Burnout, CaregiverburnoutNCT04620005
Impact of Extra Corporal Membrane Oxygenation Services on Burnout Development in Intensive Care Units.
An observational study of Burnout, Caregiver and Extracorporeal Membrane Oxygenation Complication, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The burnout phenomenon first came to clinical science 50 years ago. It is exponentially rising worldwide which prompted its discoverers to develop the most popular tool for its assessment, known as the Maslach burnout inventory (MBI)1. Common symptoms of burnout include depression, irritability, and insomnia. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout, Caregiver, Extracorporeal Membrane Oxygenation Complication, Intensive Care Unit
- What is being tested?
- Observational
- How many people
- 1,000 participants
- Where
- 1 siteQatar
- Study dates
- 1 Oct 2020to 30 Sep 2021
- Phase
- Observational
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: - The study population would include physicians, nurses, and respiratory therapists working in ICUs.
Who may be able to join
- The inclusion criteria will include practitioners working in intensive care unit including physician, respiratory therapists and nurses who agree to participate in the survey
Who cannot join
- practitioners who decline to participate and who will not complete the questionnaires.
- Non ICU practitioners
- Perfusionists
Trial locations and contacts
1 site in 1 country.
About this study
The burnout phenomenon first came to clinical science 50 years ago. It is exponentially rising worldwide which prompted its discoverers to develop the most popular tool for its assessment, known as the Maslach burnout inventory (MBI)1. Common symptoms of burnout include depression, irritability, and insomnia. The growing demand for extra-corporeal membrane oxygenation (ECMO) may have an effect on burnout as the newly introduced services is demanding in effort and put the practitioners on complex ethical and administrative situations.
We conducted a cross-sectional descriptive study using a combined methodological quantitative and qualitative approach involving a convenience sample of 1000 healthcare practitioners within surgical and medical ICUs of Hamad Medical Corporation (HMC), Qatar. We will use used two main instruments to develop an online questionnaire: - The MBI-human service survey (MBI-HSS) and the Leadership scale Expectations: we expect that we will have a new insight about the impact of these complex interventions on practitioner's burnout.
Read the detailed description
This study predominates at investigating the BOS in ECMO ICU and non-ECMO ICU, and whether the leadership attitude could have effect on the mentioned syndrome problem.
Methodology Settings This study will in a tertiary hospital in the Middle East "Hamad Medical Corporation" as a main centre, the study will be disseminated an online survey among other centres who will agree to participate on. The participants will be screened for socio-demographic data such as age, gender, profession, marital state, education, native country, years of experience, weekly working hours and salary. The questionnaire was clarified to the potential respondents in order to clear any poor understanding. English used as the official language in the organization; translation of the used instruments to individual mother languages is not required.
Design Cross-sectional descriptive survey with purposeful sampling. Mixed qualitative and quantitative methodology used in this dissertation. Invitations to participate through the mail, anonymous questionnaire survey will be presented to the staff members including physicians, nurses and respiratory therapists who work as full time.
- Study Population and Study Setting/ Location In this section describe the study population that is to be enrolled in the study, planned recruitment number and Inclusion and Exclusion Criteria to be listed here. Also list the Hospitals in which this study will be conducted ( e.g. HGH, Rumailah etc) The study population would include physicians, nurses, and respiratory therapists working in ICUs. The inclusion criteria will include practitioners working in intensive care unit including physician, respiratory therapists and nurses who agree to participate in the survey. We will exclude practitioners who decline to participate and who will not complete the questionnaires. A flow diagram will be prepared for the enrollment.
The participants will be approached through communication with one representative within the assigned ICUs within Qatar, in case of agreement we will ask for a list of mails from each department to be enrolled in the study.
- Study procedures
The study will be conducted for 12 months from the time of ethical approval. Instrumentation
The used instrumentation is questionnaire that is divided into the following sections:
- Condition of work effectiveness questionnaire (CWEQ): This scale consisted of 19 items developed by Kanter, (1977) measured by a 5-point Likert type response. (9) B) Maslach Burnout Inventory human services survey (MBI-HSS): The scale is a standardized instrument to measure burnout it utilize 9 items related to emotional exhaustion and it is most frequently used in health care researches, the nine items are calculated to get the whole score, scores of 27 and more signals severe burnout. (10) The percentage of high degree of burnout was used for advanced analysis. We will get permission to use this scale from (Mindgarden.com, USA) C) Leadership Behaviours scale (LS): The staff discernment of managers' leadership attitude will be measured using the 11 item Manager Action Scale. (11)
The questionnaires will be submitted in English form; no need for translation, as health care practitioners in the organization, must practice English that is the official language at workplace. The results of the analysis will be presented using descriptive methods. The quantitative and qualitative data will be analysed statistically, the relations between the variables will be interpreted, the relation between burnout score and socio-demographic variables, occupational stress score, and empowerment scale will be assessed statistically using (t-test, analysis of variance, correlation efficient and regression).
