Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2026-02-21 @ 6:24 AM
Study NCT ID:
NCT00806559
Status:
COMPLETED
Last Update Posted:
2011-12-14
First Post:
2008-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Space and Interaction Trial: Room Design and Patient-physician Interaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-13', 'studyFirstSubmitDate': '2008-12-10', 'studyFirstSubmitQcDate': '2008-12-10', 'lastUpdatePostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient and Clinician Interaction variables (duration of the encounter, patient sense of control in encounter, patient's ability to access information from the computer monitor and the quality of the verbal and non-verbal interaction).", 'timeFrame': 'Immediately post clinical visit (survey)'}, {'measure': 'Patient experience of the clinical encounter. The following variables will be measured: patient satisfaction with the room, patient satisfaction with the encounter and the quality of the relationship.', 'timeFrame': 'Immediately post visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['effects clinical space', 'follow-up appointments'], 'conditions': ['Internal Medicine Patients', 'Participating Staff']}, 'referencesModule': {'references': [{'pmid': '21165880', 'type': 'DERIVED', 'citation': 'Almquist JR, Kelly C, Bromberg J, Bryant SC, Christianson TH, Montori VM. Consultation room design and the clinical encounter: the space and interaction randomized trial. HERD. 2009 Fall;3(1):41-78. doi: 10.1177/193758670900300106.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to improve the clinical encounter through the design of the clinical environment. We will conduct a randomized controlled trial to measure the extent to which a newly designed clinical room, compared to a traditional room, affects the patient-physician interaction. We will judge this outcome by (a) videotaping encounters; and (b) conducting post-visit surveys with patients and an interview with physicians. We will use both qualitative and quantitative tools, including a validated and widely used interaction coding system on the videotapes, to draw inferences from these data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligible Clinicians:\n\n1. In the Department of GIM or Preventive Medicine\n2. Able and Willing to participate in research study.\n\nEligible patients:\n\n1. Patient of a clinician participating in the study\n2. 18 years or older\n3. Seeing clinician for return/summary visit.\n\nExclusion Criteria:\n\n1.) Not able to give informed consent.'}, 'identificationModule': {'nctId': 'NCT00806559', 'acronym': 'SIT', 'briefTitle': 'Space and Interaction Trial: Room Design and Patient-physician Interaction', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'SIT Trial: The Effect of Clinical Room Design on the Quality of the Clinical Encounter', 'orgStudyIdInfo': {'id': '07-000135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual room', 'description': 'Patients in this arm will see their clinician in the usual clinical exam room', 'interventionNames': ['Other: Control room']}, {'type': 'EXPERIMENTAL', 'label': 'Re-designed room', 'description': 'Patients assigned to this arm will see the physician in a redesigned clinical exam room', 'interventionNames': ['Other: Re-designed room']}], 'interventions': [{'name': 'Re-designed room', 'type': 'OTHER', 'description': 'In the redesigned room patients and clinicians are sitting at a single table in a different configuration compared to the usual clinical exam room, with the doctor at the computer and two chairs for the patient and family/friends.', 'armGroupLabels': ['Re-designed room']}, {'name': 'Control room', 'type': 'OTHER', 'description': 'This is the usual clinical room for a clinical visit, with physician at desk and chairs along the wall for patient/family.', 'armGroupLabels': ['Usual room']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Victor M. Montori, M.D., MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Steelcase', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Victor Montori, M.D.', 'oldOrganization': 'Mayo Clinic'}}}}