Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 9:57 PM
Study NCT ID:
NCT04384861
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2020-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Physician Empathy, Compassionate Care and Wellness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Because the SMART training \\& Focus Groups were done in groups, ACTIVE participants were not masked from each other or the Investigators. Because the CONTROL participants did not attend any in-person meetings, they were masked from each other, the ACTIVE participants and the Investigator.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Physician volunteers were first divided by gender and then randomly assigned to either the CONTROL (no SMART Wellness training) or ACTIVE (received SMART Wellness training) arms of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2020-04-28', 'studyFirstSubmitQcDate': '2020-05-08', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Connor-Davidson Resilience Scale (CD-RISC) scores', 'timeFrame': 'Administered prior to the intervention, and then at 12 and 24 weeks post-intervention', 'description': '* utilized for the assessment of the self-reported measures of resilience and the ability to cope with adversity\n* 25 questions; responses from 0 to 4\n* minimum total score: 0; maximum total score 100; higher scores indicative of greater levels of resilience.'}, {'measure': 'Change in Perceived Stress Scale (PSS) scores', 'timeFrame': 'Administered prior to the intervention, and then at 12 and 24 weeks post-intervention', 'description': "* utilized to assess participant's level of perceived stress\n* 10 questions; responses from 0 to 4\n* minimum total score: 0; maximum total score: 40; higher scores indicative of higher perceived chronic levels of stress"}, {'measure': 'Change in Generalized Anxiety Disorder-7 (GAD-7) scale scores', 'timeFrame': 'Administered prior to the intervention, and then at 12 and 24 weeks post-intervention', 'description': '* utilized in the assessment of anxiety\n* 7 questions; responses from 0 to 3\n* minimum total score: 0; maximum total score 21; higher scores indicative of severe anxiety symptoms'}, {'measure': 'Change in Subjective Happiness Scale (SHS) scores', 'timeFrame': 'Administered prior to the intervention, and then at 12 and 24 weeks post-intervention', 'description': "* utilized to assess participant's level of global subjective happiness\n* 4 questions; responses from 1 to 7\n* minimum total score: 4; maximum total score 28; higher scores indicative of higher levels of subjective happiness"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Professional Burnout', 'Wellness', 'Emotional Stress', 'Resilience'], 'conditions': ['Burnout, Professional', 'Resilience', 'Stress, Emotional']}, 'referencesModule': {'references': [{'pmid': '12964174', 'type': 'BACKGROUND', 'citation': 'Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.'}, {'pmid': '21895357', 'type': 'BACKGROUND', 'citation': 'Mak WW, Ng IS, Wong CC. Resilience: enhancing well-being through the positive cognitive triad. J Couns Psychol. 2011 Oct;58(4):610-7. doi: 10.1037/a0025195.'}, {'pmid': '21974793', 'type': 'BACKGROUND', 'citation': 'Mealer M, Jones J, Newman J, McFann KK, Rothbaum B, Moss M. The presence of resilience is associated with a healthier psychological profile in intensive care unit (ICU) nurses: results of a national survey. Int J Nurs Stud. 2012 Mar;49(3):292-9. doi: 10.1016/j.ijnurstu.2011.09.015. Epub 2011 Oct 5.'}, {'pmid': '23808920', 'type': 'BACKGROUND', 'citation': 'McGarry S, Girdler S, McDonald A, Valentine J, Lee SL, Blair E, Wood F, Elliott C. Paediatric health-care professionals: relationships between psychological distress, resilience and coping skills. J Paediatr Child Health. 2013 Sep;49(9):725-32. doi: 10.1111/jpc.12260. Epub 2013 Jul 1.'}, {'type': 'BACKGROUND', 'citation': 'Lü W, Wang Z, Liu Y, Zhang H. Resilience as a mediator between extraversion, neuroticism and happiness, PA and NA. Personal Individ Differ. 2014;63:128-133'}, {'pmid': '29018095', 'type': 'BACKGROUND', 'citation': "Fox S, Lydon S, Byrne D, Madden C, Connolly F, O'Connor P. A systematic review of interventions to foster physician resilience. Postgrad Med J. 2018 Mar;94(1109):162-170. doi: 10.1136/postgradmedj-2017-135212. Epub 2017 Oct 10."}, {'pmid': '25443423', 'type': 'BACKGROUND', 'citation': 'Sood A, Sharma V, Schroeder DR, Gorman B. Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial. Explore (NY). 2014 Nov-Dec;10(6):358-63. doi: 10.1016/j.explore.2014.08.002. Epub 2014 Aug 21.'}, {'type': 'BACKGROUND', 'citation': 'Charmaz K. Constructing Grounded Theory. Sage; 2014. https://us.sagepub.com/en-us/nam/constructing-grounded-theory/book235960. Accessed December 21, 2017'}, {'pmid': '35452478', 'type': 'DERIVED', 'citation': 'Spilg EG, Kuk H, Ananny L, McNeill K, LeBlanc V, Bauer BA, Sood A, Wells PS. The impact of Stress Management and Resilience Training (SMART) on academic physicians during the implementation of a new Health Information System: An exploratory randomized controlled trial. PLoS One. 2022 Apr 22;17(4):e0267240. doi: 10.1371/journal.pone.0267240. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Background\n\nDefinitions of resilience vary according to the context in which it is discussed. It is often considered from the perspective of the individual. Connor \\& Davidsondescribe it as "the personal qualities that enable an individual to thrive in the face of adversity". Various studies have now shown a link between individual resilience and various mental health outcomes such as burnout, secondary traumatic stress, depression, and anxiety. In a systematic review by Fox et al., 22 studies explicitly stated an aim of improving physician resilience. However, there was a lack of consensus concerning the conceptual understanding of resilience with low methodological rigour of the included studies.\n\nResearch Questions\n\n1. What effect will an evidence-based resilience building intervention have on levels of resilience, stress and subjective happiness in Department of Medicine Faculty at the University of Ottawa?\n2. How might implementation of an evidence-based resilience building intervention on Department of Medicine faculty, lead to the development of a community of practice for physician wellness in the Department of Medicine at The Ottawa Hospital/University of Ottawa?\n\nMethods All academic physicians in the Department of Medicine, University of Ottawa were invited to participate. We recruited 40 participants in total, randomized to either the ACTIVE or CONTROL groups.\n\nWorkshop ACTIVE participants (Group A) attended a 2-hour Stress Management and Resiliency Training (SMART) program developed by the Mayo Clinic. CONTROL (Group B) participants did not attend this training.\n\nQuestionnaires Both Group A \\& B completed questionnaires on resilience, perceived stress, anxiety and happiness at 0 weeks (pre-training) and 12 and 24-weeks post training.\n\nE-learning support Following completion of the 2-hour workshop, Group A participants were enrolled in an online e-learning support program on a website developed by the Mayo Clinic. The aim of this was to support and reinforce the messages and techniques delivered in the 2-hour workshop. Participants were invited to participate for either 12 or 24 weeks.\n\nFocus groups Group A participants were invited to join a focus group 12 weeks after the workshop was run. These focus groups explored themes of resilience, stress, and burnout.\n\nAnalysis of Results Quantitative (Questionnaires): For each measurement scale, the change from baseline will be compared between groups (Active Arm and Control Arm) using the two-sample t-test. To supplement these analyses, the within-group change (baseline vs week 4/12/24) will be assessed for the Active Arm using the paired t-test. A sample size of 40 was selected for this study after weighing statistical considerations along with logistical and resource constraints. In general, for a continuous outcome variable, a sample size of 40 provides statistical power (two-tailed, alpha=0.05) of \\>85% to detect a difference of 1 standard deviation between groups.\n\nQualitative (Focus Groups): Constructivist grounded theory informed the iterative data collection and analysis process. Transcripts were analysed using a three-staged process of initial, focused, and theoretical coding. Themes will be identified using constant comparative analysis and grouped to look at the interrelationship of categories.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a full-time physician within the Department of Medicine at the Ottawa Hospital\n\nExclusion Criteria:\n\n* part-time physicians; those external to the department'}, 'identificationModule': {'nctId': 'NCT04384861', 'briefTitle': 'Improving Physician Empathy, Compassionate Care and Wellness', 'organization': {'class': 'OTHER', 'fullName': 'University of Ottawa'}, 'officialTitle': 'Phase Three: Improving Physician Empathy, Compassionate Care and Wellness Through the Development of Resilience-building Communities of Practice and Creating a Culture of Empathy.', 'orgStudyIdInfo': {'id': '20180536-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACTIVE', 'description': "The ACTIVE arm of the project received the Mayo Clinic SMART training (1 two-hour in-person workshop) and access to the Mayo Clinic's SMART eLearning Support study modules (4 x 45 minute modules in weeks 1-4; 20 x 10 minute modules weeks 5-24)", 'interventionNames': ['Behavioral: Mayo Clinic SMART program (Stress Management and Resilience Training)']}, {'type': 'NO_INTERVENTION', 'label': 'CONTROL', 'description': 'The CONTROL did not receive any interventions.'}], 'interventions': [{'name': 'Mayo Clinic SMART program (Stress Management and Resilience Training)', 'type': 'BEHAVIORAL', 'otherNames': ['Mayo Clinic SMART eLearning Support'], 'description': 'The SMART program included a workshop and ongoing eLearning Support. The learning objectives of the workshop are: (1) learn the neuroscience and behavioural aspects of human experience, particularly with respect to stress, resiliency, performance and wellness and (2) learn practical approaches to enhance engagement and emotional intelligence and thereby decrease stress and anxiety, increase resilience, enhance performance, and improve relationships. The goal of the eLearning support is to support and reinforce the messages and techniques delivered in the 2-hour workshop.', 'armGroupLabels': ['ACTIVE']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Edward Spilg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ottawa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ottawa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor and Research Chair in Physician Wellness', 'investigatorFullName': 'Edward Spilg', 'investigatorAffiliation': 'University of Ottawa'}}}}