Multiple Chronic IllnessesNCT01761253
Assessing Costs & Cost-variability Among Enrollees of Health Insurance Programs Utilizing Charlson's Comorbidity Index and Administrative Databases
An observational study of Multiple Chronic Illnesses, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study will involve the evaluation of the cost profile of about approximately 241,000 patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network AND 226,000 members of a large self insured union trust fund). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Chronic Illnesses
- How many people
- 241,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jul 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Approximately 15,000 patients who were continuously enrolled during the calendar years 2006 and 2010 in the Generations Plus/ Northern Manhattan Health Network and 226,000 members of a large self insured union trust fund from 2007-2010 will be combined. The data will include age, gender, length of plan enrollment, whether or not the patient is disabled, their diagnoses, and their use of medical and social services.
Who may be able to join
- patients with different burdens of comorbidity who have at least two continuous years of enrollment in the Generations Plus/ Northern Manhattan Health Network between June 2007 to July 2009 and members of a large self insured union trust fund from 2007-2010
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Generations Plus/ Northern Manhattan Health Network
The Bronx, New York, 10451
About this study
This study will involve the evaluation of the cost profile of about approximately 241,000 patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network AND 226,000 members of a large self insured union trust fund). We will test the hypothesis that as comorbidity scores exceed three-four, patients will have an exponential increase in average yearly cost with a parallel exponential increase in cost variability.
We will examine the relationship between comorbidity and health insurance costs and variability in costs among patients enrolled in health plans.
- Conditions
- Multiple Chronic Illnesses
- Keywords
- comorbidity, multiple chronic conditions, Medicaid, prediction of cost, Predictive models, cost containment, managed care
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Assessing costs & cost-variability | Data for the approximately 15,000 patients who were continuously enrolled during the calendar years 2006 and 2007 in the Generations Plus/ Northern Manhattan Health Network and 226,000 members of a large self insured union trust fund from 2007-2010 will be combined. The data will include age, gender, length of plan enrollment, whether or not the patient is disabled, their diagnoses, and their use of medical and social services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing costs & cost-variability among enrollees of health insurance programs utilizing Charlson's comorbidity index and administrative databases
Data for approximately 241,000 patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network and 226,000 members of a large self insured union trust fund) during the calendar years 2006 and 2010 will be assembled and will include age, gender, length of plan enrollment, whether or not the patient is disabled, and their diagnoses. The data within this dataset was collected between July 2006 and July 2010.
Measured: The data within this dataset was collected between July 2006 and July 2010.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJun 2006
- Primary completionJul 2010
- Study completionJul 2010
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 Multiple Chronic IllnessesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 241,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary E. Charlson, MD, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761253
- Sponsor's protocol ID
- WCMC IRB No. 910010709
- Status last verified
- Feb 2017
- First submitted
- 2 Jan 2013
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Charlson M, Wells MT, Ullman R, King F, Shmukler C. The Charlson comorbidity index can be used prospectively to identify patients who will incur high future costs. PLoS One. 2014 Dec 3;9(12):e112479. doi: 10.1371/journal.pone.0112479. eCollection 2014.
PubMed 25469987
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Costs & Cost-variability Among Enrollees of Health Insurance Programs Utilizing Charlson's Comorbidity Index and Administrative Databases
- ClinicalTrials.gov ID
- NCT01761253
- Acronym / sponsor ID
- WCMC IRB No. 910010709
- Conditions
- Multiple Chronic Illnesses
- Keywords
- comorbidity, multiple chronic conditions, Medicaid, prediction of cost, Predictive models, cost containment, managed care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241,000 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Jan 2013 (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.
This study will involve the evaluation of the cost profile of about approximately 241,000 patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network AND 226,000 members of a large self insured union trust fund). We will test the hypothesis that as comorbidity scores exceed three-four, patients will have an exponential increase in average yearly cost with a parallel exponential increase in cost variability.
We will examine the relationship between comorbidity and health insurance costs and variability in costs among patients enrolled in health plans.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessing costs & cost-variability | – | –Data for the approximately 15,000 patients who were continuously enrolled during the calendar years 2006 and 2007 in the Generations Plus/ Northern Manhattan Health Network and 226,000 members of a large self insured union trust fund from 2007-2010 will be combined. The data will include age, gender, length of plan enrollment, whether or not the patient is disabled, their diagnoses, and their use of medical and social services. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 15,000 patients who were continuously enrolled during the calendar years 2006 and 2010 in the Generations Plus/ Northern Manhattan Health Network and 226,000 members of a large self insured union trust fund from 2007-2010 will be combined. The data will include age, gender, length of plan enrollment, whether or not the patient is disabled, their diagnoses, and their use of medical and social services.
Key inclusion criteria (1 listed)
- patients with different burdens of comorbidity who have at least two continuous years of enrollment in the Generations Plus/ Northern Manhattan Health Network between June 2007 to July 2009 and members of a large self insured union trust fund from 2007-2010
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessing costs & cost-variability among enrollees of health insurance programs utilizing Charlson's comorbidity index and administrative databases
Time frame: The data within this dataset was collected between July 2006 and July 2010.
Data for approximately 241,000 patients (15,000 who are members of the Generations Plus/ Northern Manhattan Health Network and 226,000 members of a large self insured union trust fund) during the calendar years 2006 and 2010 will be assembled and will include age, gender, length of plan enrollment, whether or not the patient is disabled, and their diagnoses. The data within this dataset was collected between July 2006 and July 2010.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Derived from this study: PubMed 25469987Charlson M, Wells MT, Ullman R, King F, Shmukler C. The Charlson comorbidity index can be used prospectively to identify patients who will incur high future costs. PLoS One. 2014 Dec 3;9(12):e112479. doi: 10.1371/journal.pone.0112479. eCollection 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Chronic Illnesses, run by Weill Medical College of Cornell University at 1 site in United States.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessing costs & cost-variability among enrollees of health insurance programs utilizing Charlson's comorbidity index and administrative databases (time frame: The data within this dataset was collected between July 2006 and July 2010.). 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 NCT01761253, 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 20 Feb 2017.