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Accelerating Maternal and Newborn Survival: The AMANI Study (AMANI)

23. dubna 2026 aktualizováno: Arianna Means, University of Washington

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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)

Typ studie

Intervenční

Zápis (Odhadovaný)

260

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Jennifer Unger, MD, MPH
  • Telefonní číslo: 2066859713
  • E-mail: junger@uw.edu

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Control Arm
The control arm will not receive any interventions. MPDSR committees will continue holding MPDSR meetings as usual for that facility.
Experimentální: AMANI Intervention Arm
In the intervention arm, trained practice facilitators (PFs) will deliver the practice facilitation package.
Behaviorální: 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.
Behaviorální: 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 meetings.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
MPDSR Fidelity (Implementation)
Časové okno: From enrollment to study endline at 3 years
The number and proportion of maternal and perinatal deaths for which all six MPDSR steps (identify deaths, report deaths, review deaths, recommend solutions, implement recommendations, evaluate recommendations) are implemented in full. Proportions of fully completed MPDSR cycles will be compared between intervention and control arms.
From enrollment to study endline at 3 years

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Reach of the practice facilitation package
Časové okno: From enrollment to end of the active intervention phase (2 years)
Reach is defined as the proportion of MPDSR committee members who participate in each component of the strategy package (audit and feedback and enhanced mentorship) out of the number of MPDSR committee members in each facility. We will determine if there is a significant difference in participation in each practice facilitation component over time across intervention facilities.
From enrollment to end of the active intervention phase (2 years)
Institutional Maternal Mortality Ratio (IMMR)
Časové okno: From enrollment to study endline (3 years)
Number of deaths of pregnant women within 42 days of the termination of pregnancy (from any cause related to or aggravated by the pregnancy or its management), divided by the total of deliveries in the facility over the same period of time. IMMR will be compared between intervention and control facilities.
From enrollment to study endline (3 years)
Perinatal mortality rate
Časové okno: From enrollment to study endline (3 years)
Number of stillbirths (fetal deaths at least 28 weeks of gestation) and newborn deaths (up to and including the first seven days after birth), divided by the total births in the facility over the same time. Perinatal mortality rate will be compared between intervention and control facilities.
From enrollment to study endline (3 years)
Neonatal mortality rate
Časové okno: From enrollment to study endline (3 years)
Number of deaths that occur in the first 28 days of life, divided by total live births in the facility over the same period of time. Neonatal mortality rate will be compared between intervention and control facilities.
From enrollment to study endline (3 years)
Adoption
Časové okno: From enrollment to study endline (3 years)
Adoption is defined as the proportion of deaths at each facility for which the first two steps of the MPDSR cycle are initiated (death was identified). The first two steps include deaths 1) identified and 2) reported with full documentation in maternal death review (MDR), perinatal death review (PDR), and neonatal death review (NDR) data forms within 7 days. Adoption will be considered a binary outcome (yes/no), and adoption will be compared between intervention and control facilities.
From enrollment to study endline (3 years)
Partial MPDSR fidelity
Časové okno: From enrollment to study endline (3 years)
Proportion of maternal, perinatal, and neonatal deaths for which less than six of the MPDSR steps are implemented, and average number of steps completed, to identify most challenging MPDSR step. Partial fidelity will be compared between intervention and control facilities.
From enrollment to study endline (3 years)
Adaptations
Časové okno: From enrollment to study endline (3 years)
We will use the Framework for Reporting Adaptations and Modifications to Evidence-based interventions (FRAME) to track monthly facility specific adaptations to MPDSR implementation in intervention facilities only and to identify how facilities incorporate MPDSR steps into their practice context and facility infrastructure. Of note, intervention facilities will not be adapting the implementation strategy (AMANI practice facilitation package) and will only be adapting how the MPDSR process is integrated into facility operations. Specifically, we will track the number of modifications made per month to MPDSR implementation, including documentation of the nature of the modification, goal/rationale for modification, timing, and other features.
From enrollment to study endline (3 years)
