Accelerating Maternal and Newborn Survival: The AMANI Study (AMANI)
23. april 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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)
Studietype
Intervensjonell
Registrering (Antatt)
260
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Arianna Means, PhD, MPH
- E-post: aerubin@uw.edu
Studer Kontakt Backup
- Navn: Jennifer Unger, MD, MPH
- Telefonnummer: 2066859713
- E-post: junger@uw.edu
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Member of the MPDSR committee
- ≥18 years of age
Exclusion Criteria:
- None
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control Arm
The control arm will not receive any interventions.
MPDSR committees will continue holding MPDSR meetings as usual for that facility.
|
|
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Eksperimentell: AMANI Intervention Arm
In the intervention arm, trained practice facilitators (PFs) will deliver the practice facilitation package.
|
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.
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
MPDSR Fidelity (Implementation)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Reach of the practice facilitation package
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
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Adaptations
Tidsramme: 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
Tidsramme: 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)
|
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Maintenance of MPDSR
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
|
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Perceived self-efficacy to perform MPDSR steps (Behavioral skills/fatalism)
Tidsramme: 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)
|
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Psychological safety
Tidsramme: 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.
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From enrollment to study endline (3 years)
|
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Provider Burnout
Tidsramme: 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.
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From enrollment to study endline (3 years)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Arianna Means, PhD, MPH, University of Washington
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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 roadmap based on evidence and country experience. Bull World Health Organ. 2016 May 1;94(5):398-400. doi: 10.2471/BLT.16.170431. Epub 2016 May 2. No abstract available.
- National Guidelines for Maternal and Perinatal Death Surveillance and Response. Nairobi, Kenya: Kenyan Ministry of Health; 2024.
- 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.
- 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.
- 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.
- 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 2030: a systematic analysis by the UN Inter-agency Group for Child Mortality Estimation. Lancet Glob Health. 2022 Feb;10(2):e195-e206. doi: 10.1016/S2214-109X(21)00515-5.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. juni 2029
Studiet fullført (Antatt)
1. juni 2029
Datoer for studieregistrering
Først innsendt
23. april 2026
Først innsendt som oppfylte QC-kriteriene
23. april 2026
Først lagt ut (Faktiske)
1. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00023958
- R01HD116777-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Abstracted, de-identified patient record data and survey data.
IPD-delingstidsramme
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.
Tilgangskriterier for IPD-deling
Final data gathered from this project will be archived for data sharing purposes in Dryad, NIH's recommended open-access generalist data repository.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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