NCT01802957

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,787

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

1.6 years

First QC Date

February 28, 2013

Last Update Submit

January 26, 2015

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    One Year

  • Improved provider self-efficacy

    Improved provider confidence will be assessed at baseline and at endline with a standardized data collection instrument.

    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.

    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.

    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.

    One Year

Secondary Outcomes (1)

  • Sustainable, continuous quality improvement cycles through supportive supervision

    One year

Study Arms (1)

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.

Other: Training of health workers in Basic Obstetric Emergency CareOther: Hospital-health center networking systemOther: Post Basic Emergency Obstetric Training MentorshipOther: Team-Based Supportive supervisionOther: Midwives exchange programOther: Strengthening the referral networkOther: Facility ChecklistsOther: Emergency Drills

Interventions

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).

St. Paul and Networked Health Centers

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.

St. Paul and Networked Health Centers

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

St. Paul and Networked Health Centers

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.

St. Paul and Networked Health Centers

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.

St. Paul and Networked Health Centers

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.

St. Paul and Networked Health Centers

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.

St. Paul and Networked Health Centers

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

St. Paul and Networked Health Centers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Addis Ketema Health Center

Addis Ketema Subcity, Woreda 4, Ethiopia

Location

Woreda 7 Health Center

Addis Ketema Subcity, Woreda 9, Addis Ababa,, Ethiopia

Location

Semen Health Center

Arada Sub City, Addis Ababa, Ethiopia

Location

Selam Health Center

Gulele Sub City, Woreda 9, Addis Ababa, Ethiopia

Location

St. Paul Hospital Millennium Medical College

Gulele Subcity, Addis Ababa, Ethiopia

Location

Shegole Health Center

Gulele Subcity, Woreda 10, Addis Ababa, Ethiopia

Location

Woreda 7 Health Center

Gulele Subcity, Woreda 7, Ethiopia

Location

Kolfe Health center

Kolfe Sub City, Woreda 2, Addis Ababa, Ethiopia

Location

Study Officials

  • Ana Langer, MD

    Harvard School of Public Health (HSPH)

    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

    PRINCIPAL INVESTIGATOR
  • Fernando Althabe, MD

    Institute for Clinical Effectiveness and Health Policy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of the Practice of Public Health Coordinator of the Dean's Special Initiative in Women and Health

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 4, 2013

Study Start

March 1, 2013

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations