Rheumatoid Arthritis Shared Decision Making

NCT05530694 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2026-03-06

No results posted yet for this study

Summary

Shared decision making is the first overarching principle for the treat to target guidelines for rheumatoid arthritis (RA) and has been proposed as a potential mechanism to reduce health disparities, however there is little evidence to inform effective ways to implement this practice in the care of Veterans with RA. The purpose of this project is to evaluate the effectiveness of a multi-component shared decision making intervention on RA disease activity, adherence to RA medications and patient knowledge of RA. The proposed research will contribute to fundamental knowledge about how to effectively foster shared decision making across varied VA rheumatology clinical settings to improve patient disease outcomes and experience; and support clinicians to engage patients in meaningful ways with the ultimate goal to improve health, reduce disability, and eliminate disparities.

Conditions

Interventions

BEHAVIORAL

Clinician communication training

The clinician training is a generic, skills- and attitude-based approach for clinicians to acknowledge their decision making conversations with patients that 1) there is more than one option, and 2) patient's views matter in deciding what to do next. This tools-free approach can be used on the spot when needed and is termed fostering choice awareness (FCA). The one-hour training consists of 4 parts: 1) a knowledge session on evidence and guidelines on effective conversations and SDM, 2) video-review of behaviors which foster or hinder choice awareness, 3) clinical simulations in which clinicians practice fostering choice awareness behaviors, and 4) a reminder card for use in future clinic visits. Video clips will be of patient-clinician conversations around treatment decision making to prompt and probe clinicians' experiences, improve understanding, and improve practice.

BEHAVIORAL

Patient activation

The patient activation component consists of three questions patients can ask their clinician to help them become more involved: "1. What are my options?; 2. What are the possible benefits and harms of those options?; 3. How likely are each of those benefits and harms to happen to me?" These questions have been used in studies to promote improved communication in a number of conditions including cardiovascular disease, cancer, and women's health.

BEHAVIORAL

RA Medication summary guide and RA Choice

RA Choice presents information on FDA-approved RA treatments in a set of cards, which can be used alone or in combination based on a patient's preference, values, and the clinician's experience. The RA medication summary guide describes options for medication, physical therapy, occupational therapy, and ways to stay healthy with diet and exercise. Tool development followed key principles of creating low literacy materials that featured icons, short phrases written in plain language, and included topics of interest to RA patients faced with a medication decision. For the proposed study, we will include a paper-based version of the tool, or a web-based version available for telephone or VA Video Connect (VVC) visits. The tools will be updated to include new FDA-approved therapies (e.g., JAK inhibitors).

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Jennifer Barton, MD · VA Portland Health Care System, Portland, OR

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2026-02-23
Completion
2026-02-23

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05530694 on ClinicalTrials.gov