Rheumatoid ArthritisNCT01721200
"Learning About Biologics"-Rheumatoid Arthritis
A study testing Decision Support Tool in people with Rheumatoid Arthritis, run by Geisinger Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Decision Support Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Feb 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17822
About this study
Official title: "Learning About Biologics"
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Decision Support Tool, Usual Care
- Keywords
- Rheumatoid Arthritis, web based interactive learning tool
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Support ToolOther
Educational decision support tool for patients with rheumatoid arthritis
Usual CareOther
Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.
| Study group | Role | What they receive |
|---|---|---|
| Decision Support Tool | Other | This study will examine the efficacy of a web-based educational decision support tool. Receives: Other: Decision Support Tool |
| Usual Care | Other | Usual Care Group will receive their biologic drug teaching from their rheumatologist. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (9)
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.
Measured: 8 weeks
Use of Biologics
Use of biologics: The number of patients received a prescription for a new biologic by eight weeks.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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?
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Liana Fraenkel, MD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721200
- Sponsor's protocol ID
- 2012-0294
- Other IDs
- 12-003011
- Status last verified
- Feb 2018
- First submitted
- 10 Oct 2012
- Last updated
- 19 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26195173
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Learning About Biologics"
- ClinicalTrials.gov ID
- NCT01721200
- Acronym / sponsor ID
- 2012-0294
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, web based interactive learning tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- Nov 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Nov 2012 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Support Tool | Other | Other: Decision Support ToolThis study will examine the efficacy of a web-based educational decision support tool. |
| Usual Care | Other | Other: Usual CareUsual Care Group will receive their biologic drug teaching from their rheumatologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Support ToolEducational decision support tool for patients with rheumatoid arthritis | Other | Decision Support Tool |
| Usual CareSubjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care. | Other | Usual Care |
Primary outcome
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.
9 secondary outcomes
Patient-physician Communication
Time frame: 8 weeks
Use of Biologics
Time frame: 8 weeks
To Test Screening and Recruitment Procedures
Time frame: 8 weeks
To Test Uptake
Time frame: 8 weeks
Acceptability to Physicians
Time frame: 8 weeks
To Test Adherence to the Intervention
Time frame: 8 weeks
Changes in Knowledge
Time frame: 8 weeks
Changes in Willingness
Time frame: 8 weeks
Changes in Perceived Knowledge
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26195173Fraenkel 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.
- Geisinger Health SystemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liana Fraenkel, MD, MPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Support Tool in people with Rheumatoid Arthritis, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01721200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.