Linking Facility-based Mortality Audits With Community Engagement in Gilgit-Baltistan, Pakistan

NCT03904706 | Terminated

• 1 other identifier: GB mortality audits study
• Study Type: interventional
• Target: 1,871
• Locations: 1 country
• Sites: 1

Brief Summary

Pakistan is one of the countries in South Asia where neonatal mortality rates remain stagnant. Babies born in Pakistan encounter the highest risk of dying; of every 1,000 babies born, 46 die before the end of their first month (UNICEF, 2018). Some of the highest perinatal and neonatal mortality rates in Pakistan are found in districts of Pakistan's mountainous northern region (Bhutta ZA, 2013), where geography, climate and security risks make it challenging for women in remote communities to reach health services in a timely manner. According to 2013 PDHS, the neonatal and perinatal mortality rate in the northern area of Gilgit Baltistan was 39/1,000 and 37/1,000, respectively. In the rural area of Khyber Pakhtunkhwa, the neonatal and perinatal mortality rate was 42/1,000 and 63/1,000, respectively. Implementation of a health facility mortality audit cycle has proved successful in reducing perinatal mortality by upto 30% in other LMICs. Meanwhile evidence suggests that the most common factors contributing to high mortality rates are due to phase-one delays (delay in the decision to seek care). This study will attempt to operationalize linkages between the community and facility to not only improve facility-based quality of care, but to bring change in the community through community-feedback meetings to mitigate phase one and two delays and improve maternal, perinatal and neonatal outcomes. Data from this study will inform MoH policy decisions about standardized mortality audits with community feedback. Given the geographical location of Gilgit-Baltistan (GB) and accompanying constraints such as terrain and security, this study will attempt to operationalize linkages between the community and facility to not only improve facility-based quality of care, but to bring change in the community through community-feedback meetings to mitigate phase one and two delays and improve maternal, perinatal and neonatal outcomes. Data from this study will inform MoH policy decisions about standardized mortality audits with community feedback.

Conditions

External Causes of Morbidity and Mortality; Stillbirth; Neonatal Death

Keywords

Facility-based; Mortality; Audits; Community engagement; Gilgit-Baltistan; Pakistan

Outcome Measures

Primary Outcomes (2)

• Change in proportion of women who can correctly identify at least 3 danger signs at each stage across the continuum of care

  Change in proportion of women who can correctly identify at least 3 danger signs at each stage across the continuum of care

  12 months

• Change in proportion of women for which at least 5 birthing plan actions were taken for the birth of the index child

  Change in proportion of women for which at least 5 birthing plan actions were taken for the birth of the index child: Discussed place of delivery, Discussed who will perform delivery, Set aside funds for delivery, Set aside alternate funds for costs of skilled and emergency care, Made arrangements for transport, Identified a blood donor, Discussed accompaniment to planned delivery location.

  12 months

Secondary Outcomes (6)

• Change in number of facility deliveries

  12 months

• Change in severe maternal morbidity outcomes

  12 months

• Change in the quality of delivery services

  12 months

• Change in proportion of first, second and third delays

  12 months

• Perinatal mortality (fresh stillbirth or neonatal death in the first week of life)

  12 months

Study Arms (3)

Audits only

EXPERIMENTAL

Formalized audit teams with monthly meetings at each facility. Audit Intervention phases: 1. Identification of facility leadership (i.e physicians or leading health care providers) to be trained on best practices in obstetric and perinatal care in the implementation of the audits. 2. Training of identified audit leaders (main investigator is typically a physician) a. 5-day training workshop to include: i. Day 1: maternal death and near misses, perinatal, neonatal deaths and morbidity outcomes ii. Day 2: 'Three-delay' framework and identifying modifiable factors iii. Day 3: data collection and setting up the audit system iv. Days 4-5: mentoring on the identification of the audit teams and initiating audit implementation 3. Creating audit team (composed of at least two obstetricians, 2 pediatricians plus the main investigator) 4. Establishing and launching the audit cycle (monthly meetings) 5. Annual re-certification of audit leaders

Other: Audits only

Audits with community feedback

EXPERIMENTAL

This intervention will implement the audits as described in arm 1; however, key community representatives (approximately 3-5 members) will be identified to attend monthly follow-up meetings with audit team leaders to discuss the community aspects (phase one and two-delays) that could have prevented the death, near miss or severe adverse outcome. Information regarding the cause(s) of death in the community will be collected by the LHW or CMW, who reports to the health facility on a monthly basis.

