Title: Incorporating Patient-Centered Outcomes into …...Title: Incorporating Patient-Centered Outcomes into Real World Data Abstract Patient-reported outcomes (PROs) are reports

Title: Incorporating Patient-Centered Outcomes into Real World Data

Abstract

Patient-reported outcomes (PROs) are reports of health conditions that come directly from patients and

gathering PROs are an important component to improve the health of individuals and populations. In this

lecture, the definition of PROs will be discussed and placed in the context of diabetes care. Additionally,

best practices for collecting PROs and implementing the use of PROs in clinical care will be discussed.

Lastly, future challenges to the collection and use of PROs in clinical care will be introduced.

Reference List

Deshpande PR, Rajan S, Sudeelthi BL, Abdul Nazir CP. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res 2011; 2(4): 137-144.

Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report. Value Health 2009; 12(8): 1075-83.

Graham A, Minc A, Staab E, Beiser DG, Gibbons RD, Laiteerapong N. Validation of the Computerized Adaptive Test for Mental Health in an Adult Primary Care Population. Ann Fam Med. Accepted September 2018.

Staab EM, Terras M, Dave P, Beckman NM, Yohanna D, Vinci LM, Laiteerapong N. Measuring Perceived Level of Integration during the Process of Primary Care Behavioral Health Implementation. Am J Med Qual 2018;33(3):253-261. PMID: 29072487

Corathers, S. D., et al. (2013). "Improving Depression Screening for Adolescents With Type 1 Diabetes." Pediatrics 132(5): e1395-e1402.

Incorporating Patient-Centered Outcomes into Real World Data

ADA Research Symposium – November 2018

Neda Laiteerapong, MD, MS

Assistant Professor of Medicine

Center for Chronic Disease Research and Policy

Chicago Center for Diabetes Translational Research

Section of General Internal Medicine

Funding / Disclosures

• Member of Chicago Center for Diabetes Translation

Research (NIDDK P30)

• ADA Junior Faculty Development Award

• AHRQ U18HS026151 (PORTAL-Depression)

• UChicago Bucksbaum Institute for Clinical Excellence

• UChicago Center for Healthcare Delivery Science and

Innovation

2

Outline

• What are patient-reported outcomes (PROs)?

• How to collect PROs?

• What do you do with PROs?

• Future challenges

3

What are patient-reported outcomes (PROs)?

4

Definition

“PROs provide a complementary perspective to that of clinician assessments, and may provide greater insights into health status, function, symptom burden, adherence, health behaviors, and quality of life”

5

“A PRO is a health outcome directly reported by the patient who

experienced it. It stands in contrast to an outcome reported by someone

else, such as a physician-reported outcome, a nurse-reported outcome,

and so on. PRO methods, such as questionnaires, are used in clinical

trials or other clinical settings, to help better understand a treatment's

efficacy or effectiveness”

“A PRO is any report of the status of a patient's health condition that comes

directly from the patient, without interpretation of the patient's response by a clinician or anyone else”

Definition


6


experienced it. It stands in contrast to an outcome reported by someone

else, such as a physician-reported outcome, a nurse-reported outcome,

and so on. PRO methods, such as questionnaires, are used in clinical

trials or other clinical settings, to help better understand a treatment's

efficacy or effectiveness”



Definition


7


experienced it. It stands in contrast to an outcome reported by

someone else, such as a physician-reported outcome, a nurse-

reported outcome, and so on. PRO methods, such

as questionnaires, are used in clinical trials or other clinical

settings, to help better understand a treatment's efficacy or

effectiveness”



Definition


8


experienced it. It stands in contrast to an outcome reported by

someone else, such as a physician-reported outcome, a nurse-

reported outcome, and so on. PRO methods, such

as questionnaires, are used in clinical trials or other clinical

settings, to help better understand a treatment's efficacy or

effectiveness”



Integrating PROs into clinical care has been associated with:• Increased patient satisfaction with care• Better communication• Better symptom management• Better health quality• Fewer hospitalizations / ER visits• Longer survival

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rethinkingclinicaltrials.org/cores-and-working-groups/patient-reported-outcomes-2/

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• Depression, anxiety, suicidality

• Distress

• Fear of hypoglycemia

• Health-related quality of life

How to collect PROs?

