Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus
Brief summary
The purpose of this study is to pilot test SLE@Duke, a set of tools to implement the Type 1 & 2 SLE Model in a clinical setting, as well as to gain an in-depth understanding of providers experiences using the intervention during clinic visits with patients with systemic lupus erythematosus. This record represents Aim 3 of this study.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* All providers in Duke Rheumatology who practice outside of the Duke Lupus Clinic are eligible. * Patients are eligible to participate if they have an established diagnosis of SLE and are followed in Duke Rheumatology. * All patients with a SLE diagnosis will be included in the analysis. SLE diagnosis will be based on an ICD-10 code for SLE (M32.1\*, M32.8, M32.9) in the EMR.
Exclusion criteria
* New patients will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients' Rheumatologists Using SLE@Duke | Baseline (month 1), intervention period (month 2) | 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. |
| Length of Clinic Visits | Baseline (month 1), intervention period (month 2) | Collected from EMR (electronic medical record). |
| Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey | Baseline (month 1), intervention period (month 2) | 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. |
| Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note | Baseline (month 1), intervention period (month 2) | Collected from EMR (electronic medical record). |
| Number of Lupus Patients With Type 2 SLE Treatment in Note | Baseline (month 1), intervention period (month 2) | Collected from EMR (electronic medical record). |
| Perceived Benefits of SLE@Duke, as Measured by Provider Interviews | 4 weeks | In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke. |
| Perceived Barriers of SLE@Duke, as Measured by Provider Interviews | 4 weeks | In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke. |
| How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews | 4 weeks | In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke. |
| Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note | Intervention period (month 2), month 5 | Collected from EMR (electronic medical record). |
| Difference in Perceived Quality of Visit, as Measured by Patient Survey | Baseline (month 1), intervention period (month 2) | 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. |
| Discussion of the Type 1 and 2 Model, as Measured by Patient Survey | Intervention period (month 2) | 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. |
| Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey | Baseline (month 1), intervention period (month 2) | 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. |
| Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey | Baseline (month 1), intervention period (month 2) | 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. |
| Change in Acceptability of SLE@Duke, as Measured by Provider Survey | Baseline (month 1), intervention period (month 2) | Questions pertaining to acceptability of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree. |
| Change in Appropriateness of SLE@Duke, as Measured by Provider Survey | Baseline (month 1), intervention period (month 2) | Questions pertaining to the appropriateness of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree. |
| Change in Feasibility of SLE@Duke, as Measured by Provider Survey | Baseline (month 1), intervention period (month 2) | Questions concerning feasibility of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree. |
Countries
United States
Participant flow
Pre-assignment details
Patients provided data for this study via survey and EMR (electronic medical record), but were not considered enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 0 |
| 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. | 115 |
| Total | 131 |
Baseline characteristics
| Characteristic | Patients (EMR) | Total | Providers |
|---|---|---|---|
| Age, Continuous | 48.0 years STANDARD_DEVIATION 16.2 | 48 years STANDARD_DEVIATION 16.2 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 6 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants | 119 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 67 Participants | 68 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 40 Participants | 48 Participants | 8 Participants |
| Region of Enrollment United States | 115 Participants | 131 Participants | 16 Participants |
| Sex/Gender, Customized Sex/Gender Female | 95 Participants | 103 Participants | 8 Participants |
| Sex/Gender, Customized Sex/Gender Male | 20 Participants | 25 Participants | 5 Participants |
| Sex/Gender, Customized Sex/Gender Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 49 | 0 / 115 |
| other Total, other adverse events | 0 / 16 | 0 / 49 | 0 / 115 |
| serious Total, serious adverse events | 0 / 16 | 0 / 49 | 0 / 115 |
Outcome results
Change in Acceptability of SLE@Duke, as Measured by Provider Survey
Questions pertaining to acceptability of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Time frame: Baseline (month 1), intervention period (month 2)
Population: Only applies to the Providers group. Participants who completed the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients (EMR) | 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 |
| Patients (EMR) | 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 |
| Patients (EMR) | 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 |
| Patients (EMR) | 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 Appropriateness of SLE@Duke, as Measured by Provider 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.
Time frame: Baseline (month 1), intervention period (month 2)
Population: Only applies to the Providers group. Participants who completed the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients (EMR) | 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 |
| Patients (EMR) | 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 |
| Patients (EMR) | 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 |
| Patients (EMR) | 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 |
Change in Discussion of the Type 1 and 2 Model, as Measured by Provider 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.
Time frame: Baseline (month 1), intervention period (month 2)
Population: Only applies to the Providers group. Participants who completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients (EMR) | 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 |
Change in Feasibility of SLE@Duke, as Measured by Provider Survey
Questions concerning feasibility of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Time frame: Baseline (month 1), intervention period (month 2)
Population: Only applies to the Providers group. Participants who completed the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients (EMR) | 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 |
| Patients (EMR) | 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 |
| Patients (EMR) | 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 |
| Patients (EMR) | 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 |
Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey
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.
Time frame: Baseline (month 1), intervention period (month 2)
Population: Participants who completed the baseline and follow-up surveys. Only applies to the Providers group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients (EMR) | Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey | 0.44 score on a scale | Standard Deviation 0.73 |
Difference in Perceived Quality of Visit, as Measured by Patient Survey
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients (EMR) | 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 |
| Patients (EMR) | 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 |
| Patients (EMR) | 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 |
Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients (EMR) | 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 |
| Patients (EMR) | 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 |
Discussion of the Type 1 and 2 Model, as Measured by Patient Survey
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.
Time frame: Intervention period (month 2)
Population: Only applies to the Patients (Survey) group. Patients who responded to the question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients (EMR) | Discussion of the Type 1 and 2 Model, as Measured by Patient Survey | Yes | 17 Participants |
| Patients (EMR) | Discussion of the Type 1 and 2 Model, as Measured by Patient Survey | No | 8 Participants |
How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Time frame: 4 weeks
Population: Only applies to the Providers group. Participants who completed the interview.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients (EMR) | How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews | Staff needed more training | 5 Participants |
| Patients (EMR) | How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews | Providers needed more clinic support staff | 4 Participants |
| Patients (EMR) | 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 |
| Patients (EMR) | How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews | Providers needed a more systematic way of collecting patient surveys | 3 Participants |
| Patients (EMR) | How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews | No impact on work flow | 4 Participants |
Length of Clinic Visits
Collected from EMR (electronic medical record).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients (EMR) | Length of Clinic Visits | Baseline (month 1) | 67.8 minutes | Standard Deviation 22.4 |
| Patients (EMR) | Length of Clinic Visits | Intervention period (month 2) | 70.9 minutes | Standard Deviation 28.8 |
Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note
Collected from EMR (electronic medical record).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients (EMR) | Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note | Baseline (month 1) | 0 Participants |
| Patients (EMR) | Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note | Intervention period (month 2) | 27 Participants |
Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note
Collected from EMR (electronic medical record).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients (EMR) | Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note | Intervention period (month 2) | 0 Participants |
| Patients (EMR) | Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note | Follow-up (month 5) | 0 Participants |
Number of Lupus Patients With Type 2 SLE Treatment in Note
Collected from EMR (electronic medical record).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients (EMR) | Number of Lupus Patients With Type 2 SLE Treatment in Note | Baseline (month 1) | 5 Participants |
| Patients (EMR) | Number of Lupus Patients With Type 2 SLE Treatment in Note | Intervention period (month 2) | 8 Participants |
Number of Patients' Rheumatologists Using SLE@Duke
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients (EMR) | Number of Patients' Rheumatologists Using SLE@Duke | Baseline | 16 Participants |
| Patients (EMR) | Number of Patients' Rheumatologists Using SLE@Duke | Intervention period | 30 Participants |
Perceived Barriers of SLE@Duke, as Measured by Provider Interviews
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Time frame: 4 weeks
Population: Only applies to the Providers group. Participants who completed the interview.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients (EMR) | Perceived Barriers of SLE@Duke, as Measured by Provider Interviews | Need for more training | 4 Participants |
| Patients (EMR) | Perceived Barriers of SLE@Duke, as Measured by Provider Interviews | Slows down the clinic visit | 4 Participants |
| Patients (EMR) | Perceived Barriers of SLE@Duke, as Measured by Provider Interviews | Not seeing a lot of lupus patients | 4 Participants |
| Patients (EMR) | Perceived Barriers of SLE@Duke, as Measured by Provider Interviews | Need for more information on treating Type 2 SLE | 3 Participants |
| Patients (EMR) | Perceived Barriers of SLE@Duke, as Measured by Provider Interviews | Staff buy-in | 3 Participants |
Perceived Benefits of SLE@Duke, as Measured by Provider Interviews
In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Time frame: 4 weeks
Population: Only applies to the Providers group. Participants who completed the interview.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients (EMR) | Perceived Benefits of SLE@Duke, as Measured by Provider Interviews | Improved conversations with patients | 9 Participants |
| Patients (EMR) | Perceived Benefits of SLE@Duke, as Measured by Provider Interviews | Improved patient understanding | 8 Participants |
| Patients (EMR) | Perceived Benefits of SLE@Duke, as Measured by Provider Interviews | Improved quality of care | 7 Participants |
| Patients (EMR) | Perceived Benefits of SLE@Duke, as Measured by Provider Interviews | Validation of patient experiences | 5 Participants |