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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002554 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLE@Duke | Experimental | Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic are eligible to participate in the SLE@Duke intervention. Participants complete a baseline survey and training in the Type 1 & 2 SLE Model. They are asked to perform the intervention for all eligible patients over 4 weeks. Patients complete a survey at the end of their clinic visit, and providers complete a survey at the end of the 4 week intervention period. All participating providers were invited to an in-depth interview at the end of the intervention period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLE@Duke | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (month 1), intervention period (month 2) |
| Length of Clinic Visits | Collected from EMR (electronic medical record). | Baseline (month 1), intervention period (month 2) |
| 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." | Baseline (month 1), intervention period (month 2) |
| Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note | Collected from EMR (electronic medical record). | Baseline (month 1), intervention period (month 2) |
| Number of Lupus Patients With Type 2 SLE Treatment in Note | Collected from EMR (electronic medical record). | Baseline (month 1), intervention period (month 2) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Eudy, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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Patients provided data for this study via survey and EMR (electronic medical record), but were not considered enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics data was not collected on the Patients (Survey) group.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data was not collected on Providers or the Patients (Survey) group. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Baseline (month 1), intervention period (month 2) |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Providers | Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic are eligible to participate in the SLE@Duke intervention. Participants complete a baseline survey and training in the Type 1 & 2 SLE Model. They are asked to perform the intervention for all eligible patients over 4 weeks. Patients complete a survey at the end of their clinic visit, and providers complete a survey at the end of the 4 week intervention period. All participating providers were invited to 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Eudy, MSPH, Ph.D. | Duke University | 919-681-1811 | amanda.eudy@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2019 | May 25, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 22, 2021 | Jun 22, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| 4 weeks |
| 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. | 4 weeks |
| 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. | 4 weeks |
| Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note | Collected from EMR (electronic medical record). | Intervention period (month 2), month 5 |
| 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. | Baseline (month 1), intervention period (month 2) |
| 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." | Intervention period (month 2) |
| 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. | Baseline (month 1), intervention period (month 2) |
| 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." | Baseline (month 1), intervention period (month 2) |
| 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. | Baseline (month 1), intervention period (month 2) |
| 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. | Baseline (month 1), intervention period (month 2) |
| 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. | Baseline (month 1), intervention period (month 2) |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | Length of Clinic Visits | Collected from EMR (electronic medical record). | 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. | Posted | Mean | Standard Deviation | minutes | Baseline (month 1), intervention period (month 2) |
|
|
|
|
| Primary | 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." | Participants who completed the baseline and follow-up surveys. Only applies to the Providers group. | Posted | Mean | Standard Deviation | score on a scale | Baseline (month 1), intervention period (month 2) |
|
|
|
|
| Primary | Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note | Collected from EMR (electronic medical record). | 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. | Posted | Count of Participants | Participants | Baseline (month 1), intervention period (month 2) |
|
|
|
|
| Primary | Number of Lupus Patients With Type 2 SLE Treatment in Note | Collected from EMR (electronic medical record). | 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. | Posted | Count of Participants | Participants | Baseline (month 1), intervention period (month 2) |
|
|
|
|
| Primary | 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. | Only applies to the Providers group. Participants who completed the interview. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Primary | 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. | Only applies to the Providers group. Participants who completed the interview. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Primary | 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. | Only applies to the Providers group. Participants who completed the interview. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Primary | Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note | Collected from EMR (electronic medical record). | 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. | Posted | Count of Participants | Participants | Intervention period (month 2), month 5 |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (month 1), intervention period (month 2) |
|
|
|
|
| Primary | 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." | Only applies to the Patients (Survey) group. Patients who responded to the question. | Posted | Count of Participants | Participants | Intervention period (month 2) |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (month 1), intervention period (month 2) |
|
|
|
|
| Primary | 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." | Only applies to the Providers group. Participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline (month 1), intervention period (month 2) |
|
|
|
|
| Primary | 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. | Only applies to the Providers group. Participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline (month 1), intervention period (month 2) |
|
|
|
|
| Primary | 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. | Only applies to the Providers group. Participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline (month 1), intervention period (month 2) |
|
|
|
|
| Primary | 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. | Only applies to the Providers group. Participants who completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline (month 1), intervention period (month 2) |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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 | 49 | 0 | 49 | 0 | 49 |
| EG002 | 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 3-month follow-up. | 0 | 115 | 0 | 115 | 0 | 115 |
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| Unknown or Not Reported |
|
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
|
| Validation of patient experiences |
|
| Title | Measurements |
|---|---|
|
| Need for more information on treating Type 2 SLE |
|
| Staff buy-in |
|
|
| Providers needed a more systematic way of collecting patient surveys |
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| No impact on work flow |
|
|
|
| 0.8 |
| Superiority |
| "I was able to say everything I wanted to say to my rheumatologist" at baseline (month 1) vs. intervention period (month 2). | t-test, 2 sided | 1.0 | Superiority |
| t-test, 2 sided |
| 0.8 |
| Superiority |
| Title | Measurements |
|---|---|
|
| I welcome SLE@Duke. |
|
| 1.0 |
| Superiority |
| "I like SLE@Duke" at baseline (month 1) vs. intervention period (month 2). | t-test, 2 sided | 0.5 | Superiority |
| "I welcome SLE@Duke" at baseline (month 1) vs. intervention period (month 2). | t-test, 2 sided | 0.6 | Superiority |
| Title | Measurements |
|---|---|
|
| SLE@Duke seems like a good match. |
|
| 0.7 |
| Superiority |
| "SLE@Duke seems applicable" at baseline (month 1) vs. intervention period (month 2). | t-test, 2 sided | 1.0 | Superiority |
| "SLE@Duke seems like a good match" at baseline (month 1) vs. intervention period (month 2). | t-test, 2 sided | 1.0 | Superiority |
| Title | Measurements |
|---|---|
|
| SLE@Duke seems easy to use. |
|
| 0.3 |
| Superiority |
| "SLE@Duke seems doable" at baseline (month 1) vs. intervention period (month 2). | t-test, 2 sided | 0.4 | Superiority |
| "SLE@Duke seems easy to use" at baseline (month 1) vs. intervention period (month 2). | t-test, 2 sided | 0.3 | Superiority |