Clinical trial NCT03904706: Linking Facility-based Mortality Audits With Community Engagement in Gilgit-Baltistan, Pakistan
Official title: A Pilot Study: Linking Facility-based Mortality Audits With Community Engagement to Improve Maternal and Newborn Outcomes in Gilgit-Baltistan, Pakistan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: External Causes of Morbidity and Mortality
Stillbirth
Neonatal Death
Keywords: Facility-based
Mortality
Audits
Community engagement
Gilgit-Baltistan
Pakistan
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Aga Khan Foundation, Pakistan
name: Aga Khan Health Services
name: Centre for Global Child Health, SickKids Research Institute - Toronto, Canada
name: Aga Khan Development Network - Islamabad, Pakistan
name: Department of Health Gilgit-Baltistan - Pakistan
name: Aga Khan Foundation, Canada
First posted: 2019-04-05
Enrollment: 1871
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: Pakistan has the highest global newborn mortality rate (45.6/1,000 live births), with 1 in 22 babies dying before the end of their first month (UNICEF, 2018). Some of the highest perinatal and neonatal mortality rates are found in districts of Pakistan's mountainous northern region, where geography, climate and security risks make it challenging for women in remote communities to reach health services in a timely manner. Implementation of a health facility mortality audit cycle has proved successful in reducing perinatal mortality by up to 30% in other LMICs. Meanwhile evidence suggests that the most common factors contributing to high mortality rates are due to phase-one delays. Given the geographical location of 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 delivery services, but to effect change at the community, through community-feedback meetings to mitigate phase one and two delays and improve maternal, perinatal and neonatal outcomes. Data from this study may help inform government policy decisions about standardized mortality audits with community feedback.

Objectives of the study

Broad objective:

The overall aim of the study is to assess whether implementation of facility-based maternal, perinatal and neonatal mortality audits (systemic clinical reviews of near misses and deaths), in combination with targeted community engagement and awareness activities, increases the recognition of danger signs during pregnancy, the number of facility deliveries and encourages the discussion of a birthing plan, thereby reducing phase -one, two and three delays as compared to implementing facility-based mortality audits only. This will be assessed by monitoring births and outcomes in public and private health facilities and their associated catchment communities in GB. The study will also evaluate whether these targeted community-engagement activities, informed by the clinical audits improve the quality of delivery services through better utilization of local resources and improvements in clinical signal functions.

Specific objectives Primary objective

To determine the effect of a combined approach of facility-based audits (clinical reviews) linked to community engagement on core community behaviours/practices to improve obstetric, perinatal and neonatal outcomes as compared to standard perinatal and neonatal facility-based audits only and no facility-based audits. Key practices include:

1. Recognition of danger signs among women during pregnancy, labour and delivery, after delivery and in newborns
2. Actions taken for a birthing preparation plan

Secondary objectives

1. Assess facility deliveries
2. Assess severe maternal morbidity outcomes during delivery (including maternal near misses )
3. Assess changes in quality of delivery services as measured through the delivery room checklist
4. Assess changes in first delay (care-seeking decision) I. Delay due to lack of knowledge II. Lack of empowerment (sociocultural factors/barriers such as women's decision making, women's status)
5. Assess changes in second delay (identification and reaching health facility)
6. Assess changes in third delay (receiving adequate care and treatment at facilities)
7. Assess perinatal mortality rates (fresh still birth or neonatal death in the first week of life)
8. Assess neonatal mortality rates (deaths in the first 28 days of life)

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in proportion of women who can correctly identify at least 3 danger signs at each stage across the continuum of care
timeFrame: 12 months
measure: Change in proportion of women for which at least 5 birthing plan actions were taken for the birth of the index child
timeFrame: 12 months
Secondary outcomes:
measure: Change in number of facility deliveries
timeFrame: 12 months
measure: Change in severe maternal morbidity outcomes
timeFrame: 12 months
measure: Change in the quality of delivery services
timeFrame: 12 months
measure: Change in proportion of first, second and third delays
timeFrame: 12 months
measure: Perinatal mortality (fresh stillbirth or neonatal death in the first week of life)
timeFrame: 12 months
measure: Neonatal mortality (deaths in the first 28 days of life)
timeFrame: 12 months
Other outcomes:
Locations:
city: Gilgit, Astore, Ghizer, Hunza And Nagar
country: Pakistan
facility: Government and AKHSP Health Facilities in Gilgit-Baltistan
state: Gilgit-Baltistan
Study officials:
affiliation: Aga Khan University
name: Sajid Soofi, FCPS, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Global Child Health, SickKids Research Institute - Toronto, Canada
name: Diego Bassani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan Foundation, Pakistan
name: Aminah Jahangir, MBBS, HPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Global Child Health, SickKids Research Institute - Toronto, Canada
name: Zulfiqar A Bhutta, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Gul Nawaz Khan, MA, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Global Child Health, SickKids Research Institute - Toronto, Canada
name: Suzanne E Powell, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan Health Services
name: Miraj Uddin, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan Foundation, Pakistan
name: Saad Y Sulaimani, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan Development Network - Islamabad, Pakistan
name: Asma Sittar, MSc
role: PRINCIPAL_INVESTIGATOR
References: