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)

Abstract

Prior studies suggest patient self-testing (PST) of prothrombin time (PT) can improve the quality of anticoagulation (AC) and reduce complications (e.g., bleeding and thromboembolic events). “The Home INR Study” (THINRS) compared AC management with frequent PST using a home monitoring device to high-quality AC management (HQACM) with clinic-based monitoring on major health outcomes. A key clinical and policy question is whether and which patients can successfully use such devices. We report the results of Part 1 of THINRS in which patients and caregivers were evaluated for their ability to perform PST. Study-eligible patients (n = 3643) were trained to use the home monitoring device and evaluated after 2–4 weeks for PST competency. Information about demographics, medical history, warfarin use, medications, plus measures of numeracy, literacy, cognition, dexterity, and satisfaction with AC were collected. Approximately 80% (2931 of 3643) of patients trained on PST demonstrated competency; of these, 8% (238) required caregiver assistance. Testers who were not competent to perform PST had higher numbers of practice attempts, higher cuvette wastage, and were less able to perform a fingerstick or obtain blood for the cuvette in a timely fashion. Factors associated with failure to pass PST training included increased age, previous stroke history, poor cognition, and poor manual dexterity. A majority of patients were able to perform PST. Successful home monitoring of PT with a PST device required adequate levels of cognition and manual dexterity. Training a caregiver modestly increased the proportion of patients who can perform PST.

Appendix

The following persons participated in this study.

Planning Committee: Alan Jacobson, MD (Co-Chair), Loma Linda, CA, David Matchar, MD (Co-Chair), Durham, NC and Singapore, Jack E. Ansell, MD, New York, NY, Kathy D. Boardman, RPh, Albuquerque, NM, Robert Edson, MA, Palo Alto, CA, Michael D. Ezekowitz, MD, Wynnewood, PA, Stephan D. Fihn, MD, Seattle, WA, Louis Fiore, MD, Boston, MA, Philip W. Lavori, PhD, Stanford, CA, Ciaran S. Phibbs, PhD, Palo Alto, CA, Frederick Rickles, MD, Washington, DC.

Executive Committee: Alan Jacobson, MD (Co-Chair), Loma Linda, CA, David Matchar, MD (Co-Chair), Durham, NC and Singapore, Jack E. Ansell, MD, New York, NY, Rowena Dolor, MD, Durham, NC, Robert Edson, MA, Palo Alto, CA, Freny Vaghaiwalla Mody, MD, Los Angeles, CA, Ciaran S. Phibbs, PhD, Palo Alto, CA, Julia E. Vertrees, PharmD, BCPP, Albuquerque, NM, Beverly Ventura, BS, Palo Alto, CA, Lori Churby, BS, Palo Alto, CA (past).

Data Monitoring Committee: Bruce Coull, MD (Chair), Tucson, AZ, David Glidden, PhD, San Francisco, CA, George Howard, PhD, Birmingham, AL, John Heit, MD, Rochester, MN, Tim Morris MD, San Diego, CA, Gene Sung, MD, Los Angeles, CA.

Chair’s Office, Loma Linda VAMC: National Clinical Coordinator: R. Lynne Ruybalid, MPH, CCRC.

Chair’s Office, Durham VAMC: National Research Coordinator: Diane Garrison, Meenal Patwardhan, MD, MHSA (past).

