- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02815930
Characterizing the Senior High Cost User (HCU) in Ontario
February 4, 2020 updated by: McMaster University
Characterizing the Senior High Cost User in Ontario: A Population-Based Matched Cohort Study
High cost users (HCUs) are a small group of patients who use a disproportionate amount of health care resources.
This study is a retrospective population-based matched cohort analysis of newly incident senior High Cost Users (HCUs) defined as Ontarians aged 66 years or older in the top 5% of healthcare expenditure users in fiscal year 2013 (FY2013).
The study objectives are to characterize and contrast Ontario senior HCUs to non-HCUs based on their demographics, co-morbidities, medication use, health service utilization, healthcare expenditures, medication costs and clinical outcomes, and to determine the relative contribution of medications to senior HCUs expenditures
Study Overview
Detailed Description
Senior high cost users (HCUs) with annual healthcare expenditures within the top 5% of Ontarians will be identified using established ICES costing algorithms.
This cohort will be matched to a cohort of non-HCUs using a 3:1 matching ratio (non-HCU to HCU) based on age at cohort entry (+/- 1 month), sex and geographic location of residence (based on LHIN) for comparative analysis.
Descriptive statistics will be used to describe the study populations and outcomes.
Regression analyses will be used to adjust for potential confounders when analyzing healthcare resource utilization and costs as a function of HCU status (e.g.
income, type of residence, co-morbidities, rural/urban) and/or when analyzing sub-populations [e.g.
chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF)].
Logistic regression will be performed using the patient level data to predict the impact of individual factors on the likelihood of becoming a senior HCU.
Study Type
Observational
Enrollment (Anticipated)
700000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
66 years to 105 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Newly incident senior high cost users (HCUs) in Ontario
Description
Inclusion Criteria:
- Ontario residents registered in RPDB between April 1, 2013 - March 31, 2014
- Annual total health care expenditures in FY2013 equal to or greater than financial threshold for the top 5% of all Ontarians
Exclusion Criteria:
- Death on OR prior to index date
- Age > 105
- Annual total health care expenditures in FY2012 fiscal year greater than financial threshold of 5% of all Ontarians in FY2013
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HCUs
Newly incident seniors with annual total healthcare expenditures in the top 5% of Ontarians
|
Total healthcare expenditures in the top 5% of Ontarians
|
Non-HCUs
Seniors with annual total healthcare expenditures below the top 5% of Ontarians
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total healthcare expenditures per patient
Time Frame: 1 year after index date
|
1 year after index date
|
Total drug costs per patient
Time Frame: 1 year after index date
|
1 year after index date
|
Drug cost to total healthcare expenditure ratio
Time Frame: 1 year after index date
|
1 year after index date
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All-cause mortality
Time Frame: 1 year after index date
|
1 year after index date
|
All-cause hospitalization rate
Time Frame: 1 year after index date
|
1 year after index date
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Justin Lee, BScPhm, ACPR, MD, FRCPC, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
March 1, 2014
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
June 24, 2016
First Submitted That Met QC Criteria
June 24, 2016
First Posted (Estimate)
June 28, 2016
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
February 4, 2020
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016 0760 236 000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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