Implementing the Decision-Aid for Lupus (IDEAL Strategy) (IDEAL)

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).

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Other: SMILE Computerized Decision-Aid

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1895

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Patient Inclusion Criteria:

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

Patient Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lupus Patients; All adult lupus patients, regardless of if they are having an active flare	Other: 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.; Other Names: DA; SMILE; Decision-Aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Acceptability of Intervention Measure (AIM) by Clinic Personnel for the SLE Patient Decision-aid	Clinic personnel's perception of the acceptability of the SLE Patient decision-aid (PtDA), measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater acceptability (i.e., better outcome).	24 months
Perceived DA Implementation Success by Clinic Personnel for the SLE Patient Decision-aid	Clinic personnel's perception of the implementation success of the SLE Patient decision-aid (PtDA), measured using a validated scale with three (3) items with responses ranging from 1 ("Disagree") to 5 ("Agree"). These three items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater implementation success (i.e., better outcome).	24 months
Perceived DA Permanence by Clinic Personnel for the SLE Patient Decision-aid	Clinic personnel's perception of the permanence of the SLE Patient decision-aid (PtDA), measured using one validated item that is scored ranging from 1 ("Not at all permanent") to 5 ("Extremely permanent"). This item will be examined by itself, where higher scores indicate perceptions of greater permanence of the decision-aid in the clinic (i.e., better outcome).	24 months
Perceived Intervention Appropriateness Measure (IAM) by Clinic Personnel for the SLE Patient Decision-aid	Clinic personnel's perception of the appropriateness of the SLE Patient decision-aid (PtDA), measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater appropriateness (i.e., better outcome).	24 Months
Perceived Feasibility of Intervention Measure (FIM) by Clinic Personnel for the SLE Patient Decision-aid	Clinic personnel's perception of the feasibility of the SLE Patient decision-aid (PtDA), measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater feasibility (i.e., better outcome).	24 Months
Patient Decisional Conflict Scale Related to Medication Treatment Decision-making for SLE Medications Including the Immunosuppressive Medications and Biologics After Viewing the SLE Patient Decision-aid	Decisional conflict was measured using the low literacy version of the Decisional Conflict Scale (DCS), a well-validated self-administered instrument, after viewing the SLE Patient decision-aid (PtDA). The low literacy version has 10 items with 3 response categories: yes, unsure, and no. Four subscale scores consisting of uncertainty about choice, feeling informed, values clarity, and feeling supported in decision-making were also calculated. DCS (and subscale) scores range from 0 (best) to 100 (worst) and scores >= 25 are consistent with clinically significant residual decisional conflict	6 Months
Patient-reported Interpersonal Processes of Care for Patient-Physician Communication After Viewing the SLE Patient Decision-aid	The Interpersonal Processes of Care short form (IPC-SF) is a patient-reported, 18-item validated patient-reported patient-physician communication and care processes measure, assessed after viewing the SLE Patient decision-aid (PtDA). Scores range from 18 to 90, with higher scores indicating better patient-physician communication ± care.	6 Months
Patient Satisfaction for SLE Patient Decision-aid	Patient satisfaction with the ease of the use of the SLE Patient Decision-aid (PtDA) measured using a validated single item scale scored on an ordinal scale from (strongly disagree =1) to (strongly agree = 5). This item will be examined by itself, where higher scores indicate greater patient satisfaction with the decision aid (i.e., better outcome). This is a single item scale, and there are no subscales. It was adapted from another study that assessed satisfaction with iPad or interactive voice response.	6 months
Patient Time for Reviewing SLE Patient Decision-aid	The SLE Patient Decision-aid (PtDA) review times was expressed in minutes as patient-reported; this was supplemented by study coordinator's record of patient DA review time in-clinic prior to addition of this question. This patient self-reported question was added at the onset of the COVID-19 pandemic, where shelter-in-place orders led to stopping of in-person outpatient visits and all vists were converted to virtual visits using the phone or the video (Telemedicine).	6 Months
Patient Preparation for Decision Making Assessed After Viewing the SLE Patient Decision-aid	Patient perception of the effect of the decision-aid on preparing the patient for decision making measured using the Patient Preparation for Decision Making (PDM) , a validated scale consisting of 10 questions scored on an ordinal scale from (not at all =1) to (a great deal = 5. Score ranged 0-100, 100 representing the highest preparation for decision-making. This was assessed after viewing the SLE Patient decision-aid (PtDA).	Baseline visit after viewing the SLE Patient Decision-Aid (PtDA)
Patient Acceptability of the SLE Patient Decision-Aid	The patient acceptability survey is for the assessment of patient acceptability of the SLE Patient Decision-Aid (PtDA). Each question was rated from Poor (1) to Excellent (4). Total score ranged 1-4. DA acceptability refers to rating regarding the comprehensibility of component of the decision-aid, its length, pace, amount of the information, and the balance in presentation of the information about the options available and the overall suitability for decision making.	Baseline visit after viewing the SLE PtDA
Patient Feasibility of the SLE Patient Decision-Aid	The feasibility of the study survey completion and the administration of the lupus decision aid in the busy clinic were assessed with a self-administered patient questionnaire consisting of 4 questions, 2 questions for each, the survey and for the process of viewing ± administering the lupus DA in the busy clinic. Responses ranged from strongly disagree (=1) to strongly agree (=5). Higher scores indicate higher feasibility of the survey and of the SLE Patient Decision-Aid (PtDA) administration respectively.	Baseline visit after viewing the SLE PtDA
Number of Participants Who Perceived the SLE Patient Decision-Aid to be Useful	Patient perception of the SLE Patient Decision-Aid (PtDA) usefulness was aimed at assessing whether people would consider the the SLE PtDA to be useful at present and when they would think back to the time, they had made decisions about lupus treatments in the past (question 1), and whether the information contained in the lupus DA were adequate (question 2). It measured patient response of Yes vs. no to two simple questions. The tool is not yet a validated assessment but was based on our debriefing of lupus patients in the previous randomized study of lupus decision-aid.	Baseline visit after viewing the SLE PtDA

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Jasvinder A Singh, MD, MPH, University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2018
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): June 10, 2025

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: SLE; implementation; decision making; lupus; decision conflict; decision-aid
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Investigative Techniques; Decision Support Techniques
• Other Study ID Numbers: 300002272; CE-1304-6631 (Other Grant/Funding Number: PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No