"Learning About Biologics"-Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01721200
Recruitment Status : Completed
First Posted : November 5, 2012
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Yale University
Information provided by (Responsible Party):
Geisinger Clinic

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Decision Support Tool Other: Usual Care Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: "Learning About Biologics"
Study Start Date : November 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Decision Support Tool
This study will examine the efficacy of a web-based educational decision support tool.
Other: Decision Support Tool
Educational decision support tool for patients with rheumatoid arthritis

Usual Care
Usual Care Group will receive their biologic drug teaching from their rheumatologist.
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.

Primary Outcome Measures :
  1. The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks [ Time Frame: 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.

Secondary Outcome Measures :
  1. Patient-physician Communication [ Time Frame: 8 weeks ]
    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.

  2. Use of Biologics [ Time Frame: 8 weeks ]
    Use of biologics: The number of patients received a prescription for a new biologic by eight weeks.

  3. To Test Screening and Recruitment Procedures [ Time Frame: 8 weeks ]
    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.

  4. To Test Uptake [ Time Frame: 8 weeks ]
    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.

  5. Acceptability to Physicians [ Time Frame: 8 weeks ]

    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:

    1. Did the tool make it easier to talk about treatment with your patients?
    2. Did the tool increase the amount of time you spent discussing therapy with your patients?
    3. Did the tool decrease the amount of time you spent discussing therapy with your patients?
    4. Did the tool improve the quality of informed consent for patients initiating biologics?

  6. To Test Adherence to the Intervention [ Time Frame: 8 weeks ]
    The session management system will record the time spent on each module visited within the tool to assess adherence.

  7. Changes in Knowledge [ Time Frame: 8 weeks ]
    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. Changes in Willingness [ Time Frame: 8 weeks ]
    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.

  9. Changes in Perceived Knowledge [ Time Frame: 8 weeks ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01721200

United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Sponsors and Collaborators
Geisinger Clinic
Yale University
Principal Investigator: Liana Fraenkel, MD, MPH Yale University

Additional Information:
Responsible Party: Geisinger Clinic Identifier: NCT01721200     History of Changes
Other Study ID Numbers: 2012-0294
12-003011 ( Other Identifier: Yale University )
First Posted: November 5, 2012    Key Record Dates
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Geisinger Clinic:
Rheumatoid Arthritis
web based interactive learning tool

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases