Patient Self Testing at the MGH AMS Lynn B. Oertel, MS, NP-BC, CACP - - PowerPoint PPT Presentation

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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

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

White P. Diabetes. 1956:5:44-60

Dr White: “Do you think patients should learn to do their own blood sugars?” Presented at ADA, June 5, 1955

“Laughter”

Self testing patients around the world

Germany ~200,000 All of Europe ~300,000 USA ~225,000

Summary of meta-analyses

comparing PST/PSM to Usual or Clinic Care

Heneghan et al Lancet 2006 Garcia-Alamino et al Cochrane 2010 Bloomfield et al Ann Intern Med 2011 # Patients 3049 4723 8413 # studies 14 18 22 TE Events OR 0.45 (95% CI 0.30-0.68) RR 0.50 (95% CI 0.36-0.69) OR 0.58 (95% CI 0.45-0.75) Major Bleed Events OR 0.65 (95% CI 0.42-0.99) RR 0.87 (95% CI 0.66-1.16) RR 0.87 (95% CI 0.75-1.05) Mortality OR 0.61 (95% CI 0.38-0.98) RR 0.64 (95% CI 0.46-0.89) OR 0.74 (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

DeSantis G et al. Am J Manag Care. 2014; 20(3):202-209

All TF Variable TF Weekly TF p N Mean TTR % SD N Mean TTR % SD N Mean TTR % SD

29,457 69.7 18.6 24,907 68.9 19.1 4,550 74 15.1 <.0001

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

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Fantz CR. The efficacy of patient self-testing to manage patients on warfarin. White paper published by Roche 2016

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

• 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)

CoaguChek XS Plus Roche ProTime Microcoagulation System International Technidyne INRatio Monitor Alere Mandatory recall Coag-Sense US Healthcare Supply LLC

MGH AMS PST journey

2005 2009 2010 2011 2012 2015 2016

MGH AMS support for PST

2002-CMS

National Coverage: MHV

2008-CMS

National Coverage expands: AF + VTE

CHEST 2008-

recommend

PSM + PST AMS Practice and Policy further defined Implement PST Agreement AMS poster ACF Conf ACF Conference MGH data presented

CHEST 2012-

PSM suggested (Grade 2B)

2014- Nat’l Action Plan PST

+ PSM to prevent adverse drug events

Implement Dawn AC 2007 NP credentialed by MGH 2014 Continue to increase PSTers

PST N = 560 (14% of clinic population)

September 27, 2016, unpublished data MGH AMS

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Top Indications for PST by INR range

13 50 100 150 200 250 300 AF/Afl VTE Heart Valve Replacements Hypercoaguable States

• ther

2.5-3.5 2.0-3.0

Lab designation as “Patient Self Testing Lab” type

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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)

Testing # of PTs # of INRs TTR # INRs 1.3 or below # INRs 5 or above # INRs 7 or 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%)

• 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)

Unpublished MGH AMS data: 12/28/14 – 3/17/15

What testing frequency is ideal?

• 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

Total HQACM PST Every 4 wks PST Weekly PST Twice weekly p 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 ≤1.5 or ≥4.0 11.4 12.6 13.7 9.6 7.9 0.03 Mean DASS* 48 49.5 47 46.2 47 0.53 *DASS=Duke Anticoagulation Satisfaction Score, lower DASS score, higher satisfaction

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

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MGH AMS, 2011 Pre Post Median INRs_30 days 2 3.9 <0.0001 TTR 72.9 77.6 <0.001

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

10 20 30 40 50 60 70 AC CO CG DD DW IS JO LC MG PR PB RC RL WM

What should our goal be for self testers in 2016-2017?

25%

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

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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.

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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]

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Determine what’s best for your clinic:

• Who will be testing?
• Where to report?

– Emphasize AM testing, Mon-Thu – Avoid weekends and holidays

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Sample worksheet to stay organized!

1. Discuss, then send PST agreement 2. When above returned, complete referral 3. “Hand off” Referral to credentialed provider 4. Credentialed provider reviews referral & record, signs, faxes 5. Update lab on patient record when training completed

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Top 5 reasons justifying PST/PSM

(5) Patients prefer it for many reasons (4) Improves the quality of INR control, avoids danger zones (3) Likely to reduce poor outcomes with better control (2) Right option for the right patient (1) This is patient-focused – engages patients in their health care management

Thank you! Thank you! Thank you! Thank you!

Questions?