Background/Purpose: Guidelines for the treatment of rheumatoid arthritis (RA) underscore the importance of an early and targeted approach to control inflammation. However, patients are often reluctant to agree to aggressive therapy when they believe their symptoms are tolerable, despite high disease activity scores. This study is based on the premise that educating patients about treatment risks and benefits requires a two-pronged approach: (1) Simplifying written materials to reduce user burden and (2) Teaching patients the skills needed to process complex information. DrugFactsBoxes® are designed to address the former; Gist Reasoning (GIST) Training is designed to address the latter.

Methods: The study is a randomized controlled trial in which participants with doctor-diagnosed RA are randomized to one of four groups: (1) Medication Guide without GIST Training, (2) Medication Guide with GIST Training, (3) DrugFactsBox® without GIST Training, and (4) DrugFactsBox® with GIST Training. Data are collected at baseline (prior to intervention implementation) and at 6 weeks, 3 months, and 6 month follow-up. The primary outcome is informed decision making regarding the use of disease-modifying anti-rheumatic drugs (DMARDs). Patients using a DMARD are classified as having made an informed decision if they have adequate knowledge (≥85 on a 100 point scale) and values that favor aggressive treatment of RA. Patients not using a DMARD are classified as having made an informed decision if they have adequate knowledge and have values that do not favor aggressive treatment. Knowledge is a secondary outcome variable. Data were analyzed using logistic and linear regression.

Results: Data collection is ongoing. To date, 297 participants have completed baseline data collection and 135 have completed the 6-month follow-up. Controlling for baseline knowledge, participants assigned to GIST Training exhibited greater knowledge at the 6-month follow-up, compared to those not assigned to training (Means: 86.1 vs 83.4, p =.06). In a logistic regression predicting informed decision making at the 6-month follow-up, there was a significant interaction between (1) whether the participant met the criteria for informed decision making at baseline and (2) assignment to GIST Training (p=.003). Among those classified as not meeting the criteria for informed decision making at baseline, 56.7% (n=17) of those assigned to GIST Training met the criteria at the 6-month follow-up, compared to 25% (n=11) of those not assigned to training (p=.007). However, among those classified as meeting the criteria at baseline, 35.0% (n=7) of those assigned to GIST Training did not meet the criteria at the 6-month follow-up, compared to 14.7% (n=5) of those not assigned to training (p=.09). No differences were observed between those randomized to Medication Guides versus DrugFactsBox®.

Conclusion: These findings provide preliminary support for the effectiveness of GIST Training in helping patients develop the skills needed to process complex information about medication risks/benefits. RA Treatment benefits appear to be limited to those who do not meet the criteria for informed decision making prior to the initiation of training.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/enhancing-patient-ability-to-process-and-use-information-about-medication-risks-and-benefits/