UHF Quality Institute

Patient-Reported Outcomes in Primary Care – New YorkPROPC-NY

Module 1 WebinarGuest presenter: Dr. Kurt Kroenke

December 13, 2016

Supported by The Engelberg Foundation

Agenda

1. Welcome and Roll Call2. Presentation by Dr. Kroenke3. Q & A4. Discussion/Round Robin5. What’s Ahead

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Dr. Kurt Kroenke, MD, MACP

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Patient-Reported Outcomes Moving PROs into Practice

Kurt Kroenke, MD, MACPRegenstrief Institute

Indiana University School of MedicineVA HSR&D Center for Health

Information and Communication Indianapolis, IN, USA

Symptoms Must be Measured & Monitoredlike any other disease

Sphygmomanometer

Peak Flow Meter

Glucometer

“Symptometer”

Pragmatic Psychometrics Mantra

Measures developed for research

are seldom taken up in clinical practice

Measures developed for clinical practice

are sometimes taken up in research

Outline

• PHQ Family of Scales

• Choosing a Scale

• SPADE Trial

• Implementing Scales

PHQ GenealogyPRIME-MD

PHQ

PHQ-9

PHQ-8 PHQ-2

GAD-7

GAD-2

PHQ-15

SSS-8PHQ-4

PrimeMD/PHQ-9

More than NearlyNot Several half the every

at all days days day0 1 2 3

PHQ – 9 Depression Scale

a. Little interest or pleasure in doing things

b. Feeling down, depressed, or hopeless

c. Trouble falling or staying asleep, or sleeping too much

d. Feeling tired or having little energy

e. Poor appetite or overeating

f. Feeling bad about yourself, or that you are a failure . . .

g. Trouble concentrating on things, such as reading . . .

h. Moving or speaking so slowly . . .

i. Thoughts that you would be better off dead . . .

1. Over the last 2 weeks, how often have you been bothered by the following problems?

Subtotals: 3 4 9

SCORE = 16

PHQ-9 as Severity Measure• Cutpoints for depression severity:

≥ 5 mild≥ 10 moderate≥ 15 moderately severe≥ 20 severe

• Significant improvement = 5 point ↓• Response = 50% ↓ or score < 10• Remission = score < 5

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PHQ-9 Thresholds for Treatment

≥ 15 Start treatment

10-14 Consider treatment

5-9 Monitor; no treatment

PHQ-9 vs. Competing Scales in 3 Special Populations

Population Competitor Verdict

Elderly Geriatric DepressionScale PHQ better

Postpartum Edinburgh Postnatal (EPDS)

Probablycomparable

Adolescent Beck (BDI-PC) Either

Over the last 2 weeks, how often have you been bothered by the following problems?

Not at all

(0)

Several days

(1)

More than half the days

(2)

Nearly every day(3)

Feeling nervous, anxious, or on edge

Not being able to stop or control worrying

Worrying too much about different things

Trouble relaxing

Being so restless that it is hard to sit still

Becoming easily annoyed or irritable

Feeling afraid as if something awful might happen

GAD-7 Anxiety Scale

Over the last 2 weeks, how often have you been bothered by the following problems?

Not at all

(0)

Several days

(1)

More than half the days

(2)

Nearly every day(3)

Feeling nervous, anxious, or on edge

Not being able to stop or control worrying

Little interest or pleasure in doing things

Feeling down, depressed, or hopeless

PHQ-4

GAD-2

PHQ-2

Outline

• PHQ Family of Scales

• Choosing a Scale

• SPADE Trial

• Implementing Scales

5 Characteristics of a Pragmatic PROKroenke et al, J Clin Epidemiol 2015

Characteristic DefinitionActionable Scores guide diagnostic or

therapeutic decision-makingSelf-administered Completed by patient (rather

than by interview)All-purpose Screening; Severity assess-

ment; Treatment monitoringSimple Brief; Easy to score;

Memorable cutpointsAccessible Public domain; Download-

able; Translations

The MMSE had been freely available since its initial publication in 1975, but in 2000, its authors --Marshal Folstein, MD, Susan Folstein, MD, and Paul McHugh, MD --transferred the copyright to a company they founded, which then licensed the test to PAR in 2001.

