Provider SkillNCT01802957
Health Facility Networking for Maternal Health
A study testing Training of health workers in Basic Obstetric Emergency Care, Hospital-health center networking system and Post Basic Emergency Obstetric Training Mentorship in people with Provider Skill and Provider Confidence, run by Harvard School of Public Health (HSPH) at 8 sites in Ethiopia.
Trial summary
This study will introduce a multi-faceted intervention package which will be implemented in the newly developed network of St. Paul's Hospital Millennium Medical College (St. Paul) and the surrounding seven satellite health centers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Provider Skill, Provider Confidence, Maternal Health
- What is being tested?
- Training of health workers in Basic Obstetric Emergency Care, Hospital-health center networking system and Post Basic Emergency Obstetric Training Mentorship
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,787 participants
- Where
- 8 sitesEthiopia
- Study dates
- Mar 2013to Dec 2014
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 20Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Ethiopia8 sites
Addis Ketema Health Center
Addis Ketema Subcity, Woreda 4
Woreda 7 Health Center
Addis Ketema Subcity, Woreda 9, Addis Ababa,
Semen Health Center
Arada Sub City, Addis Ababa
Selam Health Center
Gulele Sub City, Woreda 9, Addis Ababa
St. Paul Hospital Millennium Medical College
Gulele Subcity, Addis Ababa
Shegole Health Center
Gulele Subcity, Woreda 10, Addis Ababa
Woreda 7 Health Center
Gulele Subcity, Woreda 7
Kolfe Health center
Kolfe Sub City, Woreda 2, Addis Ababa
About this study
This study will introduce a multi-faceted intervention package which will be implemented in the newly developed network of St. Paul's Hospital Millennium Medical College (St. Paul) and the surrounding seven satellite health centers. The goal is to assess if this group of interventions improve the skills and confidence of providers to handle obstetric emergencies, if they streamline the referral process and if they result in improved maternal/newborn health outcomes.
- Conditions
- Provider Skill, Provider Confidence, Maternal Health, Referral Systems
- Being tested
- Training of health workers in Basic Obstetric Emergency Care, Hospital-health center networking system, Post Basic Emergency Obstetric Training Mentorship, Team-Based Supportive supervision, Midwives exchange program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training of health workers in Basic Obstetric Emergency CareOther
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).
Hospital-health center networking systemOther
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.
Post Basic Emergency Obstetric Training MentorshipOther
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
Team-Based Supportive supervisionOther
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.
Midwives exchange programOther
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.
Strengthening the referral networkOther
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 ChecklistsOther
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.
Emergency DrillsOther
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
| Study group | Role | What they receive |
|---|---|---|
| St. Paul and Networked Health Centers | Other | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved provider skill levels
Provider skill will be measured through baseline and endline evaluations, mentoring reports, and the standardized evaluations used in the Basic Emergency Obstetric Care trainings.
Measured: One Year
Improved provider self-efficacy
Improved provider confidence will be assessed at baseline and at endline with a standardized data collection instrument.
Measured: One Year
Increased use of effective interventions for obstetric emergencies
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.
Measured: One Year
Improved standards of care for pregnant women
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.
Measured: One Year
Improved Referral Systems
- Decreases the proportion of referrals made without proper prior communication to the receiving health facility
- Formalized feedback mechanisms between Saint Paul and the Health Centers
- Decreased number of inappropriate referrals from Health Centers to St. Paul
- Appropriate back-referrals from St. Paul to Health Centers
Data on Health Center/Hospital communication and referrals will be collected through phone logs, and referral sheets.
