Improving ILD Screening in Patients With RA and SSc Using EHR-Embedded CDS and PRO Tools

NCT07849673 | Not Yet Recruiting

• 1 other identifier: QIE 2024-10245
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Rheumatoid Arthritis (RA); SSc-Systemic Sclerosis

Keywords

Rheumatology; ILD; Screening for ILD; RA patients; SSc patients

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 7 days of the index rheumatology clinic visit

Study Arms (1)

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).

Other: EHR-Embedded CDS and PRO Tools Intervention

Interventions

EHR-Embedded CDS and PRO Tools Intervention OTHER

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.

EHR-Embedded CDS and PRO Tools

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boehringer Ingelheim: collaborator
• Foundation for Advancing Science Technology Education and Research: lead

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

Central Study Contacts

Jeffrey R Curtis, MD, MS, MPH

CONTACT

205-937-0585; jc@fastermedicine.org

Stephanie S Ford, MS

CONTACT

205-410-8480; sf@fastermedicine.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: The intervention model is randomized stepped-wedge cluster model. All sites receive the intervention, but at staggered, randomized time points.

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share