Supporting Patient Care With Electronic Resources in the United States
SuPER-US
1 other identifier
interventional
80
1 country
1
Brief Summary
This proof-of-concept randomized trial evaluates the effectiveness of using an online decision aid (US-ANSWER-2) in the decision-making to start or switch biologic therapy in US patients with rheumatoid arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable rheumatoid-arthritis
Started Jan 2016
Typical duration for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 26, 2016
CompletedFirst Posted
Study publicly available on registry
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedNovember 20, 2024
November 1, 2024
4 years
May 26, 2016
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decisional Conflict Scale (DCS)
The Decisional Conflict Scale (short version) measures personal perceptions of uncertainty in choosing options, factors contributing to uncertainty, and effective decision-making. It is one-dimensional and has 10 questions and three response categories (yes/no/unsure) used to compute one score.
Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1)
Secondary Outcomes (3)
Medication Education Impact Questionnaire (MeiQ)
Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2
Partners in Health Scale (PHS)
Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2
Health Resource Utilization (HRU) Questionnaire
Change measure (baseline score compared to after using the US-ANSWER-2 at Month 2)
Other Outcomes (1)
Use of biologics
6 months from baseline
Study Arms (2)
US-ANSWER-2 decision aid
EXPERIMENTALThe intervention group will receive simple instructions to access the US-ANSWER-2 decision aid and complete the program on their own computers within two days. At the end of the session, US-ANSWER-2 will produce a one-page summary with the participant's questions, concerns, and preferred medication option.
Control group (Online medication guide)
ACTIVE COMPARATORThe control group will receive the online medication guide, reflective of usual practice. The online medication guide contains standard information about biologics, including an introduction about biologic options, dosages, and effects.
Interventions
US-ANSWER-2 will consist of: 1) an Information Module that presents effectiveness and side effects of each treatment option, and 2) an interactive Value Clarification Module that guides patients to consider what matter to them the most, and the pros and cons of each treatment option. Within the Information Module, the decision support information (i.e., the benefits and harms of treatment options) will be presented in narrated text, graphics, and a series of animated patient stories demonstrating attributes required for effective communication with doctors and significant others.
Standard online medication guide.
Eligibility Criteria
You may qualify if:
- with a diagnosis of RA from a rheumatologist
- whose rheumatologists have recommended initiating a biologic or switching to another biologic
- who have internet access and email.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Arthritis Research Centre of Canadacollaborator
- Brigham and Women's Hospitalcollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyon K Choi, MD, DrPH
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
May 26, 2016
First Posted
June 1, 2016
Study Start
January 1, 2016
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
November 20, 2024
Record last verified: 2024-11