Integrated Community Engagement and Audit Systems

NCT05640050 | Unknown DMC

• 1 other identifier: 2021-6426-19638
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maternal Death; Neonatal Death; Stillbirth

Keywords

Facility Audit; morbidity; mortality

Outcome Measures

Primary Outcomes (4)

• Proportion of facilities implemented Audit System.

  number of facilities conduct monthly audit meetings

  18 months

• Distribution of mortality by places of death

  geographic identification of high-risk areas

  18 months

• Proportion of community audit representative sharing feedback with community members regularly

  sharing through community sessions

  18 months

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

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

  18 months

Secondary Outcomes (3)

• Proportion of health facility recording Referrals in and out

  18 months

• Proportion of cases referred to health facilities through LHWs

  18 months

• Increase in proportion of women who can correctly identify at least 3 danger signs at pregnancy and childbirth

  18 months

Study Arms (1)

Audit Implementation with Community Engagement

EXPERIMENTAL

This feasibility and implementation research implementing in secondary level care hospitals (Tehsil Head Quarters THQ) at Matiari district of Sindh Province, Pakistan. The audit committees will be established in three THQs including management, specialist, medical officer, and community representatives from catchment area.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. A monthly monitoring cycle will be set up within the implementing facilities to ensure effective implementation of the audit systems.

Other: Audit Implementation

Interventions

Audit Implementation OTHER

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.

Audit Implementation with Community Engagement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Maternal Death; Perinatal Death; Stillbirth

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Death

Study Officials

• Zulfiqar Bhutta, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguish Professor and Director

Model Details: We plan a mixed methods design that integrates formative research and evaluative components into iterative improvements cycles. The interventions undertaken will look at feasibility and document the process and challenges of implementing an Audit system at scale.

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)