Incorporating PRO Data Into RA Clinical Encounters Using Health IT

NCT ID: NCT06655077

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 554 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2023-08-21

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control phase

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention phase

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.

Group Type: EXPERIMENTAL

RA PRO Dashboard

Intervention Type: 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.

Interventions

RA PRO Dashboard

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.

Intervention Type: OTHER

Other Intervention Names

PACT Dashboard

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriela Schmajuk, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Health

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 39421306 (View on PubMed)

Other Identifiers

R01HS025405

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

15-18282

Identifier Type: -

Identifier Source: org_study_id