Incorporating PRO Data Into RA Clinical Encounters Using Health IT (PACT)

October 22, 2024 updated by: University of California, San Francisco

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

554

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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).
Experimental: 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.
Other: 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.
Other Names:
  • PACT Dashboard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SURE
Time Frame: 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.
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)
Time Frame: 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.
Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
Medication adherence
Time Frame: 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.
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)
Time Frame: 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.
Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDAI score
Time Frame: 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.
Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
PROMIS-PF10a score
Time Frame: 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.
Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Gabriela Schmajuk, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2020

Primary Completion (Actual)

August 21, 2023

Study Completion (Actual)

August 21, 2023

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-18282
  • R01HS025405 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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