Clinical trial NCT06655077: Incorporating PRO Data Into RA Clinical Encounters Using Health IT
Official title: Incorporating PRO Data Into RA Clinical Encounters Using Health IT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: electronic dashbaord
patient reported outcomes
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-10-23
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge cluster randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: SURE
timeFrame: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
measure: PROMIS Short Form v1.0 - Self-Efficacy for Managing Symptoms 4a (PROMIS-SE)
timeFrame: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
measure: Beliefs about Medicines Questionnaire - Specific (BMQ-Specific)
timeFrame: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
measure: Medication adherence
timeFrame: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
Secondary outcomes:
measure: CDAI score
timeFrame: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
measure: PROMIS-PF10a score
timeFrame: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Health
state: California
Study officials:
affiliation: University of California, San Francisco
name: Gabriela Schmajuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmajuk G, Nasrallah C, Berrean B, Prugh J, Wilson C, Hamblin A, Young C, Jacobsohn L, Kay J, Li J, Kersey E, Subash M, Murray S, Yazdany J. A step-by-step roadmap for the development and deployment of an electronic health record sidecar application that tracks patient outcomes: The RA PRO dashboard. Digit Health. 2024 Oct 10;10:20552076241288739. doi: 10.1177/20552076241288739. eCollection 2024 Jan-Dec.