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

A Randomized Controlled Trial

• f 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

• f 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

• utcomes,

greater mortality 1-5 50-60% develop lupus kidney disease within 10 years 4-5 Lupus kidney disease accounts for 2%

• f end-stage kidney disease in U.S. 6

1Odutola J. Current opinion in rheumatology. 2005;17(2):147-152; 2Alarcon GS. Lupus. 1999;8(3):197-209; MMWR May 3 2002;51(17):371-374; 3Krishnan

• E. ARD 2006;65(11):1500-1505; 4Alarcon GS Lupus. 2002;11(2):95-101; 5Costenbader KH Arthritis and rheumatism. 2011;63(6):1681-1688; 6Kasitanon 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

22Qu H. Arthritis Care Res. 2016; 68(12):1787–94; 23Singh JA. J Rheumatol. 2015; 42(9):1616–23; 24Singh 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

22Qu H. Arthritis Care Res. 2016; 68(12):1787–94; 23Singh JA. J Rheumatol. 2015; 42(9):1616–23; 24Singh 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 to chance.

59 out of 100 women’s kidneys get better on Cytoxan 41 out of 100 women’s kidneys do not get better on Cytoxan 46 out of 100 women’s kidneys get better on CIs 54 out of 100 women’s kidneys do 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) Mean ± Std err

• r n (%)

Decision Aid (n= 151) Mean ± Std err or n (%) Pamphlet (n= 147) Mean ± Std err or 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 (Std err) or n (%) Mean (Std err) or n (%) Odds ratio (95% CI) Mean difference (95% CI) P-value* 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 27.2 (3.4) 16.8 (3.1) N/A 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 significant decisional conflict on DCS (score ≥ 25) 34 (22.5%) 65 (44.2%) 0.4 (0.2, 0.6) N/A <0.001

***P-value was obtained from two-sample t-tests (for continuous outcomes) or chi-square tests (for categorial

• utcomes); 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

Co-Primary Outcome: Informed Choice

Informed Choice

Decision Aid Pamphlet Difference between treatment arms Mean (Std err)

• r n (%)

Mean (Std err)

• r n (%)

Odds ratio (95% CI) Mean difference (95% CI) P-value* For immunosuppressive therapy 1.5 (1.0, 2.5) N/A 0.08 Informed choice 62 (41.1%) 46 (31.3%) Not informed choice 89 (58.9%) 101 (68.7%) Informed choice components Knowledge (% correct) 76.9 (1.0) 73.9 (1.1) N/A 3.0 (0.1, 5.9) 0.04 Values for immunosuppressive therapy 0.8 (0.5, 1.3) N/A 0.34 Against 72 (47.7%) 62 (42.2%) In favor 79(53.3%) 85 (57.8%) Choice for immunosuppressive therapy 1.6 (0.9, 2.7)* N/A 0.10 Undecided 30 (19.9%) 41 (27.9%) Unwilling 11 (7.3%) 18 (12.2%) Willing 110 (72.9%) 88 (59.9%) ***P-value was obtained from two-sample t-tests (for continuous outcomes) or chi-square tests (for categorial outcomes); Std err, standard error of the mean; CI, confidence interval; N/A, not applicable

Secondary Outcomes

Patient Preference for Role in Decision Making Control Preference Scale

Decision Aid (n= 35) Pamphlet (n= 33) P-value Role played 0.95 Active 11 (31.4%) 10 (30.3%) Collaborative 15 (42.9%) 16 (48.5%) Passive 9 (25.7%) 7 (21.2%) Role preferred 1.00 Active 11 (31.4%) 11 (33.3%) Collaborative 15 (42.9%) 13 (39.4%) Passive 9 (25.7%) 9 (27.3%) Concordance between roles 0.25 Yes 33 (94.3%) 28 (84.8%) No 2 (5.7%) 5 (15.2%) Active and active shared, categorized as active role; passive and passive shared, categorized as passive role: assessed only in people with current flare

Patient Physician Communication: Interpersonal Process of Care, Short Form (IPC-SF) and audiotaped conversation

