跳至主要内容
临床试验/NCT05640050
NCT05640050Enrolling By Invitation不适用

Feasibility of Developing and Scaling up an Integrated Community Engagement and Audit Systems to Improve Maternal and Perinatal Outcomes in Rural Pakistan

Aga Khan University2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,000
试验地点
2
主要终点
Proportion of community audit representative sharing feedback with community members regularly

研究概览

简要总结

The goal of this implementation research project is to determine the feasibility of establishing and implementing an acceptable and robust audit system with community representation at secondary health facilities to improve maternal and perinatal outcomes. The implementation phases follow the standard World Health Organization (WHO) audit system. The initial step includes identifying death cases for review and subsequently collecting the detailed information on the near miss and adverse event history. A mixed methods data analysis will include both quantitative components, such as identification of trends in rates and causes of death and geographic location, and qualitative components, such as analysis of modifiable factors. The use of both types of data will provide a robust analysis of the problems and aid the audit team iin identifying and supporting priorities for action. The three-delay's model categorize the modifiable factors as the first delay (recognition of danger sign and care-seeking decision), second delay (identification and reaching health facility) and third delays (receiving adequate care and treatment at facilities). The audit team will make recommendations in collaboration with community representatives. The findings of the audits will be shared with the health facility authorities, program managers and community representatives to support policy and practice changes. A monthly monitoring cycle will be set up within the implementing facilities to ensure effective implementation of the audit systems.

详细描述

Background:

Previous Efforts at Introducing Audit Systems in Pakistan Previous efforts to introduce facility Audit Systems with the support of WHO and other government initiatives have been undertaken. The Ministry of National Health Services, Regulations and Coordination, Government of Pakistan published national protocols with detailed operational guidelines, protocols, training materials, tools on phased implementation of the Maternal & Perinatal Death Surveillance and Response (MPDSR) to enhance reporting, recording, tracking, and auditing of deaths. Implementation of the protocols at the facility level was tasked to the provinces in the light of the Eighteenth Amendment. However, there is lack of harmonization and coordination within health systems.

We hypothesize that a locally relevant and reliable audit system developed in close consult with local community representatives and providers will provide sound evidence for supporting appropriate policy regarding the implementation of standard operating procedures for implementing standardized mortality audits

The specific research questions are:

I. Will the maternal and perinatal audits improve the reporting of deaths and near misses at the health facility and DHIS? II. Will the community-facility audit interaction improve the early referral proportions and facility births and reduce the three delays? III. Will the audit systems help better identify medical and non-medical factors of deaths and near-misses and how access to and quality of care be improved through integration of feedback loops within the health facilities and communities? IV. Does the implementation of facility based maternal, perinatal and neonatal mortality audit in combination with targeted community engagement and awareness activities improve the maternal and perinatal outcomes? To test our first hypothesis, our primary objective will seek to: i) Identify and establish audit committees at health facility level with community engagement; ii) Determine the feasibility of implementing an acceptable audit system with community representation in existing secondary health facilities and serving catchment population to improve maternal and perinatal outcomes through formative research combined with continuous evaluation and scaling up approach Our Secondary Objectives are to: i) assess intervention changes observed in first delay (care-seeking decision), second delay (identification and reaching health facility) and third delays (receiving adequate care and treatment at facilities); ii) propose possible solutions and record actions taken in order to improve access to quality of care through integrated of feedback loops within health facilities and communities.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Married women aged 15-49 years
  • Children Under five years of age

排除标准

  • Women who are non- residents of the study district and who do not provide consent.

结局指标

主要结局

Proportion of community audit representative sharing feedback with community members regularly

时间窗: 18 months

sharing through community sessions

Proportion of facilities implemented Audit System.

时间窗: 18 months

number of facilities conduct monthly audit meetings

Distribution of mortality by places of death

时间窗: 18 months

geographic identification of high-risk areas

Proportion of health facilities recording stillbirth, neonatal mortality; maternal "near miss" and maternal mortality

时间窗: 18 months

data record and report in District Health Information System (DHIS)

次要结局

  • Proportion of cases referred to health facilities through LHWs(18 months)
  • Proportion of health facility recording Referrals in and out(18 months)
  • Increase in proportion of women who can correctly identify at least 3 danger signs at pregnancy and childbirth(18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Zulfiqar Ahmed Bhutta

Distinguish Professor and Director

Aga Khan University

研究点 (2)

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