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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05743205
Other study ID # 1537818
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 21, 2022
Est. completion date December 31, 2027

Study information

Verified date April 2024
Source OSF Healthcare System
Contact Colleen Klein, PhD, RN
Phone 309-655-3899
Email colleen.klein@osfhealthcare.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2027
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 68 Years
Eligibility 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 Design


Intervention

Behavioral:
voluntary consultative wellness session
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.

Locations

Country Name City State
United States OSF HealthCare System Peoria Illinois

Sponsors (1)

Lead Sponsor Collaborator
Colleen J Klein

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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: 10.1177/1049 — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. change from baseline stress measure at 1 year and 2 years.
Primary 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. change from baseline in resilience measure at 6 months, 1 year and 2 years.
Primary 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. change from baseline engagement measure at 6 months, 1 year and 2 years.
Primary 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. change from baseline well-being measure at 6 months, 1 year and 2 years.
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