"Learning About Biologics"-Rheumatoid Arthritis
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About
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.
Full 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.
Enrollment
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Inclusion criteria
- Subjects must be at least 18 years of age
- Able to speak and read English
- Meet the revised American College of Rheumatology criteria for the diagnosis of RA
- Have active disease warranting initiation of a new biologic (or small molecule if and when FDA-approved) therapy as determined by their rheumatologist
Exclusion criteria
- Fail to meet the inclusion criteria
- Have a current infection
- Have cancer of any type diagnosed within the past five years (except non-melanoma skin cancer)
- Have a history of lymphoma, leukemia, or melanoma
- Have a chronic inflammatory disease (in addition to rheumatoid arthritis) requiring treatment with immunosuppressive medications
- Have chronic liver disease due to hepatitis C or B
- Are HIV positive
- Have a positive screening test for tuberculosis (tuberculin skin test or interferon-gamma release assay) or radiographic lesions suggestive of inactive tuberculosis and have not completed an adequate course of chemoprophylactic therapy
- Are hearing or visually impaired
- Are scheduled for surgery
Trial design
Primary purpose
Allocation
Interventional model
Masking
125 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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