Maternal DeathNCT05640050
Integrated Community Engagement and Audit Systems
A study testing Audit Implementation in people with Maternal Death and Neonatal Death, run by Aga Khan University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maternal Death, Neonatal Death, Stillbirth
- What is being tested?
- Audit Implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Married women aged 15-49 years
- Children Under five years of age
Who cannot join
- Women who are non- residents of the study district and who do not provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Developing and Scaling up an Integrated Community Engagement and Audit Systems to Improve Maternal and Perinatal Outcomes in Rural Pakistan
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.
Read the detailed 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:
- 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.
- Conditions
- Maternal Death, Neonatal Death, Stillbirth
- Being tested
- Audit Implementation
- Keywords
- Facility Audit, morbidity, mortality
- Medical subject headings
- Maternal Death, Perinatal Death, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit ImplementationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Audit Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of facilities implemented Audit System.
number of facilities conduct monthly audit meetings
Measured: 18 months
Distribution of mortality by places of death
geographic identification of high-risk areas
Measured: 18 months
Proportion of community audit representative sharing feedback with community members regularly
sharing through community sessions
Measured: 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)
Measured: 18 months
Secondary outcomes (3)
Proportion of health facility recording Referrals in and out
data record and report in District Health Information System (DHIS)
Measured: 18 months
Proportion of cases referred to health facilities through LHWs
measure from monthly reports and DHIS
Measured: 18 months
Increase in proportion of women who can correctly identify at least 3 danger signs at pregnancy and childbirth
measure through community sessions
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2023
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
- Investigators
- Zulfiqar Bhutta, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640050
- Sponsor's protocol ID
- 2021-6426-19638
- Status last verified
- Aug 2023
- First submitted
- 28 Nov 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Developing and Scaling up an Integrated Community Engagement and Audit Systems to Improve Maternal and Perinatal Outcomes in Rural Pakistan
- ClinicalTrials.gov ID
- NCT05640050
- Acronym / sponsor ID
- 2021-6426-19638
- Conditions
- Maternal Death, Neonatal Death, Stillbirth
- Keywords
- Facility Audit, morbidity, mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Audit Implementation with Community Engagement | Experimental | Other: Audit ImplementationThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Married women aged 15-49 years
- Children Under five years of age
Key exclusion criteria (1 listed)
- Women who are non- residents of the study district and who do not provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audit ImplementationThe 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. | Other | Audit Implementation with Community Engagement |
Primary outcome
Proportion of facilities implemented Audit System.
Time frame: 18 months
number of facilities conduct monthly audit meetings
Distribution of mortality by places of death
Time frame: 18 months
geographic identification of high-risk areas
Proportion of community audit representative sharing feedback with community members regularly
Time frame: 18 months
sharing through community sessions
Proportion of health facilities recording stillbirth, neonatal mortality; maternal "near miss" and maternal mortality
Time frame: 18 months
data record and report in District Health Information System (DHIS)
3 secondary outcomes
Proportion of health facility recording Referrals in and out
Time frame: 18 months
Proportion of cases referred to health facilities through LHWs
Time frame: 18 months
Increase in proportion of women who can correctly identify at least 3 danger signs at pregnancy and childbirth
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulfiqar Bhutta, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audit Implementation in people with Maternal Death and Neonatal Death, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of facilities implemented Audit System. (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.