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Evaluation of Essential Surgical Skills-Emergency Maternal and Child Health Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00880204
Recruitment Status : Completed
First Posted : April 13, 2009
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
John Snow, Inc.
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Dr. Yasir Bin Nisar, Child Advocacy International

Tracking Information
First Submitted Date  ICMJE April 9, 2009
First Posted Date  ICMJE April 13, 2009
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE May 1, 2009
Actual Primary Completion Date September 30, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
To examine the ability of ESS-EMCH to change doctors' practices for managing obstetric, neonatal, and pediatric emergency care, including major trauma, in public sector hospital settings [ Time Frame: 1-2 months ]
Practices
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2009)
To examine the ability of ESS-EMCH to change doctors' practices for managing obstetric, neonatal, and pediatric emergency care, including major trauma, in public sector hospital settings [ Time Frame: 1-2 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Essential Surgical Skills-Emergency Maternal and Child Health Training
Official Title  ICMJE Evaluation of Essential Surgical Skills-Emergency Maternal and Child Health (ESS-EMCH) Training by Assessing the Doctors' Practices in Pakistan
Brief Summary The aim of the proposed study is to determine if specific training in management of general, obstetric, neonatal and pediatric emergencies results in a change in practice of doctors working in emergency departments of public sector hospitals in three districts of Pakistan. The overall goal of the proposed study is to test the ability of a standard course (5-days training) to promote the provision of effective and evidence based practices in public sector hospital settings.
Detailed Description

Pakistan is the 6th most populous country of the world 1 and has the largest population in the Eastern Mediterranean Region, accounting for about 30 percent of the regional population. The level of socio-economic development is still low - GDP per capita is US$ 7302; HDI is 142nd in the world 1; and, one fourth of the entire population lives below the poverty line 2. The health profile of Pakistan is characterized by high population growth rate, high infant and child mortality rate, high maternal mortality ratio, and high burden of communicable diseases.

In conjunction with neonatal, infant and child mortality, maternal mortality ratio is also extremely high as 350 per 100,000 population in Pakistan 3. In addition, only 23 percent of the deliveries are being conducted by skilled birth attendants and major causes of mortality include hemorrhage, hypertensive diseases, sepsis and other obstetrical complications 4. Although the health facilities are available ubiquitously, but these facilities lack proper equipments and trained health workers. Health worker also lacks necessary skills and training to manage the children, newborns and mothers in emergency situations. Management in the first few hours - the Golden hours 5 of the presentation of obstetric, neonatal and pediatric emergencies, including major trauma (if not given immediate attention are likely to result in death or severe brain damage in 6 hours) is a major determinant of the eventual outcome. If the vast majority of these potentially avoidable deaths and long-term or permanent morbidity are to be avoided, a continuity of care with particular emphasis on golden hours management and safe transfer has to be established starting from the communities to health facilities 6.

There is evidence that if structured life support trainings are introduced in a systematic method it helps in reducing mortality and morbidity during the emergency phase in a very cost effective manner 4. Local public sector hospitals need to be configured to serve a community and not just to provide episodic care for the few patients who transiently pass through their doors during an acute episode. It is mandatory to upgrade the knowledge of first line health worker in managing emergency situations. It is also necessary to elevate their capacity to recognize the common emergencies and manage accordingly. By instituting accredited structured training for these skills we can dramatically decrease mortality and morbidity rates in Pakistan 6. The training activities of Essential Surgical Skills with emphasis on Emergency Maternal and Child Health (ESS-EMCH) are based on two tried and tested structured training methodologies of Advanced Pediatric Life Support (APLS) and Management of Obstetric Emergencies and Trauma (MOET). The ESS-EMCH training programme is being conducted by Child Health Advocacy International (CAI) in Pakistan and Gambia 6. The Advanced Life Support Group-UK (ALSG-UK) and World Health Organization (WHO) provide technical support for the training and the programme has been endorsed as a first ALSG-UK certified training course targeted specifically for developing countries 7. These courses have been used for some years in various developed countries as essential requirements for all health workers involved in emergency care in these specialties. In Pakistan these training activities have been modified according to local needs and conditions 6.

The aim of the proposed study is to determine, if and what degree, specific training in management of general, obstetric, neonatal and pediatric emergencies results in a change in practice of doctors working in emergency departments of public sector hospitals in three districts of Pakistan. The overall goal of the proposed study is to test the ability of a standard course (5-days training) to promote the provision of effective and evidence based practices in public sector hospital settings.

Justification:

Improving mortality and morbidity during the emergency phase presents a major challenge in many developing countries including Pakistan. It is important that health workers working at public health facilities at district level have necessary skills and equipment to provide effective management during an emergency phase. Research has shown that structured life support trainings can help in reducing mortality and morbidity during the emergency phase in a very cost effective manner 4. However, the evaluation of course participants poses a major problem, because it is rarely possible to develop a perfect testing method, and awareness of the inherent limitations of evaluation methods used in life support courses is important 8. Jabbour and colleagues reviewed the effectiveness of life support courses and found that the majority of studies on evaluation of the ability of life support courses have focused on less direct outcomes like health workers' knowledge and silks 9. Such surrogate outcomes may not necessarily reflect practice changes, which is a more useful and direct way of measuring the effectiveness of life support training courses 9.

We are not aware of any previous randomized controlled trials determining the effect of ESS-EMCH training on health workers practices in a true clinical setting. Therefore, our intention is to test the ability of ESS-EMCH training on practices by randomly assigning pediatric ward, labor room and emergency department staff at district level to either providing ESS-EMCH training or no training, considering the health worker as a unit of cluster. Although, our primary outcome will only able to capture the initial steps in effective practice, but we believe it will indicate an important behavior change effect.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Sepsis
  • Asthma
  • Heart Failure
  • Seizure
  • Coma
Intervention  ICMJE Behavioral: ESS-EMCH training
The trainings of the ESS-EMCH programme are based on two well-tried and tested structured training methodologies of "Advanced Pediatric Life Support (APLS)" and "Management of Obstetric Emergencies and Trauma (MOET)".
Study Arms  ICMJE
  • Experimental: Trained doctors
    ESS-EMCH Training will be provided to doctors working in general emergency, pediatrics and obstetrics department in district hospitals.
    Intervention: Behavioral: ESS-EMCH training
  • No Intervention: No Training
    No training will be given to doctors (act as controls)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2009)
24
Actual Study Completion Date  ICMJE November 30, 2009
Actual Primary Completion Date September 30, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • doctors working in emergency department, pediatrics and obstetric department in district hospitals

Exclusion Criteria:

  • doctors at leave for more than 1 week
  • working in other departments of district hospitals
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00880204
Other Study ID Numbers  ICMJE CRT2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Yasir Bin Nisar, Child Advocacy International
Study Sponsor  ICMJE Child Advocacy International
Collaborators  ICMJE
  • John Snow, Inc.
  • United States Agency for International Development (USAID)
Investigators  ICMJE
Principal Investigator: Yasir B Nisar, MPH CAI
PRS Account Child Advocacy International
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP