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Patient Self Testing at the MGH AMS

Lynn B. Oertel, MS, NP-BC, CACPNursing Practice Specialist

Anticoagulation Management ServiceMassachusetts 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-analysescomparing 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

0

50

100

150

200

250

300

AF/Afl VTE Heart Valve

Replacements

Hypercoaguable

States

other

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 HQACMPST

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

0

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?