Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT04027569
Status:
WITHDRAWN
Last Update Posted:
2025-04-09
First Post:
2019-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PROMs To Improve Care- Standardized vs Patient Specific
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006230', 'term': 'Hand Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Logistics (Research Staffing)', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2040-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2019-07-18', 'studyFirstSubmitQcDate': '2019-07-18', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decisional Conflict Scale (DCS)', 'timeFrame': 'Immediately after the clinical encounter, same day as clinical encounter', 'description': 'DCS is a validated tool that measures patient uncertainty about decisions. it is scored 0 to 100, with higher scores indicating greater conflict about the decisions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand Injuries']}, 'descriptionModule': {'briefSummary': 'To examine the impact of using 2 validated PROMs during the care of an orthopaedic condition on shared decision making, patient centered care, and patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hand surgery patients over age 18, english fluency and literacy, able to take informed consent\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04027569', 'briefTitle': 'PROMs To Improve Care- Standardized vs Patient Specific', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'PROMs To Improve Care: A Pragmatic RCT on Standardized and Patient Specific PROMs on Outcomes After Hand Surgery', 'orgStudyIdInfo': {'id': '52021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PSFS group', 'description': 'Patients in this arm will complete the patient specific functional scale (PSFS) during their visits', 'interventionNames': ['Other: Patient Specific Functional Scale']}, {'type': 'EXPERIMENTAL', 'label': 'PROMIS PF group', 'description': 'Patients in this arm will complete the PROMIS Physical Function during their visits', 'interventionNames': ['Other: PROMIS PF']}], 'interventions': [{'name': 'Patient Specific Functional Scale', 'type': 'OTHER', 'description': 'A validated patient reported outcome measure that asks patients to write down activities and score them 0 to 10.', 'armGroupLabels': ['PSFS group']}, {'name': 'PROMIS PF', 'type': 'OTHER', 'description': 'A computer adaptive, validated patient reported outcome measure that measures physical function on a 1 to 100.', 'armGroupLabels': ['PROMIS PF group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robin N Kamal, MD MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Robin Kamal', 'investigatorAffiliation': 'Stanford University'}}}}