Senior High Cost Users (HCU)NCT02815930
Characterizing the Senior High Cost User (HCU) in Ontario
An observational study of Senior High Cost Users (HCU), run by McMaster University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 66 to 105 years
- Conditions the study is for
- Senior High Cost Users (HCU)
- What is being tested?
- HCU Status
- How many people
- 700,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 to 105 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Newly incident senior high cost users (HCUs) in Ontario
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
Read the 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.
- Conditions
- Senior High Cost Users (HCU)
- Being tested
- HCU Status
- Keywords
- High cost user (HCU), Healthcare utilization, Healthcare expenditures, Medication use, Medication expenditures, Multimorbidity, Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCU StatusOther
Total healthcare expenditures in the top 5% of Ontarians
| Study group | Role | What they receive |
|---|---|---|
| HCUs | Newly incident seniors with annual total healthcare expenditures in the top 5% of Ontarians Receives: Other: HCU Status | |
| Non-HCUs | Seniors with annual total healthcare expenditures below the top 5% of Ontarians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total healthcare expenditures per patient
Measured: 1 year after index date
Total drug costs per patient
Measured: 1 year after index date
Drug cost to total healthcare expenditure ratio
Measured: 1 year after index date
Secondary outcomes (2)
All-cause mortality
Measured: 1 year after index date
All-cause hospitalization rate
Measured: 1 year after index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Senior High Cost Users (HCU)Studies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Drug Policy Research Network (ODPRN), Research Institute of St. Joseph's Hamilton
- Responsible party
- Sponsor
- Investigators
- Justin Lee, BScPhm, ACPR, MD, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815930
- Sponsor's protocol ID
- 2016 0760 236 000
- Status last verified
- Mar 2019
- First submitted
- 24 Jun 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
Publications
Lee J, Muratov S, Tarride JE, Paterson JM, Thavorn K, Mbuagbaw L, Gomes T, Khuu W, Seow H, Thabane L, Holbrook A. Medication use and its impact on high-cost health care users among older adults: protocol for the population-based matched cohort HiCOSTT study. CMAJ Open. 2021 Jan 11;9(1):E44-E52. doi: 10.9778/cmajo.20190196. Print 2021 Jan-Mar.
PubMed 33436455
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Senior High Cost User in Ontario: A Population-Based Matched Cohort Study
- ClinicalTrials.gov ID
- NCT02815930
- Acronym / sponsor ID
- 2016 0760 236 000
- Conditions
- Senior High Cost Users (HCU)
- Keywords
- High cost user (HCU), Healthcare utilization, Healthcare expenditures, Medication use, Medication expenditures, Multimorbidity, Observational study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700,000 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Ontario Drug Policy Research Network (ODPRN), Research Institute of St. Joseph's Hamilton
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCUs | – | Other: HCU StatusNewly incident seniors with annual total healthcare expenditures in the top 5% of Ontarians |
| Non-HCUs | – | –Seniors with annual total healthcare expenditures below the top 5% of Ontarians |
Who may qualify
- Ages
- 66 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Newly incident senior high cost users (HCUs) in Ontario
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCU StatusTotal healthcare expenditures in the top 5% of Ontarians | Other | HCUs |
Primary outcome
Total healthcare expenditures per patient
Time frame: 1 year after index date
Total drug costs per patient
Time frame: 1 year after index date
Drug cost to total healthcare expenditure ratio
Time frame: 1 year after index date
2 secondary outcomes
All-cause mortality
Time frame: 1 year after index date
All-cause hospitalization rate
Time frame: 1 year after index date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 33436455Lee J, Muratov S, Tarride JE, Paterson JM, Thavorn K, Mbuagbaw L, Gomes T, Khuu W, Seow H, Thabane L, Holbrook A. Medication use and its impact on high-cost health care users among older adults: protocol for the population-based matched cohort HiCOSTT study. CMAJ Open. 2021 Jan 11;9(1):E44-E52. doi: 10.9778/cmajo.20190196. Print 2021 Jan-Mar.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Lee, BScPhm, ACPR, MD, FRCPC principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
An observational study of Senior High Cost Users (HCU), run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total healthcare expenditures per patient (time frame: 1 year after index date). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02815930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.