Accelerating Maternal and Newborn Survival: The AMANI Study (AMANI)
2026年4月23日 更新者：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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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)
研究の種類
介入
入学 (推定)
260
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Arianna Means, PhD, MPH
- メール：aerubin@uw.edu
研究連絡先のバックアップ
- 名前：Jennifer Unger, MD, MPH
- 電話番号：2066859713
- メール：junger@uw.edu
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Member of the MPDSR committee
- ≥18 years of age
Exclusion Criteria:
- None
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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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実験的：AMANI Intervention Arm
In the intervention arm, trained practice facilitators (PFs) will deliver the practice facilitation package.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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MPDSR Fidelity (Implementation)
時間枠：From enrollment to study endline at 3 years
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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.
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From enrollment to study endline at 3 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reach of the practice facilitation package
時間枠：From enrollment to end of the active intervention phase (2 years)
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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.
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From enrollment to end of the active intervention phase (2 years)
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Institutional Maternal Mortality Ratio (IMMR)
時間枠：From enrollment to study endline (3 years)
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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.
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From enrollment to study endline (3 years)
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Perinatal mortality rate
時間枠：From enrollment to study endline (3 years)
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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.
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From enrollment to study endline (3 years)
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Neonatal mortality rate
時間枠：From enrollment to study endline (3 years)
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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.
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From enrollment to study endline (3 years)
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Adoption
時間枠：From enrollment to study endline (3 years)
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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.
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From enrollment to study endline (3 years)
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Partial MPDSR fidelity
時間枠：From enrollment to study endline (3 years)
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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.
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From enrollment to study endline (3 years)
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Adaptations
時間枠：From enrollment to study endline (3 years)
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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.
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From enrollment to study endline (3 years)
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Maintenance of practice facilitation package
時間枠：From the end of the AMANI intervention phase to the end of the maintenance phase (1 year)
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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.
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From the end of the AMANI intervention phase to the end of the maintenance phase (1 year)
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Maintenance of MPDSR
時間枠：From enrollment to study endline (3 years)
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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.
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From enrollment to study endline (3 years)
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Provider technical MPDSR knowledge
時間枠：From enrollment to study endline (3 years)
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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.
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From enrollment to study endline (3 years)
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Attitude towards MPDSR use (Personal motivation)
時間枠：From enrollment to study endline (3 years)
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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.
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From enrollment to study endline (3 years)
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Perceived MPDSR social support (Social motivation)
時間枠：From enrollment to study endline (3 years)
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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.
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From enrollment to study endline (3 years)
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Perceived self-efficacy to perform MPDSR steps (Behavioral skills/fatalism)
時間枠：From enrollment to study endline (3 years)
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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.
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From enrollment to study endline (3 years)
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Psychological safety
時間枠：From enrollment to study endline (3 years)
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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
時間枠：From enrollment to study endline (3 years)
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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)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- 主任研究者：Arianna Means, PhD, MPH、University of Washington
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2029年6月1日
研究の完了 (推定)
2029年6月1日
試験登録日
最初に提出
2026年4月23日
QC基準を満たした最初の提出物
2026年4月23日
最初の投稿 (実際)
2026年5月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月1日
QC基準を満たした最後の更新が送信されました
2026年4月23日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00023958
- R01HD116777-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Abstracted, de-identified patient record data and survey data.
IPD 共有時間枠
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.
IPD 共有アクセス基準
Final data gathered from this project will be archived for data sharing purposes in Dryad, NIH's recommended open-access generalist data repository.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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