Integrated Community Engagement and Audit Systems

Sponsor
Aga Khan University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05640050
Collaborator
Bill and Melinda Gates Foundation (Other)
1,000
1
1
21.9
45.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Audit Implementation
N/A

Detailed Description

Background

Pakistan is a low-middle income country with significant infrastructure challenges, poor allocation of government funding for health, poor access to essential healthcare services, low quality healthcare services (1), socio-cultural constraints and a feudal system that impacts all aspects of life in provinces (2). The major impact of these issues falls on the health of mothers and their newborn children - two cohorts that are already categorized as high at-risk population groups. The manifestations of this burden include a persistently high neonatal mortality rate (NMR) accounting for 57% of child deaths across the nation (3)with 41 out of every 1000 babies born dying before the end of their first month (4) and a maternal mortality ratio of 186 per 100,000 live births (5). Pakistan's perinatal, neonatal, and infant, under-five and maternal mortality rates remain unacceptably high, and while there have been efforts to improve this post-devolution, and progress has been painfully slow (6).

Audits and review systems especially with community engagement are two key elements have been shown to improve health system's performance, maternal and perinatal health outcomes particularly for at-risk populations (7). Audits provide a documented history of the events leading up to the death, and highlight process failures amenable to teachable moments to prevent repetitions of similar untoward events. Introducing audits and reviews reduce inpatient maternal mortality (adjusted OR 0.85, 95% CI 0.73 to 0.98; 191,167 deliveries; moderate certainty evidence) and likely also inpatient neonatal mortality (adjusted OR 0.74, 95% CI 0.61 to 0.90; moderate certainty evidence) (8). Findings from a meta-analysis of seven pre-and-post studies of facility-based perinatal mortality audits in LMICs indicated a reduction in perinatal mortality of 30% (95% confidence interval, 21-38%) after introduction of perinatal audits (9).

The District Health Information System (DHIS) despite high child and maternal death rates seldom records and reports mortality (e.g., maternal mortality, neonatal mortality etc.) and severe morbidity indicators (e.g. birth asphyxia, preeclampsia etc.) leading to challenges in data completeness remain for effective capturing of vital statistics through routine health and administrative data.

Whilst audit systems at the facility level allow for sustained improvements in quality provision and delivery of services, the under-utilized affiliated, but often overlooked, community linkages and engagement ensures proactive and detailed discussion of the causes leading to the deaths, improved working relationships between the community members, health providers and policymakers (10). These highlight major causes of deaths which could be preventable with amenable interventions. Audits for stillbirths and neonates also contribute to achieving goals of reducing stillbirths and neonatal deaths to 12 deaths/1000 as set out in Every Newborn Action Plan (ENAP) (11).

The "Three Delays Model" for Child and Maternal Mortality Pregnancy-related, neonatal and infant mortality can often be attributed to delays proposed in the "Three Delays" model (12) and sheds highlights the three key periods which have time-related consequences- the first delay due to the decision to seek medical care, the second delay caused by the time to reach the health facility, and the third delay caused by receiving appropriate care after reaching the medical facility (13; 14; 15). In the case of Pakistan, the first delay has been further disaggregated into two subgroups; delay in recognition of the severity of illness and danger signs contributed to 18% out of all delays, and delays in decision making by virtue of limited action of women to make decisions regarding their transfer to facilities estimated majorly about 34% (6).

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 (16). However, there is lack of harmonization and coordination within health systems.

The WHO is currently assisting KPK and Balochistan provinces, and UNICEF in helping in Sindh in implementation of audit mechanisms. However, no information or outcomes of these training is available. The UN brief on COVID-19 (17) and the Pakistan Health Report 2020 (18) both mention MPDSR as a tremendous opportunity to bridge implementation gaps in the Civil Registration and Vital Systems and sharing of impending results and gains from the MPDSR.

Research hypothesis and aims

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:
  1. 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?

  2. 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?

  3. 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.

AUDIT-SYSTEM IMPLEMENTATION PHASES (six phases) The project development is based on formative research which identified focal personnel readiness, stakeholder participation and readiness of the health facilities. Afterwards, this will provide assistance in the intervention component and collaboration. The process will include consultative meetings of project core committee, program advisory committee, director general health and district health office.

Phase I: Identification of facility leadership and community leadership The project core team and district manager identify facilities and community representatives who will coordinate and liaise with other stakeholders of the districts for the implementation of the community audit interventions.

Phase II: Establishing Audit Committee The health facility in-charge will establish an audit committee utilizing existing health committees at the Tehsil Head Quarters (THQs)Quality control committees, medical inspection committees, health welfare committees and joint health inspection committees already exist in health facilities at Matiari. Audit committees led by Medical Superintendent (MS)of the hospital, with a member from administration, and three to four consultants or medical officers from various departments (gynecologist, pediatrician, ENT specialist, pathologist, head of emergency department and head nurse), district magistrate or focal person from district health offices. Community engagement and audit system for project audit committee will be established at each facility, preferably members will be at least two obstetricians, 2 pediatricians, 1 administrator, project focal person and Community representatives as community audit representative. Responsibilities and structure of audit committee pre- described. Members of audit committee make their credentials updated every month in the sheet for future mentoring and sustainability and trickle-down trainings will be carried out by audit committee members.