NEJM 2011

The Promise of PROMIS Measures• > $100 million dollars spent by NIH (& counting)

• CAT versions – can use large item bank (e.g, 50-80 items) to tailor questions so respondent requires only ∼ 7-8 items

• Fixed forms (4-8 items) – profiles & short forms

• Raw scores can be converted to T-score, where 50 is population norm, and each 10 points is 1 SD better or worse. (e.g., 60 on a symptom score is 1 SD worse than general population)

PROMIS Depression (8-item)

4-item6-item

1 2 3 4 5

Normal Raw Scores (t-score = 50) on PROMIS 4-item profiles

Domain “Normal” Raw ScoreDepression 5-6Anxiety 5-6Pain 5-6Fatigue 8-9Sleep 9-10Physical function * 19-20Social role satisfaction* 15-16

* LOWER scores on 2 non-symptom scales are WORSE

Converting Raw to

T-Scores4-item

PROMIS Depression

Scale

Raw.Score T.Score4 41.05 49.06 51.87 53.98 55.79 57.3

10 58.911 60.512 62.213 63.914 65.715 67.516 69.417 71.218 73.319 75.720 79.4

Cutpoint for “Clinically Depressive Symptoms”since T-score

≥ 55 represents effect size of 0.5

Decisions in Using PROMIS Measures

1. Should I use a PROMIS or a non-PROMIS legacy measure (PROMIS depression vs. PHQ-9)?

2. Should I use fixed PROMIS scales vs. CAT?

3. Should I use raw or T-scores (probably latter)?

4. Are there PROMIS scales for which brief public domain non-PROMIS measures are lacking (anger, sleep, fatigue, social satisfaction)

5. Is PROMIS measure responsive (e.g., therapy)?

Equivalence of Depression ScalesMH-CAT 45 item bank with positive & negative mood itemsPROMIS-D CAT 28 item bank with negative mood itemsPHQ-9 fixed 9-item scale250 primary care patients, half with depression

9-item scale AUCMH-CAT 0.92PROMIS-CAT 0.90PHQ-9 0.89

Rose, …, Kroenke (under review)

IOM Report on 12 Social Determinants to Include in Electronic Health Records

Race/ethnicity Physical activity

Education Residential address

Tobacco use Social connections/isolation

Alcohol use Financial constraints

Stress Census-tract median income

Depression Intimate partner violence

Adler & Stead, N Engl J Med 2015;372:698-7-1

Garg et al. Avoiding the Unintended Consequences of Screening for Social Determinants of Health, JAMA 2016;8:813-14

• “Screening for social determinants can detect adverse exposures and conditions that typically require resources well beyond the scope of clinical care. Screening for any condition in isolation without the capacity to ensure referral and linkage to appropriate treatment is ineffective and, arguably, unethical.”

• “Ensuring linkage to the many sectors critical for addressing adverse social determinants (e.g., housing, food and nutrition, transportation, mental health, human welfare, and employment) requires effective care coodination and cross-sector collaboration.”

• “Such screening could yield expectations that, if unfulfilled, could lead to frustration for patients and physicians alike.”

Current Level of Actionability in Primary Care

Level Examples

A Labs (A1C, LDL), BP, Weight

B Symptoms (depression, pain)

C Function, Quality of Life

D Employment, Housing

Outline

• PHQ Family of Scales

• Choosing a Scale

• SPADE Trial

• Implementing Scales

SPADE Symptom Cluster

• S leep• P ain• A nxiety• D epression• E nergy

To paraphrase “Animal Farm” …

All symptoms

are created equal,

but some symptoms

are more equal than others.

5 Reasons for choosing SPADE pentad

1. The most prevalent, chronic, & undertreated symptoms in clinical practice

2. Cause additive impairment and adversely affect treatment response of one another

3. Cross-cutting in that they occur across most medical and mental disorders

4. Commonly “cluster” hard to unbundle5. Account for 5 of the 7 domains in PROMIS

profiles (other 2 = physical function & social)

Anxiety

Depression

Fatigue

Pain

Sleep

Study Design

Randomize

3-Month Follow-up Assessment

SPADE Screener (5 items)

PROMIS Scales (20 items)

Control Group

(n = 150)

Feedback Group

(n = 150)

≥ 1 Symptom +

Checking your “symptometer”

Do you have a “fever”?

