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RISE Program for Nurses

Primary Purpose

Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RISE Program
Sponsored by
AdventHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress, Psychological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • AdventHealth

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 program which consists of eight 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor

The control group will attend the RISE program after the 3 month wait-list period (study months 6-7)

Outcomes

Primary Outcome Measures

Self-Reflection and Insight Scale (SRIS)
Participants will respond to a 20-item questionnaire using a 6-point scale where 1=Strongly disagree and 6=Strongly agree.

Secondary Outcome Measures

Measure Name: 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.
Self-Compassion Scale - Short Form (SCS-SF)
Participants will respond to a 12-item questionnaire, indicating how often certain behaviors are personally experienced when in difficult times. Responses are provided on 5-point scale in which 1=Almost never and 5=Almost always.
Psychological Empowerment Instrument (PEI)
Participants will respond to a 12-item questionnaire to items regarding self-orientations people may have with regard to their work role. Responses are provided on the following 7-point scale: 1=Very strongly disagree, 2=Strongly disagree, 3=Disagree, 4=Neutral, 5=Agree, 6=Strongly Agree, 7=Very Strongly Agree.
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.
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.
Maslach Burnout Inventory Human Services 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.
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).
RAND Medical 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.
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.
Absenteeism and 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.
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.

Full Information

First Posted
June 17, 2021
Last Updated
July 2, 2021
Sponsor
AdventHealth
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1. Study Identification

Unique Protocol Identification Number
NCT04952441
Brief Title
RISE Program for Nurses
Official Title
A Randomized Controlled Trial of the RISE Program for Nurses
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
June 1, 2021 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized into either the intervention group or the wait-list control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Intervention group will attend the RISE program which consists of eight 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor
Arm Title
Wait-list Control Group
Arm Type
Active Comparator
Arm Description
The control group will attend the RISE program after the 3 month wait-list period (study months 6-7)
Intervention Type
Behavioral
Intervention Name(s)
RISE Program
Intervention Description
Psychoeducational sessions designed to impact Resilience, Insight, Self-Compassion, and Empowerment
Primary Outcome Measure Information:
Title
Self-Reflection and Insight Scale (SRIS)
Description
Participants will respond to a 20-item questionnaire using a 6-point scale where 1=Strongly disagree and 6=Strongly agree.
Time Frame
Change from Baseline to 3 month follow up
Secondary Outcome Measure Information:
Title
Measure Name: Brief Resilience Scale (BRS)
Description
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.
Time Frame
Change from Baseline to 3 month follow up
Title
Self-Compassion Scale - Short Form (SCS-SF)
Description
Participants will respond to a 12-item questionnaire, indicating how often certain behaviors are personally experienced when in difficult times. Responses are provided on 5-point scale in which 1=Almost never and 5=Almost always.
Time Frame
Change from Baseline to 3 month follow up
Title
Psychological Empowerment Instrument (PEI)
Description
Participants will respond to a 12-item questionnaire to items regarding self-orientations people may have with regard to their work role. Responses are provided on the following 7-point scale: 1=Very strongly disagree, 2=Strongly disagree, 3=Disagree, 4=Neutral, 5=Agree, 6=Strongly Agree, 7=Very Strongly Agree.
Time Frame
Change from Baseline to 3 month follow up
Title
Stress Mindset Measure - General (SMM-G)
Description
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.
Time Frame
Change from Baseline to 3 month follow up
Title
Perceived Stress Scale (PSS)
Description
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.
Time Frame
Change from Baseline to 3 month follow up
Title
Maslach Burnout Inventory Human Services Survey (MBI-HSS) for Medical Personnel (MP)
Description
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.
Time Frame
Change from Baseline to 3 month follow up
Title
Public Health Surveillance - Wellbeing Scale (PHS-WB)
Description
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).
Time Frame
Change from Baseline to 3 month follow up
Title
RAND Medical Outcomes Study (MOS) Sleep Scale Survey
Description
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.
Time Frame
Change from Baseline to 3 month follow up
Title
RAND 36-Item Short Form Health Survey (SF-36)
Description
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.
Time Frame
Change from Baseline to 3 month follow up
Title
Absenteeism and Presenteeism questions of the World Health Organization's Health and Work Performance Questionnaire (WHO-HPQ)
Description
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.
Time Frame
Change from Baseline to 3 month follow up
Title
Work Productivity and Activity Impairment Questionnaire (WPAI)
Description
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.
Time Frame
Change 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 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 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 an ARNP Employed in a role that completes another RN's annual evaluations A participant of the study in IRBNet #1234568 or IRBNet #1256670 At imminent risk of harm to themselves or others.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Sawyer, PhD
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
AdventHealth
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States

12. IPD Sharing Statement

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RISE Program for Nurses

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