Back to resultsRISE RCT for Nurse Leaders (RISE)
Primary Purpose
Stress, Burnout
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RISE for Nurse Leaders Program
Sponsored by
About this trial
This is an interventional supportive care trial for Stress
Eligibility Criteria
Inclusion Criteria:
- Adult ≥ 18 years old
- Licensed as an RN
- Unit-based nurse leader (i.e., assistant nurse manager, nurse manager) employed by AdventHealth in a hospital-based setting at the Altamonte Springs, Apopka, Celebration, Daytona Beach, DeLand, East Orlando, Fish Memorial, Kissimmee, New Smyrna Beach, Orlando, Palm Coast, Waterman, or Winter Park campus
- Able to speak, read, and understand English fluently
- Able to provide informed consent
- Willing and able to comply with all study procedures and requirements for the duration of the study.
Exclusion Criteria:
- Employed as a direct care nurse or in another level of nursing leadership (i.e., director of nursing, executive leader)
- A study participant of IRBNet #1504917 titled A Pilot Study of RISE for Nurse Managers
Sites / Locations
- AdventHealth Orlando
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Wait-list control group
Arm Description
Intervention group will attend the RISE for Nurse Leaders program, which consists of nine 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor (LMHC)
Control group will attend the RISE for Nurse Leaders program after the 3-month wait-list period
Outcomes
Primary Outcome Measures
Posttraumatic Growth Inventory
21 item questionnaire with a scale of 0-5, with 0 meaning I did not experience this change as a result of my crisis; and 5 meaning I experienced this change to a very great degree as a result of my crisis
Secondary Outcome Measures
Brief Index of Affective Job Satisfaction
4 item questionnaire with a scale of 1-5, with 1 meaning strongly disagree; and 5 meaning strongly agree
Brief Resilience Scale
6 item questionnaire with a scale of 1-5, with 1 meaning strongly disagree; and 5 meaning strongly agree
General Self-Efficacy Scale
10 item questionnaire with a scale of 1-4, with 1 meaning not at all true; and 4 meaning exactly true
Perceived Stress Scale
10 item questionnaire with a scale of 0-4, with 0 meaning never; and 4 meaning very often
Professional Quality of Life (ProQOL) Scale
30 item questionnaire with a scale of 1-5 with 1 meaning never; and 5 meaning very often
Psychological Empowerment Instrument
12 item questionnaire with a scale of A-G, with A meaning very strongly disagree; and G meaning very strongly agree
Self-Reflection and Insight Scale
20 item questionnaire with a scale of 1-6; with 1 meaning strongly disagree; and 6 meaning strongly agree
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05254600
Brief Title
RISE RCT for Nurse Leaders
Acronym
RISE
Official Title
A Randomized Controlled Trial of RISE for Nurse Leaders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether RISE for Nurse Leaders has a significant impact on nurse leaders' post-traumatic growth, resilience, insight, self-compassion, and empowerment, as well as mental well-being, in their personal lives and their working environment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Burnout
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention group will attend the RISE for Nurse Leaders program, which consists of nine 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor (LMHC)
Arm Title
Wait-list control group
Arm Type
Active Comparator
Arm Description
Control group will attend the RISE for Nurse Leaders program after the 3-month wait-list period
Intervention Type
Behavioral
Intervention Name(s)
RISE for Nurse Leaders Program
Intervention Description
Psychoeducational sessions designed to impact resilience, insight, self-compassion, and empowerment
Primary Outcome Measure Information:
Title
Posttraumatic Growth Inventory
Description
21 item questionnaire with a scale of 0-5, with 0 meaning I did not experience this change as a result of my crisis; and 5 meaning I experienced this change to a very great degree as a result of my crisis
Time Frame
Group comparison from baseline to 3-month follow-up
Secondary Outcome Measure Information:
Title
Brief Index of Affective Job Satisfaction
Description
4 item questionnaire with a scale of 1-5, with 1 meaning strongly disagree; and 5 meaning strongly agree
Time Frame
Group comparison from baseline to 3-month follow-up
Title
Brief Resilience Scale
Description
6 item questionnaire with a scale of 1-5, with 1 meaning strongly disagree; and 5 meaning strongly agree
Time Frame
Group comparison from baseline to 3-month follow-up
Title
General Self-Efficacy Scale
Description
10 item questionnaire with a scale of 1-4, with 1 meaning not at all true; and 4 meaning exactly true
Time Frame
Group comparison from baseline to 3-month follow-up
Title
Perceived Stress Scale
Description
