Rheumatoid Arthritis Clinical Trial
Official title:
"Learning About Biologics"
Verified date | February 2018 |
Source | Geisinger Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Geisinger Medical Center | Danville | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Geisinger Clinic | Yale University |
United States,
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
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 |
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