Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-27 @ 6:36 AM
Study NCT ID:
NCT03034369
Status:
UNKNOWN
Last Update Posted:
2017-06-15
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caring for the Whole Person
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2017-11-03', 'unreleaseDateUnknown': True}, {'resetDate': '2018-09-28', 'releaseDate': '2018-01-31'}], 'estimatedResultsFirstSubmitDate': '2017-11-03'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D006297', 'term': 'Health Services Accessibility'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in patient reported outcomes', 'timeFrame': '12 months', 'description': 'Change in patient reported outcomes at baseline and 12 months'}, {'measure': 'Change in health care claims', 'timeFrame': '12 months', 'description': 'change in health care claims at baseline and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Integration', 'Primary Care', 'Behavioral Health', 'Health Care Reform', 'Medical Home', 'Accountable Care Organization'], 'conditions': ['Behavioral Health']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://oregon.providence.org/our-services/c/center-for-outcomes-research-and-education-core/', 'label': 'Center for Outcomes Research and Education, Providence Health \\& Services'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to identify outcomes associated with Behavioral Health Integration (BHI) that matter to patients, to compare changes in outcome over time to measure the impact of different BHI models on different patients, and to create and maintain an Integration Learning Collaborative.', 'detailedDescription': 'Twelve safety net clinics have been selected to be a part of this study. The clinics vary on a BHI continuum level, which includes minimal collaboration, basic collaboration at a distance, basic collaboration on site, close collaboration (partially integrated) and close collaboration (fully integrated).\n\nTwelve-thousand patients will be randomly selected from the 12 clinics to be invited to participate in the study. Patients who elect to participate will complete a survey at baseline to collect patient-reported outcomes and again twelve months later.\n\nThe Oregon All Providers All Claims (APAC) database will be accessed to analyze financial data regarding the patients at baseline and 12 months.\n\nThe hypothesis is that the degree of clinic BHI will predict patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients accessing care at safety net clinic in Oregon.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18\n* Received care at a safety net care clinic in Oregon\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03034369', 'briefTitle': 'Caring for the Whole Person', 'organization': {'class': 'OTHER', 'fullName': 'Providence Health & Services'}, 'officialTitle': 'Caring for the Whole Person: A Patient-Centered Assessment of Integrated Care Models in Vulnerable Populations', 'orgStudyIdInfo': {'id': '14-247A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Safety Net Clinic Patients', 'description': 'A Cohort of patients in 12 different primary care clinics will be studied to measure how changes in different integration factors impacts the following patient reported outcomes at baseline and 12 months: Access to Care, Patient-Provider Relationship, Patient-Clinic Interactions, Stigma, Provider Continuity, Symptom Severity, Diagnoses, and Social Support. Health care claims data will be accessed to analyze Depression Screening, Preventive Screening, Inpatient Hospitalization Utilization, Inpatient Readmissions, and Post-Admission follow-up at baseline and 12 months.', 'interventionNames': ['Other: Access to Care', 'Other: Depression Screening', 'Other: Patient-Provider Relationship', 'Other: Patient-Clinic Interactions', 'Other: Stigma', 'Other: Provider Continuity', 'Other: Symptom Severity', 'Other: Diagnoses', 'Other: Social support', 'Other: Preventive Screening', 'Other: Inpatient Hospitalization Utilization', 'Other: Inpatient Readmissions', 'Other: Post-Admission follow-up']}], 'interventions': [{'name': 'Access to Care', 'type': 'OTHER', 'description': 'Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with access to care.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Depression Screening', 'type': 'OTHER', 'description': 'Analysis of health care claims data for depression screenings at baseline and 12 months.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Patient-Provider Relationship', 'type': 'OTHER', 'description': 'Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-provider relationship.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Patient-Clinic Interactions', 'type': 'OTHER', 'description': 'Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-clinic interactions.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Stigma', 'type': 'OTHER', 'description': 'Patient reported outcome survey administered at baseline and 12 months to measure perceived stigma.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Provider Continuity', 'type': 'OTHER', 'description': 'Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with provider continuity.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Symptom Severity', 'type': 'OTHER', 'description': 'Patient reported outcome survey administered at baseline and 12 months to measure symptom severity.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Diagnoses', 'type': 'OTHER', 'description': 'Patient reported outcome survey administered at baseline and 12 months to measure diagnoses.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Social support', 'type': 'OTHER', 'description': 'Patient reported outcome survey administered at baseline and 12 months to assess social support and outlets.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Preventive Screening', 'type': 'OTHER', 'description': 'Analysis of health care claims data for preventive screenings at baseline and 12 months.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Inpatient Hospitalization Utilization', 'type': 'OTHER', 'description': 'Analysis of health care claims data for Inpatient Hospitalization Utilization at baseline and 12 months.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Inpatient Readmissions', 'type': 'OTHER', 'description': 'Analysis of health care claims data for Inpatient Hospitalization Readmissions at baseline and 12 months.', 'armGroupLabels': ['Safety Net Clinic Patients']}, {'name': 'Post-Admission follow-up', 'type': 'OTHER', 'description': 'Analysis of health care claims data for Post-Admission follow-up at baseline and 12 months.', 'armGroupLabels': ['Safety Net Clinic Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Center for Outcomes Research and Education, Providence Health & Services', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Bill J. Wright, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, Center for Outcomes Evaluate and Education, Providence Health & Services'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Providence Health & Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'Cascadia Addiction Research and Education, LLC', 'class': 'UNKNOWN'}, {'name': 'Umpqua Community Health Center', 'class': 'UNKNOWN'}, {'name': 'Mosaic Medical', 'class': 'UNKNOWN'}, {'name': 'North Portland Clinic', 'class': 'UNKNOWN'}, {'name': 'Providence Medical Group', 'class': 'UNKNOWN'}, {'name': 'Rockwood Clinic', 'class': 'UNKNOWN'}, {'name': 'The Bend Clinic', 'class': 'UNKNOWN'}, {'name': 'Yamhill CCO', 'class': 'UNKNOWN'}, {'name': 'The Annex', 'class': 'UNKNOWN'}, {'name': 'Cascadia Gardiner Clinic', 'class': 'UNKNOWN'}, {'name': 'Umpqua Expanded Care Clinic', 'class': 'UNKNOWN'}, {'name': 'Bridges Clinic', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-11-03', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2018-01-31', 'type': 'RELEASE'}, {'date': '2018-09-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Providence Health & Services'}}}}