NCT07560839

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Maternal MortalityNeonatal MortalityPerinatal MortalityMaternal and Perinatal Death Surveillance and Response (MPDSR) Implementation

Keywords

practice facilitationRE-AIMaudit and feedbackenhanced mentorship

Outcome Measures

Primary Outcomes (1)

  • MPDSR Fidelity (Implementation)

    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

Secondary Outcomes (15)

  • Reach of the practice facilitation package

    From enrollment to end of the active intervention phase (2 years)

  • Institutional Maternal Mortality Ratio (IMMR)

    From enrollment to study endline (3 years)

  • Perinatal mortality rate

    From enrollment to study endline (3 years)

  • Neonatal mortality rate

    From enrollment to study endline (3 years)

  • Adoption

    From enrollment to study endline (3 years)

  • +10 more secondary outcomes

Study Arms (2)

Control Arm

NO INTERVENTION

The control arm will not receive any interventions. MPDSR committees will continue holding MPDSR meetings as usual for that facility.

AMANI Intervention Arm

EXPERIMENTAL

In the intervention arm, trained practice facilitators (PFs) will deliver the practice facilitation package.

Behavioral: Audit and FeedbackBehavioral: Enhanced Mentorship

Interventions

Audit and FeedbackBEHAVIORAL

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.

AMANI Intervention Arm
Enhanced MentorshipBEHAVIORAL

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.

AMANI Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • National Guidelines for Maternal and Perinatal Death Surveillance and Response. Nairobi, Kenya: Kenyan Ministry of Health; 2024.

    BACKGROUND

  • 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: 22230833BACKGROUND

  • 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: 32212268BACKGROUND

  • 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: 28963171BACKGROUND

  • Confidentiality Enquiry into Maternal Deaths in Kenya. Ministry of Health Kenya; 2017.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 27147772BACKGROUND

  • 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.

    PMID: 35063111BACKGROUND

MeSH Terms

Conditions

Maternal DeathPerinatal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Arianna Means, PhD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Unger, MD, MPH

CONTACT

2066859713junger@uw.edu

Arianna Means, PhD, MPH

CONTACT

aerubin@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Global Health

Study Record Dates

First Submitted

April 23, 2026

First Posted

May 1, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
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.
Access Criteria
Final data gathered from this project will be archived for data sharing purposes in Dryad, NIH's recommended open-access generalist data repository.