Phase III: Audit with Community Engagement Community representatives (1-3 focal persons) male or female will be identified as community audit representatives. They will attend monthly audit meetings with facility-based audit committee to discuss the community perspectives particularly (one and two delays) and other issues pertaining in the negative maternal and perinatal outcomes. For enhancing community representation and necessary actions taken for the solution, LHWs, LHVS, CMWS, male community mobilizer (village/otaq leader or any other active member of village), or any other influential women in the village would be engaged for audit committee decisions. The aim is to develop coordinated discussion among community representative and health care provider at facility. They will provide timely oversight, monitor and response to the adverse event and later confer in the Audit meetings.

Phase IV: Training of the Audit Committee

Training for audit representatives, members of audit committee, will be conducted. 5-days training workshop to include:

Day 1: Maternal death and near misses, perinatal, neonatal deaths and morbidity outcomes Day 2: 'Three-delay' framework and identifying modifiable factors Day 3: Mentoring on the identification of the audit committees and initiating audit implementation committee

The audit committee will be trained to follow ethical guidelines to maintain the empathetic gesture while recalling the mortalities by the respondents. Training will be ensured to reflect optimal treatment of respondents according to scientific evidence available at the health facilities (i.e., national policies, standards and guidelines). Training will also include standardized case studies and completion the audit meeting minutes and action items tools.

Phase V: Establishing and Launching the Audit Cycle (monthly meetings)

The WHO audit system (7) will be adapted to assess maternal, perinatal and neonatal audits with the following steps:

Step 1. Identifying cases for review

Step 2. Collecting information

Step 3. Analyzing information

Step 4. Recommending Solutions Step 5: Implementing changes Step 6: Monitor and Evaluation Phase VI: Quarter re-certification of Audit Committee For sustainable audit system, recognition and reinforcement is inevitable. Refresher trainings and re certification will be conducted quarterly.

DATA MANAGEMENT AND ANALYSIS The data collection tool will be developed in English and then translated into the local language to be administered in the local community visiting health facilities. Data will be collected manually and entered through a specifically designed app. The app will be installed on laptop/desktop at each health facility under the supervision of project focal person. The AKU- Data Management Unit (DMU) will develop the electronic database that includes the filters and data quality check indicators. Data will be entered at the end of every week and uploaded at AKU -DMU server. All data files will be stored for 5-7 years and then deleted according to organizational procedures for the permanent destruction of electronic and paper data.

The data will be analyzed through STAT v.16 and password-protected excel files. Descriptive statistics will be used to estimate maternal, neonatal, and other key quantitative variables. Three-delay's framework will be used to categorize the identified modifiable factors. The action report will be submitted based on the recommendations proposed by Audit committee.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Feasibility of Developing and Scaling up an Integrated Community Engagement and Audit Systems to Improve Maternal and Perinatal Outcomes in Rural Pakistan
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Audit Implementation with Community Engagement

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
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.

Outcome Measures

Primary Outcome Measures

  1. Proportion of facilities implemented Audit System. [18 months]

    number of facilities conduct monthly audit meetings

  2. Distribution of mortality by places of death [18 months]

    geographic identification of high-risk areas

  3. Proportion of community audit representative sharing feedback with community members regularly [18 months]

    sharing through community sessions

  4. Proportion of health facilities recording stillbirth, neonatal mortality; maternal "near miss" and maternal mortality [18 months]

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

Secondary Outcome Measures

  1. Proportion of health facility recording Referrals in and out [18 months]

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

  2. Proportion of cases referred to health facilities through LHWs [18 months]

    measure from monthly reports and DHIS

  3. Increase in proportion of women who can correctly identify at least 3 danger signs at pregnancy and childbirth [18 months]

    measure through community sessions

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Women aged 15-49 years who reside in the selected district. Secondary level public health facilities that offer obstetric and postnatal care, and respective catchment areas are supported by LHWs, included in the study. Data for all maternal 'near misses', perinatal and neonatal mortality and morbidity outcomes recorded for all women and newborns who deliver at home (through LHW 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 who are non- residents of the study district and who do not provide consent.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aga Khan University Karachi Sindh Pakistan 74800

Sponsors and Collaborators

  • Aga Khan University
  • Bill and Melinda Gates Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Zulfiqar Ahmed Bhutta, Distinguish Professor and Director, Aga Khan University
ClinicalTrials.gov Identifier:
NCT05640050
Other Study ID Numbers:
  • 2021-6426-19638
First Posted:
Dec 7, 2022
Last Update Posted:
Dec 7, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Zulfiqar Ahmed Bhutta, Distinguish Professor and Director, Aga Khan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2022