Other: Audits with community feedback

Control

NO INTERVENTION

Monthly outcome data will be collected from health facilities where no audits will be conducted. Data from this group will help evaluate the effectiveness of the intervention arms on perinatal and neonatal mortality.

Interventions

Audits only OTHER

Formalized audit teams with monthly meetings at each facility.

Audits only

Audits with community feedback OTHER

This intervention will implement the audits as described in arm 1; however, key community representatives (approximately 3-5 members) will be identified to attend monthly follow-up meetings with audit team leaders to discuss the community aspects (phase one and two-delays) that could have prevented the death, near miss or severe adverse outcome. Information regarding the cause(s) of death in the community will be collected by the LHW or CMW, who reports to the health facility on a monthly basis.

Audits with community feedback

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women aged 15-49 years who have had a pregnancy in the last 12 months who reside in the five targeted districts. Public and private health facilities in five districts in GB that offer obstetric and postnatal care, and respective catchment areas are supported by LHWs, Lady Health Volunteers (LHVs), CMWs, and CHWs will be included in the study. Data for all maternal 'near misses', perinatal and neonatal mortality and morbidity outcomes will be recorded for all women and newborns who deliver at home (through LHW, LHV, CMW monthly reports) and who contact the health facility within 42 days post-delivery, regardless of whether or not they delivered in the health facility.

You may not qualify if:

• Women aged 15-49 years who have not had a pregnancy in the last 12 months, who reside in the five targeted districts. Health facilities in five districts of GB that do not provide any obstetric and postnatal care and are not affiliated with any LHWs, or CMWs will be excluded.

Sponsors & Collaborators

• Aga Khan University: lead
• Aga Khan Foundation, Pakistan: collaborator
• Aga Khan Health Services: collaborator
• Centre for Global Child Health, SickKids Research Institute - Toronto, Canada: collaborator
• Aga Khan Development Network - Islamabad, Pakistan: collaborator
• Department of Health Gilgit-Baltistan - Pakistan: collaborator
• Aga Khan Foundation, Canada: collaborator

Study Sites (1)

Government and AKHSP Health Facilities in Gilgit-Baltistan

Gilgit, Astore, Ghizer, Hunza and Nagar, Gilgit-Baltistan, 74800, Pakistan

Location

MeSH Terms

Conditions

Stillbirth; Perinatal Death

Condition Hierarchy (Ancestors)

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

Study Officials

• Sajid Soofi, FCPS, MBBS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Diego Bassani, PhD

  Centre for Global Child Health, SickKids Research Institute - Toronto, Canada

  PRINCIPAL INVESTIGATOR

• Aminah Jahangir, MBBS, HPM

  Aga Khan Foundation, Pakistan

  PRINCIPAL INVESTIGATOR

• Zulfiqar A Bhutta, PhD

  Centre for Global Child Health, SickKids Research Institute - Toronto, Canada

  PRINCIPAL INVESTIGATOR

• Gul Nawaz Khan, MA, MPH

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Suzanne E Powell, MSc

  Centre for Global Child Health, SickKids Research Institute - Toronto, Canada

  PRINCIPAL INVESTIGATOR

• Miraj Uddin, MA

  Aga Khan Health Services

  PRINCIPAL INVESTIGATOR

• Saad Y Sulaimani, MSc

  Aga Khan Foundation, Pakistan

  PRINCIPAL INVESTIGATOR

• Asma Sittar, MSc

  Aga Khan Development Network - Islamabad, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Health facilities (clusters) will be the units of randomization. Within each stratum, health facilities will be randomly allocated to one of the three arms. Arm 1: includes morbidity and mortality health facility audits-only; arm 2: includes morbidity and mortality health facility audits in addition to community-engagement; and arm 3: will serve as the control arm and collect outcome data only.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This will be a three-arm cluster randomized controlled study to evaluate a novel intervention. Each facility is a cluster and includes all deliveries (including stillbirths and live births) in health facilities and respective catchment areas that provide obstetric and post-natal services.

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 5, 2019
• Study Start: April 16, 2019
• Primary Completion: March 20, 2020
• Study Completion: May 31, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)