- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05743205
Advanced Practice Provider Intervention Study to Promote Wellness
April 5, 2024 updated by: Colleen J Klein
A Pilot Intervention Study to Promote Wellness in Advanced Practice Providers (APPs)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Colleen Klein, PhD, RN
- Phone Number: 309-655-3899
- Email: colleen.klein@osfhealthcare.org
Study Contact Backup
- Name: Lisa Pierce, DNP, RN
- Phone Number: 309-624-4649
- Email: lisa.m.pierce@osfhealthcare.org
Study Locations
-
-
Illinois
-
Peoria, Illinois, United States, 61602
- Recruiting
- OSF HealthCare System
-
Contact:
- Colleen J Klein, PhD, APRN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educational Intervention
Educational intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Holmes-Rahe Life Stress Inventory; The Social Readjustment Rating Scale
Time Frame: change from baseline stress measure at 1 year and 2 years.
|
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.
|
change from baseline stress measure at 1 year and 2 years.
|
The Brief Resilience Scale
Time Frame: change from baseline in resilience measure at 6 months, 1 year and 2 years.
|
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.
|
change from baseline in resilience measure at 6 months, 1 year and 2 years.
|
The Work and Well-being Survey (UWES)© Engagement Scale
Time Frame: change from baseline engagement measure at 6 months, 1 year and 2 years.
|
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.
|
change from baseline engagement measure at 6 months, 1 year and 2 years.
|
Advanced Practice Provider Well-being Index
Time Frame: change from baseline well-being measure at 6 months, 1 year and 2 years.
|
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.
|
change from baseline well-being measure at 6 months, 1 year and 2 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Colleen Klein, PhD, RN, OSF HealthCare System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2022
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
February 14, 2023
First Submitted That Met QC Criteria
February 14, 2023
First Posted (Actual)
February 24, 2023
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1537818
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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