Decision Aid (n= 149) Pamphlet (n= 147) P-value IPC-SF total score (18-90; higher = better) 83.6 ± 7.7 83.1 ± 7.3 0.50 Audiotaped conversation coded Decision Aid (n= 16) Pamphlet (n= 17) P-value Patient active participation score 8.1 ± 7.2 9.2 ± 7.3 0.80 Patient-centered MD communication (partnership building and supportive talk) 5.1 ± 2.1 3.7 ± 1.9 0.06

Patient Acceptability and Feasibility

Decision Aid (n=151) Pamphlet (n= 147) P-value Patient acceptability of information and presentation: Percentage of subjects marking “excellent” Impact of lupus kidney disease 74 (49.0%) 49 (33.3%) 0.006 Risk factors 64 (42.4%) 40 (27.2%) 0.006 Medication options 76 (50.3%) 49 (33.3%) 0.003 Evidence about medications 71 (47.0%) 35 (23.8%) <0.001 Studies about others 64 (42.4%) 32 (21.8%) <0.001 Feasibility of the study intervention: The education guide was easy to use 0.006 (Missing)

• 1 (0.7%)

Strongly Disagree 1 (0.7%) 3 (2.0%) Disagree 1 (0.7%) 13 (8.8%) Neither Agree no Disagree 73 (48.3%) 74 (50.3%) Agree 75 (49.7%) 55 (37.4%) Strongly Agree 1 (0.7%) 1 (0.7%)

Summary

 An individualized decision aid in lupus kidney disease led to:

Clinically meaningful and statistically significantly more reduction in decisional conflict regarding immunosuppressives Clinically meaningful higher informed choice regarding immunosuppressives, which showed a non-significant trend Acceptable to patients and feasible to use in clinics

 Decision aid is in English and Spanish: based on International Patient Decision aid Standards (IPDAS) principles  Limitations:

Not available in other languages Unclear relevance to men with lupus kidney disease Utility in other lupus manifestations unknown

23 Singh JA. Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A

randomized controlled trial. PLoS Med. 2019;16(5):e1002800.

Stakeholder Involvement in Lupus DA development and testing: patients, clinicians

 Decision aid developed with multi-stakeholder group  Iterative testing in target population: >30 women with lupus kidney disease, who helped us choose or modify

Content Presentation Graphics, pictures

 Added Patient preferred optional sections: Pregnancy, breast-feeding, fertility Glucocorticoid side effects  Chose the best method to present numbers with pictures and words  Clinicians: finalize the most common drug comparisons

Challenges to Implementation of Lupus DA in real-world settings24

 Slowing of the patient-flow in the clinic  Time: Clinic Staff, providers, patients  Limited resources: Clinic Staff, providers  Leadership priorities: Other QI programs; billing/revenue  Clinic staff turn-over  Automation in clinics  Technology challenges: Wi-fi; hardware/software  EMR: limited capabilities of communication with patients

24 Patient Centered Outcomes Research Institute (PCORI) D&I. SDM-2017C2-8224

(Singh, PI): Implementation of DEcision-Aid for Lupus in Practice Settings for Shared Decision-Making (SDM): IDEAL study

Acknowledgements

UAB

 Winn Chatham, MD  Brennda Caro Hernandez, BS  Candace Green, BS  Kenneth Saag, MD, MSc  Mona Fouad, MD, PhD  Nipam Shah, MPH  Chairty Morgan, PhD  Richard Shewchuk, PhD  Graciela Alarcon, MD  Robert Kimberly, MD  Haiyan Qu, PhD

Site PIs

 UCSF: Jinoos Yazdany, MD  OSU: Alexa Meara, MD  Baylor: Tara Rizvi, MD

Collaborators/Stakeholders

 Liana Fraenkel, MD, MPH  Amye Leong, MBA  Maria Suarez-Almazor, MD, MSc  Jeff Sloan, PhD (Mayo Clinic)  Kevin Winthrop (OHSU)  Elyse (Reyes) Leon  Richard Street, PhD  Jennifer Barton, MD (OHSU)  Trish Davidson (Lupus Foundation)  Laura Marrow (Arthritis Foundation)  Andrea Ring (Arthritis Foundation)  Jennifer Grossman (UCLA) FUNDING

 Patient Centered Outcomes Research Institute (PCORI)

Thank you