Compassion FatigueCSRSNCT04888000
Interprofessional Group Intervention to Enhance Compassion Satisfaction and Resilience
A study testing Educational Intervention in people with Compassion Fatigue and Resilience, run by OSF Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to evaluate an educational professional development program designed to assist health care professionals in developing self-awareness and self-care choices as a means to avoid compassion fatigue and improve resilience. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Compassion Fatigue, Resilience
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2021to 1 Nov 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- employment within inpatient or outpatient setting in non-profit healthcare system as a healthcare professional
- Professional direct caregivers (nurses, physicians, advanced practice providers, social workers, counselors, chaplains, respiratory therapists, pharmacists
Who cannot join
- actively participating in or plans to participate in any other formalized mindfulness-based stress reduction program during the time period of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study Examining Use of the Oxygen for Caregivers® Program
The purpose of this study is to evaluate an educational professional development program designed to assist health care professionals in developing self-awareness and self-care choices as a means to avoid compassion fatigue and improve resilience.
Read the detailed description
Professional caregivers are at risk of compassion fatigue due to the nature of their work and repeated exposure over time to work-related stressors. Symptoms of compassion fatigue may include decreased concentration/productivity, increased sick days, and high turnover rates which directly effect patient satisfaction and safety. Lack of data that supports this use of program, though anecdotally, it has been endorsed and benefits from its use are described. Quality of patient care, workforce engagement, and financial effects from turnover of staff are viewed as negative impacts from compassion fatigue.
Our study seeks to extend the body of knowledge with regard to use of a particular resilience program that has shown some promise in a small pilot study.
- Conditions
- Compassion Fatigue, Resilience
- Being tested
- Educational Intervention
- Keywords
- Compassion Fatigue, Resilience
- Medical subject headings
- Compassion Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Professional development program provided to small groups of health care professionals in three different sessions over a period of one month with additional independent individual work to be completed between sessions.
| Study group | Role | What they receive |
|---|---|---|
| single | Other | Educational intervention. Receives: Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Professional Quality of Life Scale (ProQOL) Version 5
Professional Quality of Life Scale (ProQOL) Version 5 Compassion Fatigue Subscale
Measured: Change from baseline compassion fatigue subscale measure at 1 and 6 months assessed by compassion fatigue subscale of ProQOL 5 [ Time Frame: Data collected before the program starts and one month after the end of the program and six months
Professional Quality of Life Scale (ProQOL) Version 5
Professional Quality of Life Scale (ProQOL) Version 5 Burnout Subscale
Measured: Change from baseline burnout subscale measure at 1 and 6 months assessed by burnout subscale of ProQOL 5 [ Time Frame: Data collected before the program starts and one month after the end of the program and six months
Professional Quality of Life Scale (ProQOL) Version 5
Professional Quality of Life Scale (ProQOL) Version 5 Compassion Satisfaction Subscale
Measured: Change from baseline compassion satisfaction subscale measure at 1 and 6 months assessed by compassion satisfaction subscale of ProQOL 5 [ Time Frame: Data collected before the program starts and one month after the end of the program and six months
Brief Resilience Scale
Resilience will be measured using the Brief Resilience Scale (BRS) a 6-item scale developed by Smith et al.(2008).
Measured: Change from baseline in resilience measure at 1 month and 6 months assessed by BRS scale [ Time Frame: Data collected before the program starts and one month after the end of the program and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start29 Apr 2021
- Primary completion27 Jun 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Compassion FatigueStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen J Klein, OSF Healthcare System
- Investigators
- Colleen Klein, PhD, MS, RN, Principal investigator, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888000
- Sponsor's protocol ID
- 1684111
- Acronym
- CSRS
- Status last verified
- Nov 2023
- First submitted
- 5 May 2021
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ang SY, Hemsworth D, Uthaman T, Ayre TC, Mordiffi SZ, Ang E, Lopez V. Understanding the influence of resilience on psychological outcomes - Comparing results from acute care nurses in Canada and Singapore. Appl Nurs Res. 2018 Oct;43:105-113. doi: 10.1016/j.apnr.2018.07.007. Epub 2018 Jul 26.
PubMed 30220356Austin CL, Saylor R, Finley PJ. Moral distress in physicians and nurses: Impact on professional quality of life and turnover. Psychol Trauma. 2017 Jul;9(4):399-406. doi: 10.1037/tra0000201. Epub 2016 Oct 31.