Ethical Considerations:
Participant identity kept confidential, final report would not contain any identity. Comprehensive explanation for the participants about the questionnaires, the type, purpose of the study and outcome was done, early rejection, or late withdrawal was permissive. Ethical approval was obtained according to the corporate regulations. The ethical consent attached after being approval from the medical research centre.
Health care practitioners working on ICU whether providing ECMO services or not will be eligible to participate in the study
The primary objective will be to detect the prevalence of burnout among health care practitioner s working in ICU with ECMO services The secondary objectives will be to compare the burnout association in ECMO and non ECMO ICU, the effect of leadership attitude on burnout syndrome and to look at the burnout in special population within the groups like respiratory therapists
- Being tested
- Observational
- Keywords
- burnout, Extracorporeal Membrane Oxygenation, Intensive care unit
- Medical subject headings
- Caregiver Burden, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Survey
| Study group | Role | What they receive |
|---|---|---|
| ECMO | The first group will include practitioners who work in intensive care unit with ECMO services Receives: Other: Observational | |
| Non-ECMO | The second group will include practitioners who work in non-ECMO inventive care unit Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire assessing prevalence of burnout among health care practitioners working in ICU with ECMO services
Measured: 1 year
Secondary outcomes (3)
The difference in burnout association in practitioners in ICU with ECMO services and in conventional ICU
Measured: 1 year
effect of leadership attitude on burnout syndrome
Through specific questionnaire
Measured: 1 year
burnout in special population within the respiratory therapists
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Burnout, CaregiverStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620005
- Sponsor's protocol ID
- MRC-01-20-113
- Acronym
- burnout
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The identification and other details will be kept confidential as per our organization rules
Publications
Moss M, Good VS, Gozal D, Kleinpell R, Sessler CN. An Official Critical Care Societies Collaborative Statement: Burnout Syndrome in Critical Care Health Care Professionals: A Call for Action. Am J Crit Care. 2016 Jul;25(4):368-76. doi: 10.4037/ajcc2016133.
PubMed 27369038Poncet MC, Toullic P, Papazian L, Kentish-Barnes N, Timsit JF, Pochard F, Chevret S, Schlemmer B, Azoulay E. Burnout syndrome in critical care nursing staff. Am J Respir Crit Care Med. 2007 Apr 1;175(7):698-704. doi: 10.1164/rccm.200606-806OC. Epub 2006 Nov 16.
PubMed 17110646Mealer M, Burnham EL, Goode CJ, Rothbaum B, Moss M. The prevalence and impact of post traumatic stress disorder and burnout syndrome in nurses. Depress Anxiety. 2009;26(12):1118-26. doi: 10.1002/da.20631.
PubMed 19918928Omar AS, Elmaraghi S, Mahmoud MS, Khalil MA, Singh R, Ostrowski PJ. Impact of leadership on ICU clinicians' burnout. Intensive Care Med. 2015 Nov;41(11):2016-7. doi: 10.1007/s00134-015-4008-6. Epub 2015 Aug 8. No abstract available.
PubMed 26254014Chuang CH, Tseng PC, Lin CY, Lin KH, Chen YY. Burnout in the intensive care unit professionals: A systematic review. Medicine (Baltimore). 2016 Dec;95(50):e5629. doi: 10.1097/MD.0000000000005629.
PubMed 27977605Omar AS, Labib A, Hanoura SE, Rahal A, Kaddoura R, Chughtai TS, Karic E, Shaikh MS, Hamad WJ, ElHassan M, AlHashemi A, Khatib MY, AlKhulaifi A. Impact of Extracorporeal Membrane Oxygenation Service on Burnout Development in Eight Intensive Care Units. A National Cross-Sectional Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):2891-2899. doi: 10.1053/j.jvca.2022.02.018. Epub 2022 Feb 18.
PubMed 35300897Omar AS, Hanoura S, Labib A, Kaddoura R, Rahhal A, Al-Zubi MM, Galvez RD, Shiju S, Al Jonidi MJ, Ragab H, Al Hashemi AA, Alumlla A. Burnout among Respiratory Therapists and Perception of Leadership: A Cross Sectional Survey Over Eight Intensive Care Units. J Intensive Care Med. 2022 Dec;37(12):1553-1562. doi: 10.1177/08850666221086208. Epub 2022 Mar 14.
