Accelerating Maternal and Newborn Survival: The AMANI Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 260
- 主要终点
- MPDSR Fidelity (Implementation)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Member of the MPDSR committee
- •≥18 years of age
排除标准
- 未提供
研究组 & 干预措施
AMANI Intervention Arm
In the intervention arm, trained practice facilitators (PFs) will deliver the practice facilitation package.
干预措施: Audit and Feedback (Behavioral)
AMANI Intervention Arm
In the intervention arm, trained practice facilitators (PFs) will deliver the practice facilitation package.
干预措施: Enhanced Mentorship (Behavioral)
Control Arm
The control arm will not receive any interventions. MPDSR committees will continue holding MPDSR meetings as usual for that facility.
结局指标
主要结局
MPDSR Fidelity (Implementation)
时间窗: 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.
次要结局
- 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))
- Perceived self-efficacy to perform MPDSR steps (Behavioral skills/fatalism)(From enrollment to study endline (3 years))
- Adoption(From enrollment to study endline (3 years))
- Partial MPDSR fidelity(From enrollment to study endline (3 years))
- Adaptations(From enrollment to study endline (3 years))
- Maintenance of practice facilitation package(From the end of the AMANI intervention phase to the end of the maintenance phase (1 year))
- Maintenance of MPDSR(From enrollment to study endline (3 years))
- Provider technical MPDSR knowledge(From enrollment to study endline (3 years))
- Attitude towards MPDSR use (Personal motivation)(From enrollment to study endline (3 years))
- Perceived MPDSR social support (Social motivation)(From enrollment to study endline (3 years))
- Psychological safety(From enrollment to study endline (3 years))
- Provider Burnout(From enrollment to study endline (3 years))
研究者
Arianna Means
Associate Professor, Global Health
University of Washington