11

How (perhaps) NOT to collect PROs

Appointment Date

Frac

tio

n S

cree

ned

1. Ask physicians to collect PROs

How (perhaps) NOT to collect PROs

2. Collect the same PRO for every patient at every visit (IMO)

CAVEAT: if the status of the PRO changes frequently

NAMCS: https://www.cdc.gov/nchs/data/databriefs/db212_fig1.png

Corathers SD, et al. Pediatrics 2013. 132(5)

How TO collect PROs

If PHQ-9 score ≥ 10, Smart Set option appears

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1. Leverage Health IT

How TO collect PROs

16

PH

Q2 d

one

rate

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

0.40

0.45

Screening month

-6 -4 -2 0 2 4 6 8 10 12 14

Residents Attending

P<0.05 for all months

except Aug, Sept, Nov

2016 where p=0.07)

Effects of Faculty Peer Comparison Feedback

2. Encourage collection

Medical Assistant screening:27.3% (n=53569) to 59.0% (n=19129), p=<0.0001

Sep 2017: MAs assume all screening responsibilities

Appointment Date (MM/YYYY)

Frac

tio

n S

cree

ned

How TO collect PROs

3. Assign medical assistants to collect data during triage

How TO collect PROs

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4. Move it outside of the 15 minute clinical visit

• Patient portals (pre-visit)

• Telephone calls (pre-visit)

• Waiting areas (pre-visit) (tablets)

• Patient portals (population health?)

PORTAL-Depression (AHRQ U18HS026151)

Randomized trials :1. To test whether using MyChart can increase rates of population-

level depression screening

2. To test whether using MyChart can increase

depression remission in patients with active depression

Locklear T et a. EGEMS. 2017; 5(1): 7

What do you do with PROs?

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Depression Screening and Management

PHQ-2

Suicidal OR homicidal / psychosis

Positive screenPHQ-9

ModeratePHQ-9: 10-14CAT-DI: 50-64

Moderately SeverePHQ-9: 15-19 CAT-DI: 65-79

SeverePHQ-9: ≥ 20CAT-DI: ≥ 80

Patient education (.pcgbmedDEPRESSION),

ANDBMED/Therapy

Patient education (.pcgbmedDEPRESSION),

BMED/Therapy ANDStart antidepressant

(.pcgbmedDEPRESSIONMEDICATION)

Patient education (.pcgbmedDEPRESSION), BMED/Therapy, Start antidepressant (.pcgbmedDEPRESSIONMEDICATION)

ANDPsychiatry for medication management

PHQ-2 ≥ 3

PHQ-2 < 3Negative screen

Use suicide screener OR Escort to ER

Escitalopram (Lexapro) 10 mg/d 10-20 mg/d SSRI Best tolerated. Good for anxiety. Rapid onset. $10-60Sertraline (Zoloft) 50 mg/d 50-200 mg/d SSRI Best tolerated. Good for anxiety. Low drug interaction potential. $9-20Citalopram (Celexa) 20 mg/d 20-40 mg/d SSRI QTc prolongation (>55yo max 20 mg/d). Low drug interaction potential. $4-15Fluoxetine (Prozac) 20 mg/d 20-60 mg/d SSRI Good if adherence issues. Less withdrawal. Slow onset. High drug interaction potential. $4-20Paroxetine (Paxil) 20 mg/d 20-60 mg/d SSRI Weight gain. Significant withdrawal. Avoid in pregnancy. $4-20Buproprion XL (Wellbutrin XL) 150 mg/d 150-300 mg/d NDRI Use if FH of bipolar. Avoid with anxiety. $20-40Venlafaxine ER (Effexor XL) 37.5-75 mg/d 75-375 mg/d SNRI Monitor BP. Significant withdrawal. GI side effects, agitation. May increase 75 mg/d every 4-7 days . $15-40Duloxetine (Cymbalta) 30 mg/d 30-60 mg/d SNRI Monitor BP. Good for neuropathic pain/fibromyalgia. $20-80