PubMed 35285747
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Extra Corporal Membrane Oxygenation Services on Burnout Development in Intensive Care Units.
- ClinicalTrials.gov ID
- NCT04620005
- Acronym / sponsor ID
- burnout / MRC-01-20-113
- Keywords
- burnout, Extracorporeal Membrane Oxygenation, Intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 6 Nov 2020 (actual)
- 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 burnout phenomenon first came to clinical science 50 years ago. It is exponentially rising worldwide which prompted its discoverers to develop the most popular tool for its assessment, known as the Maslach burnout inventory (MBI)1. Common symptoms of burnout include depression, irritability, and insomnia. The growing demand for extra-corporeal membrane oxygenation (ECMO) may have an effect on burnout as the newly introduced services is demanding in effort and put the practitioners on complex ethical and administrative situations.
We conducted a cross-sectional descriptive study using a combined methodological quantitative and qualitative approach involving a convenience sample of 1000 healthcare practitioners within surgical and medical ICUs of Hamad Medical Corporation (HMC), Qatar. We will use used two main instruments to develop an online questionnaire: - The MBI-human service survey (MBI-HSS) and the Leadership scale Expectations: we expect that we will have a new insight about the impact of these complex interventions on practitioner's burnout.
Detailed description
This study predominates at investigating the BOS in ECMO ICU and non-ECMO ICU, and whether the leadership attitude could have effect on the mentioned syndrome problem.
Methodology Settings This study will in a tertiary hospital in the Middle East "Hamad Medical Corporation" as a main centre, the study will be disseminated an online survey among other centres who will agree to participate on. The participants will be screened for socio-demographic data such as age, gender, profession, marital state, education, native country, years of experience, weekly working hours and salary. The questionnaire was clarified to the potential respondents in order to clear any poor understanding. English used as the official language in the organization; translation of the used instruments to individual mother languages is not required.
Design Cross-sectional descriptive survey with purposeful sampling. Mixed qualitative and quantitative methodology used in this dissertation. Invitations to participate through the mail, anonymous questionnaire survey will be presented to the staff members including physicians, nurses and respiratory therapists who work as full time.
- Study Population and Study Setting/ Location In this section describe the study population that is to be enrolled in the study, planned recruitment number and Inclusion and Exclusion Criteria to be listed here. Also list the Hospitals in which this study will be conducted ( e.g. HGH, Rumailah etc) The study population would include physicians, nurses, and respiratory therapists working in ICUs. The inclusion criteria will include practitioners working in intensive care unit including physician, respiratory therapists and nurses who agree to participate in the survey. We will exclude practitioners who decline to participate and who will not complete the questionnaires. A flow diagram will be prepared for the enrollment.
The participants will be approached through communication with one representative within the assigned ICUs within Qatar, in case of agreement we will ask for a list of mails from each department to be enrolled in the study.
- Study procedures
The study will be conducted for 12 months from the time of ethical approval. Instrumentation
The used instrumentation is questionnaire that is divided into the following sections:
- Condition of work effectiveness questionnaire (CWEQ): This scale consisted of 19 items developed by Kanter, (1977) measured by a 5-point Likert type response. (9) B) Maslach Burnout Inventory human services survey (MBI-HSS): The scale is a standardized instrument to measure burnout it utilize 9 items related to emotional exhaustion and it is most frequently used in health care researches, the nine items are calculated to get the whole score, scores of 27 and more signals severe burnout. (10) The percentage of high degree of burnout was used for advanced analysis. We will get permission to use this scale from (Mindgarden.com, USA) C) Leadership Behaviours scale (LS): The staff discernment of managers' leadership attitude will be measured using the 11 item Manager Action Scale. (11)
The questionnaires will be submitted in English form; no need for translation, as health care practitioners in the organization, must practice English that is the official language at workplace. The results of the analysis will be presented using descriptive methods. The quantitative and qualitative data will be analysed statistically, the relations between the variables will be interpreted, the relation between burnout score and socio-demographic variables, occupational stress score, and empowerment scale will be assessed statistically using (t-test, analysis of variance, correlation efficient and regression).
Ethical Considerations:
Participant identity kept confidential, final report would not contain any identity. Comprehensive explanation for the participants about the questionnaires, the type, purpose of the study and outcome was done, early rejection, or late withdrawal was permissive. Ethical approval was obtained according to the corporate regulations. The ethical consent attached after being approval from the medical research centre.
