Trial results for the Implementing the Decision-Aid for Lupus (IDEAL Strategy) study, investigating a shared decision-making approach for Systemic Lupus Erythematosus, were posted on ClinicalTrials.gov on 2025-10-10. The study enrolled a total of 1895 participants.
Background
Systemic Lupus Erythematosus (SLE), commonly known as Lupus, is a chronic autoimmune disease that can affect various parts of the body. Managing SLE often involves complex treatment decisions, making shared decision-making (SDM) strategies important for patient engagement and personalized care. This study aimed to implement and assess the reach of an individualized, computerized decision-aid for SLE patients within clinical settings.
Trial design
This study, titled "Implementing the Decision-Aid for Lupus (IDEAL Strategy)", was a completed trial focused on putting a shared decision-making strategy into practice using an individualized, computerized decision-aid for Systemic Lupus Erythematosus (SLE). The trial enrolled a total of 1895 participants. The study focused on the condition of Systemic Lupus Erythematosus.
Key results
The primary outcome measured was "Penetration/Reach: Number of Eligible Participants at Each Clinical Site Who Enrolled Divided by the Number of Eligible Participants at Each Clinical Site, Expressed as Overall Percent." The results, presented as the number of participants enrolled at each site, are as follows:
- Loyola University, Chicago: 96 Participants
- University of Alabama at Birmingham (UAB), Birmingham: 725 Participants
- Vanderbilt University, Nashville: 121 Participants
- University of Chicago, Chicago: 104 Participants
- University of Mississippi Medical Center (UMMC), Jackson: 105 Participants
- Cedars Cedars-Sinai Medical Center, Los Angeles: 88 Participants
- Baylor College of Medicine, Houston: 63 Participants
- Northwestern University, Chicago: 79 Participants
- Emory University, Atlanta: 73 Participants
- Medical University of South Carolina (MUSC), Charleston: 102 Participants
- Northwell Health, New York: 124 Participants
- University of California (UCLA), Los Angeles: 69 Participants
The trial was a single-arm implementation study with no comparison group. No statistical tests were performed for this outcome, and there was no null hypothesis stated. The aim was to enroll at least 28 patients per site during regular outpatient rheumatology clinic visits.
What this means
The results demonstrate the reach and penetration of the IDEAL Strategy, a shared decision-making approach utilizing a computerized decision-aid, across multiple clinical sites for patients with Systemic Lupus Erythematosus. The enrollment numbers at each site, ranging from 63 to 725 participants, indicate successful implementation and engagement, exceeding the stated aim of enrolling at least 28 patients per site. This suggests that such a strategy can be effectively integrated into routine rheumatology care, potentially improving patient involvement in treatment decisions for a complex condition like lupus.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03735238, titled "Implementing the Decision-Aid for Lupus (IDEAL Strategy)", were posted on 2025-10-10 on clinicaltrials.gov.