Rheumatoid Arthritis (RA)ILD-QUINCT07849673
Improving ILD Screening in Patients With RA and SSc Using EHR-Embedded CDS and PRO Tools
A study testing EHR-Embedded CDS and PRO Tools Intervention in people with Rheumatoid Arthritis (RA) and SSc-Systemic Sclerosis, run by Foundation for Advancing Science Technology Education and Research.
Trial summary
This is a quality improvement initiative that aims to find better ways to identify interstitial lung disease (ILD) early in people with rheumatoid arthritis (RA) or systemic sclerosis (SSc). ILD is a serious lung problem that can develop in these conditions but is often missed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA), SSc-Systemic Sclerosis
- What is being tested?
- EHR-Embedded CDS and PRO Tools Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Participants must meet all of the following to be included:
Age ≥ 18 years Diagnosis of rheumatoid arthritis (RA) or systemic sclerosis (SSc) No prior diagnosis of interstitial lung disease (ILD) No high-resolution CT (HRCT) or pulmonary function test (PFT) within the past 24 months
Participants meeting any of the following are excluded:
Confirmed diagnosis of ILD Recent HRCT or PFT within the last 24 months without new symptoms
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a quality improvement initiative that aims to find better ways to identify interstitial lung disease (ILD) early in people with rheumatoid arthritis (RA) or systemic sclerosis (SSc). ILD is a serious lung problem that can develop in these conditions but is often missed. The project will test whether tools built into the electronic health record (EHR), including symptom surveys that patients complete on a tablet and alerts that help doctors decide when lung testing is needed, can increase screening rates.
About 16 rheumatology clinics that use the same EHR system will take part. All clinics will eventually use the new tools, but they will start at different times. This allows researchers to compare usual care to the new approach within each clinic.
Read more
Adults with RA or SSc who have not previously been diagnosed with ILD and who have not had recent lung testing will be included automatically through their routine clinic visits. The study expects to include about 800 patients in total.
The main question is whether more eligible patients receive recommended ILD screening, which includes either a pulmonary function test or a high-resolution CT scan, within seven days of their clinic visit. The study will also look at how often lung tests are ordered and completed, how often patients report symptoms such as shortness of breath or cough, and whether the alerts lead to real-time clinical decisions.
This project lasts two years and uses information already collected during routine clinical care. No additional procedures or medications are required.
Read the detailed description
Interstitial lung disease (ILD) is a common and serious complication of rheumatoid arthritis (RA) and systemic sclerosis (SSc). Despite guideline recommendations, ILD screening in routine care remains low, and many patients are not evaluated until their lung disease is advanced. This study evaluates a pragmatic, clinic-integrated strategy designed to increase timely ILD screening using tools embedded directly into the electronic health record (EHR).
The project is conducted within community rheumatology practices that share a common EHR platform (NextGen). All participating sites transition from usual care to the intervention, but at different scheduled time points. This stepped-wedge design allows each site to contribute both control-phase and intervention-phase data. Screening is not researcher-initiated; instead, the intervention is designed to support and standardize existing clinical workflows.
The intervention consists of two components implemented at the clinic level. First, patients complete a brief respiratory symptom survey on a tablet at check-in. The questionnaire captures dyspnea and cough severity and is designed to take under two minutes. The results become available to clinicians in real time. Second, EHR-embedded clinical decision support (CDS) prompts appear for clinicians when patients meet predefined criteria based on diagnosis, test history, and symptom scores. These prompts remind clinicians of guideline-recommended ILD screening and facilitate ordering of pulmonary function tests or high-resolution computed tomography when appropriate. Sites also receive training and a structured workflow guide to support implementation.
Because the intervention is deployed within routine clinical care, patients are passively included when they present for appointments and meet study criteria in the EHR. No additional study visits, procedures, or medications are required. Data are collected from the EHR, CDS activity logs, and patient-reported surveys. The study observes ordering and completion of ILD screening tests, provider responses to alerts, symptom patterns, and documentation of new ILD diagnoses. Data are analyzed to compare screening activity before and after the clinic transitions to the intervention, adjusting for time effects and patient and site characteristics.
