Patient Self Testing at the MGH AMS Lynn B. Oertel, MS, NP-BC, CACP Nursing Practice Specialist Anticoagulation Management Service Massachusetts General Hospital, Boston, MA 1
Disclosures Boehringer Ingelheim – Consultant • Bristol-Myers Squibb - Consultant • Roche – Consultant • Chair of Board: National Certification Board for Anticoagulation Providers • Board Member: Medical and Scientific Advisory Board for the National • Blood Clot Alliance Advisory Board Member: Anticoagulation Forum •
An early history lesson about self management in diabetes Presented at ADA, June 5, 1955 Dr White : “ Do you think patients should learn to do their own “Laughter” blood sugars?” White P. Diabetes. 1956:5:44-60
Self testing patients around the world USA ~225,000 All of Europe ~300,000 Germany ~200,000
Summary of meta-analyses comparing PST/PSM to Usual or Clinic Care Heneghan et al Garcia-Alamino et al Bloomfield et al Lancet 2006 Cochrane 2010 Ann Intern Med 2011 # Patients 3049 4723 8413 # studies 14 18 22 TE Events OR 0.45 RR 0.50 OR 0.58 (95% CI 0.30-0.68) (95% CI 0.36-0.69) (95% CI 0.45-0.75) Major Bleed OR 0.65 RR 0.87 RR 0.87 Events (95% CI 0.42-0.99) (95% CI 0.66-1.16) (95% CI 0.75-1.05) Mortality OR 0.61 RR 0.64 OR 0.74 (95% CI 0.38-0.98) (95% CI 0.46-0.89) (95% 0.63-0.87) TE=Thromboembolic, OR=Odds Ratio, RR=Relative Risk, CI=Confidence Interval Heneghan C et al. Lancet 2006:367:404-411 Garcia-Alamino JM et al. Cohrane Database Syst Review. 2010:CD003839 Bloomfield HE et al. Ann Intern Med 2011. 154:472-482
Self-Testing Analysis Based on Long- term Evaluation (STABLE) Assessed 2 groups • determined by testing frequency (TF): – Variable – Weekly 42 month observation • All TF Variable TF Weekly TF p N Mean SD N Mean SD N Mean SD TTR % TTR % TTR % 29,457 69.7 18.6 24,907 68.9 19.1 4,550 74 15.1 <.0001 DeSantis G et al. Am J Manag Care. 2014; 20(3):202-209
TTR by CoaguChek Patient Services # Patients = 18,243 ▪ #INRs = 1,055,265 ▪ 2008-2015 • Mean TTR Variable = 70.2% • Mean TTR Weekly = 72.8% p<0.0001 Fantz CR. The efficacy of patient self-testing to manage patients on warfarin. White paper published by Roche 2016 7
Working with Industry: Collaboration with IDTFs (Independent Diagnostic Testing Facilities) Agile Home Monitoring (www.agilehm.com) • Alere Anticoagulation Solutions • (AlereCoag.com) Cardiac Remote Services - formerly Philips • (www.remotecardiacservices.com) Cardionet (www.gobio.com/inr) • mdINR (www.mdinr.com) • Patient Home Monitoring - PHM • (www.myphm.com) Roche – Coaguchek Patient Services • (www.coaguchek-usa.com) US Healthcare Supply LLC – (www.ushsnj.com) •
Advantages of partnering with IDTFs • Review/determine insurance benefit and patient’s out of pocket costs • Provide in-home training and supplies (testing meter and strips) • Communicate INR results to warfarin manager via fax/page/phone/web portal • Ongoing support of patient compliance with prescribed testing frequency (if desired) • Technical support and assistance
Approved by the US FDA CoaguChek XS Plus ProTime Microcoagulation System Roche International Technidyne INRatio Monitor Alere Coag-Sense Mandatory recall US Healthcare Supply LLC • Meter Cost: $1500-2000 USD • Test strips: $7-12 USD per strip • Medicare covers: MHV, Afib, DVT/PE, other insurers same (but may have flexibility to authorize other indications)
MGH AMS PST journey 2002- CMS National Coverage: MHV 2014- Nat’l 2008- CMS CHEST 2012- Action Plan PST National CHEST 2008- PSM + PSM to recommend Coverage suggested prevent PSM + PST expands: adverse drug (Grade 2B) AF + VTE events 2005 2009 2010 2011 2012 2015 2016 AMS ACF MGH AMS Practice Implement AMS Continue Conference support for and Policy PST poster ACF to increase MGH data PST further Agreement Conf PSTers presented defined NP Implement credentialed Dawn AC by MGH 2007 2014
PST N = 560 (14% of clinic population) September 27, 2016, unpublished data MGH AMS 12
Top Indications for PST by INR range 300 250 200 150 2.5-3.5 2.0-3.0 100 50 0 AF/Afl VTE Heart Valve Hypercoaguable other Replacements States 13
Lab designation as “Patient Self Testing Lab” type 14
Performance improvement project to determine if TTR improved for PSTers • N = 121, INR range 2-3 • Age (mean±SD) = 68.9±11.7, range 25.6-89.3) • Gender, Male = 62% MGH AMS, Poster presentation at ACF Conference, May 2011
