Incorporating PRO Data Into RA Clinical Encounters Using Health IT

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT06655077
• Lead Sponsor: University of California, San Francisco

Brief Summary

The goal of this pragmatic clinical trial is to learn if a new health IT tool that was rolled out at UCSF Health rheumatology clinics (the RA PRO dashboard) can help improve the lives of individuals with rheumatoid arthritis. The RA PRO dashboard displays important outcomes for individuals with rheumatoid arthritis, including disease activity, physical functioning, and pain scores in an easy-to-read, digital interface that can be displayed on the computer screen during a clinical visit. These outcomes are tracked over time, so patients and clinicians can see changes across multiple time points. Additional features of the dashboard include displaying medication use over time and recent lab test results.

The main questions the study aims to answer are: Does displaying the dashboard during a clinical visit ...

1. reduce decisional conflict when making a medication choice?

2. improve self-efficacy in symptom management?

3. change beliefs about medications?

4. improve medication adherence?

5. improve RA outcomes such as disease activity or physical functioning?

Researchers will compare these outcomes in the patients of clinicians who have access to the RA PRO dashboard to those who do not to see if these outcomes change over time.

Clinicians with access to the dashboard may choose to share it from the computer screen with patients during the clinic visit. Participants will be asked to complete surveys as part of their routine clinic visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-26
• Primary Completion: 2023-08-21
• Study Completion: 2023-08-21
• Status Verified: 2024-10
• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Last Update Submitted: 2024-10-22
• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

Inclusion Criteria

• Diagnosis of rheumatoid arthritis
• Visits with clinicians at UCSF Health clinic
• At least 1 CDAI score documented in UCSF EHR

Exclusion Criteria

• Unable to read, speak, or understand English
• Unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
SURE	Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.	The SURE Test (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) is a 4-item scale that measures decisional conflict in patients using a binary scale (where 0 = "no"; 1 = "yes") for a simple sum of up to 4 points. A higher score indicates greater decisional clarity.
PROMIS Short Form v1.0 - Self-Efficacy for Managing Symptoms 4a (PROMIS-SE)	Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.	The PROMIS Short Form v1.0 - Self-Efficacy for Managing Symptoms 4a (PROMIS-SE) is a 4-item scale that measures self-efficacy in symptom management using a 5-point Likert-type scale (where 1 = "not at all confident"; 5 = "very confident") for a raw score range of 4 to 20, translated into T-scores with a mean of 50, and a standard deviation of 10. A higher T-score indicates greater self-efficacy.
Beliefs about Medicines Questionnaire - Specific (BMQ-Specific)	Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.	The Beliefs about Medicines Questionnaire - Specific (BMQ-Specific) is comprised of two 5-item subscales that assess patients' beliefs about their need for medication to maintain health (Specific-Necessity) and their concerns about its potential negative effects (Specific-Concerns) using a Likert-type scale (1 = "strongly agree"; 5 = "strongly disagree") for a simple sum of 5 to 25 points for each subscale. Responses are used to calculate the Necessity-Concerns differential (Specific-Necessity minus Specific-Concerns) to assess patients' need for medication in comparison to their concerns. Scores range from -20 to +20, where a positive score indicates that necessity beliefs outweigh concerns.
Medication adherence	Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.	Medication adherence was measured using a single item ("How many times do you think you may have missed taking your pills in the last week?"). A higher result indicates lower medication adherence.

Secondary Outcome Measures

Name	Time	Method
CDAI score	Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.	CDAI is a validated RA disease activity outcome (range 0-76) used in a treat-to-target approach to RA treatment. It is collected routinely in the clinic by clinicians and documented in the EHR. A higher score indicates more disease activity.
PROMIS-PF10a score	Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.	PROMIS-PF10a score is a validated RA functional status measure. It is collected routinely in the clinic and documented in the EHR. A higher score indicates better function.

Trial Locations

Locations (1)

UCSF Health; 🇺🇸 San Francisco, California, United States