Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT05743205
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2023-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advanced Practice Provider Intervention Study to Promote Wellness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Holmes-Rahe Life Stress Inventory; The Social Readjustment Rating Scale', 'timeFrame': 'change from baseline stress measure at 1 year and 2 years.', '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.'}, {'measure': 'The Brief Resilience Scale', 'timeFrame': 'change from baseline in resilience measure at 6 months, 1 year and 2 years.', '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.'}, {'measure': 'The Work and Well-being Survey (UWES)© Engagement Scale', 'timeFrame': 'change from baseline engagement measure at 6 months, 1 year and 2 years.', '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.'}, {'measure': 'Advanced Practice Provider Well-being Index', 'timeFrame': 'change from baseline well-being measure at 6 months, 1 year and 2 years.', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resilience', 'Burnout', 'Work engagement'], 'conditions': ['Job Stress', 'Professional Burnout']}, 'referencesModule': {'references': [{'pmid': '31708107', 'type': 'BACKGROUND', '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.'}, {'pmid': '31868125', 'type': 'BACKGROUND', '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.'}, {'pmid': '32491978', 'type': 'BACKGROUND', '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.'}, {'pmid': '34334766', 'type': 'BACKGROUND', '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.'}, {'pmid': '18696313', 'type': 'BACKGROUND', '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.'}, {'pmid': '30829967', 'type': 'RESULT', '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.'}, {'pmid': '29169248', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* employment within non-profit health care setting as a health care professional\n* working at least 50% of time in direct patient care\n* availability and interest in initial and follow-up wellness visits\n\nExclusion Criteria:\n\n* actively participating in formalized counseling sessions through other services at time of recruitment into the study'}, 'identificationModule': {'nctId': 'NCT05743205', 'briefTitle': 'Advanced Practice Provider Intervention Study to Promote Wellness', 'organization': {'class': 'OTHER', 'fullName': 'OSF Healthcare System'}, 'officialTitle': 'A Pilot Intervention Study to Promote Wellness in Advanced Practice Providers (APPs)', 'orgStudyIdInfo': {'id': '1537818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational Intervention', 'description': 'Educational intervention', 'interventionNames': ['Behavioral: voluntary consultative wellness session']}], 'interventions': [{'name': 'voluntary consultative wellness session', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Educational Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61602', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF HealthCare System', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}], 'overallOfficials': [{'name': 'Colleen Klein, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSF Healthcare System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colleen J Klein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Education and Research Scientist', 'investigatorFullName': 'Colleen J Klein', 'investigatorAffiliation': 'OSF Healthcare System'}}}}