Trial Outcomes & Findings for Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE) (NCT NCT05426902)

NCT ID: NCT05426902

Last Updated: 2023-09-14

Results Overview

Collected from EMR (electronic medical record). This is a composite measure that includes documentation in the clinic note of any component of SLE@Duke: (1) Type 1 \& 2 SLE Model mentioned, (2) dotphrase used, (3) Type 1 \& Type 2 PGAs (Physician Global Assessments) scored in note, (4) handout mentioned, (5) Type 2 symptoms discussed, or (6) purple sheet documented.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: Baseline (month 1), intervention period (month 2)
• Results posted on: 2023-09-14

Participant Flow

Patients provided data for this study via survey and EMR (electronic medical record), but were not considered enrolled.

Participant milestones

Measure	Providers Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period. SLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \& 2 SLE.	Patients (Survey) Patients who completed an anonymous survey at the end of their clinic visit during the 4-week baseline period and 4-week intervention period.	Patients (EMR) Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Overall Study STARTED	16	49	115
Overall Study COMPLETED	16	49	115
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age data was not collected on Providers or the Patients (Survey) group.

Baseline characteristics by cohort

Measure	Providers n=16 Participants Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic were eligible to participate in the SLE@Duke intervention. Participants completed a baseline survey and training on the Type 1 \& 2 SLE Model. They were asked to perform the intervention for all eligible patients over 4 weeks. Patients completed a survey at the end of their clinic visit, and providers completed a survey at the end of the 4-week intervention period. All participating providers were invited to participate in an in-depth interview at the end of the intervention period. SLE@Duke: SLE@Duke is a set of tools to implement the Type 1 \& 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 \& 2 SLE.	Patients (Survey) Patients who completed an anonymous survey at the end of their clinic visit during the 4-week baseline period and 4-week intervention period.	Patients (EMR) n=115 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.	Total n=131 Participants Total of all reporting groups
Age, Continuous	—	—	48.0 years STANDARD_DEVIATION 16.2 • n=115 Participants • Age data was not collected on Providers or the Patients (Survey) group.	48 years STANDARD_DEVIATION 16.2 • n=115 Participants • Age data was not collected on Providers or the Patients (Survey) group.
Sex/Gender, Customized Sex/Gender · Female	8 Participants n=16 Participants	—	95 Participants n=115 Participants	103 Participants n=131 Participants
Sex/Gender, Customized Sex/Gender · Male	5 Participants n=16 Participants	—	20 Participants n=115 Participants	25 Participants n=131 Participants
Sex/Gender, Customized Sex/Gender · Unknown or Not Reported	3 Participants n=16 Participants	—	0 Participants n=115 Participants	3 Participants n=131 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=16 Participants	—	6 Participants n=115 Participants	6 Participants n=131 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=16 Participants	—	106 Participants n=115 Participants	119 Participants n=131 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=16 Participants	—	3 Participants n=115 Participants	6 Participants n=131 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=16 Participants	—	0 Participants n=115 Participants	0 Participants n=131 Participants
Race (NIH/OMB) Asian	4 Participants n=16 Participants	—	5 Participants n=115 Participants	9 Participants n=131 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants	—	0 Participants n=115 Participants	0 Participants n=131 Participants
Race (NIH/OMB) Black or African American	1 Participants n=16 Participants	—	67 Participants n=115 Participants	68 Participants n=131 Participants
Race (NIH/OMB) White	8 Participants n=16 Participants	—	40 Participants n=115 Participants	48 Participants n=131 Participants
Race (NIH/OMB) More than one race	0 Participants n=16 Participants	—	0 Participants n=115 Participants	0 Participants n=131 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=16 Participants	—	3 Participants n=115 Participants	6 Participants n=131 Participants
Region of Enrollment United States	16 Participants n=16 Participants	—	115 Participants n=115 Participants	131 Participants n=131 Participants

PRIMARY outcome

Timeframe: Baseline (month 1), intervention period (month 2)

Population: Only applies to the Patients (EMR) group. 36 patient medical records were reviewed during the 4-week baseline period. 31 patient medical records were reviewed during the 4-week intervention period.

Collected from EMR (electronic medical record). This is a composite measure that includes documentation in the clinic note of any component of SLE@Duke: (1) Type 1 & 2 SLE Model mentioned, (2) dotphrase used, (3) Type 1 & Type 2 PGAs (Physician Global Assessments) scored in note, (4) handout mentioned, (5) Type 2 symptoms discussed, or (6) purple sheet documented.

Outcome measures

Measure	Patients (EMR) n=67 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Number of Patients' Rheumatologists Using SLE@Duke Intervention period	30 Participants
Number of Patients' Rheumatologists Using SLE@Duke Baseline	16 Participants

PRIMARY outcome

Timeframe: Baseline (month 1), intervention period (month 2)

Population: Only applies to the Patients (EMR) group. 36 patient medical records were reviewed during the 4-week baseline period. 31 patient medical records were reviewed during the 4-week intervention period.

