Clinical trial NCT01721200: "Learning About Biologics"-Rheumatoid Arthritis
Official title: "Learning About Biologics"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
web based interactive learning tool
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2012-11-04
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks
timeFrame: 2 weeks
Secondary outcomes:
measure: Patient-physician Communication
timeFrame: 8 weeks
measure: Use of Biologics
timeFrame: 8 weeks
measure: To Test Screening and Recruitment Procedures
timeFrame: 8 weeks
measure: To Test Uptake
timeFrame: 8 weeks
measure: Acceptability to Physicians
timeFrame: 8 weeks
measure: To Test Adherence to the Intervention
timeFrame: 8 weeks
measure: Changes in Knowledge
timeFrame: 8 weeks
measure: Changes in Willingness
timeFrame: 8 weeks
measure: Changes in Perceived Knowledge
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: Yale University
name: Liana Fraenkel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fraenkel L, Matzko CK, Webb DE, Oppermann B, Charpentier P, Peters E, Reyna V, Newman ED. Use of Decision Support for Improved Knowledge, Values Clarification, and Informed Choice in Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov;67(11):1496-502. doi: 10.1002/acr.22659.