Measured: One Year
Secondary outcomes (1)
Sustainable, continuous quality improvement cycles through supportive supervision
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Provider SkillStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,787 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Maternal Health Task Force, St. Paul's Hospital Millennium Medical College, Ethiopia, Addis Continental Institute of Public Health, Institute for Clinical Effectiveness and Health Policy
- Responsible party
- Principal investigator, Ana Langer, Harvard School of Public Health (HSPH)
- Investigators
- Ana Langer, MD, Principal investigator, Harvard School of Public Health (HSPH)Yemane Berhane, MD, MPH, PhD, Principal investigator, Addis Continental Institute of Public HealthDelayehu Bekele, MD, Principal investigator, St. Paul's Hospital Millennium Medical College, EthiopiaFernando Althabe, MD, Study director, Institute for Clinical Effectiveness and Health Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802957
- Sponsor's protocol ID
- MHTF IR Ethiopia
- Status last verified
- Jan 2015
- First submitted
- 28 Feb 2013
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Facility Networking for Maternal Health
- ClinicalTrials.gov ID
- NCT01802957
- Acronym / sponsor ID
- MHTF IR Ethiopia
- Conditions
- Provider Skill, Provider Confidence, Maternal Health, Referral Systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,787 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Maternal Health Task Force, St. Paul's Hospital Millennium Medical College, Ethiopia, Addis Continental Institute of Public Health, Institute for Clinical Effectiveness and Health Policy
- Study start
- Mar 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Mar 2013 (estimated)
- 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.
This study will introduce a multi-faceted intervention package which will be implemented in the newly developed network of St. Paul's Hospital Millennium Medical College (St. Paul) and the surrounding seven satellite health centers. The goal is to assess if this group of interventions improve the skills and confidence of providers to handle obstetric emergencies, if they streamline the referral process and if they result in improved maternal/newborn health outcomes.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| St. Paul and Networked Health Centers | Other | 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 DrillsAn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- 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
- Manager/most senior health worker asked (one from each facility)
- All providers in the MCH at both the hospital and health center level
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Training of health workers in Basic Obstetric Emergency CareHealth 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). | Other | St. Paul and Networked Health Centers |
| Hospital-health center networking systemA 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. | Other | St. Paul and Networked Health Centers |
| Post Basic Emergency Obstetric Training MentorshipAt 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 | Other | St. Paul and Networked Health Centers |
| Team-Based Supportive supervisionSaint 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. | Other | St. Paul and Networked Health Centers |
| Midwives exchange programSaint 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. | Other | St. Paul and Networked Health Centers |
| Strengthening the referral networkMechanisms 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. | Other | St. Paul and Networked Health Centers |
| Facility ChecklistsFacility 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. | Other | St. Paul and Networked Health Centers |
| Emergency DrillsNon-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 | Other | St. Paul and Networked Health Centers |
Primary outcome
Improved provider skill levels
Time frame: One Year
Provider skill will be measured through baseline and endline evaluations, mentoring reports, and the standardized evaluations used in the Basic Emergency Obstetric Care trainings.
Improved provider self-efficacy
Time frame: One Year
Improved provider confidence will be assessed at baseline and at endline with a standardized data collection instrument.
Increased use of effective interventions for obstetric emergencies
Time frame: One Year
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.
Improved standards of care for pregnant women
Time frame: One Year
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.
Improved Referral Systems
Time frame: One Year
* Decreases the proportion of referrals made without proper prior communication to the receiving health facility * Formalized feedback mechanisms between Saint Paul and the Health Centers * Decreased number of inappropriate referrals from Health Centers to St. Paul * Appropriate back-referrals from St. Paul to Health Centers Data on Health Center/Hospital communication and referrals will be collected through phone logs, and referral sheets.
1 secondary outcome
Sustainable, continuous quality improvement cycles through supportive supervision
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
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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.
Ana Langer, MD principal investigator
Harvard School of Public Health (HSPH)
Yemane Berhane, MD, MPH, PhD principal investigator
Addis Continental Institute of Public Health
Delayehu Bekele, MD principal investigator
St. Paul's Hospital Millennium Medical College, Ethiopia
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training of health workers in Basic Obstetric Emergency Care, Hospital-health center networking system and Post Basic Emergency Obstetric Training Mentorship in people with Provider Skill and Provider Confidence, run by Harvard School of Public Health (HSPH) at 8 sites in Ethiopia.
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 20 inclusion and 0 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: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Ethiopia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improved provider skill levels (time frame: One Year). The study lists 5 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 28 Jan 2015.