Trial Outcomes & Findings for "Learning About Biologics"-Rheumatoid Arthritis (NCT NCT01721200)

Subjects were RA patients currently being treated by one of six rheumatologists practicing in the Geisinger Rheumatology Department in Danville, Pennsylvania who were at least 18 years of age, able to speak and read English \& had active disease warranting initiation, or change, of a biologic therapy as determined by their treating rheumatologist.

Subjects excluded if hearing or visually impaired; scheduled for surgery;current infection; cancer past five years (except non-melanoma),lymphoma, leukemia,melanoma;chronic inflammatory disease (+ RA) immunosuppressive RX; chronic liver disease, hepatitis C or B;HIV +; TB+x-ray lesions of inactive TB \& no chemoprophylactic therapy..

"Learning About Biologics"-Rheumatoid Arthritis

We classified subjects as having made an informed choice to escalate care if they answered at least 75% of the knowledge questions correctly and had low decisional conflict as defined by a score of 25 or lower on the combined subjective knowledge and values clarity subscales.

Patient-physician communication will be measured using the COMRADE (Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness): a 20-item scale composed of two subscales which address the quality of risk communication (process measure) and the quality of the decision making process (outcome measure). Items are measured on a 5-point agree scales. The COMRADE is a includes two sub-scales (each composed of 10 items): one for risk communication (a process measure) and a second for confidence in decision (an outcome measure). Subscales are summed to generate a total score (Range 20-100). Higher scores reflect poorer outcomes.

Use of biologics: The number of patients received a prescription for a new biologic by eight weeks.

To test screening and recruitment procedures we will measure the number of eligible patients, the number of patients excluded by each exclusion criterion, the number of patients referred by rheumatologists each week, and the proportion of patients who agree to participate.

To test uptake and adherence to the intervention we will measure the proportion of patients randomized to the intervention who access the tool, complete the Best Worse Scaling exercise, print a handout, and use the handout during a follow-up visit with their rheumatologist (for subjects having a second visit within eight weeks). Note, subjects without access to a printer will have the opportunity to do so in the office.

Acceptability to physicians will be assessed using four items coded on 5-point Frequency scales (1= None of the time and 5= All of the time) administered by the research assistant once all patient follow-up interviews have been completed: 1. Did the tool make it easier to talk about treatment with your patients? 2. Did the tool increase the amount of time you spent discussing therapy with your patients? 3. Did the tool decrease the amount of time you spent discussing therapy with your patients? 4. Did the tool improve the quality of informed consent for patients initiating biologics?

The session management system will record the time spent on each module visited within the tool to assess adherence.

Knowledge will be measured using the 20 True/False statements developed for the initial pre-post test study. The number of correct responses are summed to yield a knowledge score (possible range= 0-20). The item order was determined using a random-numbers generator.

Willingness: Patients' propensity towards biologics will be measured using the choice predisposition scale (65): This item is coded on a 11-point scale anchored by "Not willing at all" and "Extremely willing" with "Unsure" at the midpoint (65). Higher scores reflect greater willingness.

Perceived knowledge and value clarity will be measured using two subscales from the well-validated Decisional Conflict Scale (66). Each subscale is composed of 3 items measured on 5-point agree scales. Scores are rescaled to range from 0 to 100. Higher scores reflect greater conflict (poorer outcomes).