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| ID | Type | Description | Link |
|---|---|---|---|
| CE-1304-6631 | Other Grant/Funding Number | PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE (PCORI) |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The study will attempt to put into practice a shared decision making (SDM) strategy, using an individualized, computerized decision- aid (DA) for Systemic lupus erythematosus (SLE).
The proposed study will evaluate methods to implement a shared decision making strategy, using an individualized, computerized decision- aid (DA). The investigators will test the effectiveness of this implementation with 3 strategies in 15 clinics. Formative evaluation strategies will be used to assess needs at each clinic, with key clinic informants participating in semi-structured interviews. The study will enroll patient participants across all 16 sites, who will review the decision aid and be asked a feasibility and acceptability assessment. At the conclusion of the study, key clinic informants, as well as selected patient participants will participate in semi-structured interviews to assess the effectiveness in implementing the DA in the clinic setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lupus Patients | All adult lupus patients, regardless of if they are having an active flare |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMILE Computerized Decision-Aid | Other | SMILE is a computerized decision-aid designed to give lupus patients information about lupus, treatments for lupus available to them, as well as side effects. This will be administered at every lupus clinic session. Every patient will see the SMILE Computerized Decision-Aid at their index baseline clinic visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Penetration/Reach: Number of Eligible Participants at Each Clinical Site Who Enrolled Divided by the Number of Eligible Participants at Each Clinical Site, Expressed as Overall Percent | Reach/penetration was measured by calculating a ratio of patients who were enrolled in the implementation project (# of patients who viewed the SLE PtDA) divided by the number of Eligible Participants at Each Clinical Site identified using the electronic medical record (EMR) in the respective clinic (# of eligible patients). The number of eligible patients was based on the average number of patients with a diagnosis of lupus seen in each clinic over the study period (2019-2023). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Acceptability of Intervention Measure (AIM) by Clinic Personnel for the SLE Patient Decision-aid | Clinic personnel's perception of the acceptability of the SLE Patient decision-aid (PtDA), measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater acceptability (i.e., better outcome). |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
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Patients will be enrolled from lupus clinics at 15 sites throughout the country.
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| Name | Affiliation | Role |
|---|---|---|
| Jasvinder A Singh, MD, MPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40975111 | Derived | Singh JA, Hearld LR, Eisen S, Chatham WW, Narain S, Annapureddy N, Kamen DL, Trotter K, Majithia V, Ching CL, Aouhab Z, Venuturupalli S, Wallace DJ, Ramsey-Goldman R, Kim AHJ, McMahon M, Lim SS, Bhairavarasu K, Meara A, Kalunian K, Beasley M. Patient outcomes from implementing a shared decision-making aid for systemic lupus erythematosus: a prospective implementation study. Lancet Rheumatol. 2026 Apr;8(4):e253-e264. doi: 10.1016/S2665-9913(25)00130-4. Epub 2025 Sep 17. | |
| 40953958 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lupus Patients | All lupus patients, regardless of if they are having an active flare, participated. There was no randomly assigned arms or conditions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lupus Patients | All lupus patients, regardless of if they are having an active flare. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Missing data = 6 |
| 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 | Penetration/Reach: Number of Eligible Participants at Each Clinical Site Who Enrolled Divided by the Number of Eligible Participants at Each Clinical Site, Expressed as Overall Percent | Reach/penetration was measured by calculating a ratio of patients who were enrolled in the implementation project (# of patients who viewed the SLE PtDA) divided by the number of Eligible Participants at Each Clinical Site identified using the electronic medical record (EMR) in the respective clinic (# of eligible patients). The number of eligible patients was based on the average number of patients with a diagnosis of lupus seen in each clinic over the study period (2019-2023). | Reach/penetration = # of patients viewed DA / # of eligible patients | Posted | Number | Participants | 24 months |
|
6 months
Our evidence-based patient-centered lupus PtDA is an educational tool that addresses important preference-sensitive treatment decisions faced by patients with SLE by providing balanced information.
