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Advanced Practice Provider Intervention Study to Promote Wellness

Primary Purpose

Job Stress, Professional Burnout

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
voluntary consultative wellness session
Sponsored by
Colleen J Klein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Job Stress focused on measuring Resilience, Burnout, Work engagement

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: employment within non-profit health care setting as a health care professional working at least 50% of time in direct patient care availability and interest in initial and follow-up wellness visits Exclusion Criteria: actively participating in formalized counseling sessions through other services at time of recruitment into the study

Sites / Locations

  • OSF HealthCare SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Educational Intervention

Arm Description

Educational intervention

Outcomes

Primary Outcome Measures

Holmes-Rahe Life Stress Inventory; The Social Readjustment Rating Scale
The Holmes-Rahe Scale is used to life changes that may impact stress. Minimum values =150 pts or less; maximum values = 300 pts. or more; higher scores indicate higher susceptibility to stress-induced health problems.
The Brief Resilience Scale
The Brief Resilience Scale developed by Smith et al. (2008) is used to measure resilience. Minimum value =6 and maximum value = 30; mean value is used to determine scoring with higher value indicating more resilience.
The Work and Well-being Survey (UWES)© Engagement Scale
Work engagement is measured using the Utrecht Work and Well-being Survey Engagement instrument (UWES). The minimum value =0 and the maximum value = 54. Mean is used to determine scoring. Higher value indicates greater work engagement.
Advanced Practice Provider Well-being Index
measures the increased probability of distress risk for personal or professional consequences. Minimum value =0 and maximum value =7. Mean and standard deviation is computed and compared to normative data.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2023
Last Updated
February 24, 2023
Sponsor
Colleen J Klein
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1. Study Identification

Unique Protocol Identification Number
NCT05743205
Brief Title
Advanced Practice Provider Intervention Study to Promote Wellness
Official Title
A Pilot Intervention Study to Promote Wellness in Advanced Practice Providers (APPs)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Colleen J Klein

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
This exploratory pilot study is designed as interventional study to examine the efficacy of a wellness initiative that involves use of a licensed clinical professional counselor (LCPC) to assist in the development of diverse coping strategies such as management of stressors, self-care, time management, and any other goals, problems or concerns that APPs would like assistance with during the intervention period.
Detailed Description
The purpose of this study is to evaluate an educational professional wellness program designed to assist professional clinicians in developing self-awareness and self-care choices as a means to improve engagement and resilience and to avoid/reduce burnout.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Job Stress, Professional Burnout
Keywords
Resilience, Burnout, Work engagement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Educational Intervention
Arm Type
Experimental
Arm Description
Educational intervention
Intervention Type
Behavioral
Intervention Name(s)
voluntary consultative wellness session
Intervention Description
Professional wellness counseling sessions provided to health care professionals through voluntary enrollment. Consultative sessions will conducted throughout the course of 1 year and number of subsequent sessions will be determined by the participant.
Primary Outcome Measure Information:
Title
Holmes-Rahe Life Stress Inventory; The Social Readjustment Rating Scale
Description
The Holmes-Rahe Scale is used to life changes that may impact stress. Minimum values =150 pts or less; maximum values = 300 pts. or more; higher scores indicate higher susceptibility to stress-induced health problems.
Time Frame
change from baseline stress measure at 1 year and 2 years.
Title
The Brief Resilience Scale
Description
The Brief Resilience Scale developed by Smith et al. (2008) is used to measure resilience. Minimum value =6 and maximum value = 30; mean value is used to determine scoring with higher value indicating more resilience.
Time Frame
change from baseline in resilience measure at 6 months, 1 year and 2 years.
Title
The Work and Well-being Survey (UWES)© Engagement Scale
Description
Work engagement is measured using the Utrecht Work and Well-being Survey Engagement instrument (UWES). The minimum value =0 and the maximum value = 54. Mean is used to determine scoring. Higher value indicates greater work engagement.
Time Frame
change from baseline engagement measure at 6 months, 1 year and 2 years.
Title
Advanced Practice Provider Well-being Index
Description
measures the increased probability of distress risk for personal or professional consequences. Minimum value =0 and maximum value =7. Mean and standard deviation is computed and compared to normative data.
Time Frame
change from baseline well-being measure at 6 months, 1 year and 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: employment within non-profit health care setting as a health care professional working at least 50% of time in direct patient care availability and interest in initial and follow-up wellness visits Exclusion Criteria: actively participating in formalized counseling sessions through other services at time of recruitment into the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Klein, PhD, RN
Phone
309-655-3899
Email
colleen.klein@osfhealthcare.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Pierce, DNP, RN
Phone
309-624-4649
Email
lisa.m.pierce@osfhealthcare.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Klein, PhD, RN
Organizational Affiliation
OSF Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
OSF HealthCare System
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen J Klein, PhD, APRN

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31708107
Citation
Klein CJ, Weinzimmer LG, Cooling M, Lizer S, Pierce L, Dalstrom M. Exploring burnout and job stressors among advanced practice providers. Nurs Outlook. 2020 Mar-Apr;68(2):145-154. doi: 10.1016/j.outlook.2019.09.005. Epub 2019 Nov 8.
Results Reference
background
PubMed Identifier
31868125
Citation
Klein CJ, Dalstrom M, Lizer S, Cooling M, Pierce L, Weinzimmer LG. Advanced Practice Provider Perspectives on Organizational Strategies for Work Stress Reduction. West J Nurs Res. 2020 Sep;42(9):708-717. doi: 10.1177/0193945919896606. Epub 2019 Dec 22.
Results Reference
background
PubMed Identifier
32491978
Citation
Klein CJ, Dalstrom MD, Weinzimmer LG, Cooling M, Pierce L, Lizer S. Strategies of Advanced Practice Providers to Reduce Stress at Work. Workplace Health Saf. 2020 Sep;68(9):432-442. doi: 10.1177/2165079920924060. Epub 2020 Jun 3.
Results Reference
background
PubMed Identifier
34334766
Citation
Klein CJ, Weinzimmer LG, Dalstrom M, Lizer S, Cooling M, Pierce L. Investigating practice-level and individual factors of advanced practice registered nurses and physician assistants and their relationship to resilience. J Am Assoc Nurse Pract. 2021 Jul 29;34(2):310-321. doi: 10.1097/JXX.0000000000000639.
Results Reference
background
PubMed Identifier
18696313
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.
Results Reference
background
PubMed Identifier
30829967
Citation
Dyrbye LN, Johnson PO, Johnson LM, Halasy MP, Gossard AA, Satele D, Shanafelt T. Efficacy of the Well-Being Index to identify distress and stratify well-being in nurse practitioners and physician assistants. J Am Assoc Nurse Pract. 2019 Jul;31(7):403-412. doi: 10.1097/JXX.0000000000000179.
Results Reference
result
PubMed Identifier
29169248
Citation
Klein CJ, Riggenbach-Hays JJ, Sollenberger LM, Harney DM, McGarvey JS. Quality of Life and Compassion Satisfaction in Clinicians: A Pilot Intervention Study for Reducing Compassion Fatigue. Am J Hosp Palliat Care. 2018 Jun;35(6):882-888. doi: 10.1177/1049909117740848. Epub 2017 Nov 23.
Results Reference
result

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Advanced Practice Provider Intervention Study to Promote Wellness

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