Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT04932993
Status:
WITHDRAWN
Last Update Posted:
2025-07-31
First Post:
2021-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Writing Down Goals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All new, adult (18+ years old) patients seeing an orthopedic surgeon for a consultation will be invited to participate in this study. Patients randomly will be assigned to: write down goals their goals for their medical care (intervention) or not (usual visit control group). The research assistant will ask the patient to fill out a survey entailing demographics, JSPPE, the communication effectiveness score, the PAM score and a satisfaction scale at the end of the visit. A research assistant will record the diagnosis,'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Deemed not feasible.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decision conflict questionnaire', 'timeFrame': 'Baseline', 'description': 'Questionnaire assessing decision conflict'}], 'secondaryOutcomes': [{'measure': 'Decision regret questionnaire', 'timeFrame': 'Baseline', 'description': 'Questionnaire assessing the degree of regret of decision'}, {'measure': "Jefferson Scale of Patient's Perceptions of Physician Empathy", 'timeFrame': 'Baseline', 'description': 'Patient perceived of physician empathy as measured by the JSPPE'}, {'measure': 'Patient Activation Measure-13', 'timeFrame': 'Baseline', 'description': 'Patient activation as measured by PAM-13'}, {'measure': 'Guttman Satisfaction scale', 'timeFrame': 'Baseline', 'description': 'Questionnaire measuring to what degree patients are satisfied with the care they received.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['decisional conflict', 'Orthopedics'], 'conditions': ['Musculoskeletal Diseases']}, 'descriptionModule': {'briefSummary': "The women's health IPU at UT Health Austin is happy with having patients write down their goals at their first visit and then tracking those. It would be interesting to study people seeking musculoskeletal specialty care to determine whether asking patients what result of their care would be rated a success helps direct the clinician-patient interaction in a more fruitful direction compared to the usual clinical interaction.", 'detailedDescription': 'People\'s stated preferences are often inconsistent with what matters most to them (their values). And they are often based on misconceptions, distress, and less effective cognitive coping strategies. For instance, a person might say "My goal is to have no pain" when that is not possible. Or they might say "My goal is to get the shot that fixes this" when there is no such shot. It may go without saying that people want: "To be able to live a normal lifestyle" and "To be able to accomplish most of their goals." In other words, people want to be able to be themselves. They are seeking care because they are not able to be themselves or they are concerned that they may not be able to be themselves. The word health comes from an old German word meaning "whole."\n\nOne part of good health is correcting or alleviating pathophysiology (e.g. reading glasses). Another part of good health is evolving one\'s inner narrative (e.g. "I\'m older now and need glasses to read").\n\nThe women\'s health IPU at UT Health Austin is happy with having patients write down their goals at their first visit and then tracking those. It would be interesting to study people seeking musculoskeletal specialty care to determine whether asking patients what result of their care would be rated a success helps direct the clinician-patient interaction in a more fruitful direction compared to the usual clinical interaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18+)\n* Orthopedic visit\n\nExclusion Criteria:\n\n* Patients who are illiterate.\n* Patients who do not speak English.'}, 'identificationModule': {'nctId': 'NCT04932993', 'briefTitle': 'Writing Down Goals', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Writing Down Goals', 'orgStudyIdInfo': {'id': '2019-07-0089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Will not write down goals their goals for their medical care (usual care).'}, {'type': 'EXPERIMENTAL', 'label': 'Writing down goals', 'description': 'Will write down goals their goals for their medical care.', 'interventionNames': ['Behavioral: Writing down goals']}], 'interventions': [{'name': 'Writing down goals', 'type': 'BEHAVIORAL', 'description': 'Patient will write their health goals down before the visit.', 'armGroupLabels': ['Writing down goals']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Ring, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Surgery, Dell Medical School at The University of Texas at Austin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'David Ring, MD, PhD Associate Dean for Comprehensive Care, Professor of Surgery and Psychiatry', 'investigatorFullName': 'David Ring', 'investigatorAffiliation': 'University of Texas at Austin'}}}}