PROMIS Symptom Scores Visual Display

SPADE Prevalence in Primary CarePROMIS 4-item symptom scale T-score ≥55

SPADE Symptoms

Chronic Pain(n=250)

SPADE screen +(n=300)

0 9.6 % 5.3 %1 20.0 % 11.0 %2 15.6 % 13.0 %3 22.8 % 18.0 % 4 11.6 % 21.3 %5 20.4 % 31.3 %

Davis, Kroenke, et al, Clin J Pain 2015; Kroenke et al, in preparation

Symptom Improvement at 3 Months

1. Both groups had small improvements (median ES = 0.31, range 0.17 to 0.52)

2. Absolute change slightly favored feedback group.3. However, differences between groups not significant.

Patient-Reported Symptom Discussion & Treatment at Index Visit and Residual

Desire for Treatment at 3 Month Follow-UpDis-

cussed%

Treated

%

Desire Treat-ment at 3 mo

%Pain 88 60 40Fatigue 78 37 36Sleep 78 44 31Anxiety 65 39 25Depression 64 39 23

Patient-Reported Reasons for Not Discussing Symptom at Index Visit

Reason for not discussing (%)

There were more important medical issues to deal with during the visit

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I did not need treatment for the symptom 47I did not want treatment for the symptom 29The doctor did not bring it up 21I did not feel comfortable talking about symptom 16The doctor did not seem comfortable talking aboutsymptom

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The doctor seemed too busy 7

SPADE Symptom Screener

Outline

• PHQ Family of Scales

• Choosing a Scale

• SPADE Trial

• Implementing Scales

3 Axioms for Clinical Use of a Measure

1. It is not about the measure but the measurement.

2. It is less about detection than monitoring.

3. It is rarely about the score but coupling it with patient preferences.

However, there may be an advantage to a “lingua franca”

A Confusion of Tongues

PHQ-9

CES-D

BDI

PROMIS

HADS

QIDS

GDS

MHI-5WHO-5“That is why it was called Babel—because there the LORD confused the language of the whole world.”

Genesis 11:9

Implementation Decisions for PROsDecision OptionsTarget Single or Multiple conditionsPurpose Screening (all) or Case-FindingAim Detection or MonitoringSite Clinic (pre-visit) or HomeMethod Paper or Laptop or I-PadEHR Separate from or Integrated intoDisplay Numerical or GraphicalReport Cross-sectional or Longitudinal

3 things that might increase the use & utility of PROS

1. Competency in symptom management

2. Visit time or support (care manager, medical home, referral options)

3. Incentives (reimbursement, quality indicators, patient satisfaction)

Key PHQ Resources• Website www.phqscreeners.com

• Review articles– Kroenke K, et al. The Patient Health Questionnaire

somatic, anxiety, and depressive symptom scales: a systematic review. Gen Hosp Psychiatry 2010;32:345-359.

– Kroenke K, et al. Pragmatic characterisics of patient-reported outcome measures are important for use in clinical practice. J ClinEpidemiology 2015;68:1085-1092.

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• Insert Dr. Kroenke’s slides

Please remember to limit background noise to facilitate effective discussion.

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Discussion/Round Robin

• Since we last met, how has your work progressed (e.g., success, challenge)?

• Is there anything you heard today that has triggered your attention and is relevant to your work?

Coming Soon - Module 2

Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan FebIn-person meeting X X XDeep-dive call (or site visits) with each participating organization

X X X X X X

Collaborative call with all participants X X X

Webinars X X X X X

Module 1: Planning phase,establishing the foundation X X X X

Module 2: Process mapping of PROs and clinicalworkflows

X X X X X

Module 3: Piloting X X X X X X

Module 4: SynthesizeLearnings and Identify Next Steps

X X X

51*Tentative schedule – actual schedule will be flexible to the collaborative’s needs

September 2016 – February 2018*

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Upcoming Dates

• January: Module 2 begins– Process mapping and clinical workflows

• January 13: Module 1 Reporting Form due to rmahadevan@uhfnyc.org

• January 24, 1-2:30 pm: Webinar by faculty member Lucy Savitz, Intermountain Healthcare, UT

• February: Deep dive calls with each team

Questions? Contact UHF Quality Institute

• Anne-Marie AudetSenior Medical Officeramaudet@uhfnyc.org

• Lynn RogutDirector, Quality Measurement and Care Transformationlrogut@uhfnyc.org

• Roopa MahadevanPolicy and Program Managerrmahadevan@uhfnyc.org

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Thank you for your hard work and commitment to PROPC-NY!