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Abstract Number: 1924

Mitigating Medication Risk Aversion in the Confident Treatment Decisions for Living with Rheumatoid Arthritis Trial

Maria I. Danila1, Lang Chen1, Justin K Owensby1, Ronan O'Beirne1, Joshua A. Melnick1, Eric M. Ruderman2, Leslie R. Harrold3 and Jeffrey R. Curtis1, 1University of Alabama at Birmingham, Birmingham, AL, 2Medicine/Rheumatology, Northwestern University Feinberg School of Medicine, Chicago, IL, 3University of Massachusetts Medical School, Worcester, MA

Meeting: ACR/ARHP Annual Meeting 2018

Keywords: Behavioral strategies and rheumatoid arthritis (RA)

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Session Information

Date: Monday, October 22, 2018

Title: 4M104 ACR Abstract: Patient Outcomes, Preferences, & Attitudes I: Beliefs & Behaviors (1923–1928)

Session Type: ACR Concurrent Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: Controlling disease activity in RA using a treat-to-target (T2T) strategy can optimize clinical and patient-important outcomes. Yet, many patients are not familiar with T2T and report medication risk aversion as a major barrier to changing therapy. To improve willingness of patients to escalate treatment, we developed and evaluated an educational, direct-to-patient video intervention that included information relevant to managing RA using a T2T strategy.

Methods: We conducted a controlled, randomized trial of our intervention among US patients with self-reported RA enrolled in the ArthritisPower patient registry. We recruited participants by email, and surveyed their satisfaction with disease control, values about RA medications, decisional conflict about treatment change and willingness to change treatment if/when recommended by their rheumatologist (Table). Intervention group participants were invited to view up to 6 videos (mean duration 2 min each) relevant to T2T; those in the control group viewed vaccination-related videos (mean duration 1:23 min each) unrelated to T2T as an “attention control”. Participants were required to view 3 (intervention) and 2 (control) videos, respectively. The primary outcome, collected using surveys, was patient-reported willingness to change RA treatment, measured by the choice predisposition scale (0-10, anchors: “Not willing at all”; “Extremely willing”) that reflected preference for RA treatment change. We stopped recruitment when 208 (N=104 per group) participants enrolled based on a priori sample size estimation. We compared the difference in pre-post differences in willingness to change RA treatment between the two groups using t-test.

Results: We invited 1264 RA patients by email. We reached our enrollment goal in 8 weeks. Study participants (N=208) were 90% Caucasian, 90% women, with mean (SD) age 50 (11) years, in good health (51%); 52% reported familiarity with T2T. A majority (89%) reported having values that favored RA medications. We observed no differences in baseline sociodemographics, patient global assessment of disease activity, health literacy, willingness to change treatment, or decisional conflict (Table). We found a significant improvement in pre-post willingness to change treatment in intervention vs. control participants (0.5 vs 0.01, p=0.01). We calculated an effect size (Glass’s delta) for the intervention of 0.48 (i.e. moderate). Moreover, decisional conflict about treatment change decreased; there was no significant difference in pre-post differences in decision conflict between groups.

Conclusion: This randomized trial testing a novel patient-directed intervention advocating for T2T strategy implementation in RA care increased self-reported willingness to change RA treatment. Further studies are needed to evaluate if this effect is sustained over time and if it translates into actionable behavior change.

Table: Patient Demographic, Clinical Characteristics, Values Regarding Rheumatoid Arthritis (RA) Treatment, Decisional Conflict about RA Treatment and Willingness to Change RA Treatment by Group.

Variable

Intervention (N=104)

Control (N=104)

p value

Baseline

Age, years, mean (SD)

49.31 (10.75)

49.81 (11.15)

0.82

Race, Caucasian, N (%)

92 (88.5)

96 (92.3)

0.60

Sex, female, N (%)

92 (88.5)

94 (91.3)

0.51

Biologic DMARD use, ever, N (%)

29 (27.9)

36 (35.0)

0.27

Conventional DMARD use, ever, N (%)

33 (31.7)

43 (41.7)

0.14

General health, good or better, N (%)

53 (51.0)

54 (51.9)

0.89

Health literacy, excellent, N (%)

102 (98.1)

104 (100.0)

0.16

Familiar with T2T strategy, N (%)

54 (51.9)

54 (51.9)

1

Patient global assessment of disease activity*

5.44 (2.31)

5.68 (2.29)

0.37

Patient acceptable symptoms state, yes, N (%)

42 (40.4)

39 (37.5)

0.67

Reported values that favored RA medication use†, yes, N (%)

91 (87.5)

95 (91.3)

0.38

Prior year discussion with rheumatologist about active RA, yes, N (%)

89 (85.6)

91 (87.5)

0.69

Prior year discussion with rheumatologist about goals of RA treatment, yes, N (%)

77 (74.0)

81 (77.9)

0.52

Decisional conflict about RA treatment change‡, mean (SD)

32.59 (16.81)

32.74 (18.75)

0.98

Willingness to change RA treatment§, mean (SD)

6.72 (2.44)

7.25 (2.24)

0.15

Follow up

Decisional conflict about RA treatment change‡, mean (SD)

29.73 (16.62)

29.82 (19.12)

0.84

Willingness to change RA treatment§, mean (SD)

7.22 (2.20)

7.26 (2.15)

0.93

DMARD, disease modifying antirheumatic drug, T2T, treat-to-target; *Patient global assessment of disease activity, 0-10 scale, 0=very well, 10=very poorly, lower scores are better; † Values that favored RA medication use assessed using a previously published tool that determines participants’ agreement with 5 positive and 5 negative statements about use of medications in RA. ‡Decisional conflict about RA treatment change measured by decisional conflict scale, 16 items, 5-point Likert items ranging from “Strongly agree” to “Strongly disagree”, lower scores are better; §Willingness to change RA treatment measured by choice predisposition scale, 0-10 scale anchored by “Not willing at all” and “Extremely willing” with “Unsure” at the midpoint, higher scores are better.


Disclosure: M. I. Danila, Pfizer, Inc., 2; L. Chen, None; J. K. Owensby, None; R. O'Beirne, Pfizer, Inc., 2; J. A. Melnick, None; E. M. Ruderman, Pfizer, Inc., 2, 5; L. R. Harrold, Corrona, LLC, 1,Corrona, LLC, 3,Pfizer, Inc., 2,Roche and Bristol Myers Squibb, 5; J. R. Curtis, AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Radius, Roche/Genentech, UCB, 2,AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Radius, Roche/Genentech, UCB, 5.

To cite this abstract in AMA style:

Danila MI, Chen L, Owensby JK, O'Beirne R, Melnick JA, Ruderman EM, Harrold LR, Curtis JR. Mitigating Medication Risk Aversion in the Confident Treatment Decisions for Living with Rheumatoid Arthritis Trial [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/mitigating-medication-risk-aversion-in-the-confident-treatment-decisions-for-living-with-rheumatoid-arthritis-trial/. Accessed .
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