Participating VA Medical Centers: (site investigators; study coordinators; and anticoagulation managers): Baltimore—Carol Rudo, MD; Rosetta Corbett, Kathleen Yeager; Blanca Morales-Ratzloff. Bronx—Calvin Eng, MD; Ann Haynos, Ali Saeed (past), Sanjay Agarwal, Warangkana Chokesuwattanaskul MD (past), Proserfino Patacsil (past); Olga Sherman. Buffalo—Kenneth Kellick, PharmD; Elongia Farrell; Lisa Samol, PharmD, Kathleen Doyle, PharmD, Denise Farolino, PharmD, Greg Wojcik, PharmD. Cleveland—Maurice Jones, PharmD; Tara Byrd, Carol Ingle, Gina Pauskt. Dallas—Peter Yunyongying, MD, Wen Lai, MD (past); Cassie Lusk, Elizabeth Price (past), Pintu Amratlal (past), Shane Huffman (past). Denver—Patricia Schoch, PharmD; Lyndy Balderman, Pam Aakhus (past). Detroit—Preeti Ramappa, MD, Deepak Thatai, MD (past); Elizabeth Jones, BS, Katie Kelly Toby, RN, BSN, Carole Adams, PharmD (past). Durham—Rowena Dolor, MD; Jennifer Taylor; PharmD, Jennifer Cornejo, RA (past). Fresno—Paulette Ginier, MD; Suzanne Venturino (past), Carol Schulz, RN, Billie Jones, RN. Hines—Abdul Choudhury, MD; Jacolyn Jaconetty, RN, David Oprondek (past), Amanda Pietrucha (past), Louise Corzine (past); Patricia Gully. Iowa City—Doug Geraets, PharmD; Sara Miller, RN, Jane Morse, RN (past), Melody Scherubel (past), Angie Hoth (past). Kansas City—Michael Liston, MD; Julie Kraemer, RN, Talita Hill, RN (past) Dorinda Sutton (past); Maqual Graham, PharmD, Cynthia Infranca, RA. Las Vegas—Raynaldo Sandoval, MD; Jose Lopez, Leonel Gallegos (past), Denise Duren (past), Mina Maquindang (past), Elizabeth Campbell (past). Loma Linda—Ronald Fernando, MD; Tiffany Gunneman, Barbara Howe (past); Myra Peterson. Madison—Carla Staresinic, PharmD; Lou Ellen Williams, BS; Mary Falls, MSN, RN-CS, NP-C. Minneapolis—Gerhard Johnson, MD; Bobbie Masoud, PharmD, (past), Jean Kanter, RN (past) Jeri McIntosh, RN (past); John Toscano, PharmD. North Chicago—Sheila Mailekel, MD; Jill Nyland, RN; Marilyn Sullivan, RN. Oklahoma City—Udho Thadani, MD; John Turner, RN, Lisa Rogan, RN, Barbara Parker, RN (past), Michelle Thresher, RN (past). Palo Alto—Lars Osterberg, MD; Elizabeth Packer, Leah Holloway (past). Pittsburgh—Visala Muluk, MD; Thomas Ansell, RN, April Bradburn, RN (past). Providence—Satish Sharma, MD; Lynn Marquis, RN; Margaret Quillin. Reno—Linda Clifford, PharmD, Ann Haynos, Susan Holly, PharmD; Janet Frey, RN; Kimberly Long, BSBI, Adrienne Smith, RN (past). Salem—Thomas Martin, MD, Muhammad Isa, MD (past), Jose Mendoza, MD (past), Nabil Jarmukli, MD (past); Tonda Yates, LPN, Allison Beck (past), Sherri Odat, LPN (past). Syracuse—Tammy Anthony, MD; Karen Degre, NP, RN, MSN; Paul Pry, NP, RN, MSN. San Antonio—George Melnik, PharmD; Judith Nicastro, RN (past), Patricia Baker (past). San Juan—Giselle Rivera, PharmD; Annette Melendez. West Haven (closed early)—Farid Jadbabaie, MD (past), Brian Abbott, MD (past); Caroline Ruwet (past), Shannon Dyke (past), Luisa Sheehan (past). West Los Angeles—Freny Vaghaiwalla Mody MD; Peter Petriashvili, Negin Taher, Bita Hajzadeh, Lanille Cua (past), Ramyar Mahdavi (past), Julie Mann, RN (past), Jahandar Saleh (past), Rosa Radbod (past).

Biostatistics and Research Data Processing: Palo Alto VA Cooperative Studies Program Coordinating Center (Director; Biostatistician; Project Manager; Health Economist; Statistical Programmer; Data Management Programmers; Health Economics Programmer; Clinical Data Manager; Clinical Data Assistants; Project Coordinator; Research Assistant)—Ying Lu, PhD, Mark Holodniy, MD (Acting, past), Javaid Sheikh, MD, MBA (past), Philip Lavori, PhD (past); Robert Edson, MA; Beverly Ventura, Lori Churby (past); Ciaran S. Phibbs, PhD; Lauren Uyeda, MA; Andres Busette, Anjali Kukde, Joanna Thorgrimsson; Pon Su, MS; Amy Brown, MHS, Alaina Mae Difuntorum, Carole Keim, Parinaz Lajevardi, Jeff Ratto (past), Meredith Miller (past), Lenore Sheridan (past), Felina Roque (past), Briana Davis (past), Ryan Duffy (past); Michelle Mullens, Pei-Pei Woo, Chris Punzalan; Elaine Nastor; Deanne Hirshfield.

Clinical Research Pharmacy: VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (Director; Clinical Research Pharmacist; Pharmaceutical Project Manager; IT Group); Mike R. Sather, PhD, FSHP; Julia E. Vertrees, PharmD, BCPP, Kathy D. Boardman, RPh (past); Donald Conner, Bonnie Matura (past), Erica Copeland (past); Jimmy Pontzer, Dave Garnand.

Human Rights Committee: Charlotte Giese, Ph.D.(Chair); Virginia Bachrach, MD, MPH, Ward Hart, MD, Carl Winterstein, MD, Gregory Bates, DVM, Leon Rochester, Ph.D, William B. Bronson, Susan Levenberg, Steve Malone, Cora Scheel, M.Div., Chaplain Ed Bastille (past), Robert M. Cardelli, MD (past), William R. Blythe, PhD (past), Lyndel Monroe (past), Byron W. Brown, Jr., PhD (deceased), Paul Lachetti (past), Virginia Shahrok, MD (past), William L. Fong, J.D., PharmD (past), Father Te Van Nguyen (past).

Cooperative Studies Program Central Office: (Director; Deputy Director)—Timothy O’Leary, MD, Brian Schuster, MD (past), John Feussner, MD (past); Grant D. Huang, PhD, MPH.

Clinical Endpoints Committee (CEC): Duke Clinical Research Institute, Durham NC; Kenneth Mahaffey, MD (CEC Director and PI), Patty Connolly, RN, Diana McFarron, RN, Sheila Dickerson, RN, Meredith Smith, RN, Gregg Stashenko, MD, Jennifer Vergara, MD, Chiara Melloni, MD, Pierluigi Triccoci, MD, Michael Felker, MD, Michael Gharacholou, MD, Willie Hester, MD, Adrian Hernandez, MD, Matt Brennan, MD, Manesh Patel, MD, Lynda Szczech, MD, Matthew Roe, MD, John Alexander, MD, Patrick Pun, MD, Bimal Shah, MD, Rujuta Patel, MD, Sana Al-Khatib, MD, and Kristin Newby, MD.