Collected from EMR (electronic medical record).

Outcome measures

Measure	Patients (EMR) n=67 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Length of Clinic Visits Baseline (month 1)	67.8 minutes Standard Deviation 22.4
Length of Clinic Visits Intervention period (month 2)	70.9 minutes Standard Deviation 28.8

PRIMARY outcome

Timeframe: Baseline (month 1), intervention period (month 2)

Population: Participants who completed the baseline and follow-up surveys. Only applies to the Providers group.

Satisfaction was measured on a scale of 1-5, where 1 = never and 5 = always in response to the statement: "After seeing a patient with lupus, I leave the exam room feeling satisfied with the encounter."

Outcome measures

Measure	Patients (EMR) n=12 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey	0.44 score on a scale Standard Deviation 0.73

PRIMARY outcome

Timeframe: Baseline (month 1), intervention period (month 2)

Population: Only applies to the Patients (EMR) group. 36 patient medical records were reviewed during the 4-week baseline period. 31 patient medical records were reviewed during the 4-week intervention period.

Collected from EMR (electronic medical record).

Outcome measures

Measure	Patients (EMR) n=67 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note Baseline (month 1)	0 Participants
Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note Intervention period (month 2)	27 Participants

PRIMARY outcome

Timeframe: Baseline (month 1), intervention period (month 2)

Population: Only applies to the Patients (EMR) group. 36 patient medical records were reviewed during the 4-week baseline period. 31 patient medical records were reviewed during the 4-week intervention period.

Collected from EMR (electronic medical record).

Outcome measures

Measure	Patients (EMR) n=67 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Number of Lupus Patients With Type 2 SLE Treatment in Note Baseline (month 1)	5 Participants
Number of Lupus Patients With Type 2 SLE Treatment in Note Intervention period (month 2)	8 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Only applies to the Providers group. Participants who completed the interview.

In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.

Outcome measures

Measure	Patients (EMR) n=13 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Perceived Benefits of SLE@Duke, as Measured by Provider Interviews Improved conversations with patients	9 Participants
Perceived Benefits of SLE@Duke, as Measured by Provider Interviews Improved patient understanding	8 Participants
Perceived Benefits of SLE@Duke, as Measured by Provider Interviews Improved quality of care	7 Participants
Perceived Benefits of SLE@Duke, as Measured by Provider Interviews Validation of patient experiences	5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Only applies to the Providers group. Participants who completed the interview.

In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.

Outcome measures

Measure	Patients (EMR) n=13 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Perceived Barriers of SLE@Duke, as Measured by Provider Interviews Not seeing a lot of lupus patients	4 Participants
Perceived Barriers of SLE@Duke, as Measured by Provider Interviews Need for more information on treating Type 2 SLE	3 Participants
Perceived Barriers of SLE@Duke, as Measured by Provider Interviews Staff buy-in	3 Participants
Perceived Barriers of SLE@Duke, as Measured by Provider Interviews Need for more training	4 Participants
Perceived Barriers of SLE@Duke, as Measured by Provider Interviews Slows down the clinic visit	4 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Only applies to the Providers group. Participants who completed the interview.

In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.

Outcome measures

Measure	Patients (EMR) n=13 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews Staff needed more training	5 Participants
How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews Providers needed more clinic support staff	4 Participants
How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews Providers had difficulty getting into a routine because of small lupus population in their clinic	4 Participants
How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews Providers needed a more systematic way of collecting patient surveys	3 Participants
How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews No impact on work flow	4 Participants

PRIMARY outcome

Timeframe: Intervention period (month 2), month 5

Population: Only applies to the Patients (EMR) group. 31 patient medical records were reviewed during the 4-week intervention period. 48 patient medical records were reviewed during the 4-week 3-month follow-up period.

Collected from EMR (electronic medical record).

Outcome measures

Measure	Patients (EMR) n=79 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note Intervention period (month 2)	0 Participants
Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note Follow-up (month 5)	0 Participants

PRIMARY outcome

Timeframe: Baseline (month 1), intervention period (month 2)

Population: Only applies to the Patients (Survey) group. 19 patients completed surveys during the 4-week baseline period. 30 different patients completed surveys during the 4-week intervention period.

Each question pertaining to quality of visit was measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.