10 item questionnaire with a scale of 0-4, with 0 meaning never; and 4 meaning very often
Time Frame
Group comparison from baseline to 3-month follow-up
Title
Professional Quality of Life (ProQOL) Scale
Description
30 item questionnaire with a scale of 1-5 with 1 meaning never; and 5 meaning very often
Time Frame
Group comparison from baseline to 3-month follow-up
Title
Psychological Empowerment Instrument
Description
12 item questionnaire with a scale of A-G, with A meaning very strongly disagree; and G meaning very strongly agree
Time Frame
Group comparison from baseline to 3-month follow-up
Title
Self-Reflection and Insight Scale
Description
20 item questionnaire with a scale of 1-6; with 1 meaning strongly disagree; and 6 meaning strongly agree
Time Frame
Group comparison from baseline to 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult ≥ 18 years old
Licensed as an RN
Unit-based nurse leader (i.e., assistant nurse manager, nurse manager) employed by AdventHealth in a hospital-based setting at the Altamonte Springs, Apopka, Celebration, Daytona Beach, DeLand, East Orlando, Fish Memorial, Kissimmee, New Smyrna Beach, Orlando, Palm Coast, Waterman, or Winter Park campus
Able to speak, read, and understand English fluently
Able to provide informed consent
Willing and able to comply with all study procedures and requirements for the duration of the study.
Exclusion Criteria:
Employed as a direct care nurse or in another level of nursing leadership (i.e., director of nursing, executive leader)
A study participant of IRBNet #1504917 titled A Pilot Study of RISE for Nurse Managers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda T Sawyer, PhD
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy Scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. (pp. 35-37). Windsor, UK: NFER-NELSON
Results Reference
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PubMed Identifier
6668417
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.
Results Reference
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PubMed Identifier
22441404
Citation
Kath LM, Stichler JF, Ehrhart MG. Moderators of the negative outcomes of nurse manager stress. J Nurs Adm. 2012 Apr;42(4):215-21. doi: 10.1097/NNA.0b013e31824ccd25.
Results Reference
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PubMed Identifier
23522937
Citation
Kath LM, Stichler JF, Ehrhart MG, Sievers A. Predictors of nurse manager stress: a dominance analysis of potential work environment stressors. Int J Nurs Stud. 2013 Nov;50(11):1474-80. doi: 10.1016/j.ijnurstu.2013.02.011. Epub 2013 Mar 21.
Results Reference
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PubMed Identifier
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Citation
Labrague LJ, McEnroe-Petitte DM, Leocadio MC, Van Bogaert P, Cummings GG. Stress and ways of coping among nurse managers: An integrative review. J Clin Nurs. 2018 Apr;27(7-8):1346-1359. doi: 10.1111/jocn.14165. Epub 2018 Jan 24.
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PubMed Identifier
19017239
Citation
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Results Reference
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Citation
• Grant AM, Franklin J, Langford P. The Self-Reflection and Insight Scale: A new measure of private self-consciousness. Social Behavior and Personality. 2002; 30(8): 821-836.
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• Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005; 4(4): 287-291.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
20124961
Citation
Shirey MR, McDaniel AM, Ebright PR, Fisher ML, Doebbeling BN. Understanding nurse manager stress and work complexity: factors that make a difference. J Nurs Adm. 2010 Feb;40(2):82-91. doi: 10.1097/NNA.0b013e3181cb9f88.
Results Reference
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PubMed Identifier
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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.
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Citation
• Spreitzer GM. Psychological empowerment in the workplace: Dimensions, measurement, and validation. Academy of Management Journal. 1995; 38(5):1442-1465.
Results Reference
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Citation
• Stamm, B. H. (2009). Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL). http://www.proqol.org.
Results Reference
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PubMed Identifier
28244184
Citation
Steege LM, Pinekenstein BJ, Arsenault Knudsen E, Rainbow JG. Exploring nurse leader fatigue: a mixed methods study. J Nurs Manag. 2017 May;25(4):276-286. doi: 10.1111/jonm.12464. Epub 2017 Feb 27.
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Citation
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RISE RCT for Nurse Leaders
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