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

Primary Purpose

Sepsis, Asthma, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
ESS-EMCH training
Sponsored by
Child Advocacy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sepsis focused on measuring Cluster Randomized Trial, ESS-EMCH, Neonatal, Maternal, Life threatening emergency event

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CAI
  • District Headquarters Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Trained doctors

No Training

Arm Description

ESS-EMCH Training will be provided to doctors working in general emergency, pediatrics and obstetrics department in district hospitals.

No training will be given to doctors (act as controls)

Outcomes

Primary Outcome Measures

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
Practices

Secondary Outcome Measures

Full Information

First Posted
April 9, 2009
Last Updated
February 1, 2019
Sponsor
Child Advocacy International
Collaborators
John Snow, Inc., United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00880204
Brief Title
Evaluation of Essential Surgical Skills-Emergency Maternal and Child Health Training
Official Title
Evaluation of Essential Surgical Skills-Emergency Maternal and Child Health (ESS-EMCH) Training by Assessing the Doctors' Practices in Pakistan
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2009 (Actual)
Primary Completion Date
September 30, 2009 (Actual)
Study Completion Date
November 30, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Child Advocacy International
Collaborators
John Snow, Inc., United States Agency for International Development (USAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Asthma, Heart Failure, Seizure, Coma
Keywords
Cluster Randomized Trial, ESS-EMCH, Neonatal, Maternal, Life threatening emergency event

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trained doctors
Arm Type
Experimental
Arm Description
ESS-EMCH Training will be provided to doctors working in general emergency, pediatrics and obstetrics department in district hospitals.
Arm Title
No Training
Arm Type
No Intervention
Arm Description
No training will be given to doctors (act as controls)
Intervention Type
Behavioral
Intervention Name(s)
ESS-EMCH training
Intervention Description
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)".
Primary Outcome Measure Information:
Title
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
Description
Practices
Time Frame
1-2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasir B Nisar, MPH
Organizational Affiliation
CAI
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAI
City
Islamabad
State/Province
Capital
ZIP/Postal Code
44000
Country
Pakistan
Facility Name
District Headquarters Hospital
City
Vehari
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

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

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