Trial Outcomes & Findings for Implementing the Decision-Aid for Lupus (IDEAL Strategy) (NCT NCT03735238)

NCT ID: NCT03735238

Last Updated: 2025-10-10

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 1895 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2025-10-10

Participant Flow

All 15 participating sites were asked to enroll a minimum number of SLE patient participants at the site (n=28/site), and to continue enrolling once the threshold was met. The clinic personnel were not enrolled.

Participant milestones

Measure	Lupus Patients All lupus patients, regardless of if they are having an active flare, participated. There was no randomly assigned arms or conditions.
Overall Study STARTED	1895
Overall Study COMPLETED	1866
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Measure	Lupus Patients All lupus patients, regardless of if they are having an active flare, participated. There was no randomly assigned arms or conditions.
Overall Study Did not want to participate in research	3
Overall Study Time constraints, patient preference or percieved burden of survey completion	26

Baseline Characteristics

Missing data = 6

Baseline characteristics by cohort

Measure	Lupus Patients n=1855 Participants All lupus patients, regardless of if they are having an active flare.
Age, Continuous	44.68 years STANDARD_DEVIATION 14.35 • n=1849 Participants • Missing data = 6
Sex: Female, Male Female	1731 Participants n=1855 Participants
Sex: Female, Male Male	124 Participants n=1855 Participants
Race/Ethnicity, Customized Race · Asian	80 Participants n=1832 Participants • Missing data = 23
Race/Ethnicity, Customized Race · African American	827 Participants n=1832 Participants • Missing data = 23
Race/Ethnicity, Customized Race · Hispanic	149 Participants n=1832 Participants • Missing data = 23
Race/Ethnicity, Customized Race · Other/Mixed	22 Participants n=1832 Participants • Missing data = 23
Race/Ethnicity, Customized Race · White	754 Participants n=1832 Participants • Missing data = 23
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	149 Participants n=1834 Participants • Missing data = 21
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	1685 Participants n=1834 Participants • Missing data = 21
Insurance Payer Type Commercial/Private	655 Participants n=1450 Participants • Missing data = 405 (Insurance payer type question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Insurance Payer Type Medicare	340 Participants n=1450 Participants • Missing data = 405 (Insurance payer type question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Insurance Payer Type Medicaid	221 Participants n=1450 Participants • Missing data = 405 (Insurance payer type question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Insurance Payer Type Other	234 Participants n=1450 Participants • Missing data = 405 (Insurance payer type question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Education level Less than HS	27 Participants n=1006 Participants • Missing data = 849 (Education level question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Education level HS degree or GED	152 Participants n=1006 Participants • Missing data = 849 (Education level question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Education level Greater than HS	827 Participants n=1006 Participants • Missing data = 849 (Education level question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Marital status Married	443 Participants n=1006 Participants • Missing data = 849 (Marital status question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Marital status Separated	19 Participants n=1006 Participants • Missing data = 849 (Marital status question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Marital status Divorced	87 Participants n=1006 Participants • Missing data = 849 (Marital status question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Marital status Single	372 Participants n=1006 Participants • Missing data = 849 (Marital status question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Marital status Living with partner	45 Participants n=1006 Participants • Missing data = 849 (Marital status question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Marital status Widowed	33 Participants n=1006 Participants • Missing data = 849 (Marital status question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Marital status Other	7 Participants n=1006 Participants • Missing data = 849 (Marital status question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Residence Urban	305 Participants n=1006 Participants • Missing data = 849 (Residence question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Residence Suburban	483 Participants n=1006 Participants • Missing data = 849 (Residence question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)
Residence Rural	218 Participants n=1006 Participants • Missing data = 849 (Residence question was added much later after the start of the study, based on stakeholder feedback, therefore missingness is higher for this variable)

PRIMARY outcome

Timeframe: 24 months

Population: Reach/penetration = # of patients viewed DA / # of eligible patients

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).