Maintenance of practice facilitation package
Časové okno: From the end of the AMANI intervention phase to the end of the maintenance phase (1 year)
Proportion of intervention facilities sustaining audit and feedback and/or enhanced mentorship 6 and 12 months after external PF support is withdrawn. We will determine if there is a significant difference in the prevalence ratio comparing participation in strategy components during the maintenance phase among intervention facilities.
From the end of the AMANI intervention phase to the end of the maintenance phase (1 year)
Maintenance of MPDSR
Časové okno: From enrollment to study endline (3 years)
The proportion of maternal and perinatal deaths for which all six MPDSR steps are implemented in full within 3 months, measured 6 and 12 months after external PF support is withdrawn. We will test the effect size of the immediate post-intervention change in fidelity and the overall slope to determine if moving from phase 1 (intervention phase) to phase 2 (maintenance phase) had a meaningful impact on fidelity, comparing intervention and control facilities.
From enrollment to study endline (3 years)
Provider technical MPDSR knowledge
Časové okno: From enrollment to study endline (3 years)
MPDSR technical knowledge will be measured at baseline, and months 12, 24, 30, and 36 across intervention and control facilities using a brief survey tool. The survey includes 38 questions in 3 domains (MPDSR knowledge, Data sources/forms/processes, and clinical competency), with three to four answer options per question. The total score and domain scores will be compared between intervention and control facilities.
From enrollment to study endline (3 years)
Attitude towards MPDSR use (Personal motivation)
Časové okno: From enrollment to study endline (3 years)
Mean responses to four questions using a 5-point Likert scale (strongly disagree to strongly agree) will be calculated and compared between intervention and control facilities. Personal motivation will be assessed at baseline, and at months 12, 24, 30, and 36.
From enrollment to study endline (3 years)
Perceived MPDSR social support (Social motivation)
Časové okno: From enrollment to study endline (3 years)
Mean responses to five questions using a 5-point Likert scale (strongly disagree to strongly agree) will be calculated and compared between intervention and control facilities. Social motivation will be assessed at baseline, and at months 12, 24, 30, and 36.
From enrollment to study endline (3 years)
Perceived self-efficacy to perform MPDSR steps (Behavioral skills/fatalism)
Časové okno: From enrollment to study endline (3 years)
Mean responses to six questions using a 5-point Likert scale (strongly disagree to strongly agree) will be calculated and compared between intervention and control facilities. Behavioral skills will be assessed at baseline, and at months 12, 24, 30, and 36.
From enrollment to study endline (3 years)
Psychological safety
Časové okno: From enrollment to study endline (3 years)
Mean responses to nineteen questions using a 5-point Likert scale (strongly disagree to strongly agree) will be calculated and compared between intervention and control facilities. Psychological safety will be assessed at baseline, and at months 12, 24, 30, and 36.
From enrollment to study endline (3 years)
Provider Burnout
Časové okno: From enrollment to study endline (3 years)
Provider burnout is assessed with 23 questions using a 5-point Likert scale (never to always). these 23 questions capture four domains: 1) exhaustion (8 questions); 2) mental distance (5 questions); 3) cognitive impairment (5 questions); and 4) emotional impairment (5 questions). Mean domain-specific scores will be calculated and compared between intervention and control facilities. Provider burnout will be assessed at baseline, and at months 12, 24, 30, and 36.
From enrollment to study endline (3 years)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Washington

Spolupracovníci

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Kenyatta National Hospital

Vyšetřovatelé

  • Vrchní vyšetřovatel: Arianna Means, PhD, MPH, University of Washington

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. června 2029

Dokončení studie (Odhadovaný)

1. června 2029

Termíny zápisu do studia

První předloženo

23. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

23. dubna 2026

První zveřejněno (Aktuální)

1. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • STUDY00023958
  • R01HD116777-01 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Abstracted, de-identified patient record data and survey data.

Časový rámec sdílení IPD

The final versions of any de-identified data collected and/or generated will be made publicly available within 12 months of publication. Data deposited in Dryad is intended to remain permanently archived and available.

Kritéria přístupu pro sdílení IPD

Final data gathered from this project will be archived for data sharing purposes in Dryad, NIH's recommended open-access generalist data repository.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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