Accelerating Maternal and Newborn Survival: The AMANI Study

Обзор

The goal of this cluster randomized controlled trial is to learn if a practice facilitation package (including both audit and feedback and enhanced mentorship) can increase the use of maternal and perinatal death surveillance and response (MPDSR) in Kenyan health facilities and reduce maternal and perinatal deaths. Twenty facilities will be enrolled (10 intervention; 10 control) and the intervention will be tested with facility staff including the MPDSR committee members and facility administrators. The main questions this study aims to answer are: * Does the practice facilitation package improve the reach, effectiveness, adoption, implementation, and maintenance of MPDSR in Kenyan health facilities? * What is the primary pathway through which the practice facilitation package influences MPDSR implementation with fidelity? Researchers will compare outcomes between the intervention and control facilities to see if the practice facilitation package influences the degree to which facility MPDSR committees can complete all of the steps of the MPDSR process. Participants in both intervention and control facilities will be asked to respond to short surveys and engage in focus group discussions. Participants in the intervention facilities will be asked to engage regularly with the practice facilitators in enhanced mentorship and audit and feedback.

Подробное описание

The AMANI study will take place over three years. During the first two years, practice facilitators will deliver the practice facilitation package with intervention facilities. During the third year, practice facilitators will withdraw from intervention facilities, and both intervention and control facilities will be monitored to understand what elements of practice facilitation and MPDSR are maintained without external support.

Prior to beginning the practice facilitation intervention, a baseline service readiness assessment and data quality audit will be conducted in all enrolled facilities to understand the context of maternal and child healthcare provision at baseline. During the data quality audit, the previous year of facility death and MPDSR documentation will be abstracted from all facilities. During the three years of the AMANI study, facility records will be abstracted from all facilities on a monthly basis.

Within the first question that this study aims to answer, we have several sub-questions:

* What is the number, proportion, and representativeness of health workers who participate in the practice facilitation package? (Reach) * What is the effect of the practice facilitation package on maternal, neonatal, and perinatal mortality and MPDSR technical knowledge among facility staff? (Effectiveness) * What is the number and proportion of deaths for which the MPDSR process is started? (Adoption) * What is the effect of the practice facilitation intervention on MPDSR implementation with fidelity? What organizational, individual, and intervention characteristics influence the use of MPDSR in facilities? What changes do the facility MPDSR committees make to MPDSR processes? (Implementation) * What is the proportion of facilities implementing MPDSR with fidelity and the proportion of intervention facilities sustaining each component of the practice facilitation package at 6 and 12 months after withdrawing practice facilitator support? (Maintenance)

Вмешательства

• Поведенческое Audit and Feedback
  For audit and feedback (component 1), practice facilitators will hold regular meetings with MPDSR committees and facility administrators to present data on facility mortality and MPDSR implementation. Practice facilitators will discuss challenges in MPDSR implementation and help committees engage in quality improvement, including tracking adaptations to the MPDSR process.
• Поведенческое Enhanced Mentorship
  For enhanced mentorship (component 2), practice facilitators will attend regular MPDSR committee meetings and provide coaching on navigating data sources and provide information about MPDSR, how to complete quality improvement cycles, and how to problem solve. Practice facilitatorswill also be available for individual mentorship in person or via Zoom/phone call. During meetings, practice facilitators will support the committee to co-develop a tracking system for recommendations made during MPDSR

Первичные конечные точки

• MPDSR Fidelity (Implementation) [Срок оценки: From enrollment to study endline at 3 years]

Вторичные конечные точки (12)

• Reach of the practice facilitation package [Срок оценки: From enrollment to end of the active intervention phase (2 years)]
• Institutional Maternal Mortality Ratio (IMMR) [Срок оценки: From enrollment to study endline (3 years)]
• Perinatal mortality rate [Срок оценки: From enrollment to study endline (3 years)]
• Neonatal mortality rate [Срок оценки: From enrollment to study endline (3 years)]
• Adoption [Срок оценки: From enrollment to study endline (3 years)]
• Partial MPDSR fidelity [Срок оценки: From enrollment to study endline (3 years)]
• Adaptations [Срок оценки: From enrollment to study endline (3 years)]
• Maintenance of practice facilitation package [Срок оценки: From the end of the AMANI intervention phase to the end of the maintenance phase (1 year)]
• Maintenance of MPDSR [Срок оценки: From enrollment to study endline (3 years)]
• Provider technical MPDSR knowledge [Срок оценки: From enrollment to study endline (3 years)]
• Attitude towards MPDSR use (Personal motivation) [Срок оценки: From enrollment to study endline (3 years)]
• Perceived MPDSR social support (Social motivation) [Срок оценки: From enrollment to study endline (3 years)]

Критерии участия

Критерии включения

• Member of the MPDSR committee
• ≥18 years of age

Критерии исключения

• None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• National Guidelines for Maternal and Perinatal Death Surveillance and Response. Nairobi, Kenya: Kenyan Ministry of Health; 2024.
• Baskerville NB, Liddy C, Hogg W. Systematic review and meta-analysis of practice facilitation within primary care settings. Ann Fam Med. 2012 Jan-Feb;10(1):63-74. doi: 10.1370/afm.1312. PMID 22230833
• Willcox ML, Price J, Scott S, Nicholson BD, Stuart B, Roberts NW, Allott H, Mubangizi V, Dumont A, Harnden A. Death audits and reviews for reducing maternal, perinatal and child mortality. Cochrane Database Syst Rev. 2020 Mar 25;3(3):CD012982. doi: 10.1002/14651858.CD012982.pub2. PMID 32212268
• Smith H, Ameh C, Godia P, Maua J, Bartilol K, Amoth P, Mathai M, van den Broek N. Implementing Maternal Death Surveillance and Response in Kenya: Incremental Progress and Lessons Learned. Glob Health Sci Pract. 2017 Sep 28;5(3):345-354. doi: 10.9745/GHSP-D-17-00130. Print 2017 Sep 27. PMID 28963171
• Confidentiality Enquiry into Maternal Deaths in Kenya. Ministry of Health Kenya; 2017.
• Maputo Plan of Action 2016-2030: Universal Access to Comprehensive Sexual and Reproductive Health Services in Africa. Addis Ababa, Ethiopia: The African Union Commission; 2015.
• Kuruvilla S, Bustreo F, Kuo T, Mishra CK, Taylor K, Fogstad H, Gupta GR, Gilmore K, Temmerman M, Thomas J, Rasanathan K, Chaiban T, Mohan A, Gruending A, Schweitzer J, Dini HS, Borrazzo J, Fassil H, Gronseth L, Khosla R, Cheeseman R, Gorna R, McDougall L, Toure K, Rogers K, Dodson K, Sharma A, Seoane M, Costello A. The Global strategy for women's, children's and adolescents' health (2016-2030): a PMID 27147772
• Sharrow D, Hug L, You D, Alkema L, Black R, Cousens S, Croft T, Gaigbe-Togbe V, Gerland P, Guillot M, Hill K, Masquelier B, Mathers C, Pedersen J, Strong KL, Suzuki E, Wakefield J, Walker N; UN Inter-agency Group for Child Mortality Estimation and its Technical Advisory Group. Global, regional, and national trends in under-5 mortality between 1990 and 2019 with scenario-based projections until 203 PMID 35063111

Идентификаторы

NCT: NCT07560839 · STUDY00023958 · R01HD116777-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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