Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT03256734
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2017-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does a Complex Care Discharge Planning Initiative Reduce Unplanned Hospital Readmissions? (G78717-Readmits)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-18', 'releaseDate': '2024-07-17'}], 'estimatedResultsFirstSubmitDate': '2024-07-17'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2017-08-18', 'studyFirstSubmitQcDate': '2017-08-18', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unplanned hospital readmission within 30 days', 'timeFrame': '30 days', 'description': 'Unplanned hospital readmission within 30 days'}], 'secondaryOutcomes': [{'measure': 'Unplanned (urgent) hospital readmission within 1 year of index hospital discharge', 'timeFrame': '1 year', 'description': 'Unplanned (urgent) hospital readmission within 1 year of index hospital discharge'}, {'measure': 'Primary care visits within 30 days and 1 year of index hospital discharge', 'timeFrame': '30 days and 1 year', 'description': 'Primary care visits within 30 days and 1 year of index hospital discharge'}, {'measure': 'Emergency department visit', 'timeFrame': '30 days and 1 year', 'description': 'Emergency department visit within 30 days and 1 year of index hospital discharge'}, {'measure': 'Death', 'timeFrame': '30 days and 1 year', 'description': 'Death within 30 days and 1 year of index hospital discharge'}, {'measure': 'Use of transitional or stepdown care', 'timeFrame': '30 days and 1 year', 'description': 'Use of transitional or stepdown care (eg. rehabilitation, extended care, intermediate /personal care) after discharge from acute care but prior to return home'}, {'measure': 'Improvements in appropriate population-level post-discharge prescription prevalence of an indicated medication', 'timeFrame': '60 days', 'description': 'Using health services records, we will identify a sub-cohort of patients with an index admission for acute coronary syndrome, heart failure, or chronic ischemic heart disease. Within this subcohort, we will determine the proportion of patients who filled at least one prescription for beta-blockers within 60 days of index hospital discharge date.'}, {'measure': 'Improvements in appropriate population-level post-discharge prescription prevalence of a contraindicated medication', 'timeFrame': '60 days', 'description': 'Using health services records, we will identify a sub-cohort of older adults (aged \\>/=65 years at date of index hospital discharge date). Within this subcohort, we will determine the proportion of patients who filled at least one prescription for a "potentially inappropriate medication" within 60 days of index hospital discharge date. Our list of "potentially inappropriate medications" has been adapted from those listed in the American Geriatrics Society 2015 Updated Beers Criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Readmission']}, 'referencesModule': {'references': [{'pmid': '38750712', 'type': 'DERIVED', 'citation': 'Staples JA, Yu Y, Khan M, Naik H, Liu G, Brubacher JR, Karimuddin A, Sutherland JM. Physician Financial Incentives to Reduce Unplanned Hospital Readmissions: A Propensity Score Weighted Cohort Study. Am J Med. 2024 Sep;137(9):847-856.e11. doi: 10.1016/j.amjmed.2024.04.042. Epub 2024 May 14.'}, {'pmid': '33948803', 'type': 'DERIVED', 'citation': 'Staples JA, Liu G, Brubacher JR, Karimuddin A, Sutherland JM. Physician Financial Incentives to Reduce Unplanned Hospital Readmissions: an Interrupted Time Series Analysis. J Gen Intern Med. 2021 Nov;36(11):3431-3440. doi: 10.1007/s11606-021-06803-8. Epub 2021 May 4.'}]}, 'descriptionModule': {'briefSummary': 'Unplanned hospital readmissions are associated with increases in morbidity, mortality, cost and patient dissatisfaction,. Policymakers continue to seek effective policy solutions to avoid readmissions in order to improve quality of care and reduce unnecessary expenditures,. One attempt to reduce readmissions was implemented on June 1 2012, when the Specialist Services Committee of British Columbia (a partnership of Doctors of BC and the Ministry of Health) introduced the new "G78717" fee code for physicians. The objective of the fee code was to create a financial incentive for physicians to provide a point-of-care supplemental discharge summary to patients and their primary care providers prior to discharge from hospital. Initially, only urgent hospital admissions were eligible for this incentive payment but on Nov 1 2015 the incentive was extended to include elective admissions as well. The other eligibility criteria remained unchanged.\n\nThe effectiveness and cost-effectiveness of the fee code intervention is unknown. This study will address important questions relevant to this policy intervention using rigorous methods and empirical data.\n\nThis study will employ two methods for measuring changes in readmission risk. First, we will use interrupted (multivariate) time series to measure whether there was a temporal change in provincial readmission risk associated with the implementation of the new fee code.\n\nWe will complement the above analyses with a stronger design, comparing hospitalizations for which the fee code was charged (intervention group) with a cohort of clinically similar hospitalizations for which the fee code was not charged (control group). For this approach, multivariate logistic regression will be the primary statistical method. Using this analytic strategy, 30-day readmission risk between the intervention and control group will be measured over time, adjusted for patient-, provider-, and hospitalization-level covariates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Our study population will be representative of medical and surgical hospital admissions in BC.\n\nThe Interrupted time series (ITS) cohort will be comprised of hospital separations eligible for submission of fee code G78717. We will include all urgent admissions to BC hospitals with discharge dates between 1 Jan 2002 and 30 June 2017 that had a length of stay (LOS) of \\>4 days and are associated with a specialist Most Responsible Physician (MRP).\n\nThe regression analysis cohort study will be identical to the ITS cohort but will be restricted to index hospitalization discharge dates between 1 Jun 2012 and 31 Jul 2017 (ie. the post-G78717 period).\n\nThe unit of analysis is the index hospital admission (ie. the initial hospital admission of interest). Individual patients can contribute multiple hospital admissions to the cohort over time (although only hospital admissions occurring \\>30 days after a prior discharge are eligible as index hospital admissions).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe study population will be comprised of all hospital discharges in British Columbia between 1 Jan 2002 and 30 June 2017.\n\nExclusion Criteria:\n\nWe will exclude separations with the following International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Canada (ICD-10-CA) codes as the Most Responsible Diagnosis:\n\n* Codes O00 - O99 \\[Pregnancy, childbirth and the puerperium\\]\n* Codes P00 - P96 \\[Certain conditions originating in the perinatal period\\]'}, 'identificationModule': {'nctId': 'NCT03256734', 'briefTitle': 'Does a Complex Care Discharge Planning Initiative Reduce Unplanned Hospital Readmissions? (G78717-Readmits)', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Does a Complex Care Discharge Planning Initiative Reduce Unplanned Hospital Readmissions?', 'orgStudyIdInfo': {'id': 'H17-01039'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Policy intervention', 'type': 'OTHER', 'description': 'Incentive payment for physicians'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 1Z3', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Tim Choi', 'role': 'CONTACT'}], 'facility': 'Population Data BC', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'John A Staples, MD', 'role': 'CONTACT', 'email': 'john.a.staples@gmail.com', 'phone': '604-682-2344'}, {'name': 'Jason M Sutherland, PhD', 'role': 'CONTACT', 'email': 'jsutherland@chspr.ubc.ca', 'phone': '604-822-6812'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data stewards are legally prohibited from sharing IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'John Staples', 'investigatorAffiliation': 'University of British Columbia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-17', 'type': 'RELEASE'}, {'date': '2024-10-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'John Staples, Clinical Assistant Professor, University of British Columbia'}}}}