Implementing the Decision-Aid for Lupus (IDEAL Strategy)

NCT ID: NCT03735238

Last Updated: 2025-10-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1895 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-15

Study Completion Date

2025-06-10

Brief Summary

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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).

Detailed Description

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The proposed study will evaluate methods to implement a shared decision making strategy, using an individualized, computerized decision- aid (DA). The investigators will test the effectiveness of this implementation with 3 strategies in 15 clinics. Formative evaluation strategies will be used to assess needs at each clinic, with key clinic informants participating in semi-structured interviews. The study will enroll patient participants across all 16 sites, who will review the decision aid and be asked a feasibility and acceptability assessment. At the conclusion of the study, key clinic informants, as well as selected patient participants will participate in semi-structured interviews to assess the effectiveness in implementing the DA in the clinic setting.

Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Lupus Patients

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

SMILE Computerized Decision-Aid

Intervention Type 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.

Interventions

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SMILE Computerized Decision-Aid

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.

Intervention Type OTHER

Other Intervention Names

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SMILE Decision-Aid DA

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No diagnosis of lupus, not English or Spanish speaking, visually impaired, altered mental status
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Jasvinder A Singh

Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jasvinder A Singh, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40975111 (View on PubMed)

Singh JA, Beasley M. Patient Resilience is associated with Better Patient-Reported Physical and Mental/Emotional Quality of Life in Systemic Lupus Erythematosus. J Rheumatol. 2025 Sep 15:jrheum.2025-0396. doi: 10.3899/jrheum.2025-0396. Online ahead of print.

Reference Type DERIVED
PMID: 40953958 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40221856 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39873723 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33706813 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Doc2

View Document

Other Identifiers

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CE-1304-6631

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

300002272

Identifier Type: -

Identifier Source: org_study_id

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