Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 7:22 PM
Study NCT ID:
NCT01031134
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2009-12-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Shared Decision-Making for Elderly Depressed Primary Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'praue@uw.edu', 'phone': '206-543-3807', 'title': 'Patrick Raue, Ph.D.', 'organization': 'Weill Cornell Medical College'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Shared Decision Making', 'description': '1 in person session followed by 2 telephone calls 1 and 2 weeks later.\n\nShared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 0, 'seriousNumAtRisk': 114, 'deathsNumAffected': 1, 'seriousNumAffected': 49}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Physician Usual Care of depressed patients.\n\nUsual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 0, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 47}], 'seriousEvents': [{'term': 'ER visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ambulatory surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Adhered to Physician Recommended Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Shared Decision Making', 'description': '1 in person session followed by 2 telephone calls 1 and 2 weeks later.\n\nShared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Physician Usual Care of depressed patients.\n\nUsual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Any mental health service use over 12 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Hamilton Depression Rating Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Shared Decision Making', 'description': '1 in person session followed by 2 telephone calls 1 and 2 weeks later.\n\nShared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Physician Usual Care of depressed patients.\n\nUsual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.05', 'spread': '7.03', 'groupId': 'OG000'}, {'value': '-7.35', 'spread': '6.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 week', 'description': 'Hamilton Depression Rating Scale change score from baseline to 12 weeks. This scale measures severity of depressive symptoms (range 0-76), with higher scores indicating more severe symptomatology.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'fewer number of participants in comparison to primary outcome measure reflect greater numbers of missing observations for the Hamilton outcome'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Shared Decision Making', 'description': '1 in person session followed by 2 telephone calls 1 and 2 weeks later.\n\nShared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Physician Usual Care of depressed patients.\n\nUsual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Shared Decision Making', 'description': '1 in person session followed by 2 telephone calls 1 and 2 weeks later.\n\nShared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Physician Usual Care of depressed patients.\n\nUsual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2009-12-11', 'resultsFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2009-12-11', 'lastUpdatePostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-31', 'studyFirstPostDateStruct': {'date': '2009-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Adhered to Physician Recommended Treatment', 'timeFrame': '12 weeks', 'description': 'Any mental health service use over 12 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change in Hamilton Depression Rating Scale Scores', 'timeFrame': 'Baseline and 12 week', 'description': 'Hamilton Depression Rating Scale change score from baseline to 12 weeks. This scale measures severity of depressive symptoms (range 0-76), with higher scores indicating more severe symptomatology.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '30967321', 'type': 'DERIVED', 'citation': 'Raue PJ, Schulberg HC, Bruce ML, Banerjee S, Artis A, Espejo M, Catalan I, Romero S. Effectiveness of Shared Decision-Making for Elderly Depressed Minority Primary Care Patients. Am J Geriatr Psychiatry. 2019 Aug;27(8):883-893. doi: 10.1016/j.jagp.2019.02.016. Epub 2019 Mar 1.'}]}, 'descriptionModule': {'briefSummary': 'Shared decision-making (SDM), in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The proposed study will evaluate the impact of a brief SDM nursing intervention among elderly, depressed primary care patient subjects in comparison to physician recommended Usual Care. The focus of the SDM intervention is to empower depressed patients and help them arrive at a treatment decision that can be successfully carried out.', 'detailedDescription': "Shared Decision Making (SDM) may be particularly relevant for depressed individuals, as it seeks to enhance their autonomy and empowerment in a manner that directly addresses the helplessness and hopelessness associated with depression. Shared decision-making interventions are being developed for depression in primary care, but have yet to be adequately tested. It is also unknown whether the same premises regarding shared decision-making's ability to enhance autonomy and empowerment pertain to elderly populations.\n\nThis randomized study will recruit elderly depressed primary care patient subjects and evaluate the impact of a three-session SDM nursing intervention on their (1) adherence to antidepressant medication or psychotherapy and on (2) their reduction in depressive symptoms. The comparison group will be physician-recommended Usual Care (UC). The focus of the SDM intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.\n\nThe study randomizes physicians to provide their depressed patients with SDM or UC. A total of 210 elderly depressed patient subjects whose physicians recommend starting depression treatment, will receive either Shared Decision-Making (SDM) or the physician recommended Usual Care (UC) comparison condition. Participants will be assessed at baseline and at weeks 4, 8, 12, and 24 to determine treatment adherence and depressive status. Nurses currently employed by the participating physicians will administer the SDM intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 65 years and older;\n* Medical outpatient presenting to Lincoln Hospital, Bronx NY, the New York City Health and Hospitals Corporation (HHC);\n* Screen positive (PHQ-9 score\\>9 for depression, in addition to primary care physician recommendation for depression treatment.\n\nExclusion Criteria:\n\n* Presence of significant alcohol or substance abuse, psychotic disorder, or bipolar disorder;\n* High suicide risk, i.e. intent or plan to attempt suicide in near future;\n* Current treatment with antidepressant medication or psychotherapy prior to index physician visit (with the exception of low doses of antidepressant medication for pain disorders);\n* Cognitive impairment: MMSE score \\<20 or clinical diagnosis of dementia;\n* Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver, or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs often causing depression, e.g., steroids, reserpine, alpha-methyl-dopa, tamoxifen, vincristine;\n* Aphasia interfering with communication.'}, 'identificationModule': {'nctId': 'NCT01031134', 'briefTitle': 'Shared Decision-Making for Elderly Depressed Primary Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Shared Decision-Making for Elderly Depressed Primary Care Patients', 'orgStudyIdInfo': {'id': '1R01MH084872-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH084872-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R01MH084872-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01MH084872-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shared Decision Making', 'description': '1 in person session followed by 2 telephone calls 1 and 2 weeks later.', 'interventionNames': ['Behavioral: Shared Decision Making']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Physician Usual Care of depressed patients.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Shared Decision Making', 'type': 'BEHAVIORAL', 'description': 'Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.', 'armGroupLabels': ['Shared Decision Making']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10451', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Lincoln Hospital - the New York City Health and Hospitals Corporation (HHC)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10605', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell Institute of Geriatric Psychiatry', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}], 'overallOfficials': [{'name': 'Patrick J. Raue, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}