Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
Study NCT ID:
NCT03912168
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2019-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Question Prompt List for Orthopaedic Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-18', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-09', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived involvement in care scale', 'timeFrame': 'Immediately after the clinical encounter, same day as clinical encounter', 'description': "The Perceived involvement in care scale PICS measures a patient's perceived involvement in their visit. it is a 13 item validated scale, scored 0-13, with higher scores indicating greater perceived involvement"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tendon Injuries', 'Fracture', 'Arthritis', 'Sprains', 'Strains', 'Tumor', 'Pain']}, 'referencesModule': {'references': [{'pmid': '33239521', 'type': 'DERIVED', 'citation': 'Mariano DJ, Liu A, Eppler SL, Gardner MJ, Hu S, Safran M, Chou L, Amanatullah DF, Kamal RN. Does a Question Prompt List Improve Perceived Involvement in Care in Orthopaedic Surgery Compared with the AskShareKnow Questions? A Pragmatic Randomized Controlled Trial. Clin Orthop Relat Res. 2021 Feb 1;479(2):225-232. doi: 10.1097/CORR.0000000000001582.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether providing patients with a question prompt list (QPL) prior to their orthopaedic surgery clinic appointment improves their perceived involvement in care (PICs) score compared to being given 3 questions from the AskShareKnow model'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* common orthopaedic condition new patient\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03912168', 'briefTitle': 'Question Prompt List for Orthopaedic Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Does Giving a Question Prompt List to Patients With Orthopaedic Conditions Improve Their Perceived Involvement in Care? A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '50238'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Question Prompt List', 'interventionNames': ['Other: Question Prompt List']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 questions list', 'interventionNames': ['Other: 3 questions list']}], 'interventions': [{'name': 'Question Prompt List', 'type': 'OTHER', 'description': 'Question prompt list for common orthopaedic conditions', 'armGroupLabels': ['Question Prompt List']}, {'name': '3 questions list', 'type': 'OTHER', 'description': '3 questions from the AskShareKnow model', 'armGroupLabels': ['3 questions list']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Health Care', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}], 'overallOfficials': [{'name': 'Robin N Kamal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Robin Kamal', 'investigatorAffiliation': 'Stanford University'}}}}