Maternal Health Toolkit Phase Two: Pilot Evaluation of Implementation Planning Toolkit

Maternal Health Toolkit Project Phase 2: Registration Information (Open Science) Registered with Open Science on: May 31, 2023. Study Title and Timescale: 1. Study Title: Maternal Health Toolkit Phase Two: Pilot Evaluation of Implementation Planning Toolkit 2. Start Date: June 2023 (Argentina site). July 2023 (Ghana site) 3. Anticipated Completion Date: June 2024 (Argentina site). July 2024 (Ghana site). 4. Stage of study at Time of this Submission: Ethical approval has been obtained from all sites, with data collection to begin in June 2023. Study Team Details: 5. Named Contact: Lisa Puchalski Ritchie 6. Named Contact Email: lisa.puchalski@utoronto.ca 7. Named Contact Address: Knowledge Translation Program, Li Ka Shing knowledge Institute, St. Michael’s Hospital, 30 Bond Street Toronto, Ontario, Canada, M5B 1W8. 8. Named Contact Phone Number: 416-864-6060 9. Organizational Affiliation of the study: Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Unity Health Network, Toronto, Canada 10. Study Team Members and Organizational Affiliations: Name: Organizational Affiliation: Role on Study Dr. Lisa M Puchalski Ritchie: Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michaels Hospital, Unity Health Network, Toronto, Canada; Department of Medicine, University of Toronto, Toronto, Canada; University Health Network, Toronto, Canada; Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Canada: Principal Investigator Mercedes Vila Ortiz: Centro Rosarino de Estudios Perinatales, Rosarino, Argentina: Co-Investigator Dr. Ani-Amponsah: Maternal and Child Health Department, School of Nursing and Midwifery, University of Ghana: Co-Investigator Dr. Edguardo Abalos: Centro Rosarino de Estudios Perinatales, Rosarino, Argentina: Co-Investigator Dr. Christine Fahim: Knowledge Translation Program, Li Ka Shing Knowledge Institute, Unity Health Network, Toronto, Canada: Co-Investigator Dr. Sharon Straus: Knowledge Translation Program, Li Ka Shing Knowledge Institute, Unity Health Network, Toronto, Canada: Co-Investigator 11. Funding Sources/Sponsors: Canadian Institutes of Health Research (CIHR) 12. Conflict of Interest: There are no conflicts of interest to declare. Methods 13. Study Design: This study will employ a multi-component qualitative design including: field observation, focus groups and a document review of notes from the initial implementation planning meetings, study team meeting notes, and any documents produced as a result of the meeting such as subsequent planning meetings or implementation plans. 14. Study Objectives: A) To assess strengths and weaknesses of the toolkit when applied by non-experts using a real-life implementation planning activity, to inform refinement and further development of the toolkit. B) To assess if, how, and to what extent findings of the toolkit’s barrier and facilitator assessment and mapping activities are subsequently incorporated into implementation plans. 15. Condition or Domain Being Studied: The of this goal of this study, is to pilot the toolkit with non-experts within the context of locally identified maternal health implementation priorities and collect information on the strengths and weaknesses, and areas for improvement of the toolkit. 16. Participants/Population: Participants will include health care providers, researchers/academics, policy/decision makers, and patient representatives. Participants will be selected in collaboration with in-country study-team leads to represent the range of stakeholders relevant to the locally identified priority for implementation. 17. Interventions/Exposures: Not Applicable 18. Comparator/Control: Not Applicable 19. Inclusion/Exclusion Criteria: This study will include the implementation planning meeting lead(s) and participants. Participants will include a range of stakeholders relevant to the locally identified priority for implementation, including providers (physicians, nurses, midwives, allied health care, etc.), policy/ decision makers, academics/researchers and patient representatives. Participants unwilling or unable to provide informed consent will be excluded from participation. 20. Primary Outcomes: The primary outcome of this study will be an understanding of strengths and weaknesses of the toolkit when applied by non-experts in a real-world implementation planning activity within the context of maternal health. 21. Secondary Outcomes: To gain an understanding of how and to what extent findings from use of the toolkit are subsequently incorporated into implementation plans. 22. Data Collection: Meetings will be held over two days at a central location convenient to participants. Day one will be led by the local study team in the local language (Spanish in Argentina, and English in Ghana), and will involve working through the toolkit as a group to identify barriers and facilitators (B/F) to the locally identified priority for implementation, through a combination of large and small group discussions. Day two of the meeting will be led by Dr. Puchlaski Ritchie who will lead participants through a review of the B/Fs identified day one to ensure that participants are satisfied with the list and importance ratings applied to the b/f's listed. Once the b/f list and rankings are finalized, Dr. Puchlaski Ritchie who will lead participants through a B/Fs mapping exercise to develop a list of strategies to address identified b/fs. Field observation by the Toronto based study team (PI and study coordinator) will be conducted throughout the meeting, with in-line translation provided in Argentina and as needed in Ghana. The meetings will be video recorded using a secure platform. A focus group(s) with all representatives in attendance at the meeting invited to participate will be held at the conclusion of the toolkit testing, led by the Toronto PI using a semi-structured focus group guide with the assistance of in-line translation in Argentina and as needed in Ghana. The focus group(s) will be audio recorded and transcribed verbatim. A quality check will be conducted on focus group transcripts by a second sociolinguistic level translator to assess for accuracy and conceptual equivalence where in-line translation has been utilized. 23. Analysis Plan: Field notes, focus group(s) and documents will be analyzed independently by two study team members, with support from the in-country study lead. Nvivo 12 will be used to code and organize data into themes, and to assess for differences/similarities across key participants groups based on stakeholder group. A draft coding scheme will be created based on the data collected through the field notes, focus group and document review. The framework will be revised collaboratively following an initial round of independent coding and revised until a final coding scheme is agreed upon. The final coding scheme will then be applied independently, and discrepancies resolved through discussion and involvement of a third team member as needed. Study General Information: Study Type: Qualitative Study, employing field observations, focus groups, and a document review Country: Argentina and Ghana Other Registration Details: Phase one of this study was registered with Open Science on June 4, 2022 and an amendment added (for the addition of a second site, Ethiopia) on December 11, 2022. Dissemination Plans: Study findings will be submitted for peer reviewed publication and for presentation at appropriate international conferences. In addition, study findings will be disseminated to participants and stakeholders through presentation at a local meeting(s) and a one page lay summary provided to interested participants. Finally, a report of meeting proceedings including both the findings of the barrier and facilitator assessment and mapping exercise to identify potential implementation strategies to address identified barriers and facilitators will be provided to meeting leads in each country. Key Words: implementation, toolkit, maternal health Details of any existing study of the same Topic by the Same Author: Not Applicable Current Study Status: Study has received ethical approval from all sites, with data collection to begin in June 2023. Any Additional Information: Not Applicable. Details of Final Report/Publications: Not Applicable.

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