Module 1 Webinar Guest presenter: Dr. Kurt Kroenke

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1 UHF Quality Institute Patient-Reported Outcomes in Primary Care New York PROPC-NY Module 1 Webinar Guest presenter: Dr. Kurt Kroenke December 13, 2016 Supported by The Engelberg Foundation

2 Agenda 1. Welcome and Roll Call 2. Presentation by Dr. Kroenke 3. Q & A 4. Discussion/Round Robin 5. What s Ahead 2

3 Dr. Kurt Kroenke, MD, MACP 3

4 Patient-Reported Outcomes Moving PROs into Practice Kurt Kroenke, MD, MACP Regenstrief Institute Indiana University School of Medicine VA HSR&D Center for Health Information and Communication Indianapolis, IN, USA

5 Symptoms Must be Measured & Monitored Sphygmomanometer like any other disease Glucometer Peak Flow Meter Symptometer

6 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

7 Outline PHQ Family of Scales Choosing a Scale SPADE Trial Implementing Scales

8 PHQ Genealogy PRIME-MD PHQ PHQ-9 GAD-7 PHQ-15 PHQ-8 PHQ-2 PHQ-4 GAD-2 SSS-8

9 PHQ 9 Depression Scale 1. Over the last 2 weeks, how often have you been bothered by the following problems? More than Nearly Not Several half the every at all days days day 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... Subtotals: PrimeMD/PHQ-9 SCORE = 16

10 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 10

11 PHQ-9 Thresholds for Treatment 15 Start treatment Consider treatment 5-9 Monitor; no treatment

12 PHQ-9 vs. Competing Scales in 3 Special Populations Population Competitor Verdict Elderly Postpartum Geriatric Depression Scale Edinburgh Postnatal (EPDS) PHQ better Probably comparable Adolescent Beck (BDI-PC) Either

13 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 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

14 PHQ-4 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 GAD-2 Little interest or pleasure in doing things Feeling down, depressed, or hopeless PHQ-2

15 Outline PHQ Family of Scales Choosing a Scale SPADE Trial Implementing Scales

16 5 Characteristics of a Pragmatic PRO Kroenke et al, J Clin Epidemiol 2015 Characteristic Definition Actionable Scores guide diagnostic or therapeutic decision-making Self-administered Completed by patient (rather than by interview) All-purpose Screening; Severity assessment; Treatment monitoring Simple Brief; Easy to score; Memorable cutpoints Accessible Public domain; Downloadable; Translations

17

18 NEJM 2011 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.

19 The Promise of PROMIS Measures > $100 million dollars spent by NIH (& counting) CAT versions can use large item bank (e.g, 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)

20 PROMIS Depression (8-item) item 6-item

21 Normal Raw Scores (t-score = 50) on PROMIS 4-item profiles Domain Normal Raw Score Depression 5-6 Anxiety 5-6 Pain 5-6 Fatigue 8-9 Sleep 9-10 Physical function * Social role satisfaction* * LOWER scores on 2 non-symptom scales are WORSE

22 Cutpoint for Clinically Depressive Symptoms since T-score 55 represents effect size of 0.5 Raw.Score T.Score Converting Raw to T-Scores 4-item PROMIS Depression Scale

23 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)?

24 Equivalence of Depression Scales MH-CAT 45 item bank with positive & negative mood items PROMIS-D CAT 28 item bank with negative mood items PHQ-9 fixed 9-item scale 250 primary care patients, half with depression Rose,, Kroenke (under review) 9-item scale AUC MH-CAT 0.92 PROMIS-CAT 0.90 PHQ

25 IOM Report on 12 Social Determinants to Include in Electronic Health Records Race/ethnicity Physical activity Education Tobacco use Alcohol use Stress Depression Residential address Social connections/isolation Financial constraints Census-tract median income Intimate partner violence Adler & Stead, N Engl J Med 2015;372:

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

27 Current Level of Actionability in Primary Care Level Examples A B C D Labs (A1C, LDL), BP, Weight Symptoms (depression, pain) Function, Quality of Life Employment, Housing

28 Outline PHQ Family of Scales Choosing a Scale SPADE Trial Implementing Scales

29 SPADE Symptom Cluster S leep P ain A nxiety D epression E nergy

30 To paraphrase Animal Farm All symptoms are created equal, but some symptoms are more equal than others.

31 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 unbundle 5. Account for 5 of the 7 domains in PROMIS profiles (other 2 = physical function & social)

32 Anxiety Depression Fatigue Pain Sleep

33 Study Design SPADE Screener (5 items) 1 Symptom + PROMIS Scales (20 items) Randomize Feedback Group (n = 150) Control Group (n = 150) 3-Month Follow-up Assessment

34 Checking your symptometer Do you have a fever?

35 PROMIS Symptom Scores Visual Display

36 SPADE Prevalence in Primary Care PROMIS 4-item symptom scale T-score 55 SPADE Symptoms Chronic Pain (n=250) SPADE screen + (n=300) % 5.3 % % 11.0 % % 13.0 % % 18.0 % % 21.3 % % 31.3 % Davis, Kroenke, et al, Clin J Pain 2015; Kroenke et al, in preparation

37 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.

38 Patient-Reported Symptom Discussion & Treatment at Index Visit and Residual Desire for Treatment at 3 Month Follow-Up Discussed % Treated % Desire Treatment at 3 mo % Pain Fatigue Sleep Anxiety Depression

39 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 49 I did not need treatment for the symptom 47 I did not want treatment for the symptom 29 The doctor did not bring it up 21 I did not feel comfortable talking about symptom 16 The doctor did not seem comfortable talking about symptom 9 The doctor seemed too busy 7

40 SPADE Symptom Screener

41

42 Outline PHQ Family of Scales Choosing a Scale SPADE Trial Implementing Scales

43 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. However, there may be an advantage to a lingua franca 3. It is rarely about the score but coupling it with patient preferences.

44 A Confusion of Tongues BDI QIDS PHQ-9 HADS PROMIS That is why it was called Babel because there the LORD confused the language of the whole world. Genesis 11:9 WHO-5 CES-D MHI-5 GDS

45 Implementation Decisions for PROs Decision Target Purpose Aim Site Method EHR Display Report Options Single or Multiple conditions Screening (all) or Case-Finding Detection or Monitoring Clinic (pre-visit) or Home Paper or Laptop or I-Pad Separate from or Integrated into Numerical or Graphical Cross-sectional or Longitudinal

46 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)

47

48 Key PHQ Resources Website Review articles Kroenke K, et al. The Patient Health Questionnaire somatic, anxiety, and depressive symptom scales: a systematic review. Gen Hosp Psychiatry 2010;32: Kroenke K, et al. Pragmatic characterisics of patient-reported outcome measures are important for use in clinical practice. J Clin Epidemiology 2015;68:

49 Insert Dr. Kroenke s slides Please remember to limit background noise to facilitate effective discussion. 49

50 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? 50

51 Coming Soon - Module 2 September 2016 February 2018* Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb In-person meeting X X X Deep-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 clinical workflows X X X X X Module 3: Piloting X X X X X X Module 4: Synthesize Learnings and Identify Next Steps X X X *Tentative schedule actual schedule will be flexible to the collaborative s needs 51

52 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 52

53 Questions? Contact UHF Quality Institute Anne-Marie Audet Senior Medical Officer Lynn Rogut Director, Quality Measurement and Care Transformation Roopa Mahadevan Policy and Program Manager 53

54 Thank you for your hard work and commitment to PROPC-NY! 54

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