Outcome measures

Measure	Loyola University, Chicago n=200 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham n=1612 Participants Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville n=447 Participants Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago n=522 Participants Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson n=463 Participants Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles n=512 Participants Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston n=389 Participants Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago n=500 Participants Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta n=818 Participants Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston n=1388 Participants Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York n=2087 Participants Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles n=1292 Participants Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus n=666 Participants Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA n=850 Participants Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis n=1148 Participants Penetration of DA at the Washington University, St. Louis, Missouri
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	96 Participants	725 Participants	121 Participants	104 Participants	105 Participants	88 Participants	63 Participants	79 Participants	73 Participants	102 Participants	124 Participants	69 Participants	37 Participants	28 Participants	81 Participants

SECONDARY outcome

Timeframe: 24 months

Population: The main study flow diagram is for the patient participants who were invited to view the SLE PtDA. We also evaluated clinic personnel reported outcomes, which are provided for outcomes #2-6, including this outcome. As expected, the denominator for the clinic personnel outcomes is different from that for the patient participants. In summary, our implementation study had separate aims focused on patient-reported effectiveness outcomes, and clinic personnel reported implementation outcomes.

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).

Outcome measures

Measure	Loyola University, Chicago n=97 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham n=82 Participants Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville n=70 Participants Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Perceived Acceptability of Intervention Measure (AIM) by Clinic Personnel for the SLE Patient Decision-aid	3.53 score on a scale (range 1-5) Standard Deviation 0.83	3.84 score on a scale (range 1-5) Standard Deviation 0.80	3.63 score on a scale (range 1-5) Standard Deviation 0.79	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 24 months

Population: The main study flow diagram is for the patient participants. We also evaluated clinic personnel reported outcomes in this study, which are provided for outcomes #2-6, including this outcome. The denominator for the clinic personnel is different from those of the patient participants, as expected.

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).

Outcome measures

Measure	Loyola University, Chicago n=97 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham n=82 Participants Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville n=70 Participants Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Perceived DA Implementation Success by Clinic Personnel for the SLE Patient Decision-aid	3.41 score on a scale (range 1-5) Standard Deviation 0.73	3.54 score on a scale (range 1-5) Standard Deviation 0.70	3.47 score on a scale (range 1-5) Standard Deviation 0.91	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 24 months

Population: The main study flow diagram is for the patient participants. We also evaluated clinic personnel reported outcomes in this study, which are provided for outcomes #2-6, including this outcome. The denominator for the clinic personnel is different from those of the patient participants, as expected.

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).

Outcome measures

Measure	Loyola University, Chicago n=99 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham n=79 Participants Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville n=70 Participants Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Perceived DA Permanence by Clinic Personnel for the SLE Patient Decision-aid	3.22 score on a scale (range 1-5) Standard Deviation 0.74	3.02 score on a scale (range 1-5) Standard Deviation 0.96	3.11 score on a scale (range 1-5) Standard Deviation 1.03	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 24 Months

Population: The main study flow diagram is for the patient participants. We also evaluated clinic personnel reported outcomes in this study, which are provided for outcomes #2-6, including this outcome. The denominator for the clinic personnel is different from those of the patient participants, as expected.

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).

Outcome measures

Measure	Loyola University, Chicago n=98 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham n=79 Participants Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville n=69 Participants Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Perceived Intervention Appropriateness Measure (IAM) by Clinic Personnel for the SLE Patient Decision-aid	3.43 score on a scale (range 1-5) Standard Deviation 0.86	3.76 score on a scale (range 1-5) Standard Deviation 0.74	3.64 score on a scale (range 1-5) Standard Deviation 0.85	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 24 Months

Population: The main study flow diagram is for the patient participants. We also evaluated clinic personnel reported outcomes in this study, which are provided for outcomes #2-6, including this outcome. The denominator for the clinic personnel is different from those of the patient participants, as expected.

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).

Outcome measures

Measure	Loyola University, Chicago n=100 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham n=79 Participants Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville n=70 Participants Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Perceived Feasibility of Intervention Measure (FIM) by Clinic Personnel for the SLE Patient Decision-aid	3.44 score on a scale (range 1-5) Standard Deviation 0.71	3.61 score on a scale (range 1-5) Standard Deviation 0.75	3.53 score on a scale (range 1-5) Standard Deviation 0.81	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 Months

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

Outcome measures

Measure	Loyola University, Chicago n=1849 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham n=1211 Participants Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville n=1255 Participants Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
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	19.48 score on a scale (DCS; 0-100) Standard Deviation 23.78	21.77 score on a scale (DCS; 0-100) Standard Deviation 25.70	20.23 score on a scale (DCS; 0-100) Standard Deviation 24.67	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 Months

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.