PubMed 27797570Cavanagh N, Cockett G, Heinrich C, Doig L, Fiest K, Guichon JR, Page S, Mitchell I, Doig CJ. Compassion fatigue in healthcare providers: A systematic review and meta-analysis. Nurs Ethics. 2020 May;27(3):639-665. doi: 10.1177/0969733019889400. Epub 2019 Dec 12.
PubMed 31829113Fortney L, Luchterhand C, Zakletskaia L, Zgierska A, Rakel D. Abbreviated mindfulness intervention for job satisfaction, quality of life, and compassion in primary care clinicians: a pilot study. Ann Fam Med. 2013 Sep-Oct;11(5):412-20. doi: 10.1370/afm.1511.
PubMed 24019272Huey CWT, Palaganas JC. What are the factors affecting resilience in health professionals? A synthesis of systematic reviews. Med Teach. 2020 May;42(5):550-560. doi: 10.1080/0142159X.2020.1714020. Epub 2020 Jan 25.
PubMed 31984844Kelly L, Runge J, Spencer C. Predictors of Compassion Fatigue and Compassion Satisfaction in Acute Care Nurses. J Nurs Scholarsh. 2015 Nov;47(6):522-8. doi: 10.1111/jnu.12162. Epub 2015 Aug 19.
PubMed 26287741Klein CJ, Riggenbach-Hays JJ, Sollenberger LM, Harney DM, McGarvey JS. Quality of Life and Compassion Satisfaction in Clinicians: A Pilot Intervention Study for Reducing Compassion Fatigue. Am J Hosp Palliat Care. 2018 Jun;35(6):882-888. doi: 10.1177/1049909117740848. Epub 2017 Nov 23.
PubMed 29169248McKinley N, Karayiannis PN, Convie L, Clarke M, Kirk SJ, Campbell WJ. Resilience in medical doctors: a systematic review. Postgrad Med J. 2019 Mar;95(1121):140-147. doi: 10.1136/postgradmedj-2018-136135. Epub 2019 Mar 29.
PubMed 30926716Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
PubMed 18696313Potter P, Deshields T, Berger JA, Clarke M, Olsen S, Chen L. Evaluation of a compassion fatigue resiliency program for oncology nurses. Oncol Nurs Forum. 2013 Mar;40(2):180-7. doi: 10.1188/13.ONF.180-187.
PubMed 23448743
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study Examining Use of the Oxygen for Caregivers® Program
- ClinicalTrials.gov ID
- NCT04888000
- Acronym / sponsor ID
- CSRS / 1684111
- Conditions
- Compassion Fatigue, Resilience
- Keywords
- Compassion Fatigue, Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 17 May 2021 (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 purpose of this study is to evaluate an educational professional development program designed to assist health care professionals in developing self-awareness and self-care choices as a means to avoid compassion fatigue and improve resilience.
Detailed description
Professional caregivers are at risk of compassion fatigue due to the nature of their work and repeated exposure over time to work-related stressors. Symptoms of compassion fatigue may include decreased concentration/productivity, increased sick days, and high turnover rates which directly effect patient satisfaction and safety. Lack of data that supports this use of program, though anecdotally, it has been endorsed and benefits from its use are described. Quality of patient care, workforce engagement, and financial effects from turnover of staff are viewed as negative impacts from compassion fatigue.
Our study seeks to extend the body of knowledge with regard to use of a particular resilience program that has shown some promise in a small pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| single | Other | Other: Educational InterventionEducational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- employment within inpatient or outpatient setting in non-profit healthcare system as a healthcare professional
- Professional direct caregivers (nurses, physicians, advanced practice providers, social workers, counselors, chaplains, respiratory therapists, pharmacists
Key exclusion criteria (1 listed)
- actively participating in or plans to participate in any other formalized mindfulness-based stress reduction program during the time period of the study
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 |
|---|---|---|
| Educational InterventionProfessional development program provided to small groups of health care professionals in three different sessions over a period of one month with additional independent individual work to be completed between sessions. | Other | single |
Primary outcome
Professional Quality of Life Scale (ProQOL) Version 5
Time frame: Change from baseline compassion fatigue subscale measure at 1 and 6 months assessed by compassion fatigue subscale of ProQOL 5 [ Time Frame: Data collected before the program starts and one month after the end of the program and six months
Professional Quality of Life Scale (ProQOL) Version 5 Compassion Fatigue Subscale
Professional Quality of Life Scale (ProQOL) Version 5
Time frame: Change from baseline burnout subscale measure at 1 and 6 months assessed by burnout subscale of ProQOL 5 [ Time Frame: Data collected before the program starts and one month after the end of the program and six months
Professional Quality of Life Scale (ProQOL) Version 5 Burnout Subscale
Professional Quality of Life Scale (ProQOL) Version 5
Time frame: Change from baseline compassion satisfaction subscale measure at 1 and 6 months assessed by compassion satisfaction subscale of ProQOL 5 [ Time Frame: Data collected before the program starts and one month after the end of the program and six months
Professional Quality of Life Scale (ProQOL) Version 5 Compassion Satisfaction Subscale
Brief Resilience Scale
Time frame: Change from baseline in resilience measure at 1 month and 6 months assessed by BRS scale [ Time Frame: Data collected before the program starts and one month after the end of the program and six months
Resilience will be measured using the Brief Resilience Scale (BRS) a 6-item scale developed by Smith et al.(2008).