Health care practitioners working on ICU whether providing ECMO services or not will be eligible to participate in the study
The primary objective will be to detect the prevalence of burnout among health care practitioner s working in ICU with ECMO services The secondary objectives will be to compare the burnout association in ECMO and non ECMO ICU, the effect of leadership attitude on burnout syndrome and to look at the burnout in special population within the groups like respiratory therapists
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMO | – | Other: ObservationalThe first group will include practitioners who work in intensive care unit with ECMO services |
| Non-ECMO | – | Other: ObservationalThe second group will include practitioners who work in non-ECMO inventive care unit |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- - The study population would include physicians, nurses, and respiratory therapists working in ICUs.
Key inclusion criteria (1 listed)
- The inclusion criteria will include practitioners working in intensive care unit including physician, respiratory therapists and nurses who agree to participate in the survey
Key exclusion criteria (3 listed)
- practitioners who decline to participate and who will not complete the questionnaires.
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 |
|---|---|---|
| ObservationalSurvey | Other | ECMO, Non-ECMO |
Primary outcome
Questionnaire assessing prevalence of burnout among health care practitioners working in ICU with ECMO services
Time frame: 1 year
3 secondary outcomes
The difference in burnout association in practitioners in ICU with ECMO services and in conventional ICU
Time frame: 1 year
effect of leadership attitude on burnout syndrome
Time frame: 1 year
burnout in special population within the respiratory therapists
Time frame: 1 years
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 3 Dec 2021.
- Results publication: PubMed 27369038Moss M, Good VS, Gozal D, Kleinpell R, Sessler CN. An Official Critical Care Societies Collaborative Statement: Burnout Syndrome in Critical Care Health Care Professionals: A Call for Action. Am J Crit Care. 2016 Jul;25(4):368-76. doi: 10.4037/ajcc2016133.
- Results publication: PubMed 17110646Poncet MC, Toullic P, Papazian L, Kentish-Barnes N, Timsit JF, Pochard F, Chevret S, Schlemmer B, Azoulay E. Burnout syndrome in critical care nursing staff. Am J Respir Crit Care Med. 2007 Apr 1;175(7):698-704. doi: 10.1164/rccm.200606-806OC. Epub 2006 Nov 16.
- Results publication: PubMed 19918928Mealer M, Burnham EL, Goode CJ, Rothbaum B, Moss M. The prevalence and impact of post traumatic stress disorder and burnout syndrome in nurses. Depress Anxiety. 2009;26(12):1118-26. doi: 10.1002/da.20631.
- Results publication: PubMed 26254014Omar AS, Elmaraghi S, Mahmoud MS, Khalil MA, Singh R, Ostrowski PJ. Impact of leadership on ICU clinicians' burnout. Intensive Care Med. 2015 Nov;41(11):2016-7. doi: 10.1007/s00134-015-4008-6. Epub 2015 Aug 8. No abstract available.
- Results publication: PubMed 27977605Chuang CH, Tseng PC, Lin CY, Lin KH, Chen YY. Burnout in the intensive care unit professionals: A systematic review. Medicine (Baltimore). 2016 Dec;95(50):e5629. doi: 10.1097/MD.0000000000005629.
- Derived from this study: PubMed 35300897Omar AS, Labib A, Hanoura SE, Rahal A, Kaddoura R, Chughtai TS, Karic E, Shaikh MS, Hamad WJ, ElHassan M, AlHashemi A, Khatib MY, AlKhulaifi A. Impact of Extracorporeal Membrane Oxygenation Service on Burnout Development in Eight Intensive Care Units. A National Cross-Sectional Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):2891-2899. doi: 10.1053/j.jvca.2022.02.018. Epub 2022 Feb 18.
- Derived from this study: PubMed 35285747Omar AS, Hanoura S, Labib A, Kaddoura R, Rahhal A, Al-Zubi MM, Galvez RD, Shiju S, Al Jonidi MJ, Ragab H, Al Hashemi AA, Alumlla A. Burnout among Respiratory Therapists and Perception of Leadership: A Cross Sectional Survey Over Eight Intensive Care Units. J Intensive Care Med. 2022 Dec;37(12):1553-1562. doi: 10.1177/08850666221086208. Epub 2022 Mar 14.
- Individual participant dataSharing planned: No. The identification and other details will be kept confidential as per our organization rules
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burnout, Caregiver and Extracorporeal Membrane Oxygenation Complication, run by Hamad Medical Corporation at 1 site in Qatar.
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 3 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. 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?
Questionnaire assessing prevalence of burnout among health care practitioners working in ICU with ECMO services (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04620005, which also lists 7 linked publications.
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 3 Dec 2021.