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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 | Lupus Patients | All lupus patients, regardless of if they are having an active flare |
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We had few private practice clinics. Most sites were largely academic center clinics. Potential applications of the SLE PtDA to other settings are unexplored to date. Most outcome measures were patient-reported and subjective in nature and therefore may be impacted by social desirability. Satisfaction, acceptability and feasibility, likely had ceiling effects. Not every participant completed all follow-up surveys. Actual sustainability in these clinics cannot be assessed until years have passed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jasvinder Singh, MD, MPH; Senior Faculty and Chief of Immunology, Allergy, and Rheumatology | Baylor College of Medicine | 713.798.1365 | jasvinder.md@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Doc2 | Jun 10, 2020 | Aug 13, 2025 | Prot_SAP_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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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
|
| 24 months |
| Perceived DA Implementation Success by Clinic Personnel for the SLE Patient Decision-aid | Clinic personnel's perception of the implementation success of the SLE Patient decision-aid (PtDA), measured using a validated scale with three (3) items with responses ranging from 1 ("Disagree") to 5 ("Agree"). These three items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater implementation success (i.e., better outcome). | 24 months |
| Perceived DA Permanence by Clinic Personnel for the SLE Patient Decision-aid | Clinic personnel's perception of the permanence of the SLE Patient decision-aid (PtDA), measured using one validated item that is scored ranging from 1 ("Not at all permanent") to 5 ("Extremely permanent"). This item will be examined by itself, where higher scores indicate perceptions of greater permanence of the decision-aid in the clinic (i.e., better outcome). | 24 months |
| Perceived Intervention Appropriateness Measure (IAM) by Clinic Personnel for the SLE Patient Decision-aid | Clinic personnel's perception of the appropriateness of the SLE Patient decision-aid (PtDA), measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater appropriateness (i.e., better outcome). | 24 Months |
| Perceived Feasibility of Intervention Measure (FIM) by Clinic Personnel for the SLE Patient Decision-aid | Clinic personnel's perception of the feasibility of the SLE Patient decision-aid (PtDA), measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater feasibility (i.e., better outcome). | 24 Months |
| Patient Decisional Conflict Scale Related to Medication Treatment Decision-making for SLE Medications Including the Immunosuppressive Medications and Biologics After Viewing the SLE Patient Decision-aid | Decisional conflict was measured using the low literacy version of the Decisional Conflict Scale (DCS), a well-validated self-administered instrument, after viewing the SLE Patient decision-aid (PtDA). The low literacy version has 10 items with 3 response categories: yes, unsure, and no. Four subscale scores consisting of uncertainty about choice, feeling informed, values clarity, and feeling supported in decision-making were also calculated. DCS (and subscale) scores range from 0 (best) to 100 (worst) and scores >= 25 are consistent with clinically significant residual decisional conflict | 6 Months |
| Patient-reported Interpersonal Processes of Care for Patient-Physician Communication After Viewing the SLE Patient Decision-aid | The Interpersonal Processes of Care short form (IPC-SF) is a patient-reported, 18-item validated patient-reported patient-physician communication and care processes measure, assessed after viewing the SLE Patient decision-aid (PtDA). Scores range from 18 to 90, with higher scores indicating better patient-physician communication ± care. | 6 Months |
| Patient Satisfaction for SLE Patient Decision-aid | Patient satisfaction with the ease of the use of the SLE Patient Decision-aid (PtDA) measured using a validated single item scale scored on an ordinal scale from (strongly disagree =1) to (strongly agree = 5). This item will be examined by itself, where higher scores indicate greater patient satisfaction with the decision aid (i.e., better outcome). This is a single item scale, and there are no subscales. It was adapted from another study that assessed satisfaction with iPad or interactive voice response. | 6 months |
| Patient Time for Reviewing SLE Patient Decision-aid | The SLE Patient Decision-aid (PtDA) review times was expressed in minutes as patient-reported; this was supplemented by study coordinator's record of patient DA review time in-clinic prior to addition of this question. This patient self-reported question was added at the onset of the COVID-19 pandemic, where shelter-in-place orders led to stopping of in-person outpatient visits and all vists were converted to virtual visits using the phone or the video (Telemedicine). | 6 Months |
