Incorporating PRO Data Into RA Clinical Encounters Using Health IT

NCT06655077 | Completed

• 2 other identifiers: 15-18282R01HS025405
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 1

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. 1.reduce decisional conflict when making a medication choice?
2. 2.improve self-efficacy in symptom management?
3. 3.change beliefs about medications?
4. 4.improve medication adherence?
5. 5.improve RA outcomes such as disease activity or physical functioning?

Conditions

Rheumatoid Arthritis

Keywords

electronic dashbaord; patient reported outcomes

Outcome Measures

Primary Outcomes (4)

• SURE

  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.

  Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.

• PROMIS Short Form v1.0 - Self-Efficacy for Managing Symptoms 4a (PROMIS-SE)

  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.

  Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.

• Beliefs about Medicines Questionnaire - Specific (BMQ-Specific)

  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.

  Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.

• Medication adherence

  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.

  Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.

Secondary Outcomes (2)

• CDAI score

  Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.

• PROMIS-PF10a score

  Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.

Study Arms (2)

Control phase

NO INTERVENTION

Any patient visits that occur before the time at which clinicians are granted access to the RA PRO dashboard will be part of the control phase (usual care).

Intervention phase

EXPERIMENTAL

Any patient visits that occur after the time at which clinicians are granted access to the RA PRO dashboard will be part of the intervention phase. The RA PRO dashboard will automatically launch into a new "tab" when the EHR is opened for any RA patient with at least 1 CDAI documented.

Other: RA PRO Dashboard

Interventions

RA PRO Dashboard OTHER

The RA PRO Dashboard was developed by UCSF rheumatology investigators in collaboration with the UCSF SOMTech Unit. Briefly, investigators used a human-centered design approach to build a new, EHR-integrated, patient-facing visualization tool that displays RA outcome data to RA patients during clinical visits. The RA PRO dashboard was tailored for deployment at the UCSF Health's rheumatology clinic using a EHR side-car application (Salesforce). The dashboard was launched into the production environment in August 2021. With the launch, investigators integrated quality improvement, user monitoring, and lean management techniques to promote use of RA outcomes and the dashboard (for clinicians granted access) during clinical visits.

Also known as: PACT Dashboard

Intervention phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

UCSF Health

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 39421306 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gabriela Schmajuk, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster randomized trial

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: February 26, 2020
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2023
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)