The study aims to generate practical evidence on whether embedding guideline-aligned CDS and rapid symptom assessments into existing workflows can improve ILD screening for RA and SSc patients in real-world community practice. Findings may help inform broader implementation strategies for early detection of ILD and other pulmonary complications in rheumatology populations.
- Conditions
- Rheumatoid Arthritis (RA), SSc-Systemic Sclerosis
- Being tested
- EHR-Embedded CDS and PRO Tools Intervention
- Keywords
- Rheumatology, ILD, Screening for ILD, RA patients, SSc patients
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR-Embedded CDS and PRO Tools InterventionOther
This intervention integrates two components directly into routine rheumatology clinic workflows using the shared NextGen electronic health record (EHR). First, patients complete a brief tablet-based respiratory symptom questionnaire at check-in, capturing dyspnea and cough severity in under two minutes. Responses are transmitted instantly into the EHR. Second, the system activates ILD-focused clinical decision support (CDS) prompts for clinicians based on diagnosis, prior testing history, and symptom scores. These prompts recommend guideline-aligned ILD screening and provide structured options for ordering pulmonary function tests or high-resolution chest CT. The CDS also records provider responses and reasons for deferring screening. The intervention is deployed at the site level and is intended to standardize ILD screening behavior, enhance recognition of respiratory symptoms, and support timely clinical action in RA and SSc patients.
| Study group | Role | What they receive |
|---|---|---|
| EHR-Embedded CDS and PRO Tools | Experimental | This is a quality-improvement, workflow-embedded intervention, the stepped-wedge design evaluates the effect of an active intervention (EHR-embedded CDS + PRO tools). Receives: Other: EHR-Embedded CDS and PRO Tools Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of ILD Screening
Proportion of eligible patients who receive an ILD screening test (high-resolution CT [HRCT] or pulmonary function test [PFT]) within 7 days of a clinic visit.
Measured: Within 7 days of the index rheumatology clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The intervention model is randomized stepped-wedge cluster model. All sites receive the intervention, but at staggered, randomized time points.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Advancing Science Technology Education and Research
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Jeffrey Curtis, Foundation for Advancing Science Technology Education and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849673
- Sponsor's protocol ID
- QIE 2024-10245
- Acronym
- ILD-QUI
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP will not be shared because this study is a quality-improvement, workflow-embedded project that uses routine clinical data obtained through participating practices' EHR systems. Data use is restricted under site agreements, HIPAA requirements, and the terms of the QIE grant, which allow only aggregated, de-identified reporting and do not permit external sharing of IPD.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving ILD Screening in Patients With RA and SSc Using EHR-Embedded CDS and PRO Tools
- ClinicalTrials.gov ID
- NCT07849673
- Acronym / sponsor ID
- ILD-QUI / QIE 2024-10245
- Conditions
- Rheumatoid Arthritis (RA), SSc-Systemic Sclerosis
- Keywords
- Rheumatology, ILD, Screening for ILD, RA patients, SSc patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Foundation for Advancing Science Technology Education and ResearchUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Sep 2026 (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.
This is a quality improvement initiative that aims to find better ways to identify interstitial lung disease (ILD) early in people with rheumatoid arthritis (RA) or systemic sclerosis (SSc). ILD is a serious lung problem that can develop in these conditions but is often missed. The project will test whether tools built into the electronic health record (EHR), including symptom surveys that patients complete on a tablet and alerts that help doctors decide when lung testing is needed, can increase screening rates.
About 16 rheumatology clinics that use the same EHR system will take part. All clinics will eventually use the new tools, but they will start at different times. This allows researchers to compare usual care to the new approach within each clinic.
Adults with RA or SSc who have not previously been diagnosed with ILD and who have not had recent lung testing will be included automatically through their routine clinic visits. The study expects to include about 800 patients in total.
The main question is whether more eligible patients receive recommended ILD screening, which includes either a pulmonary function test or a high-resolution CT scan, within seven days of their clinic visit. The study will also look at how often lung tests are ordered and completed, how often patients report symptoms such as shortness of breath or cough, and whether the alerts lead to real-time clinical decisions.
This project lasts two years and uses information already collected during routine clinical care. No additional procedures or medications are required.