INR performance: PST vs laboratory (limited to 2-3 Range) Self Testers = 513 (~12% of clinic population) • 413 (81%) patients in INR range 2-3 • Age ± SD (yrs) = 69.8 ± 13.2, Range 27-95 • Gender (male) = 57% • Collaborate with 4 IDTFs: Alere (82), MDInr (3), Remote Cardiac • Services (27), Roche (381), Self Reporting (20) Testing # of PTs # of INRs TTR # INRs 1.3 or # INRs 5 or # INRs 7 or below above above PST 413 3,450 75 164 (4.75%) 21 (0.6%) 2 (0.06%) Laboratory 3,457 18,018 73.9 1,175 (6.5%) 156 (0.87%) 33 (0.18%) Unpublished MGH AMS data: 12/28/14 – 3/17/15
What testing frequency is ideal? PST PST PST Total HQACM Twice p Every 4 wks Weekly weekly N at 1 yr 690 335 102 149 104 TTR % 62.1 60.8 59.9 63.3 66.8 .0068 % In-range INRs 57.5 54.8 53.5 61.5 64.1 <0.0001 % Extreme INRs 11.4 12.6 13.7 9.6 7.9 0.03 ≤1.5 or ≥4.0 Mean DASS* 48 49.5 47 46.2 47 0.53 *DASS=Duke Anticoagulation Satisfaction Score, lower DASS score, higher satisfaction • Conclusion from THINRS sub-study: “more frequent PST improved TTR and reduced the proportion of poorly managed patients” Matchar DB et al. J Thromb Thrombolysis 2014. doi:10.1007/s11239-014-1128-8
Frequency of INR Testing at MGH AMS Changes made to the default values on the Treatment Plan: • 7 days at the start • Maximum is 14 days MGH AMS, 2011 Pre Post Median INRs_30 2 3.9 <0.0001 days TTR 72.9 77.6 <0.001 18
How to manage increased # INRs? • Use innovation and technology to create solutions for managing: – Incoming INRs to clinic: • From patient (dedicated phone line, interactive voice-response system, web portal, mobile app) • From IDTF (Fax, phone, page, web portal retrieval) – Outgoing communication to assess and/or inform patients: • Telephony services • Email or mail (USPS mail has time delay) • Smart phones • Mobile apps • Web portals • Tailor approach to who benefits most from increased frequency
What PST means to our patients ... • Empowerment – actively engaged in their care and disease management • Achieve more time in therapeutic range – Likely to reduce adverse events (improved TTR and reduced INRs in danger zones) and health care costs associated with these • Convenience • Removes limitations associated with getting to a laboratory • Preference for fingerstick over venous puncture (poor venous access) • Improves quality of life (less time spent with traveling to/from laboratories, doctor’s office) • Maintains consistent lab for patient – mobile life style, frequent traveler
Number of self testers by nurse 70 60 50 40 30 20 10 0 AC CO CG DD DW IS JO LC MG PR PB RC RL WM 25% What should our goal be for self testers in 2016-2017?
Practical tips at the clinic level • Utilize PST agreement (supplements general AMS agreement). Scan and attach to Dawn Docs Tab • Practical / educational discussion with patient for expectations and practicalities • Organize / streamline the process • Document in clinic and hospital records 22
Sample Documentation (created in Epic, copied to Dawn AC) Patient self testing of INRs at home. I reviewed concepts and expectations for patient self testing (PST) at home with NAM. Patient's compliance in past is acceptable. NAME (or his/her significant other) seems able to perform and wishes to proceed. Permission was obtained to release contact information to the Independent Diagnostic Testing Facility (IDTF) we will eventually work with. I reviewed the purpose of the AMS Patient Agreement for PST and will send to patient. Patient understands we need this document signed and returned before the PST referral is initiated. Additionally, I stressed the importance of weekly testing in order to maximize the benefit to maintain therapeutic INRs. I reviewed expectations for testing and reporting INR values directly to the IDTF and our plan to communicate results and dose instructions to patient. This was summarized in writing and provided to NAME, he/she understands and agrees to our plan. 23
Practical Tips to get started • Physician Order for Patient Self Testing (IDTF referral) • Patient Authorization Form (not all IDTFs require this) for patient’s signature to release healthcare information to determine benefit coverage • Use ICD-10 codes for approved diagnoses [include: Z79.01 Long term (current) use of anticoagulants] 24
Determine what’s best for your clinic: • Who will be testing? • Where to report? – Emphasize AM testing, Mon-Thu – Avoid weekends and holidays 25
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