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 Nov 2023.
- Background: PubMed 30220356Ang SY, Hemsworth D, Uthaman T, Ayre TC, Mordiffi SZ, Ang E, Lopez V. Understanding the influence of resilience on psychological outcomes - Comparing results from acute care nurses in Canada and Singapore. Appl Nurs Res. 2018 Oct;43:105-113. doi: 10.1016/j.apnr.2018.07.007. Epub 2018 Jul 26.
- Background: PubMed 27797570Austin CL, Saylor R, Finley PJ. Moral distress in physicians and nurses: Impact on professional quality of life and turnover. Psychol Trauma. 2017 Jul;9(4):399-406. doi: 10.1037/tra0000201. Epub 2016 Oct 31.
- Background: PubMed 31829113Cavanagh N, Cockett G, Heinrich C, Doig L, Fiest K, Guichon JR, Page S, Mitchell I, Doig CJ. Compassion fatigue in healthcare providers: A systematic review and meta-analysis. Nurs Ethics. 2020 May;27(3):639-665. doi: 10.1177/0969733019889400. Epub 2019 Dec 12.
- Background: PubMed 24019272Fortney L, Luchterhand C, Zakletskaia L, Zgierska A, Rakel D. Abbreviated mindfulness intervention for job satisfaction, quality of life, and compassion in primary care clinicians: a pilot study. Ann Fam Med. 2013 Sep-Oct;11(5):412-20. doi: 10.1370/afm.1511.
- Background: PubMed 31984844Huey CWT, Palaganas JC. What are the factors affecting resilience in health professionals? A synthesis of systematic reviews. Med Teach. 2020 May;42(5):550-560. doi: 10.1080/0142159X.2020.1714020. Epub 2020 Jan 25.
- Background: PubMed 26287741Kelly L, Runge J, Spencer C. Predictors of Compassion Fatigue and Compassion Satisfaction in Acute Care Nurses. J Nurs Scholarsh. 2015 Nov;47(6):522-8. doi: 10.1111/jnu.12162. Epub 2015 Aug 19.
- Background: PubMed 29169248Klein CJ, Riggenbach-Hays JJ, Sollenberger LM, Harney DM, McGarvey JS. Quality of Life and Compassion Satisfaction in Clinicians: A Pilot Intervention Study for Reducing Compassion Fatigue. Am J Hosp Palliat Care. 2018 Jun;35(6):882-888. doi: 10.1177/1049909117740848. Epub 2017 Nov 23.
- Background: PubMed 30926716McKinley N, Karayiannis PN, Convie L, Clarke M, Kirk SJ, Campbell WJ. Resilience in medical doctors: a systematic review. Postgrad Med J. 2019 Mar;95(1121):140-147. doi: 10.1136/postgradmedj-2018-136135. Epub 2019 Mar 29.
- Background: PubMed 18696313Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
- Background: PubMed 23448743Potter P, Deshields T, Berger JA, Clarke M, Olsen S, Chen L. Evaluation of a compassion fatigue resiliency program for oncology nurses. Oncol Nurs Forum. 2013 Mar;40(2):180-7. doi: 10.1188/13.ONF.180-187.
- Individual participant dataSharing planned: No
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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.
Colleen Klein, PhD, MS, RN principal investigator
OSF Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Compassion Fatigue and Resilience, run by OSF Healthcare System at 1 site in United States.
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 2 inclusion and 1 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 Nov 2023. 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 United States. 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?
Professional Quality of Life Scale (ProQOL) Version 5 (time frame: Change from baseline compassion fatigue subscale measure at 1 and 6 months assessed by compassion fatigue subscale of ProQOL 5 [ Time Frame: Data collected before the program starts and one month after the end of the program and six months). The study lists 4 primary outcomes in all. 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 NCT04888000, which also lists 10 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 Nov 2023.