Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-02-21 @ 12:14 AM
Study NCT ID:
NCT03648866
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2018-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Thematic Analysis of Compassion Rounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2018-08-15', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validated Thematic Framework to Explain the Effects of Compassion Rounding', 'timeFrame': 'five months', 'description': 'Analysis of data collected throughout the study will result in a validated theoretical framework to understand and explain the psychosocial processes that influence participant experience and reported outcomes.'}], 'secondaryOutcomes': [{'measure': 'Compendium of Evidence-Based Best Practices for the Implementation of Compassion Rounding', 'timeFrame': 'five months', 'description': 'Analysis of data collected throughout the study will result in an evidence-based compendium of best practices for the implementation of compassion rounding.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spiritual Wellness']}, 'descriptionModule': {'briefSummary': 'The primary objective of this thematic analysis is to understand the experience of "Compassion Rounds" for patients, families, friends, and clinicians. The secondary objective of this study is to evaluate and interpret data to determine best practice recommendations for standardization and scalability.', 'detailedDescription': 'This research will be conducted as a Thematic Analysis. Participants will be recruited from those who take part in compassion rounds, including patients, their loved ones, physicians, chaplains, social workers, nurses, and other care providers.\n\nQualitative data on participants\' experiences throughout the intervention will be collected and analyzed using thematic methodology. The data will be used to explain the psychosocial processes that influence participant experience and reported outcomes.\n\nQualitative methodology does not seek to verify hypotheses based on logical assumptions, as quantitative measures do, instead it is used to derive salient constructs directly from the data. This methodology allows inductive understanding of participants\' social reality and perceptions of the treatment, resulting in explanations of how the treatment leads to outcomes and the identification of variables that may then be quantified for more generalizable study.\n\nSemi-structured Interviews\n\nThrough semi-structured interviews, which will be recorded and transcribed, the researcher asks participants open-ended questions intended to elicit perspectives on their experience of compassion rounds, without limiting responses to pre-determined categories of interest. The following are examples:\n\n"What/who do you remember most vividly?" "How would you describe your experience to a friend?" "What was most meaningful to you? "What made you feel uncomfortable?" "Would you do it again? Why or why not?" "What, if anything, changed after compassion rounding?"\n\nCoding\n\nThe researcher codes and documents throughout data collection and analysis to lend transparency to the coding process and to keep a record of ideas to inform thematic exposition. The researcher assigns categorical codes (labels or concepts) to the transcribed responses line-by-line, analyzing patterns of relationships and using a constant comparison technique to identify similarities and differences throughout the data. The following coding techniques will be used to analyze transcriptions:\n\n* open coding: the researcher segments the data into preliminary categories, based on similarity\n* axial coding: the researcher groups the categories into themes that provide new ways of seeing and understanding the phenomenon under study\n* selective coding: the researcher integrates the categories and themes to articulate a coherent theory of the phenomenon of study.\n\nTheoretical Sampling Grounded theory research uses "theoretical sampling" to identify participants for interviews. Purposive samples are identified to initiate data collection and analysis, and to select participants who are likely to clarify, verify, or contradict data as it is collected. Sampling concludes when the data is "saturated," which occurs when coded categories are well-defined and no new significant insights are emerging from interviews.\n\nThematic Development and Validation\n\nThe researcher develops thematic explanations that stem from rendering participants\' experiences throughout the practice of compassion rounding.\n\nThemes are evaluated for fit and relevance and employee participants may be asked to validate the researcher\'s findings in follow-up interviews and focus groups.\n\nObservation The researcher will also observe compassion rounding to collect data that will provide further insight to participants\' experiences. Observations of interactions and reactions in real time will be documented and the data will be coded and analyzed using the techniques described above. Observational data will not be integrated into interview data, but will be used to confirm or contrast reported data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from participants in compassion rounding, including patients, their loved ones, physicians, chaplains, social workers, nurses, and other care providers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. An employee of Florida Hospital or Adventist Health System, or a physician with privileges there, or a patient, or a family or friend who has participated in compassion rounding at a Florida Hospital critical care unit\n2. Over the age of 18\n3. Able to provide informed consent\n4. Must speak and understand English\n5. Willing and able to provide a contact phone number\n\nExclusion Criteria:\n\n1\\. Discernible cognitive impairment'}, 'identificationModule': {'nctId': 'NCT03648866', 'briefTitle': 'A Thematic Analysis of Compassion Rounds', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'A Thematic Analysis of the Effects of Compassion Rounds on Clinicians and the Families of NICU Patients', 'orgStudyIdInfo': {'id': '1320386'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Physicians', 'description': 'interview physicians who have conducted compassion rounds', 'interventionNames': ['Other: interview']}, {'label': 'Chaplains', 'description': 'interview chaplains who have conducted compassion rounds', 'interventionNames': ['Other: interview']}, {'label': 'Other Healthcare Providers', 'description': 'interview other healthcare providers who have conducted compassion rounds', 'interventionNames': ['Other: interview']}, {'label': 'Patients', 'description': 'interview patients who have participated in compassion rounds', 'interventionNames': ['Other: interview']}, {'label': 'Patient family members/friends', 'description': "interview patient's loved ones who have participated with the patient in compassion rounds", 'interventionNames': ['Other: interview']}], 'interventions': [{'name': 'interview', 'type': 'OTHER', 'description': 'Initial interview and potential follow-up interviews and focus group with Florida Hospital employees.\n\nInterview participants in compassion rounds', 'armGroupLabels': ['Chaplains', 'Other Healthcare Providers', 'Patient family members/friends', 'Patients', 'Physicians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Kim McManus, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FH Center for CREATION Health Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}