AnticoagulationNCT00205400
Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
A study testing medical care delivery model in people with Anticoagulation and Thromboembolism, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Hypothesis: Does the time spent within the target INR range differ when patients are managed by AMD or IT models of anticoagulation care? Experimental Design: The 36-month trial enrolled 192 eligible patients currently receiving chronic warfarin therapy at the William S. Middleton Memorial VA Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation, Thromboembolism
- What is being tested?
- medical care delivery model
- Type of treatment
- Surgery or procedure
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Mar 2005
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completion of >3 months of warfarin
- indefinite warfarin therapy
Who cannot join
- patients who currently receive >25% of INR determinations per year from local labs
- extended absences from VA
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: Does the time spent within the target INR range differ when patients are managed by AMD or IT models of anticoagulation care?
Experimental Design: The 36-month trial enrolled 192 eligible patients currently receiving chronic warfarin therapy at the William S. Middleton Memorial VA Hospital. Consenting patients are enrolled and randomized to 1 of 2 groups: usual clinic care with face-to-face visits every 4 weeks (AMS model) or clinic visits every 3 months with interim laboratory visits and telephone follow-up every 4 weeks (IT model). At study conclusion, the amount of time the INR is within target range will be compared between the two groups. Thromboembolic and bleeding event rates, patient knowledge, quality of life and healthcare utilization will also be analyzed.
- Conditions
- Anticoagulation, Thromboembolism
- Being tested
- medical care delivery model
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical care delivery modelProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent time in therapeutic range (TTR) using modified version of Rosendaal method
Secondary outcomes (1)
Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 1999
- Primary completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Sorkness, Pharm D, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205400
- Sponsor's protocol ID
- M-1999-0280
- Status last verified
- Oct 2016
- First submitted
- 13 Sep 2005
- Last updated
- 27 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Outcomes Using Different Delivery Models of Anticoagulation Care
- ClinicalTrials.gov ID
- NCT00205400
- Acronym / sponsor ID
- M-1999-0280
- Conditions
- Anticoagulation, Thromboembolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 1999
- Primary completion
- Mar 2005 (actual)
- First posted
- 20 Sep 2005 (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.
Hypothesis: Does the time spent within the target INR range differ when patients are managed by AMD or IT models of anticoagulation care?
Experimental Design: The 36-month trial enrolled 192 eligible patients currently receiving chronic warfarin therapy at the William S. Middleton Memorial VA Hospital. Consenting patients are enrolled and randomized to 1 of 2 groups: usual clinic care with face-to-face visits every 4 weeks (AMS model) or clinic visits every 3 months with interim laboratory visits and telephone follow-up every 4 weeks (IT model). At study conclusion, the amount of time the INR is within target range will be compared between the two groups. Thromboembolic and bleeding event rates, patient knowledge, quality of life and healthcare utilization will also be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- completion of >3 months of warfarin
- indefinite warfarin therapy
Key exclusion criteria (2 listed)
- patients who currently receive >25% of INR determinations per year from local labs
- extended absences from VA
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 |
|---|---|---|
| medical care delivery model | Procedure or surgery | – |
Primary outcome
Percent time in therapeutic range (TTR) using modified version of Rosendaal method
1 secondary outcome
Event rates for thromboembolism, hemorrhages, hospitalizations, urgent care visits, emergency department visits, triage calls, INRs greater than 6.0 and quality of life
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 27 Oct 2016.
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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.
Christine Sorkness, Pharm D principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical care delivery model in people with Anticoagulation and Thromboembolism, run by University of Wisconsin, Madison 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 2 inclusion and 2 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 27 Oct 2016. 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?
Percent time in therapeutic range (TTR) using modified version of Rosendaal method. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2016.