- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01802957
Health Facility Networking for Maternal Health
Study Overview
Status
Intervention / Treatment
- Other: Training of health workers in Basic Obstetric Emergency Care
- Other: Hospital-health center networking system
- Other: Post Basic Emergency Obstetric Training Mentorship
- Other: Team-Based Supportive supervision
- Other: Midwives exchange program
- Other: Strengthening the referral network
- Other: Facility Checklists
- Other: Emergency Drills
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Addis Ketema Subcity, Woreda 4, Ethiopia
- Addis Ketema Health Center
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Addis Ketema Subcity, Woreda 9, Addis Ababa,, Ethiopia
- Woreda 7 Health Center
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Arada Sub City, Addis Ababa, Ethiopia
- Semen Health Center
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Gulele Sub City, Woreda 9, Addis Ababa, Ethiopia
- Selam Health Center
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Gulele Subcity, Addis Ababa, Ethiopia
- St. Paul Hospital Millennium Medical College
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Gulele Subcity, Woreda 10, Addis Ababa, Ethiopia
- Shegole Health Center
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Gulele Subcity, Woreda 7, Ethiopia
- Woreda 7 Health Center
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Kolfe sub City, Woreda 2, Addis Ababa, Ethiopia
- Kolfe Health center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Sample population for each data collection instrument:
Baseline/Endline:
Key Informant Interviews:
- St. Paul hospital: Maternal Child Health (MCH) Head, Midwife/nurse from Labor and Delivery (L&D), Midwife/nurse from Emergency
- Health Centers: Medical Director, Head of MCH (midwife) Midwife from L&D, Referral focal person
Health Facility Assessment:
- Manager/most senior health worker asked (one from each facility)
Provider Survey:
- All providers in the MCH at both the hospital and health center level
Chart review:
- All deliveries in all centers will be screened during the intervention phase. Data on every birth will be collected from the log books of each facility. The data collector will then find the medical record of that patient to assess the Standard of Care (SOC) during Ante-natal care (ANC)- if available from the chart, L&D and screen for an obstetric complication. If there was a complication, the near miss data will be collected.
Telephone registration log book:
- all phone calls between HC and Hospital
Facility Checklists:
- Forms completed by Supportive Supervision Teams at quarterly visits
Standardized BEmONC training evaluation
- Will be given to every provider undergoing the training, as part of the training curriculum.
Monthly mentoring evaluations - for the six months post-training mentorship, for all providers who have undergone BEmONC training.
Supportive Supervision Gap Identification Checklists
- Collected quarterly from each of the 9 facilities
Study Plan
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: St. Paul and Networked Health Centers
An uncontrolled before and after design with baseline and follow-up cross sectional measurements will be used at the overall site level (St.
Paul Hospital and the 8 associated HCs).
There will be no control unit.
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Health workers at the eight health centers will be trained in maternal, newborn, and child health (MNCH) care, including all basic emergency obstetric and neonatal care (BEmONC) signal functions and other essential MNCH services.
The training is a three week competency-based curriculum developed recently by the Ethiopian Federal Ministry of Health (FMoH).
A key intervention will be the creation of an effective, formalized networking system between Saint Paul Millennium Hospital and its eight satellite health centers in Addis Ababa.
The networking system will create a conducive environment for the transfer of knowledge and skills between health care providers working at the hospital and in the health centers.
Monthly review meetings will bring together staff from the hospital and health centers, and dedicated cell phones will be distributed to improve communication between the networked facilities.
At Saint Paul Millennium Hospital and the health centers, providers who have undergone BEmONC training will undergo regular monthly mentorship visits for the first six months post training.
The frequency of visits after six months will be adjusted based on the retention of BEmONC skills and provider performance
Saint Paul Hospital will use team-based models to provide supportive supervision to health centers in its network.
Representatives of the supportive supervision teams may, in addition to Saint Paul Hospital employees, include representatives from the Addis Ababa Regional Health Bureau.
Saint Paul Millennium Hospital's maternity wards are often over-crowded and have to turn patients away.
Health professionals incorrectly refer non-complicated deliveries, resulting in the occupation of beds that should be used for emergency deliveries.
This action is attributed to inexperienced midwives at the health center level who are uncomfortable performing normal labor and delivery duties.
In order to address this challenge, this project will establish an exchange program in which well-trained, experienced midwives from the hospitals will temporarily exchange places with less-experienced midwives in the health centers.
This exchange would allow less-experienced midwives to work in the hospital environment, gaining the experience and confidence necessary to attend normal deliveries and identify appropriate referrals.
Mechanisms and protocols for smooth communication between the health centers and the hospital have been developed, allowing health centers to utilize the hospital's ambulance, and implementing mechanisms for back referrals and feedback.
To facilitate this work, we will support the use of dedicated cell phones in each of the eight networked facilities and at Saint Paul Millennium Hospital, and institute referral log books at both the referring and receiving institutions.
Facility checklists will be used daily in each of the facilities to assess readiness for obstetric emergencies.
Formally, the checklists will be used at the quarterly supportive supervision visits, to assess improvements over time.
Non-punitive obstetric drills will provide multiple measurable indicators of quality maternal care, will illustrate opportunities for improving facility capabilities and provider care, and will allow providers to assess appropriate referral mechanisms and facility readiness.
Incorporating emergency drills into current training and at all levels of health facilities will also give providers hands-on experience
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improved provider skill levels
Time Frame: One Year
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Provider skill will be measured through baseline and endline evaluations, mentoring reports, and the standardized evaluations used in the Basic Emergency Obstetric Care trainings.
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One Year
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Improved provider self-efficacy
Time Frame: One Year
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Improved provider confidence will be assessed at baseline and at endline with a standardized data collection instrument.
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One Year
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Increased use of effective interventions for obstetric emergencies
Time Frame: One Year
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Continuous data extraction from patient charts will be used to assess the appropriate treatment for obstetric emergencies over the study period.
Additionally changes in time-to-treatment for post-partum hemorrhage and pre-eclampsia/eclampsia cases will also be assessed from patient charts.
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One Year
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Improved standards of care for pregnant women
Time Frame: One Year
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Continuous extraction from patient records throughout the study period will be used to assess the trends in the Standards of Care (SOC) for Ante-natal (ANC), and care during Labor and Delivery.
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One Year
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Improved Referral Systems
Time Frame: One Year
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Data on Health Center/Hospital communication and referrals will be collected through phone logs, and referral sheets. |
One Year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustainable, continuous quality improvement cycles through supportive supervision
Time Frame: One year
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Quarterly, a supportive supervision team will visit each of the health facilities involved in this study, and, using a checklist and a participatory approach, will identify areas to improve the quality of care provided.
Each action item will will have a person assigned to it, and a plan to resolve the issue.
Follow up supportive supervision visits will begin with an assessment of the previous visit's action plan, and then work to identify new areas for quality improvement.
This process is iterative.
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One year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yemane Berhane, MD, MPH, PhD, Addis Continental Institute of Public Health
- Principal Investigator: Delayehu Bekele, MD, St. Paul's Hospital Millennium Medical College, Ethiopia
- Study Director: Fernando Althabe, MD, Institute for Clinical Effectiveness and Health Policy
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MHTF IR Ethiopia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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