The Home INR Study (THINRS)
18 mars 2014 uppdaterad av: US Department of Veterans Affairs
CSP #481 - The Home INR Study (THINRS)
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients.
The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding.
The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
Intervention: Weekly patient self-testing (PST) of prothrombin time by international normalized ratio (PT INR) versus conventional monthly high quality anticoagulation management (HQACM) from an anticoagulation clinic with a minimum two years follow-up.
Primary Hypothesis: Compared to conventional monitoring in the clinic, PST of anticoagulation intensity will decrease the number of events of thromboembolism (strokes), bleeding, and all cause deaths and improve the quality of anticoagulation.
Second Hypothesis: PST and conventional monitoring will be comparable in terms of health care utilization and cost.
Primary Outcomes: Event rates (thromboembolism or bleeding episodes), time to first event, time within therapeutic range for anticoagulation intensity, and total health care cost (including price of PST monitors) and utilization.
Study Abstract: Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for PST is that it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events.
Original plan was for a study at 32 sites with a total sample size of about 3,200 patients and a length of three years (one for recruitment and two years of follow-up). Final status was 28 sites that randomized 2922 patients in 2.75 years of recruitment with a minimum of two years of follow-up.
Studietyp
Interventionell
Inskrivning (Faktisk)
2922
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- VA Medical Center, Birmingham
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California
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Fresno, California, Förenta staterna, 93703
- VA Central California Health Care System, Fresno
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Loma Linda, California, Förenta staterna, 92357
- VA Medical Center, Loma Linda
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Palo Alto, California, Förenta staterna, 94304-1290
- VA Palo Alto Health Care System
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West Los Angeles, California, Förenta staterna, 90073
- VA Greater Los Angeles Healthcare System, West LA
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Colorado
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Denver, Colorado, Förenta staterna, 80220
- VA Eastern Colorado Health Care System, Denver
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Connecticut
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West Haven, Connecticut, Förenta staterna, 06516
- VA Connecticut Health Care System (West Haven)
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Illinois
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Hines, Illinois, Förenta staterna, 60141-5000
- Edward Hines, Jr. VA Hospital
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North Chicago, Illinois, Förenta staterna, 60064
- VA Medical Center, North Chicago
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Iowa
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Iowa City, Iowa, Förenta staterna, 52246-2208
- VA Medical Center, Iowa City
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- VA Maryland Health Care System, Baltimore
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Michigan
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Detroit, Michigan, Förenta staterna, 48201
- John D. Dingell VA Medical Center, Detroit
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55417
- VA Medical Center, Minneapolis
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Missouri
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Kansas City, Missouri, Förenta staterna, 64128
- VA Medical Center, Kansas City MO
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Nevada
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North Las Vegas, Nevada, Förenta staterna, 89036
- Las Vegas
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Reno, Nevada, Förenta staterna, 89502
- VA Sierra Nevada Health Care System
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New York
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Bronx, New York, Förenta staterna, 10468
- VA Medical Center, Bronx
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Buffalo, New York, Förenta staterna, 14215
- VA Western New York Healthcare System at Buffalo
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Syracuse, New York, Förenta staterna, 13210
- VA Medical Center, Syracuse
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North Carolina
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Durham, North Carolina, Förenta staterna, 27705
- Durham VA Medical Center HSR&D COE
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106
- VA Medical Center, Cleveland
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- VA Medical Center, Oklahoma City
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15240
- VA Pittsburgh Health Care System
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02908
- VA Medical Center, Providence
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Texas
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Dallas, Texas, Förenta staterna, 75216
- VA North Texas Health Care System, Dallas
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San Antonio, Texas, Förenta staterna, 78229
- VA South Texas Health Care System, San Antonio
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Virginia
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Salem, Virginia, Förenta staterna, 24153
- VA Medical Center, Salem VA
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Wisconsin
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Madison, Wisconsin, Förenta staterna, 53705
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
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San Juan, Puerto Rico, 00921
- VA Medical Center, San Juan
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
To be enrolled in this study, patients must:
- have AF and/or a MHV;
- be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
- be using warfarin according to the criteria described in the Coumadin package insert (no off-label uses);
- be expected to survive for the duration of the study;
- not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the Coumadin package insert;
- be willing to perform PST;
- be willing to be randomized;
- possess adequate cognitive and language skills to follow the protocol and all related instructions;
- be willing to participate for the full duration of the study;
- sign the informed consent form; and
- not be enrolled in another randomized clinical trial that involves a drug or device intervention.
Exclusion Criteria:
Patients are excluded in this study if:
- subject has had intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
- subject enrolled in another randomized clinical trial that involves a drug or device intervention
- subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm 1
Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
|
|
|
Övrig: Arm 2
High quality anticoagulation management (HQACM) with conventional monthly testing
|
HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to First Event (Death, Stroke, Major Bleed)
Tidsram: Time to event
|
Time to first event (death, stroke, major bleed) The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information. |
Time to event
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)
Tidsram: Full length of follow-up; average of 3 years
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Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio
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Full length of follow-up; average of 3 years
|
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DASS at 2 Years of Follow-up
Tidsram: At two years of follow-up
|
Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS).
Scores range from 25 to 225, with lower scores indicating higher satisfaction.
|
At two years of follow-up
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Cumulative Gain in Health Utilities at 2 Year
Tidsram: After 2 years of follow-up for each subject
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Scores range from -0.36 to 1.00 per year, with a negative score indicating a state worse than being dead and a score of 1.00 indicating perfect health.
Since the time frame is 2 years, the range is -0.72 to 2.00.
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After 2 years of follow-up for each subject
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Health Care Costs at 2 Year
Tidsram: After 2 years of follow-up for each subject
|
After 2 years of follow-up for each subject
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: David B. Matchar, MD, Durham VA Medical Center HSR&D COE
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Dolor RJ, Ruybalid RL, Uyeda L, Edson RG, Phibbs C, Vertrees JE, Shih MC, Jacobson AK, Matchar DB; THINRS Site Investigators. An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomization results of VA Cooperative Study #481--The Home INR Study (THINRS). J Thromb Thrombolysis. 2010 Oct;30(3):263-75. doi: 10.1007/s11239-010-0499-8.
- Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih MC, Holodniy M, Lavori P; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20. doi: 10.1056/NEJMoa1002617. Erratum In: N Engl J Med. 2011 Jan 6;364(1):93.
- Matchar DB, Jacobson AK, Edson RG, Lavori PW, Ansell JE, Ezekowitz MD, Rickles F, Fiore L, Boardman K, Phibbs C, Fihn SD, Vertrees JE, Dolor R. The impact of patient self-testing of prothrombin time for managing anticoagulation: rationale and design of VA Cooperative Study #481--the Home INR Study (THINRS). J Thromb Thrombolysis. 2005 Jun;19(3):163-72. doi: 10.1007/s11239-005-1452-0.
- Phibbs CS, Love SR, Jacobson AK, Edson R, Su P, Uyeda L, Matchar DB; writing for the THINRS Executive Committee and Site Investigators. At-Home Versus In-Clinic INR Monitoring: A Cost-Utility Analysis from The Home INR Study (THINRS). J Gen Intern Med. 2016 Sep;31(9):1061-7. doi: 10.1007/s11606-016-3700-8. Epub 2016 May 27.
- Matchar DB, Love SR, Jacobson AK, Edson R, Uyeda L, Phibbs CS, Dolor RJ. The impact of frequency of patient self-testing of prothrombin time on time in target range within VA Cooperative Study #481: The Home INR Study (THINRS), a randomized, controlled trial. J Thromb Thrombolysis. 2015 Jul;40(1):17-25. doi: 10.1007/s11239-014-1128-8.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2003
Primärt slutförande (Faktisk)
1 maj 2008
Avslutad studie (Faktisk)
1 maj 2008
Studieregistreringsdatum
Först inskickad
27 mars 2002
Först inskickad som uppfyllde QC-kriterierna
27 mars 2002
Första postat (Uppskatta)
28 mars 2002
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
15 april 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 mars 2014
Senast verifierad
1 mars 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 481
Läkemedels- och apparatinformation, studiedokument
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produkt tillverkad i och exporterad från U.S.A.
Nej
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