Measure PHQ-9 every 4-6 weeksvia MyChart, phone, or in person

Continue antidepressant ≥ 6 moIncrease, augment, or switch antidepressant

AND/OR Initiate therapy

If ≥3 months, consider Psychiatry

Increased agitation, Psychiatry referral

AUGMENTBuspirone 7.5-15mg BID Aripiprazole 5-10 mg daily

PHQ-9 <5 PHQ-9 ≥5

MildPHQ-9: 5-9

CAT-DI: 30-49

Patient education(.pcgbmedDEPRESSION,

.pcgbmedSTRESS,.pcgbmedGRIEF)

Developed by the UChicago Medicine Primary Care Group-Behavioral Health Integration Program Primary Care Behavioral Health Integration Director: Neda Laiteerapong, MD, MS Last updated 11/14/2018

1. Create decision support tools to respond to PROs

Behavioral Health SmartSet

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2. Integrate decision support into day to day clinical care

Co-located BMED Clinic

During warm hand-offs,

patients will often get a full therapy session

Scheduled appointments

Curbside consults

Warm hand-offs

3. Advocate for more resources as necessary

Results: Screening by Demographics

Pre-InterventionPost-Intervention

p = 0.001, Ho rejected using Hochberg multiple comparisons adjustment

Gender

Age

Race

Female

40-64

65 +

Asian

Black/ AA

Other

0.6 0.8 1 1.2 1.4

Odds Ratio

4. Examine for disparities in PROs data collection

Future challenges

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• Unclear match between PRO and intended claim

• Lack of direct patient input into PRO content from target population

• No evidence that most relevant and important item content is contained in instrument

• Lack of documentation to support modifications to PRO instrument

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Challenge 1: Content Validity

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Challenge 2: External Validity

Accepted in Annals of Family Medicine

Major Depressive Disorder CAD-MDD PHQ-9 PHQ-2Sensitivity 0.77 0.75 0.58

Specificity 0.93 0.94 0.93

Positive predictive value 0.57 0.62 0.52

Negative predictive value 0.97 0.97 0.95

AUC [95% CI] 0.85 [0.76-0.94] 0.84 [0.75-0.94] 0.76 [0.65-0.87]

• PROMIS® measures

– over 300 measures of physical, mental, and social health

– Short forms, unidimensional CATs, profiles

• PROMIS® measures in EPIC

– 2012 – limited short-forms

– 2017 – CATs

– Doesn’t come for free

• Multi-dimensional CATs can decrease question burden without sacrificing precision

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Challenge 3: Volume

• EHR Access to Seamless Integration of PROMIS®

– 6.3 M NCATS grant

– Justin Starren, PI (Northwestern)

– David Liebovitz, site PI (UChicago)

– 9 universities

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Challenge 4: Stagnation

University of Florida

University of Utah

Harvard Catalyst CTS

Southern California CTSI

Northwestern

University of Chicago

University of Illinois at Chicago

University of Alabama at Birmingham

University of Kentucky

• PROs are important outcomes to integrate into diabetes care and research

• PROs collection should consider

– Time and timing

– Staffing

– Seamless integration, clinical decision support tools

– Leveraging health IT

• Many future challenges

– Validity – content, external

– Stagnation – implementation, volume

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Summary

Acknowledgments

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• Dan Yohanna

• Lisa Vinci

• Nancy Beckman

• Pooja Dave

• George Weyer

• Jessica Kolek

• Sonia Zhang

• Sarah Bach

• Robert Gibbons

• Valerie Press

• David Beiser

• Andrea Kass

• Sachin Shah

• Yashas Attanayake

• John Moses

• David Liebovitz

• Isabel Yin

• Parmida Zarai

• Erin Staab

• Sandi Ham

• Wen Wan

• Kimberly Banks

• Antoinette Williams

• Raj Krishnamurthy

• Deirdre Gorman

• Tuyaa Montgomery

• Ashley Isaacson

All the Primary Care

Group Faculty,

Residents, Staff, and

patients

Thank you!

31

Contact info:

[email protected]

@nedalai

Center for Chronic Disease Research and Policy

Chicago Center for Diabetes Translational Research

mailto:[email protected]

Documents

Title: Incorporating Patient-Centered Outcomes into …...Title: Incorporating Patient-Centered Outcomes into Real World Data Abstract Patient-reported outcomes (PROs) are reports