaders, and 5) qualitative interviews with postpartum women and health workers in two healthcare facilities per country, as part of a case study approach. We foresee that the QUALI-DEC process evaluation will generate valuable information that will improve interpretation of the effectiveness evaluation. At the policy level, we anticipate that important lessons and methodological insights will be drawn, with application to other settings and stakeholders looking to implement complex interventions aiming to improve maternal and newborn health and wellbeing.

Trial registration: ISRCTN67214403.

KEYWORDS:

• Non-clinical interventions
• informed decision-making
• evidence-based practices
• QUALI-DEC
• multifaceted intervention
• implementation science
• theory of change
• maternal health

Responsible Editor Julia Schröders

Responsible Editor Julia Schröders

Acknowledgments

We wish to thank the French Research Institute for Sustainable Development (IRD), which supported the QUALI-DEC consortium in the context of the Horizon 2020 research and innovation program. We are grateful to all members of the QUALI-DEC research group, including: Gino Bartolelli, Liana Cañpodonico, Berenise Carroli, Marina Llobert; Dittakarn Boriboonhirunsarn, Nampet Jampathong, Kiattisak Kongwattanakul, Pisanu Kantipong, Ameporn Ratinthorn, Somporn Rungreangkulkij, Nilubon Rujiraprasert, Natthapat Buaboon, Sasitara Nuampa, Paradee Tung Tang; Olga Canet, Xavier Espada; Fadima Yaya Bocoum, Simon Tiendrebeogo, Zerbo Roger; Vo Tran Chau, Huynh Nguyen Khanh Trang, Hoang Thi Thuy Trang, To Van Trung, Hoang Thi Diem Tuyet, Nguyen Ngoc Van; Camille Etcheverry, Myriam de Loenzien, Ouarda Lunetta-Namane, Isabella Ramos Mendoza, Marion Ravit, Delia Visan and Phuong Nguyen. Finally, we are grateful to Noon Pakavaleetorn for graphic design support.

Authors contributions

All authors (AC, APB, AD, CH, HMA, CG, CK, GC, KSA, KZ, MAB, MVO, MR, NO, PL, MQNH, RE, and SEH, participated in the development and planning of the study process evaluation. AC coordinated the planning of the process evaluation and led the writing of the protocol. The work was supervised by CH. All authors provided feedback and approved the final manuscript.

Disclosure statement

No potential conflict of interest was reported by the authors.

Ethics and consent

Ethical clearances were obtained from: the Centro Rosarino de Estudios Perinatales of Rosario, Argentina (Record Notice No. 1/20); Pham Ngoc Thach University of Ho Chi Minh City, Vietnam; Khon Kaen University in Thailand (CREC2563); and the Ethics Committee for Health Research of Burkina Faso (Decision No. 2020-3-038); the Ethical Review Committee of the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (WHO study No. A66006), last renewed in May 2023. All methods, including procedures to obtain informed consent from all study participants, will be carried out according to relevant regulations as well as the Helsinki Declaration, 1975.

Paper Context

Rates of caesarean sections are steadily increasing worldwide. Many settings are characterised by a complex scenario in which unmet needs and overuse coexist. Our complex intervention combines four non-clinical interventions to optimise caesarean sections rates and to improve maternal and newborn health across 4 countries. Using a mixed methods approach, we plan a theory-driven process evaluation that will generate methodological insights and in-depth understanding of implementation processes and experiences, including information on scalability and cost-effectiveness.

Data availability statement

The data produced and published during the QUALI-DEC project will be accessible in Zenodo (https://www.zenodo.org/), a general-purpose open access repository developed under the European OpenAIRE program and operated by the European Organization for Nuclear Research (CERN).

Supplementary data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/16549716.2023.2290636.

Additional information

Funding

The QUALI-DEC project is co-funded by the European Union’s Horizon 2020 research and innovation program under grant agreement [No. 847567], who also reviewed the project, and by the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored program executed by the World Health Organization (WHO) in the Department of Sexual and Reproductive Health and Research (SRH) (WHO Study A66006). The contents of this article are solely the responsibility of the authors and do not reflect the views of the EU, UNDP, UNFPA, UNICEF, WHO, or the World Bank or their respective institutions.