Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Supporting Patient Care With Electronic Resources in the United States (SuPER-US)

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.
 
ClinicalTrials.gov Identifier: NCT02787538
Recruitment Status : Unknown
Verified May 2016 by Hyon Choi, Massachusetts General Hospital.
Recruitment status was:  Recruiting
First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Collaborators:
Arthritis Research Centre of Canada
Brigham and Women's Hospital
Information provided by (Responsible Party):
Hyon Choi, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: US-ANSWER-2 decision aid Behavioral: Control group (Online medication guide) Not Applicable

Detailed Description:

The proposed project aims to improve the process of making evidence-informed treatment decisions by patients with rheumatoid arthritis (RA) and ultimately empower patient self-management. Current RA treatment emphasizes: 1) the need for early and aggressive treatment, and 2) the use of a treat-to-target approach. However, patients often struggle with treatment decisions, especially when the options have both benefits and risks. To address this challenge, investigators based at Arthritis Research Canada have previously developed an online decision aid called ANSWER-2 (ANimated, Self-serve, WEb-based, Research Tool: Version 2) for RA patients who are considering a biologic, and this tool has been recently adapted for the US healthcare setting (called US-ANSWER-2).

Objectives: 1) To evaluate the effectiveness of US-ANSWER-2 in reducing patients' decisional conflict. 2) To assess the extent to which US-ANSWER-2 improves patients' knowledge about RA medications and confidence in managing their health. 3) To examine the experiences of patients and rheumatologists in using US-ANSWER-2.

The investigators will conduct a proof-of-concept randomized controlled trial with 80 patients with RA. Eligible individuals are those: 1) with a diagnosis of RA from a rheumatologist, 2) whose rheumatologists have recommended initiating a biologic or switching to another biologic, and 3) who have internet access and email. The Intervention Group will receive simple instructions to access the US-ANSWER-2 decision aid and complete the program on their own within two days. At the end of the session, a one-page summary will be produced to help them discuss their questions, concerns, and preferred choices with their health care providers. The Control Group will receive a standard online medication guide, reflective of usual practice. Participants will complete the Decisional Conflict Scale (primary outcome) before and after the intervention (US-ANSWER-2 or standard online medication guide). The following secondary outcome measures will be collected at baseline, Month 1, and Month 2: 1) Medication Education Impact Questionnaire, and 2) Partners in Health Scale. In addition, the use of healthcare resources will be collected at baseline and Month 2, and the use of biologics will be collected at Month 6. All participants and their rheumatologists will be invited to participate in a qualitative interview about their experience with the patient decision aid.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Supporting Patient Care With Electronic Resources in the United States (SuPER-US): Effectiveness of an Online Decision Aid for Patients Considering Biologic Therapy for Rheumatoid Arthritis
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: US-ANSWER-2 decision aid
The 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.
Behavioral: US-ANSWER-2 decision aid
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.

Active Comparator: Control group (Online medication guide)
The 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.
Behavioral: Control group (Online medication guide)
Standard online medication guide.




Primary Outcome Measures :
  1. Decisional Conflict Scale (DCS) [ Time Frame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1) ]
    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.


Secondary Outcome Measures :
  1. Medication Education Impact Questionnaire (MeiQ) [ Time Frame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2 ]
    The MeiQ consists of 6 subscales and a total of 29 items. MeiQ was developed and tested in three different samples of patients with rheumatic conditions on their knowledge of medications.

  2. Partners in Health Scale (PHS) [ Time Frame: Change measure (baseline score compared to after using the US-ANSWER-2 intervention at Month 1 and at Month 2 ]
    The Partners in Health Scale is an 11-item measure designed to assess self-efficacy, knowledge of RA and treatment, and self-management behaviours such as taking medication appropriately and adopting a healthy lifestyle.

  3. Health Resource Utilization (HRU) Questionnaire [ Time Frame: Change measure (baseline score compared to after using the US-ANSWER-2 at Month 2) ]
    The HRU questionnaire was developed for both self and interviewer administration in people with arthritis and other chronic conditions. It consists of a series of open-ended questions about individuals' visits to health professionals, use of investigative tests, hospital visits, use of medications, purchases of adaptive aids, and estimable productivity loss incurred by the individual and their caregivers due to his/her health.


Other Outcome Measures:
  1. Use of biologics [ Time Frame: 6 months from baseline ]
    Patients will be asked whether they started or switched a biologic, and the name, since using the US-ANSWER-2.



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.


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

Inclusion Criteria:

  • The inclusion criteria are as follows:

    1. with a diagnosis of RA from a rheumatologist
    2. whose rheumatologists have recommended initiating a biologic or switching to another biologic
    3. who have internet access and email.

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria.

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 ClinicalTrials.gov identifier (NCT number): NCT02787538


Contacts
Layout table for location contacts
Contact: Sharan K Rai, BSc srai1@mgh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sharan Rai, BSc       srai1@mgh.harvard.edu   
Principal Investigator: Hyon K Choi, MD, DrPH         
Sponsors and Collaborators
Massachusetts General Hospital
Arthritis Research Centre of Canada
Brigham and Women's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hyon K Choi, MD, DrPH Massachusetts General Hospital
Layout table for additonal information
Responsible Party: Hyon Choi, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02787538    
Other Study ID Numbers: 2015P002116
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Keywords provided by Hyon Choi, Massachusetts General Hospital:
Rheumatoid Arthritis
Decision Aids
Biologics
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases