Implementing the Decision-Aid for Lupus (IDEAL Strategy)

NCT03735238 | Completed Results

• 2 other identifiers: 300002272CE-1304-6631
• Study Type: observational
• Target: 1,895
• Locations: 1 country
• Sites: 1

Brief Summary

The study will attempt to put into practice a shared decision making (SDM) strategy, using an individualized, computerized decision- aid (DA) for Systemic lupus erythematosus (SLE).

Conditions

Systemic Lupus Erythematosus

Keywords

lupus; decision making; implementation; SLE; decision-aid; decision conflict

Outcome Measures

Primary Outcomes (1)

• 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

  Reach/penetration was measured by calculating a ratio of patients who were enrolled in the implementation project (# of patients who viewed the SLE PtDA) divided by the number of Eligible Participants at Each Clinical Site identified using the electronic medical record (EMR) in the respective clinic (# of eligible patients). The number of eligible patients was based on the average number of patients with a diagnosis of lupus seen in each clinic over the study period (2019-2023).

  24 months

Secondary Outcomes (13)

• Perceived Acceptability of Intervention Measure (AIM) by Clinic Personnel for the SLE Patient Decision-aid

  24 months

• Perceived DA Implementation Success by Clinic Personnel for the SLE Patient Decision-aid

  24 months

• Perceived DA Permanence by Clinic Personnel for the SLE Patient Decision-aid

  24 months

• Perceived Intervention Appropriateness Measure (IAM) by Clinic Personnel for the SLE Patient Decision-aid

  24 Months

• Perceived Feasibility of Intervention Measure (FIM) by Clinic Personnel for the SLE Patient Decision-aid

  24 Months

Study Arms (1)

Lupus Patients

All adult lupus patients, regardless of if they are having an active flare

Other: SMILE Computerized Decision-Aid

Interventions

SMILE Computerized Decision-Aid OTHER

SMILE is a computerized decision-aid designed to give lupus patients information about lupus, treatments for lupus available to them, as well as side effects. This will be administered at every lupus clinic session. Every patient will see the SMILE Computerized Decision-Aid at their index baseline clinic visit.

Also known as: SMILE, Decision-Aid, DA

Lupus Patients

Eligibility Criteria

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

Study Population

Patients will be enrolled from lupus clinics at 15 sites throughout the country.

You may qualify if:

• Adults with a diagnosis of Systemic Lupus Erythematosus (SLE) by a rheumatologist

You may not qualify if:

• No diagnosis of lupus, not English or Spanish speaking, visually impaired, altered mental status

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (5)

• Singh JA, Hearld LR, Eisen S, Chatham WW, Narain S, Annapureddy N, Kamen DL, Trotter K, Majithia V, Ching CL, Aouhab Z, Venuturupalli S, Wallace DJ, Ramsey-Goldman R, Kim AHJ, McMahon M, Lim SS, Bhairavarasu K, Meara A, Kalunian K, Beasley M. Patient outcomes from implementing a shared decision-making aid for systemic lupus erythematosus: a prospective implementation study. Lancet Rheumatol. 2025 Sep 17:S2665-9913(25)00130-4. doi: 10.1016/S2665-9913(25)00130-4. Online ahead of print.

  PMID: 40975111 DERIVED

• Singh JA, Beasley TM. Association of Patient Resilience With Patient-Reported Physical and Mental/Emotional Quality of Life in Systemic Lupus Erythematosus. J Rheumatol. 2025 Dec 1;52(12):1263-1273. doi: 10.3899/jrheum.2025-0396.

  PMID: 40953958 DERIVED

• Singh JA, Hearld LR, Eisen S, Chatham WW, Narain S, Annapureddy N, Kamen DL, Trotter K, Majithia V, Lee Ching C, Aouhab Z, Venuturupalli S, Wallace DJ, Ramsey-Goldman R, Kim A, McMahon M, Sam Lim S, Bhairavarasu K, Meara A, Kalunian K, Beasley TM; Implementing DEcision-Aid for Lupus in clinics (IDEAL) Consortium. Implementation outcomes of a patient decision-aid in a diverse population with systemic lupus erythematosus in 15 US rheumatology clinics. Rheumatology (Oxford). 2025 Aug 1;64(8):4631-4640. doi: 10.1093/rheumatology/keaf205.

  PMID: 40221856 DERIVED

• Blanchard EE, Hall AG, Gore E, Jami PY, Karabukayeva A, Hearld LR, Gontarz S, Singh JA. Barriers to and facilitators of sustaining a systemic lupus erythematosus (SLE) patient decision aid in regular rheumatology outpatient care in the USA. Rheumatology (Oxford). 2025 Jun 1;64(6):3580-3586. doi: 10.1093/rheumatology/keaf043.

  PMID: 39873723 DERIVED

• Singh JA, Hearld LR, Hall AG, Beasley TM. Implementing the DEcision-Aid for Lupus (IDEAL): study protocol of a multi-site implementation trial with observational, case study design : Implementing the DEcision-Aid for Lupus. Implement Sci Commun. 2021 Mar 11;2(1):30. doi: 10.1186/s43058-021-00118-9.

  PMID: 33706813 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

We had few private practice clinics. Most sites were largely academic center clinics. Potential applications of the SLE PtDA to other settings are unexplored to date. Most outcome measures were patient-reported and subjective in nature and therefore may be impacted by social desirability. Satisfaction, acceptability and feasibility, likely had ceiling effects. Not every participant completed all follow-up surveys. Actual sustainability in these clinics cannot be assessed until years have passed.

Results Point of Contact

• Title: Jasvinder Singh, MD, MPH; Senior Faculty and Chief of Immunology, Allergy, and Rheumatology
• Organization: Baylor College of Medicine

jasvinder.md@gmail.com

713.798.1365

Study Officials

• Jasvinder A Singh, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 8, 2018
• Study Start: December 15, 2018
• Primary Completion: November 15, 2024
• Study Completion: June 10, 2025
• Last Updated: October 10, 2025
• Results First Posted: October 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)