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"Learning About Biologics"-Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01721200
Recruitment Status : Completed
First Posted : November 5, 2012
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Geisinger Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Condition Rheumatoid Arthritis
Interventions Other: Decision Support Tool
Other: Usual Care
Enrollment 125

Recruitment Details Subjects were RA patients currently being treated by one of six rheumatologists practicing in the Geisinger Rheumatology Department in Danville, Pennsylvania who were at least 18 years of age, able to speak and read English & had active disease warranting initiation, or change, of a biologic therapy as determined by their treating rheumatologist.
Pre-assignment Details Subjects excluded if hearing or visually impaired; scheduled for surgery;current infection; cancer past five years (except non-melanoma),lymphoma, leukemia,melanoma;chronic inflammatory disease (+ RA) immunosuppressive RX; chronic liver disease, hepatitis C or B;HIV +; TB+x-ray lesions of inactive TB & no chemoprophylactic therapy..
Arm/Group Title Decision Support Tool Usual Care
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This study will examine the efficacy of a web-based educational decision support tool.

Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis

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

Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.

Period Title: Overall Study
Started 62 63
Completed 2 Week Follow-up 60 61
Completed 59 58
Not Completed 3 5
Reason Not Completed
Lost to Follow-up             3             5
Arm/Group Title Decision Support Tool Usual Care Total
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This study will examine the efficacy of a web-based educational decision support tool.

Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis

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

Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.

Total of all reporting groups
Overall Number of Baseline Participants 62 63 125
Hide Baseline Analysis Population Description
152 subjects approached. out of this number 125 patients agreed to participate and were randomized. 125 subjects completed baseline survey. 63 were randomized to control group and 62 to intervention. 61 completed two week follow-up survey in control group and 60 in intervention group. 58 completed 8 week survey and 59 in intervention group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 63 participants 125 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
62
 100.0%
63
 100.0%
125
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 63 participants 125 participants
54.3  (13.3) 56.2  (11.4) 55.3  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 63 participants 125 participants
Female
41
  66.1%
44
  69.8%
85
  68.0%
Male
21
  33.9%
19
  30.2%
40
  32.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 62 participants 63 participants 125 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 0 1 1
White 59 59 118
More than one of the above races 0 0 0
Unknown or Not Reported 3 3 6
1.Primary Outcome
Title The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks
Hide Description 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.
Time Frame 2 weeks
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[Not Specified]
Arm/Group Title Intervention Group Control
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Randomized to view the decision support tool.
Usual Care
Overall Number of Participants Analyzed 60 61
Measure Type: Number
Unit of Measure: Percentage of subjects
32 13
2.Secondary Outcome
Title Patient-physician Communication
Hide Description 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.
Time Frame 8 weeks
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[Not Specified]
Arm/Group Title 1 Intervention Control
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[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
35.8  (12.2) 35.6  (11.3)
3.Secondary Outcome
Title Use of Biologics
Hide Description Use of biologics: The number of patients received a prescription for a new biologic by eight weeks.
Time Frame 8 weeks
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[Not Specified]
Arm/Group Title 1 Intervention Control
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[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 60 61
Measure Type: Number
Unit of Measure: Number of subjects
51 49
4.Secondary Outcome
Title To Test Screening and Recruitment Procedures
Hide Description 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.
Time Frame 8 weeks
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Hide Analysis Population Description
Data not collected
Arm/Group Title Intervention Group Control
Hide Arm/Group Description:
Randomized to view the decision support tool.
Usual Care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title To Test Uptake
Hide Description 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.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Intervention Group Control
Hide Arm/Group Description:
Randomized to view the decision support tool.
Usual Care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Acceptability to Physicians
Hide Description

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?
Time Frame 8 weeks
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Data not collected
Arm/Group Title Intervention Group
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[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title To Test Adherence to the Intervention
Hide Description The session management system will record the time spent on each module visited within the tool to assess adherence.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These data were not collected.
Arm/Group Title Usual Care Decision Support Tool
Hide Arm/Group Description:

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

Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.

This study will examine the efficacy of a web-based educational decision support tool.

Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Changes in Knowledge
Hide Description 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.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 Intervention Control
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[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 62 63
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1
(-1 to 2)
0
(-2 to 1)
9.Secondary Outcome
Title Changes in Willingness
Hide Description 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.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Follow-up data not collected because of ceiling effect.
Arm/Group Title Intervention Group Control
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Randomized to view the decision support tool.
Usual Care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Changes in Perceived Knowledge
Hide Description 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).
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control
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[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 59 58
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
-16.7
(-33 to 0)
-8.3
(-25 to 8.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Decision Support Tool
Hide Arm/Group Description

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

Usual Care: Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.

This study will examine the efficacy of a web-based educational decision support tool.

Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis

All-Cause Mortality
Usual Care Decision Support Tool
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/60 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Decision Support Tool
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Decision Support Tool
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/60 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Liana Fraenkel, MD, MPH, Department of Medicine
Organization: Yale University
Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT01721200     History of Changes
Other Study ID Numbers: 2012-0294
12-003011 ( Other Identifier: Yale University )
First Submitted: October 10, 2012
First Posted: November 5, 2012
Results First Submitted: February 15, 2016
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018