Rheumatoid ArthritisPACTNCT06655077
Incorporating PRO Data Into RA Clinical Encounters Using Health IT
A study testing RA PRO Dashboard in people with Rheumatoid Arthritis, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- RA PRO Dashboard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to 21 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of rheumatoid arthritis
- Visits with clinicians at UCSF Health clinic
- At least 1 CDAI score documented in UCSF EHR
Who cannot join
- Unable to read, speak, or understand English
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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 ...
Read more
- reduce decisional conflict when making a medication choice?
- improve self-efficacy in symptom management?
- change beliefs about medications?
- improve medication adherence?
- 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
- Being tested
- RA PRO Dashboard
- Keywords
- electronic dashbaord, patient reported outcomes
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RA PRO DashboardOther
Also called PACT 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: RA PRO Dashboard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
Secondary outcomes (2)
CDAI score
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.
Measured: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
PROMIS-PF10a score
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.
Measured: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start26 Feb 2020
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Gabriela Schmajuk, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655077
- Sponsor's protocol ID
- 15-18282
- Other IDs
- R01HS025405
- Acronym
- PACT
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39421306
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating PRO Data Into RA Clinical Encounters Using Health IT
- ClinicalTrials.gov ID
- NCT06655077
- Acronym / sponsor ID
- PACT / 15-18282
- Conditions
- Rheumatoid Arthritis
- Keywords
- electronic dashbaord, patient reported outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ...
- reduce decisional conflict when making a medication choice?
- improve self-efficacy in symptom management?
- change beliefs about medications?
- improve medication adherence?
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: RA PRO DashboardAny 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of rheumatoid arthritis
- Visits with clinicians at UCSF Health clinic
- At least 1 CDAI score documented in UCSF EHR
Key exclusion criteria (2 listed)
- Unable to read, speak, or understand English
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RA PRO DashboardAlso: PACT DashboardThe 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 | Intervention phase |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
CDAI score
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 39421306Schmajuk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Schmajuk, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RA PRO Dashboard in people with Rheumatoid Arthritis, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SURE (time frame: Collected during routine clinical visits throughout study period; on average 3 times per year, up to 2 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06655077, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.