SepsisNCT00880204
Evaluation of Essential Surgical Skills-Emergency Maternal and Child Health Training
A study testing ESS-EMCH training in people with Sepsis and Asthma, run by Child Advocacy International at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Sepsis, Asthma, Heart Failure
- What is being tested?
- ESS-EMCH training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 May 2009to 30 Nov 2009
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- doctors working in emergency department, pediatrics and obstetric department in district hospitals
Who cannot join
- doctors at leave for more than 1 week
- working in other departments of district hospitals
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
CAI
Islamabad, Capital, 44000
District Headquarters Hospital
Vehari, Punjab Province
About this study
Official title: Evaluation of Essential Surgical Skills-Emergency Maternal and Child Health (ESS-EMCH) Training by Assessing the Doctors' Practices in Pakistan
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.
Read the 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.
- Conditions
- Sepsis, Asthma, Heart Failure, Seizure, Coma
- Being tested
- ESS-EMCH training
- Keywords
- Cluster Randomized Trial, ESS-EMCH, Neonatal, Maternal, Life threatening emergency event
- Medical subject headings
- Sepsis, Asthma, Heart Failure, Seizures, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESS-EMCH trainingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Trained doctors | Experimental | ESS-EMCH Training will be provided to doctors working in general emergency, pediatrics and obstetrics department in district hospitals. Receives: Behavioral: ESS-EMCH training |
| No Training | No intervention | No training will be given to doctors (act as controls) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study start1 May 2009
- Primary completion30 Sep 2009
- Study completion30 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Child Advocacy International
- Sponsor type
- University, hospital or other
- Collaborators
- John Snow, Inc., United States Agency for International Development (USAID)
- Responsible party
- Principal investigator, Dr. Yasir Bin Nisar, Child Advocacy International
- Investigators
- Yasir B Nisar, MPH, Principal investigator, CAI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880204
- Sponsor's protocol ID
- CRT2008
- Status last verified
- Feb 2019
- First submitted
- 9 Apr 2009
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Essential Surgical Skills-Emergency Maternal and Child Health (ESS-EMCH) Training by Assessing the Doctors' Practices in Pakistan
- ClinicalTrials.gov ID
- NCT00880204
- Acronym / sponsor ID
- CRT2008
- Conditions
- Sepsis, Asthma, Heart Failure, Seizure, Coma
- Keywords
- Cluster Randomized Trial, ESS-EMCH, Neonatal, Maternal, Life threatening emergency event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Child Advocacy InternationalUniversity, hospital or other
- Collaborators
- John Snow, Inc., United States Agency for International Development (USAID)
- Study start
- 1 May 2009 (actual)
- Primary completion
- 30 Sep 2009 (actual)
- Study completion
- 30 Nov 2009 (actual)
- First posted
- 13 Apr 2009 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trained doctors | Experimental | Behavioral: ESS-EMCH trainingESS-EMCH Training will be provided to doctors working in general emergency, pediatrics and obstetrics department in district hospitals. |
| No Training | No intervention | –No training will be given to doctors (act as controls) |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- doctors working in emergency department, pediatrics and obstetric department in district hospitals
Key exclusion criteria (2 listed)
- doctors at leave for more than 1 week
- working in other departments of district hospitals
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 |
|---|---|---|
| ESS-EMCH trainingThe 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)". | Behavioural | Trained doctors |
Primary outcome
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
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 5 Feb 2019.
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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.
Yasir B Nisar, MPH principal investigator
CAI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESS-EMCH training in people with Sepsis and Asthma, run by Child Advocacy International at 2 sites in Pakistan.
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 1 inclusion and 2 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
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). 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 5 Feb 2019.