"Learning About Biologics"-Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

"Learning About Biologics"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721200
• Other study ID #: 2012-0294
• Secondary ID: 12-003011
• Status: Completed
• Phase: N/A
• First received: October 10, 2012
• Last updated: February 16, 2018
• Start date: November 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2018
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Geisinger Clinic	Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks	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.	2 weeks
Secondary	Patient-physician Communication	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.	8 weeks
Secondary	Use of Biologics	Use of biologics: The number of patients received a prescription for a new biologic by eight weeks.	8 weeks
Secondary	To Test Screening and Recruitment Procedures	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.	8 weeks
Secondary	To Test Uptake	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.	8 weeks
Secondary	Acceptability to Physicians	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: Did the tool make it easier to talk about treatment with your patients?; Did the tool increase the amount of time you spent discussing therapy with your patients?; Did the tool decrease the amount of time you spent discussing therapy with your patients?; Did the tool improve the quality of informed consent for patients initiating biologics?	8 weeks
Secondary	To Test Adherence to the Intervention	The session management system will record the time spent on each module visited within the tool to assess adherence.	8 weeks
Secondary	Changes in Knowledge	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.	8 weeks
Secondary	Changes in Willingness	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.	8 weeks
Secondary	Changes in Perceived Knowledge	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).	8 weeks

External Links

•   Geisinger Health System