Clinical trial NCT04952441: RISE Program for Nurses
Official title: A Randomized Controlled Trial of the RISE Program for Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into either the intervention group or the wait-list control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether the RISE program has a significant impact on nurses' resilience, insight, self-compassion, and empowerment, as well as mental and physical well-being, in their personal lives and their working environment.

Detailed description: This study will include the face-to-face visits of eight weekly 90-minute psychoeducational group sessions in a private conference room at AdventHealth. No absences are permitted due to lack of engagement. Participants will only be compensated for the number of attended sessions. The LMHC facilitator will send a reminder email to the control group participants after the intervention group participants attend their eighth session.

There will be three unpaid optional follow-up monthly booster sessions that focus on skill development. Participants will be invited to attend these booster sessions during the 3 months following their group's RISE Program. Attendance will be recorded. No other data will be collected during the booster sessions.

The following assessments will be used to measure study outcomes: Brief Resilience Scale (BRS); Self-Reflection and Insight Scale (SRIS); Self-Compassion Scale - Short Form (SCS-SF); Psychological Empowerment Instrument (PEI); Stress Mindset Measure - General (SMM-G); Perceived Stress Survey (PSS); Maslach Burnout Inventory (MBI); Public Health Surveillance - Wellbeing Scale (PHS-WB); RAND MOS Sleep Scale Survey; RAND 36-Item Short Form Health Survey (SF-36); World Health Organization Health and Work Performance questionnaire (WHO-HPQ); and Work Productivity and Activity Impairment (WPAI) questionnaire. In addition, demographic assessments will be collected. Employment with AdventHealth will also be tracked longitudinally at 12 months with Human Resources.

Eligibility criteria: Inclusion Criteria:

1. Adult ≥ 18 years old
2. Licensed as an RN
3. RN employed by AdventHealth in a hospital-based setting at the Altamonte, Apopka, Celebration, Daytona Beach, DeLand, East, Fish Memorial, Kissimmee, New Smyrna Beach, Orlando, Palm Coast, Waterman, or Winter Park campus
4. Able to speak, read, and understand English fluently
5. Able to provide informed consent
6. Willing and able to comply with all study procedures and requirements for the duration of the study.

Exclusion Criteria:

1. Employed as an ARNP
2. Employed in a role that completes another RN's annual evaluations
3. A participant of the study in IRBNet #1234568 or IRBNet #1256670
4. At imminent risk of harm to themselves or others.

Primary outcomes:
measure: Self-Reflection and Insight Scale (SRIS)
timeFrame: Change from Baseline to 3 month follow up
Secondary outcomes:
measure: Measure Name: Brief Resilience Scale (BRS)
timeFrame: Change from Baseline to 3 month follow up
measure: Self-Compassion Scale - Short Form (SCS-SF)
timeFrame: Change from Baseline to 3 month follow up
measure: Psychological Empowerment Instrument (PEI)
timeFrame: Change from Baseline to 3 month follow up
measure: Stress Mindset Measure - General (SMM-G)
timeFrame: Change from Baseline to 3 month follow up
measure: Perceived Stress Scale (PSS)
timeFrame: Change from Baseline to 3 month follow up
measure: Maslach Burnout Inventory Human Services Survey (MBI-HSS) for Medical Personnel (MP)
timeFrame: Change from Baseline to 3 month follow up
measure: Public Health Surveillance - Wellbeing Scale (PHS-WB)
timeFrame: Change from Baseline to 3 month follow up
measure: RAND Medical Outcomes Study (MOS) Sleep Scale Survey
timeFrame: Change from Baseline to 3 month follow up
measure: RAND 36-Item Short Form Health Survey (SF-36)
timeFrame: Change from Baseline to 3 month follow up
measure: Absenteeism and Presenteeism questions of the World Health Organization's Health and Work Performance Questionnaire (WHO-HPQ)
timeFrame: Change from Baseline to 3 month follow up
measure: Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: Change from Baseline to 3 month follow up
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth
state: Florida
Study officials:
affiliation: AdventHealth
name: Amanda Sawyer, PhD
role: PRINCIPAL_INVESTIGATOR
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