A Randomized Controlled Trial of an Individualized Decision aid for - PowerPoint PPT Presentation

A Randomized Controlled Trial of an Individualized Decision aid for Diverse Women with Lupus Nephritis (IDEA-WON) Jasvinder Singh on behalf of the SMILE team University of Alabama at Birmingham, Birmingham, AL PCORI Annual Meeting, September 19, 2019 Twitter: @jassingh00

Disclosures  Research Funding:  Patient Centered Outcomes Research Institute (PCORI)  NIAMS: UAB Gout and Hyperuricemia Center for Research Translation (CoRT)  NIA: R01 AG 028359, U01 AG18947  VA: Health Services Research & Development  JAS:  Consultant fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Medscape, WebMD, Clinical Care options, Clearview healthcare partners, Putnam associates, Spherix, the National Institutes of Health and the American College of Rheumatology.  JAS owns stock options in Amarin pharmaceuticals and Viking therapeutics. JAS is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 36 companies  MD : Independent Data Monitoring Committee for Biogen, Genentech, and Janssen Pharmaceuticals and as a consultant to Abbvie, Kezar, and AstraZeneca.  KLW reports grants and personal fees from Pfizer, grants and personal fees from BMS, personal fees from Abbvie, grants and personal fees from UCB, personal fees from Lilly, personal fees from  JLB: None

2 Main Messages  A Lupus patient decision aid for treatment decision-making is more effective than a standardized lupus paper pamphlet in African-American, Hispanic and White women with lupus kidney disease .  More reduction in decisional conflict about immunosuppressives  Higher informed choice regarding immunosuppressives  More acceptable to patients and feasible to use in clinics  Barriers to wide-spread implementation and dissemination of Lupus patient decision aid exist in busy U.S. clinics  Patient-specific  Context-specific: geography, clinic type (academic vs. private)

Systemic Lupus Erythematosus (SLE) ~ Lupus  Chronic autoimmune disease  Significant morbidity and mortality  African-Americans and Hispanics have  higher lupus incidence,  worse disease severity and outcomes,  greater mortality 1-5  50-60% develop lupus kidney disease within 10 years 4-5  Lupus kidney disease accounts for 2% of end-stage kidney disease in U.S. 6 1 Odutola J. Current opinion in rheumatology. 2005;17(2):147-152; 2 Alarcon GS. Lupus. 1999;8(3):197-209; MMWR May 3 2002;51(17):371-374; 3 Krishnan E. ARD 2006;65(11):1500-1505; 4 Alarcon GS Lupus. 2002;11(2):95-101; 5 Costenbader KH Arthritis and rheumatism. 2011;63(6):1681-1688; 6 Kasitanon N, Medicine. May 2006;85(3):147-156; Maisonneuve P, American journal of kidney diseases. 2000; 35(1):157–65.

Decisional Dilemma for Immunosuppressive drugs: At-Risk Racial/ethnic Minorities  In the U.S., 41% of Hispanic groups, 24% of African-Americans, and 9% of whites have below basic health literacy skills 18  Lower health literacy and numeracy are associated with greater risk aversion 19  Many patients decline immunosuppressive medications  fear of side effects and the lack of recognition of benefits 20  Most lupus educational materials  written at above the recommended sixth grade reading level  have only adequate suitability  no assessment of numeracy level 21 18 Institute of Medicine (US) Committee on Health Literacy. 2004; 19 Rosen AB. Medical decision making. 2003; 23(6):511–7; 20 Chambers SA . Rheumatology (Oxford). 2009; 48(3):266–71; 21 Rhee RL. Arthritis care & research. 2013; 65(10):1702–6.

Decisional Dilemma: A Lupus patient  “I am 26 and was recently hospitalized with newly diagnosed systemic lupus. Doctors prescribed some medications [cellcept] for me, but I really did not know anything about it. It is scary to look ahead. This whole thing [lupus] is pretty new for me, I really need some help to make a correct treatment decision. Should I take this drug? Can I choose another drug? What are the severe side effects of these drugs? Will these drugs lead to develop a cancer later? Am I able to have kids after treatment? What if I don’t take it? Am I going to lose my kidneys?”

PCORI Lupus Decision Aid Study: Study Objective 22, 23  To test the effectiveness of an individualized, computerized patient decision aid for treatment decision-making in a randomized trial by comparing it with usual care (ACR lupus paper pamphlet) in 300 African-American, Hispanic and White women with lupus nephritis (kidney disease) . 22 Patient Centered Outcome Research Institute (PCORI) CE-1304-6631 (Singh). Individualized Patient Decision Making for Treatment Choices among Minorities with Lupus. 23 Singh JA. Individualized decision aid for diverse women with lupus nephritis ( IDEA-WON ): A randomized controlled trial. PLoS Med. 2019;16(5):e1002800.

Methods  Who :  ≥18 years old  Lupus kidney disease, diagnosed by rheumatologist  Current lupus flare or at risk of future lupus flare  Have lupus by the 1997 American College of Rheumatology (ACR) revised classification criteria for lupus  Where : 4 U.S. university-based lupus clinics (Alabama, California, Ohio, Texas)  When: Doctor’s office at regular clinic visit  What: Randomization to the provision of individualized, computerized patient decision aid or the ACR lupus paper pamphlet in 1:1 ratio 22 Qu H. Arthritis Care Res. 2016; 68(12):1787–94; 23 Singh JA. J Rheumatol. 2015; 42(9):1616–23; 24 Singh JA. Arthritis Res Ther. 2015; 17:367.

Methods: Individualization of Lupus DA  Tailored to the target population’s numeracy, health & graphical literacy • Incorporated barriers and facilitators to medication decision-making 22- 24 and comparative effectiveness on medication benefits and risks • Individualized content based on • Treatment phase (start vs. maintenance) • Options being considered, and current treatment/s • Optional information on each medication benefit and harm • Patient preferred optional sections: • pregnancy, breast-feeding, fertility • glucocorticoid side effects • Majority participants in qualitative research: racial/ethnic minorities 22 Qu H. Arthritis Care Res. 2016; 68(12):1787–94; 23 Singh JA. J Rheumatol. 2015; 42(9):1616–23; 24 Singh JA. Arthritis Res Ther. 2015; 17:367.

Decision aid Example: Improve Kidney Function  Both medications improve kidney function in patients who have already tried medications like Imuran and Cellcept.  As you might know, 59 out of 100 women have improved kidney function while on Cytoxan and 46 out of 100 women on CIs.  The difference in these numbers may be due 46 out of 100 women’s to chance. 59 out of 100 women’s kidneys kidneys get better on CIs get better on Cytoxan 41 out of 100 women’s kidneys 54 out of 100 women’s kidneys do do not get better on Cytoxan not get better on CIs SMILE, shared decision-making in lupus electronic tool

ACR Lupus Pamphlet

Methods – Co-primary outcomes  Change in decisional conflict score : low literacy version, 10 items, 3 response options: yes (=0)/unsure (=2)/no (=4)  Range 0-100  Scores ≥ 25 = clinically significant decisional conflict  Proportion with an informed value-concordant choice:  Assessed 3 constructs: values, objective knowledge, choice  Informed choice = adequate knowledge (≥ 75% correct) and choice concordant with one’s values (favoring or against immunosuppressive therapies)

Results

Patient Flow Chart: CONSORT

Baseline Patient Characteristics All (n= 298) Decision Aid (n= 151) Pamphlet (n= 147) Mean ± Std err Mean ± Std err or n Mean ± Std err or or n (%) (%) n (%) Age in years, mean (± Std err) 37.3 ± 0.7 37.1 ± 1.0 37.6 ± 1.0 Race/Ethnicity, n(%) Non-Hispanic Black 141 (47.3%) 70 (46.4%) 71 (48.3%) Hispanic/Latino 78 (26.2%) 41 (27.1%) 37 (25.2%) Non-Hispanic White 44 (14.8%) 20 (13.2 %) 24 (16.3%) Asian 20 (6.7%) 11 (7.3%) 9 (6.1%) Other 13 (4.4%) 7 (4.6%) 6 (4.1%) Not answered 2 (0.7%) 2 (1.3%) --- Education Don’t know/ not answered 3 (1%) 3 (2%) --- High school or less 106 (35.6%) 48 (31.8%) 58 (39.5%) Greater than high school 189 (63.4%) 100 (66.2%) 89 (60.5%)

Co-Primary Outcomes: Decisional Conflict Scale Reduction in Score = Less decisional conflict

Decisional Conflict Scale (0-100) 23 Decision Aid Pamphlet Difference between treatment arms Mean Mean (Std Mean (Std Odds ratio difference P-value* err) or n (%) err) or n (%) (95% CI) (95% CI) Change is DCS total score 21.8 (2.5) 12.7 (2.0) N/A 9.1 (2.8, 15.5) 0.005 Change in DCS subscale score Uncertainty subscale 17.3 (3.5) 5.0 (3.2) N/A 12.2 (2.9, 21.6) 0.01 Informed subscale 30.6 (3.3) 21.7 (2.8) N/A 8.9 (0.4, 17.4) 0.04 Values clarity subscale N/A 27.2 (3.4) 16.8 (3.1) 10.3 (1.3, 19.4) 0.03 Support subscale 12.4 (2.5) 6.1 (2.2) N/A 6.4 (-0.2, 12.9) 0.06 Unresolved clinically 0.4 significant decisional 34 (22.5%) 65 (44.2%) N/A <0.001 (0.2, 0.6) conflict on DCS (score ≥ 25) ***P-value was obtained from two-sample t-tests (for continuous outcomes) or chi-square tests (for categorial outcomes); SEM, standard error of the mean; CI, confidence interval; N/A, not applicable 23 Singh JA. Individualized decision aid for diverse women with lupus nephritis ( IDEA-WON ): A randomized controlled trial. PLoS Med. 2019;16(5):e1002800.

Pre- and post-intervention decisional conflict (0- 100, higher score indicates more conflict) Dashed line = threshold for unresolved clinically significant decisional conflict ≥25