Resilience Intervention for Critical Care Nurses

Stress Clinical Trial

Official title:

A Randomized Controlled Trial of a Resilience Intervention for Critical Care Nurses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645512
• Other study ID #: 1234568
• Status: Completed
• Phase: N/A
• Start date: October 26, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2020
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

The purpose of this RCT is to determine whether the CAR Training Program 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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 at the Altamonte, Orlando, or Winter Park campus

3. Able to speak, read, and understand English fluently

4. Able to provide informed consent

5. Meet = 2 stress experience level parameters on the Stress Mindset Measure - General (SMM-G)

6. Meet = 4.3 on the Brief Resilience Scale (BRS)

7. Willing to attend a full-day training program at HPI on the designated training date

8. Willing and able to comply with all study procedures and requirements for the duration of the study.

Exclusion Criteria:

1. Meet < 2 stress experience level parameters on the SMM-G

2. Meet > 4.3 on the BRS

3. 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)

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Corporate Athlete Resilience (CAR) Training Program
A 1-day training program developed by the J&J Human Performance Institute (HPI), which uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.

Locations

Country	Name	City	State
United States	Florida Hospital	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida Hospital	Johnson & Johnson

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View 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. — View Citation

Carayon, P. & Gurses, A. P. (2008). Nursing workload and patient safety - A human factors engineering perspective. In Hughes, R. G. (Ed.), Patient safety and quality: An evidence-based handbook for nurses. Rockville, MD: Agency for Healthcare Research and Quality.

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View 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. — View Citation

Johnson & Johnson Health & Wellness Solutions Research Team. 2017. Validation and Analysis of Johnson & Johnson Human Performance Institute™ (HPI) Assessment Inventory. Unpublished manuscript.

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. — View Citation

Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach Burnout Inventory manual (3rd ed.). Palo Alto, CA: Consulting Psychologists Press.

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. — View 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. Erratum in: Am J Crit Care. 2016 Mar;25(2):172. — View 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. — View 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. Epub 2006 Dec 21. — View 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. — View 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.

RAND Corporation. (2018). Sleep Scale Survey. Retrieved from https://www.rand.org/health/surveys_tools/mos/sleep-scale.html.

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. — View 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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress Mindset Measure - General (SMM-G)	Participants will respond to an 8-item questionnaire measuring stress. Responses will be provided on the following 5-point scale: 0=Strongly Disagree, 1=Disagree, 2=Neither Agree nor Disagree, 3=Agree, 4=Strongly Agree.	Change from Baseline SMM-G score at 6-months post CAR Training
Secondary	Perceived Stress Scale (PSS)	Participants will respond to a 10-item questionnaire measuring perceived stress. Responses will be provided on the following 5-point scale: 0=Never, 1=Almost Never, 2=Sometimes, 3=Fairly Often, 4=Very Often.	Change from Baseline PSS score at 6-months post CAR Training
Secondary	Brief Resilience Scale (BRS)	Participants will respond to a 6-item questionnaire measuring resilience. Responses will be provided on the following 5-point scale: 1=Strongly Disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree.	Change from Baseline BRS score at 6-months post CAR Training
Secondary	Maslach Burnout Inventory Human Serices Survey (MBI-HSS) for Medical Personnel (MP)	Participants will respond to a 22-item questionnaire measuring burnout. Responses will be provided on the following 7-point scale: 0=Never, 1=A few times a year or less, 2=Once a month or less, 3=A few times a month, 4=Once a week, 5=A few times a week, 6=Everyday.	Change from Baseline MBI-HSS (MP) score at 6-months post CAR Training
Secondary	Public Health Surveillance - Wellbeing Scale (PHS-WB)	Participants will respond to a 10-item questionnaire measuring perception of personal well-being and satisfaction. Responses will be provided on a 5-point scale (6 items) and a 10-point scale (4 items).	Change from Baseline PHS-WB score at 6-months post CAR Training
Secondary	RAND Medial Outcomes Study (MOS) Sleep Scale Survey	Participants will respond to a 12-item questionnaire with self-reported information related to sleep patterns. Responses will be provided on the following 6-point scale: 1=All of the time, 2=Most of the time, 3=A good bit of the time, 4=Some of the time, 5=A little of the time, 6=None of the time.	Change from Baseline RAND MOS Sleep Scale Survey score at 6-months post CAR Training
Secondary	RAND 36-Item Short Form Health Survey (SF-36)	Participants will respond to a 36-item questionnaire with self-reported health ratings and perceived impact of one's health on a variety of daily activities. Response options for questionnaire items vary from 3-point scale, 5-point scale, and Yes/No responses.	Change from Baseline RAND SF-36 score at 6-months post CAR Training
Secondary	Absenteeism & Presenteeism questions of the World Health Organization's Health and Work Performance Questionnaire (WHO-HPQ)	Participants will respond to 11 absenteeism and presenteeism questions abstracted from the full HPQ. Responses for 2 items require self-reported information regarding hours worked and hours the employer expects the participant to work in 7 days. 6 items require participants to provide work experience information from the past 4 weeks. Responses for 3 items are provided on a 10-point scale in which 0=Worst Performance, and 10=Top Performance. Responses are input into a provided formula for scoring; a higher absenteeism score indicates higher amount of absenteeism, while a higher presenteeism score indicates lower amount of lost performance.	Change from Baseline WHO-HPQ score at 6-months post CAR Training
Secondary	Work Productivity and Activity Impairment Questionnaire (WPAI)	Participants will respond to a 6-item questionnaire, answering questions about the perceived effect of personal health problems on one's ability to work or perform activities. Responses are provided in a Yes/No format or using a 10-point scale in which 0=Health problems had no effect on my work and 10=Health problems completely prevented me from working.	Change from Baseline WPAI score at 6-months post CAR Training
Secondary	Energy Management Behaviors Questionnaire (EMB)	Participants will respond to a 21-item questionnaire, providing a self-reported level of engagement in various activities. Responses are provided using the following 7-point scale: 1=Never, 2=Almost never, 3=Seldom, 4=Sometimes, 5=Usually, 6=Very Often, 7=Always.	Change from Baseline EMB score at 6-months post CAR Training