NCT01721200

"Learning About Biologics"-Rheumatoid Arthritis

"Learning About Biologics"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Geisinger Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized controlled trial designed to examine the efficacy of an educational decision support tool for patients with rheumatoid arthritis who continue to have active disease despite use of traditional disease modifying drugs. The study will take place at Geisinger Medical Center in Danville, PA. Eligible subjects will be identified by the treating physician and those providing consent will be randomized to usual care versus use of the decision support tool.

Detailed description

Data suggest that undertreatment of rheumatoid arthritis (RA) patients may be in part due to inadequate decision support when they face whether or not to start biologic therapy. No proven way exists to inform or support RA patients who are candidates for biologic therapy. Communicating information about biologic medication is particularly challenging because of the sheer number of risks to disclose, the difficulty explaining the risks of extremely rare adverse events (AEs), and the tendency for people to discount (or underweight) future benefits. Dr Liana Fraenkel at Yale University is the Primary Investigator and developer of this theory-based high quality decision support tool to effectively inform RA patients who are candidates for biologics. Dr. Eric Newman will be Principal Investigator for the project which will be conducted at Geisinger Medical Center. All subjects enrolled will complete a baseline survey and then will be randomized to use of the decision support tool or to usual care. Those randomized to usual care will be offered the opportunity to access the tool once enrollment is closed and all follow-up visits have been completed. Outcomes will be assessed at two and six weeks after the baseline visit by the Geisinger Telephone Survey and Interviewing Facility. This facility is equipped with 12 computers and runs two shifts a day. The Survey Unit uses a state-of-the-art Windows based Computer Assisted Telephone Interview (CATI) system to administer surveys and collect research data. The group holds 12 interviewer licenses for the CATI system. Trained and experienced interviewers are available to make the calls from 9 am to 9 pm Monday through Friday and from 10 am to 2 pm on Saturdays.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
OTHER	Decision Support Tool	Educational decision support tool for patients with rheumatoid arthritis
OTHER	Usual Care	Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2012-11-05
• Last updated: 2018-02-19
• Results posted: 2018-02-19

Locations

1 site across 1 country: United States