Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05640050 |
| Other study ID # |
2021-6426-19638 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Aga Khan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
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 Phase V:
Establishing and Launching the Audit Cycle (monthly meetings)
The WHO audit system 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.