Detailed description
Interstitial lung disease (ILD) is a common and serious complication of rheumatoid arthritis (RA) and systemic sclerosis (SSc). Despite guideline recommendations, ILD screening in routine care remains low, and many patients are not evaluated until their lung disease is advanced. This study evaluates a pragmatic, clinic-integrated strategy designed to increase timely ILD screening using tools embedded directly into the electronic health record (EHR).
The project is conducted within community rheumatology practices that share a common EHR platform (NextGen). All participating sites transition from usual care to the intervention, but at different scheduled time points. This stepped-wedge design allows each site to contribute both control-phase and intervention-phase data. Screening is not researcher-initiated; instead, the intervention is designed to support and standardize existing clinical workflows.
The intervention consists of two components implemented at the clinic level. First, patients complete a brief respiratory symptom survey on a tablet at check-in. The questionnaire captures dyspnea and cough severity and is designed to take under two minutes. The results become available to clinicians in real time. Second, EHR-embedded clinical decision support (CDS) prompts appear for clinicians when patients meet predefined criteria based on diagnosis, test history, and symptom scores. These prompts remind clinicians of guideline-recommended ILD screening and facilitate ordering of pulmonary function tests or high-resolution computed tomography when appropriate. Sites also receive training and a structured workflow guide to support implementation.
Because the intervention is deployed within routine clinical care, patients are passively included when they present for appointments and meet study criteria in the EHR. No additional study visits, procedures, or medications are required. Data are collected from the EHR, CDS activity logs, and patient-reported surveys. The study observes ordering and completion of ILD screening tests, provider responses to alerts, symptom patterns, and documentation of new ILD diagnoses. Data are analyzed to compare screening activity before and after the clinic transitions to the intervention, adjusting for time effects and patient and site characteristics.
The study aims to generate practical evidence on whether embedding guideline-aligned CDS and rapid symptom assessments into existing workflows can improve ILD screening for RA and SSc patients in real-world community practice. Findings may help inform broader implementation strategies for early detection of ILD and other pulmonary complications in rheumatology populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention model is randomized stepped-wedge cluster model. All sites receive the intervention, but at staggered, randomized time points.
| Arm | Type | Receives |
|---|---|---|
| EHR-Embedded CDS and PRO Tools | Experimental | Other: EHR-Embedded CDS and PRO Tools InterventionThis is a quality-improvement, workflow-embedded intervention, the stepped-wedge design evaluates the effect of an active intervention (EHR-embedded CDS + PRO tools). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| EHR-Embedded CDS and PRO Tools InterventionThis intervention integrates two components directly into routine rheumatology clinic workflows using the shared NextGen electronic health record (EHR). First, patients complete a brief tablet-based respiratory symptom questionnaire at check-in, capturing dyspnea and cough severity in under two minutes. Responses are transmitted instantly into the EHR. Second, the system activates ILD-focused clinical decision support (CDS) prompts for clinicians based on diagnosis, prior testing history, and symptom scores. These prompts recommend guideline-aligned ILD screening and provide structured options for ordering pulmonary function tests or high-resolution chest CT. The CDS also records provider responses and reasons for deferring screening. The intervention is deployed at the site level and is intended to standardize ILD screening behavior, enhance recognition of respiratory symptoms, and support timely clinical action in RA and SSc patients. | Other | EHR-Embedded CDS and PRO Tools |
Primary outcome
Receipt of ILD Screening
Time frame: Within 7 days of the index rheumatology clinic visit
Proportion of eligible patients who receive an ILD screening test (high-resolution CT [HRCT] or pulmonary function test [PFT]) within 7 days of a clinic visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. IDP will not be shared because this study is a quality-improvement, workflow-embedded project that uses routine clinical data obtained through participating practices' EHR systems. Data use is restricted under site agreements, HIPAA requirements, and the terms of the QIE grant, which allow only aggregated, de-identified reporting and do not permit external sharing of IPD.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing EHR-Embedded CDS and PRO Tools Intervention in people with Rheumatoid Arthritis (RA) and SSc-Systemic Sclerosis, run by Foundation for Advancing Science Technology Education and Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey R Curtis, MD, MS, MPH (205-937-0585, jc@fastermedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of ILD Screening (time frame: Within 7 days of the index rheumatology clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.