Outcome measures

Measure	Patients (EMR) n=49 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Difference in Perceived Quality of Visit, as Measured by Patient Survey I feel good about my medical visit.	0.1 score on a scale Standard Deviation 0.8
Difference in Perceived Quality of Visit, as Measured by Patient Survey My rheumatologist gave me his/her full attention.	0.06 score on a scale Standard Deviation 0.8
Difference in Perceived Quality of Visit, as Measured by Patient Survey I was able to say everything I wanted to say to my rheumatologist.	0.01 score on a scale Standard Deviation 0.7

PRIMARY outcome

Timeframe: Intervention period (month 2)

Population: Only applies to the Patients (Survey) group. Patients who responded to the question.

The patient survey asked patients to respond "Yes" or "No" in response to the statement: "My rheumatologist discussed Type 1 & Type 2 lupus with me today."

Outcome measures

Measure	Patients (EMR) n=25 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Discussion of the Type 1 and 2 Model, as Measured by Patient Survey Yes	17 Participants
Discussion of the Type 1 and 2 Model, as Measured by Patient Survey No	8 Participants

PRIMARY outcome

Timeframe: Baseline (month 1), intervention period (month 2)

Population: Only applies to Patients (Survey) group. 19 patients completed surveys during the 4-week baseline period. 30 different patients completed surveys during the 4-week intervention period.

Questions pertaining to understanding were measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.

Outcome measures

Measure	Patients (EMR) n=49 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey My rheumatologist and I agreed on how active my lupus was today.	0.1 score on a scale Standard Deviation 0.8
Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey I understand the care recommendations that my doctor or provider gave me today.	0.1 score on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: Baseline (month 1), intervention period (month 2)

Population: Only applies to the Providers group. Participants who completed the survey.

Discussion of the Type 1 & 2 SLE Model was measured on a scale of 1-5, where 1 = "never" and 5 = "always" in response to the statement: "I discuss the Type 1 & 2 SLE Model with the patient."

Outcome measures

Measure	Patients (EMR) n=14 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey	1.0 score on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: Baseline (month 1), intervention period (month 2)

Population: Only applies to the Providers group. Participants who completed the survey.

Questions pertaining to acceptability of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.

Outcome measures

Measure	Patients (EMR) n=14 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Change in Acceptability of SLE@Duke, as Measured by Provider Survey I welcome SLE@Duke.	-0.2 score on a scale Standard Deviation 0.7
Change in Acceptability of SLE@Duke, as Measured by Provider Survey SLE@Duke meets my approval.	-0.1 score on a scale Standard Deviation 0.6
Change in Acceptability of SLE@Duke, as Measured by Provider Survey SLE@Duke is appealing to me.	0.0 score on a scale Standard Deviation 0.6
Change in Acceptability of SLE@Duke, as Measured by Provider Survey I like SLE@Duke.	-0.2 score on a scale Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline (month 1), intervention period (month 2)

Population: Only applies to the Providers group. Participants who completed the survey.

Questions pertaining to the appropriateness of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.

Outcome measures

Measure	Patients (EMR) n=14 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Change in Appropriateness of SLE@Duke, as Measured by Provider Survey SLE@Duke seems fitting.	-0.1 score on a scale Standard Deviation 0.6
Change in Appropriateness of SLE@Duke, as Measured by Provider Survey SLE@Duke seems suitable.	-0.1 score on a scale Standard Deviation 0.6
Change in Appropriateness of SLE@Duke, as Measured by Provider Survey SLE@Duke seems applicable.	0.0 score on a scale Standard Deviation 0.6
Change in Appropriateness of SLE@Duke, as Measured by Provider Survey SLE@Duke seems like a good match.	0.0 score on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline (month 1), intervention period (month 2)

Population: Only applies to the Providers group. Participants who completed the survey.

Questions concerning feasibility of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.

Outcome measures

Measure	Patients (EMR) n=14 Participants Electronic medical records (EMRs) of patients with a return visit and diagnosis of SLE who were seen by a participating rheumatology provider were reviewed for outcomes during the 4-week baseline period, 4-week intervention period, and a 4-week follow-up period starting at 3 months after the intervention period.
Change in Feasibility of SLE@Duke, as Measured by Provider Survey SLE@Duke seems implementable.	0.3 score on a scale Standard Deviation 0.6
Change in Feasibility of SLE@Duke, as Measured by Provider Survey SLE@Duke seems possible.	0.3 score on a scale Standard Deviation 0.5
Change in Feasibility of SLE@Duke, as Measured by Provider Survey SLE@Duke seems doable.	0.2 score on a scale Standard Deviation 0.5
Change in Feasibility of SLE@Duke, as Measured by Provider Survey SLE@Duke seems easy to use.	0.4 score on a scale Standard Deviation 0.9

Adverse Events

Providers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients (Survey)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients (EMR)

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

Amanda Eudy, MSPH, Ph.D.

Duke University

Phone: 919-681-1811

Email: amanda.eudy@duke.edu

Results disclosure agreements

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