Outcome measures

Measure	Loyola University, Chicago n=1844 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham n=1207 Participants Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville n=1255 Participants Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Patient-reported Interpersonal Processes of Care for Patient-Physician Communication After Viewing the SLE Patient Decision-aid	82.19 score on a scale (IPC; 18-90) Standard Deviation 9.28	81.88 score on a scale (IPC; 18-90) Standard Deviation 9.84	82.34 score on a scale (IPC; 18-90) Standard Deviation 9.36	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Loyola University, Chicago n=1839 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham n=1197 Participants Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville n=1237 Participants Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Patient Satisfaction for SLE Patient Decision-aid	4.41 score on a scale (range 1-5) Standard Deviation 1.08	4.44 score on a scale (range 1-5) Standard Deviation 0.87	4.44 score on a scale (range 1-5) Standard Deviation 0.85	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 Months

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).

Outcome measures

Measure	Loyola University, Chicago n=755 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham n=477 Participants Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville n=509 Participants Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Patient Time for Reviewing SLE Patient Decision-aid	23 Minutes Standard Deviation 16.18	22.44 Minutes Standard Deviation 13.44	21.63 Minutes Standard Deviation 14.81	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline visit after viewing the SLE Patient Decision-Aid (PtDA)

Population: All SLE Patients who viewed the SLE PtDA patients, regardless of if they are having an active flare, and responded to this part of the patient survey

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).

Outcome measures

Measure	Loyola University, Chicago n=1827 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Patient Preparation for Decision Making Assessed After Viewing the SLE Patient Decision-aid	74.44 score on a scale (PDM; 0-100) Standard Deviation 23.76	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline visit after viewing the SLE PtDA

Population: All SLE Patients who viewed the SLE PtDA patients, regardless of if they are having an active flare, and responded to this part of the patient survey

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.

Outcome measures

Measure	Loyola University, Chicago n=1858 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Patient Acceptability of the SLE Patient Decision-Aid	3.26 score on a scale (range:1-4) Standard Deviation 0.63	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline visit after viewing the SLE PtDA

Population: All SLE Patients who viewed the SLE PtDA patients, regardless of if they are having an active flare, and responded to this part of the patient survey

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.

Outcome measures

Measure	Loyola University, Chicago n=1822 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Patient Feasibility of the SLE Patient Decision-Aid	4.33 score on a scale (range:1-4) Standard Deviation 0.77	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline visit after viewing the SLE PtDA

Population: All SLE Patients who viewed the SLE PtDA patients, regardless of if they are having an active flare, and responded to this part of the patient survey

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.

Outcome measures

Measure	Loyola University, Chicago n=1828 Participants Penetration of DA at Loyola University, Chicago	University of Alabama at Birmingham (UAB), Birmingham Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama	Vanderbilt University, Nashville Penetration of DA at Vanderbilt University, Nashville, Tennessee	University of Chicago, Chicago Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois	University of Mississippi Medical Center (UMMC), Jackson Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi	Cedars Cedars-Sinai Medical Center, Los Angeles Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California	Baylor College of Medicine, Houston Penetration of DA at the Baylor College of Medicine, Houston, Texas	Northwestern University, Chicago Penetration of DA at the Northwestern University, Chicago, Illinois	Emory University, Atlanta Penetration of DA at the Emory University, Atlanta, Georgia	Medical University of South Carolina (MUSC), Charleston Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC	Northwell Health, New York Penetration of DA at the Northwell Health, New York, New York	University of California (UCLA), Los Angeles Penetration of DA at the University of California (UCLA), Los Angeles, California	Ohio State University (OSU), Columbus Penetration of DA at the Ohio State University (OSU), Columbus, Ohio	University of California at San Diego (UCSD), San Diego, CA Penetration of DA at the University of California at San Diego (UCSD), San Diego, CA	Washington University, St. Louis Penetration of DA at the Washington University, St. Louis, Missouri
Number of Participants Who Perceived the SLE Patient Decision-Aid to be Useful Patient perception of DA Usefulness in decision-making	1640 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Number of Participants Who Perceived the SLE Patient Decision-Aid to be Useful Patient perception of DA Usefulness for information adequacy	1448 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Lupus Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jasvinder Singh, MD, MPH; Senior Faculty and Chief of Immunology, Allergy, and Rheumatology

Baylor College of Medicine

Phone: 713.798.1365

Email: jasvinder.md@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place