Clinical trial NCT03645707: Resilience Insight Self Compassion and Empowerment (RISE) Pilot
Official title: A Mixed Methods Evaluation of a Resilience Intervention With Psychoeducational Sessions for Critical Care Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Critical Care Nurse
Resilience
Stress Mindset
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a secondary study to the primary study titled "A Randomized Controlled Trial of a Resilience Intervention for Critical Care Nurses" (Florida Hospital IRBNet #1234568). In the primary study, participants will be randomized into the intervention group or wait-list control group. However, in this secondary study, all participants will attend the 1-day CAR Training Program and the follow-up psychoeducational group sessions.
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to determine whether the combination of the Corporate Athlete® Resilience (CAR) Training Program and follow-up psychoeducational group sessions has significant impact on nurses' resilience and stress mindset in their personal lives and their working environment. Knowledge from this study can be applied to interventions in the future to improve resilience behavior.

Detailed description: The ongoing nursing shortage in the U.S health care system is a multifaceted issue. One factor leading to the nursing shortage is high turnover, particularly among critical care nurses due to their experiences with stressful work environments, ethical dilemmas, and high rates of patient morbidity and mortality. There is also a high prevalence of psychological disorders, such as anxiety, depression, and Post Traumatic Stress Disorder (PTSD) among critical care nurses. Consequences of turnover and low nurse staffing include lower quality of care, lower patient satisfaction, increased medical errors, increased rates of health care associated infections, and higher 30-day mortality rates.

Resilience is defined as "the ability to adapt to life's ever-changing landscape and recover quickly from the stressors and potential stressors". It is a learned psychological characteristic that can be used to bounce back after disruption and successfully adapt to stressful work experiences in a positive manner.

The Corporate Athlete® Resilience (CAR) Training Program is a 1-day training program that uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.

Eligibility criteria: Inclusion Criteria:

1. Adult ≥ 18 years old.
2. Employed as a critical care nurse at Florida Hospital in an adult ICU, PICU, PCVICU, or Level 3 NICU.
3. Able to speak, read, and understand English fluently.
4. Able to provide informed consent.
5. Receive a high score of ≥ 27 on the Emotional Exhaustion domain and/or a high score of ≥ 13 on the Depersonalization domain of the Maslach Burnout Inventory (MBI) as part of Florida Hospital IRBNet #1234568.
6. Willing to attend a full-day training program at HPI on the designated training date.
7. Willing and able to comply with all study procedures and requirements for the duration of the study.

Exclusion Criteria:

1. At imminent risk of harm to themselves or others

Primary outcomes:
measure: Stress Mindset Measure - General (SMM-G)
timeFrame: Change from Baseline SMM-G score at 6-months post CAR Training
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Change from Baseline PSS score at 6-months post CAR Training
measure: Brief Resilience Scale (BRS)
timeFrame: Change from Baseline BRS score at 6-months post CAR Training
measure: Maslach Burnout Inventory Human Services Survey (MBI-HSS) for Medical Personnel (MP)
timeFrame: Change from Baseline MBI-HSS (MP) score at 6-months post CAR Training
measure: Public Health Surveillance - Wellbeing Scale (PHS-WB)
timeFrame: Change from Baseline PHS-WBscore at 6-months post CAR Training
measure: RAND Medical Outcomes Study (MOS) Sleep Scale Survey
timeFrame: Change from Baseline RAND MOS Sleep Scale score at 6-months post CAR Training
measure: RAND 36-Item Short Form Health Survey (SF-36)
timeFrame: Change from Baseline SF-36 score at 6-months post CAR Training
measure: Absenteeism and Presenteeism questions of the World Health Organization's Health and Work Performance Questionnaire (WHO-HPQ)
timeFrame: Change from Baseline WHO-HPQ score at 6-months post CAR Training
measure: Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: Change from Baseline WPAI score at 6-months post CAR Training
measure: Self-Reflection and Insight Scale (SRIS)
timeFrame: Change from Baseline SRIS score at 6-months post CAR Training
measure: Self-Compassion Scale - Short Form (SCS-SF)
timeFrame: Change from Baseline SCS-SF score at 6-months post CAR Training
measure: Psychological Empowerment Instrument
timeFrame: Change from Baseline Psychological Empowerment Instrument score at 6-months post CAR Training
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth
state: Florida
Study officials:
affiliation: AdventHealth
name: Amanda T. Sawyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Acker KH. Do critical care nurses face burnout, PTSD, or is it something else?: getting help for the helpers. AACN Clin Issues Crit Care Nurs. 1993 Aug;4(3):558-65.
citation: Bann CM, Kobau R, Lewis MA, Zack MM, Luncheon C, Thompson WW. Development and psychometric evaluation of the public health surveillance well-being scale. Qual Life Res. 2012 Aug;21(6):1031-43. doi: 10.1007/s11136-011-0002-9. Epub 2011 Sep 23.
citation: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK2651/
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
citation: Crum AJ, Salovey P, Achor S. Rethinking stress: the role of mindsets in determining the stress response. J Pers Soc Psychol. 2013 Apr;104(4):716-33. doi: 10.1037/a0031201. Epub 2013 Feb 25.
citation: Grant, A. M., Franklin, J., & Langford, P. (2002). The Self-Reflection and Insight Scale: A new measure of private self-consciousness. Social Behavior and Personality, 30(8), 821-836.
citation: Johnson & Johnson Health & Wellness Solutions Research Team. 2017. Validation and Analysis of Johnson & Johnson Human Performance Institute™ (HPI) Assessment Inventory. Unpublished manuscript.
citation: Kessler RC, Barber C, Beck A, Berglund P, Cleary PD, McKenas D, Pronk N, Simon G, Stang P, Ustun TB, Wang P. The World Health Organization Health and Work Performance Questionnaire (HPQ). J Occup Environ Med. 2003 Feb;45(2):156-74. doi: 10.1097/01.jom.0000052967.43131.51.
citation: Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach Burnout Inventory manual (3rd ed.). Palo Alto, CA: Consulting Psychologists Press.
citation: Mealer ML, Shelton A, Berg B, Rothbaum B, Moss M. Increased prevalence of post-traumatic stress disorder symptoms in critical care nurses. Am J Respir Crit Care Med. 2007 Apr 1;175(7):693-7. doi: 10.1164/rccm.200606-735OC. Epub 2006 Dec 21.
citation: Mealer 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.
citation: 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.
citation: 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.
citation: Pipe TB, Buchda VL, Launder S, Hudak B, Hulvey L, Karns KE, Pendergast D. Building personal and professional resources of resilience and agility in the healthcare workplace. Stress Health. 2012 Feb;28(1):11-22. doi: 10.1002/smi.1396. Epub 2011 Mar 13.
citation: Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
citation: RAND Corporation. (2018). Sleep Scale Survey. Retrieved from https://www.rand.org/health/surveys_tools/mos/sleep-scale.html.
citation: RAND Corporation. (2018). 36-Item Short Form Survey (SF-36). Retrieved from https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html.
citation: Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
citation: Smith 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.
citation: Spreitzer, G. M. (1995). Psychological empowerment in the workplace: Dimensions, measurement, and validation. Academy of Management Journal, 38(5), 1442-1465.