Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-04 @ 12:17 AM
Study NCT ID:
NCT03645135
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2018-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Goal Elicitation Improve Patient Perceived Involvement
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': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'The care provider will not be informed as to which group their patient is in.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into 1 of 2 study arms arm 1: control arm 2: intervention.\n\nWe will use a random block generator to assign participants to their study arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2018-08-22', 'studyFirstSubmitQcDate': '2018-08-22', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Involvement in Care Scale (PICS)', 'timeFrame': 'Immediately after visit', 'description': 'PICS measures the following: doctor facilitation of patient involvement, level of information exchange, and patient participation in decision making. Scale: 0-13, higher score means higher perceived involvement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthopedic Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if goal elicitation among orthopaedic patients improves their perceived involvement in care.', 'detailedDescription': 'This is a RCT with 2 intervention arms. In the first arm, the control arm, patients will be asked to complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care. The second arm, the intervention arm, will be asked to list 2 goals for their visit and complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New patients visiting the orthopaedic service\n* English fluency and literacy\n\nExclusion Criteria:\n\n* Returning patients\n* Children\n* Non-English speaking patients'}, 'identificationModule': {'nctId': 'NCT03645135', 'briefTitle': 'Does Goal Elicitation Improve Patient Perceived Involvement', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Does Goal Elicitation Improve Patient Perceived Involvement?', 'orgStudyIdInfo': {'id': '45823'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in the control group will be asked to complete a demographics survey and assess their perceived involvement in care after their visit'}, {'type': 'EXPERIMENTAL', 'label': 'Goal elicitation', 'description': 'Patients in the intervention group will be asked to list 2 goals for their visit. They will also be asked to complete a demographics survey and access their perceived involvement in care after their visit.', 'interventionNames': ['Other: Goal elicitation']}], 'interventions': [{'name': 'Goal elicitation', 'type': 'OTHER', 'description': 'Patients will be asked to list 2 goals for their visit', 'armGroupLabels': ['Goal elicitation']}]}, '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, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared for this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Robin Kamal', 'investigatorAffiliation': 'Stanford University'}}}}