CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 900 enrolled
Drug / intervention
Clinician communication training +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05530694
NCT05530694N/ACompleted

Implementation of Shared Decision Making in Rheumatoid Arthritis: A Stepped Wedge, Cluster-randomized Trial

VA Office of Research and Development·interventional·Posted Sep 7, 2022·Updated Mar 6, 2026

In Brief

A clinical study evaluating Clinician communication training, Patient activation, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 900 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 7, 2022
Enrollment StartSep 19, 2022
Primary CompletionFeb 23, 2026
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 3.8 years ago

Interventions

Clinician communication trainingbehavioral

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.

Patient activationbehavioral

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.

RA Medication summary guide and RA Choicebehavioral

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).