- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03017469
Achieving Resilience in Acute Care Nurses (ARISE).
April 16, 2018 updated by: Orla Smith, Unity Health Toronto
Achieving Resilience in Acute Care Nurses (ARISE): A Randomized Controlled Trial of a Multi-component Intervention for Nurses in Critical Care and Trauma.
Nurses are exposed to myriad stressors, both in the workplace and in their everyday lives, which can lead to adverse personal and professional outcomes.
While workplace stress cannot be eliminated, nurses can learn techniques to build resilience, mitigate stress, and decrease fatigue.
Organizational employee health, wellness, and assistance programs are all intentioned to provide this type of support; however, nurses often lack awareness of options and opportunities, and access can be a challenge.
The purpose of the proposed study is to assess the outcomes of a multi-modal intervention and toolkit, ARISE, designed to enhance resilience and promote awareness of organizational resources for health, wellness, and employee assistance.
We will evaluate the impact of participation in ARISE on resilience and other outcomes in nurses in critical care and trauma settings.
As a Best Practice Spotlight Organization designated by the Registered Nurses Association of Ontario (RNAO), this project will incorporate relevant recommendations from Best Practice Guidelines (BPG) related to Workplace Health, Safety, and Well-being of the Nurse; and Preventing and Mitigating Nurse Fatigue in Health Care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B1W8
- St. Michael's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Nurse in the medical-surgical and trauma-neurosurgical intensive care units (MSICU and TNICU) and the medical/surgical floor (9CCN),
- full-time or part-time employment status,
- approval of clinical leader manager (CLM),
- receipt of written informed consent.
Exclusion Crieria:
- casual employment status
- inability to attend intervention days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ARISE Intervention
Nurses who participate in the 1.5 day ARISE Intervention
|
|
No Intervention: Control Group
Nurses who do not participate in the ARISE Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Connor Davidson Resilience Scale (CD-RISC)
Time Frame: 1 month post intervention
|
1 month post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Connor Davidson Resilience Scale (CD-RISC)
Time Frame: 3 months post intervention
|
3 months post intervention
|
|
Occupational fatigue and recovery (OFER) scale
Time Frame: 1 month post intervention
|
Acute fatigue and inter-shift recovery scales only
|
1 month post intervention
|
Occupational fatigue and recovery (OFER) scale
Time Frame: 3 months post intervention
|
Acute fatigue and inter-shift recovery scales only
|
3 months post intervention
|
Professional Quality of Life (ProQOL5) scale
Time Frame: 1 month post intervention
|
1 month post intervention
|
|
Professional Quality of Life (ProQOL5) scale
Time Frame: 3 months post intervention
|
3 months post intervention
|
|
Perceived Stress Scale (PSS)
Time Frame: 1 month post intervention
|
1 month post intervention
|
|
Perceived Stress Scale (PSS)
Time Frame: 3 months post intervention
|
3 months post intervention
|
|
Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N).
Time Frame: 1 month post intervention
|
1 month post intervention
|
|
Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N).
Time Frame: 3 months post intervention
|
3 months post intervention
|
|
Mindfulness Attention Awareness Scale (MASS)
Time Frame: 1 month post intervention
|
1 month post intervention
|
|
Mindfulness Attention Awareness Scale (MASS)
Time Frame: 3 months post intervention
|
Mindfulness attention awareness will be measured using the Mindfulness Attention Awareness Scale (MASS).
|
3 months post intervention
|
Program Evaluation Outcomes for ARISE participants
Time Frame: 1 month post intervention
|
For each component of the intervention, and for the ARISE program as a whole, we will ask participants to rate utility, satisfaction, and frequency of use of intervention components.
|
1 month post intervention
|
Program Evaluation Outcomes for ARISE participants
Time Frame: 3 months post intervention
|
For each component of the intervention, and for the ARISE program as a whole, we will ask participants to rate utility, satisfaction, and frequency of use of intervention components.
|
3 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
- Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.
- Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- Mealer M, Jones J, Newman J, McFann KK, Rothbaum B, Moss M. The presence of resilience is associated with a healthier psychological profile in intensive care unit (ICU) nurses: results of a national survey. Int J Nurs Stud. 2012 Mar;49(3):292-9. doi: 10.1016/j.ijnurstu.2011.09.015. Epub 2011 Oct 5.
- Deible S, Fioravanti M, Tarantino B, Cohen S. Implementation of an integrative coping and resiliency program for nurses. Glob Adv Health Med. 2015 Jan;4(1):28-33. doi: 10.7453/gahmj.2014.057.
- Rushton CH, Batcheller J, Schroeder K, Donohue P. Burnout and Resilience Among Nurses Practicing in High-Intensity Settings. Am J Crit Care. 2015 Sep;24(5):412-20. doi: 10.4037/ajcc2015291.
- Aiken LH, Clarke SP, Sloane DM; International Hospital Outcomes Research Consortium. Hospital staffing, organization, and quality of care: cross-national findings. Int J Qual Health Care. 2002 Feb;14(1):5-13. doi: 10.1093/intqhc/14.1.5.
- Akgum S, Al-Assaf AF, & Bakar C. Reducing Burnout among Hospital Professionals. Journal of Employee Assistance, 3:15-17, 2008.
- Alexander GK, Rollins K, Walker D, Wong L, Pennings J. Yoga for Self-Care and Burnout Prevention Among Nurses. Workplace Health Saf. 2015 Oct;63(10):462-70; quiz 471. doi: 10.1177/2165079915596102.
- Peter E, Storch JL; Canadian Nurses Association. The CNA code of ethics for registered nurses. Nurs Leadersh (Tor Ont). 2008;21(2):28-33. doi: 10.12927/cjnl.2008.19872. No abstract available.
- Casella E, Mills J, Usher K. Social media and nursing practice: changing the balance between the social and technical aspects of work. Collegian. 2014;21(2):121-6. doi: 10.1016/j.colegn.2014.03.005.
- Chana N, Kennedy P, Chessell ZJ. Nursing staffs' emotional well-being and caring behaviours. J Clin Nurs. 2015 Oct;24(19-20):2835-48. doi: 10.1111/jocn.12891. Epub 2015 Jul 16.
- Charney DS. Psychobiological mechanisms of resilience and vulnerability: implications for successful adaptation to extreme stress. Am J Psychiatry. 2004 Feb;161(2):195-216. doi: 10.1176/appi.ajp.161.2.195.
- Coetzee SK, Klopper HC. Compassion fatigue within nursing practice: a concept analysis. Nurs Health Sci. 2010 Jun;12(2):235-43. doi: 10.1111/j.1442-2018.2010.00526.x.
- Craigie M, Slatyer S, Hegney DG, Osseiran-Moisson R, Gentry E, Davis S., . . . Rees C. A Pilot Evaluation of a Mindful Self-care and Resiliency (MSCR) Intervention for Nurses. Mindfulness, 7(3), 764-774, 2016. doi:10.1007/s12671-016-0516-x
- Dolan G, Strodl E, Hamernik E. Why renal nurses cope so well with their workplace stressors. J Ren Care. 2012 Dec;38(4):222-32. doi: 10.1111/j.1755-6686.2012.00319.x. Epub 2012 Aug 30.
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- Fang R, Li X. A regular yoga intervention for staff nurse sleep quality and work stress: a randomised controlled trial. J Clin Nurs. 2015 Dec;24(23-24):3374-9. doi: 10.1111/jocn.12983. Epub 2015 Oct 19.
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- Gillespie BM, Chaboyer W, Wallis M. The influence of personal characteristics on the resilience of operating room nurses: a predictor study. Int J Nurs Stud. 2009 Jul;46(7):968-76. doi: 10.1016/j.ijnurstu.2007.08.006. Epub 2007 Oct 3.
- Hall LH, Johnson J, Watt I, Tsipa A, O'Connor DB. Healthcare Staff Wellbeing, Burnout, and Patient Safety: A Systematic Review. PLoS One. 2016 Jul 8;11(7):e0159015. doi: 10.1371/journal.pone.0159015. eCollection 2016.
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- Hegney DG, Craigie M, Hemsworth D, Osseiran-Moisson R, Aoun S, Francis K, Drury V. Compassion satisfaction, compassion fatigue, anxiety, depression and stress in registered nurses in Australia: study 1 results. J Nurs Manag. 2014 May;22(4):506-18. doi: 10.1111/jonm.12160. Epub 2013 Nov 1.
- Houck D. Helping nurses cope with grief and compassion fatigue: an educational intervention. Clin J Oncol Nurs. 2014 Aug;18(4):454-8. doi: 10.1188/14.CJON.454-458.
- Jackson D, Firtko A, Edenborough M. Personal resilience as a strategy for surviving and thriving in the face of workplace adversity: a literature review. J Adv Nurs. 2007 Oct;60(1):1-9. doi: 10.1111/j.1365-2648.2007.04412.x.
- Kemper K, Bulla S, Krueger D, Ott MJ, McCool JA, Gardiner P. Nurses' experiences, expectations, and preferences for mind-body practices to reduce stress. BMC Complement Altern Med. 2011 Apr 11;11:26. doi: 10.1186/1472-6882-11-26.
- Kemper KJ. Brief Online Mindfulness Training: Immediate Impact. J Evid Based Complementary Altern Med. 2017 Jan;22(1):75-80. doi: 10.1177/2156587216639199. Epub 2016 Mar 21.
- Kemper KJ, Khirallah M. Acute Effects of Online Mind-Body Skills Training on Resilience, Mindfulness, and Empathy. J Evid Based Complementary Altern Med. 2015 Oct;20(4):247-53. doi: 10.1177/2156587215575816. Epub 2015 Mar 17.
- Kemper KJ, Mo X, Khayat R. Are Mindfulness and Self-Compassion Associated with Sleep and Resilience in Health Professionals? J Altern Complement Med. 2015 Aug;21(8):496-503. doi: 10.1089/acm.2014.0281. Epub 2015 Jun 2.
- Klatt M, Steinberg B, Duchemin AM. Mindfulness in Motion (MIM): An Onsite Mindfulness Based Intervention (MBI) for Chronically High Stress Work Environments to Increase Resiliency and Work Engagement. J Vis Exp. 2015 Jul 1;(101):e52359. doi: 10.3791/52359.
- Klatt M, Steinberg B, Marks D & Duchemin A. Changes in physiological and psychological markers of stress in hospital personnel after a low-dose mindfulness-based worksite intervention. BMC Complementary and Alternative Medicine(12), 2014. doi:1472-6882/12/S1/O16
- Kornhaber RA, Wilson A. Enduring feelings of powerlessness as a burns nurse: a descriptive phenomenological inquiry. Contemp Nurse. 2011 Oct;39(2):172-9. doi: 10.5172/conu.2011.172.
- Leners C, Sowers R, Quinn Griffin MT, Fitzpatrick JJ. Resilience and professional quality of life among military healthcare providers. Issues Ment Health Nurs. 2014 Jul;35(7):497-502. doi: 10.3109/01612840.2014.887164.
- Mcdonald G, Jackson D, Vickers MH, Wilkes L. Surviving workplace adversity: a qualitative study of nurses and midwives and their strategies to increase personal resilience. J Nurs Manag. 2016 Jan;24(1):123-31. doi: 10.1111/jonm.12293. Epub 2015 Apr 13.
- McDonald G, Jackson D, Wilkes L, Vickers MH. Personal resilience in nurses and midwives: effects of a work-based educational intervention. Contemp Nurse. 2013 Aug;45(1):134-43. doi: 10.5172/conu.2013.45.1.134.
- Mealer M, Conrad D, Evans J, Jooste K, Solyntjes J, Rothbaum B, Moss M. Feasibility and acceptability of a resilience training program for intensive care unit nurses. Am J Crit Care. 2014 Nov;23(6):e97-105. doi: 10.4037/ajcc2014747. Erratum In: Am J Crit Care. 2016 Mar;25(2):172.
- Mealer M, Jones J, Moss M. A qualitative study of resilience and posttraumatic stress disorder in United States ICU nurses. Intensive Care Med. 2012 Sep;38(9):1445-51. doi: 10.1007/s00134-012-2600-6. Epub 2012 May 23.
- Moorley C, Chinn T. Developing nursing leadership in social media. J Adv Nurs. 2016 Mar;72(3):514-20. doi: 10.1111/jan.12870. Epub 2016 Jan 6.
- Moorley CR, Chinn T. Nursing and Twitter: creating an online community using hashtags. Collegian. 2014;21(2):103-9. doi: 10.1016/j.colegn.2014.03.003.
- 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.
- Sun N, Lv DM, Man J, Wang XY, Cheng Q, Fang HL, Fu Z, Liu S, Wu QH. The correlation between quality of life and social support in female nurses. J Clin Nurs. 2017 Apr;26(7-8):1005-1010. doi: 10.1111/jocn.13393.
- Panagioti M, Panagopoulou E, Bower P, Lewith G, Kontopantelis E, Chew-Graham C, Dawson S, van Marwijk H, Geraghty K, Esmail A. Controlled Interventions to Reduce Burnout in Physicians: A Systematic Review and Meta-analysis. JAMA Intern Med. 2017 Feb 1;177(2):195-205. doi: 10.1001/jamainternmed.2016.7674.
- Pisanti R, Lombardo C, Lucidi F, Lazzari D, Bertini M. Development and validation of a brief Occupational Coping Self-Efficacy Questionnaire for Nurses. J Adv Nurs. 2008 Apr;62(2):238-47. doi: 10.1111/j.1365-2648.2007.04582.x.
- Potter 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.
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- Winwood PC, Winefield AH, Dawson D, Lushington K. Development and validation of a scale to measure work-related fatigue and recovery: the Occupational Fatigue Exhaustion/Recovery Scale (OFER). J Occup Environ Med. 2005 Jun;47(6):594-606. doi: 10.1097/01.jom.0000161740.71049.c4.
- Winwood PC, Winefield AH, Lushington K. Work-related fatigue and recovery: the contribution of age, domestic responsibilities and shiftwork. J Adv Nurs. 2006 Nov;56(4):438-49. doi: 10.1111/j.1365-2648.2006.04011.x.
- Wittenberg-Lyles E, Goldsmith J, Reno J. Perceived benefits and challenges of an oncology nurse support group. Clin J Oncol Nurs. 2014 Aug;18(4):E71-6. doi: 10.1188/14.CJON.E71-E76.
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Helpful Links
- Cohen, S. (1994). Perceived Stress Scale.
- Registered Nurses' Association of Ontario [RNAO]. (2011). Preventing and Mitigating Nurse Fatigue in Health Care Toronto, Canada Registered Nurses' Association of Ontario
- Stamm, B. (2005 ). The ProQOL Manual: THE PROFESSIONAL QUALITY OF LIFE SCALE: Compassion Satisfaction, Burnout & Compassion Fatigue/Secondary Trauma Scales. Pocatello, ID.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2017
Primary Completion (Actual)
May 31, 2017
Study Completion (Actual)
October 15, 2017
Study Registration Dates
First Submitted
January 9, 2017
First Submitted That Met QC Criteria
January 9, 2017
First Posted (Estimate)
January 11, 2017
Study Record Updates
Last Update Posted (Actual)
April 17, 2018
Last Update Submitted That Met QC Criteria
April 16, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMH30Dec2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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