| Patient Preparation for Decision Making Assessed After Viewing the SLE Patient Decision-aid | Patient perception of the effect of the decision-aid on preparing the patient for decision making measured using the Patient Preparation for Decision Making (PDM) , a validated scale consisting of 10 questions scored on an ordinal scale from (not at all =1) to (a great deal = 5. Score ranged 0-100, 100 representing the highest preparation for decision-making. This was assessed after viewing the SLE Patient decision-aid (PtDA). | Baseline visit after viewing the SLE Patient Decision-Aid (PtDA) |
| Patient Acceptability of the SLE Patient Decision-Aid | The patient acceptability survey is for the assessment of patient acceptability of the SLE Patient Decision-Aid (PtDA). Each question was rated from Poor (1) to Excellent (4). Total score ranged 1-4. DA acceptability refers to rating regarding the comprehensibility of component of the decision-aid, its length, pace, amount of the information, and the balance in presentation of the information about the options available and the overall suitability for decision making. | Baseline visit after viewing the SLE PtDA |
| Patient Feasibility of the SLE Patient Decision-Aid | The feasibility of the study survey completion and the administration of the lupus decision aid in the busy clinic were assessed with a self-administered patient questionnaire consisting of 4 questions, 2 questions for each, the survey and for the process of viewing ± administering the lupus DA in the busy clinic. Responses ranged from strongly disagree (=1) to strongly agree (=5). Higher scores indicate higher feasibility of the survey and of the SLE Patient Decision-Aid (PtDA) administration respectively. | Baseline visit after viewing the SLE PtDA |
| Number of Participants Who Perceived the SLE Patient Decision-Aid to be Useful | Patient perception of the SLE Patient Decision-Aid (PtDA) usefulness was aimed at assessing whether people would consider the the SLE PtDA to be useful at present and when they would think back to the time, they had made decisions about lupus treatments in the past (question 1), and whether the information contained in the lupus DA were adequate (question 2). It measured patient response of Yes vs. no to two simple questions. The tool is not yet a validated assessment but was based on our debriefing of lupus patients in the previous randomized study of lupus decision-aid. | Baseline visit after viewing the SLE PtDA |
| Derived |
| Singh JA, Beasley TM. Association of Patient Resilience With Patient-Reported Physical and Mental/Emotional Quality of Life in Systemic Lupus Erythematosus. J Rheumatol. 2025 Dec 1;52(12):1263-1273. doi: 10.3899/jrheum.2025-0396. |
| 40221862 | Derived | Ribeiro AL, Singla S, Hay-Rollins C, Chronis N, Liao W, Lindsay C, Soriano ER, Chandran V, Letarouilly JG, Mease PJ, Proft F. Deciphering difficult-to-treat psoriatic arthritis: insights from an international survey of patients with psoriatic arthritis. Rheumatology (Oxford). 2025 Aug 1;64(8):4641-4649. doi: 10.1093/rheumatology/keaf207. |
| 40221856 | Derived | Singh JA, Hearld LR, Eisen S, Chatham WW, Narain S, Annapureddy N, Kamen DL, Trotter K, Majithia V, Lee Ching C, Aouhab Z, Venuturupalli S, Wallace DJ, Ramsey-Goldman R, Kim A, McMahon M, Sam Lim S, Bhairavarasu K, Meara A, Kalunian K, Beasley TM; Implementing DEcision-Aid for Lupus in clinics (IDEAL) Consortium. Implementation outcomes of a patient decision-aid in a diverse population with systemic lupus erythematosus in 15 US rheumatology clinics. Rheumatology (Oxford). 2025 Aug 1;64(8):4631-4640. doi: 10.1093/rheumatology/keaf205. |
| 39873723 | Derived | Blanchard EE, Hall AG, Gore E, Jami PY, Karabukayeva A, Hearld LR, Gontarz S, Singh JA. Barriers to and facilitators of sustaining a systemic lupus erythematosus (SLE) patient decision aid in regular rheumatology outpatient care in the USA. Rheumatology (Oxford). 2025 Jun 1;64(6):3580-3586. doi: 10.1093/rheumatology/keaf043. |
| 33706813 | Derived | Singh JA, Hearld LR, Hall AG, Beasley TM. Implementing the DEcision-Aid for Lupus (IDEAL): study protocol of a multi-site implementation trial with observational, case study design : Implementing the DEcision-Aid for Lupus. Implement Sci Commun. 2021 Mar 11;2(1):30. doi: 10.1186/s43058-021-00118-9. |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Missing data = 23 | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Missing data = 21 | Count of Participants | Participants | No |
|
| Insurance Payer Type | 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) | Count of Participants | Participants | No |
|
| Education level | 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) | Count of Participants | Participants | No |
|
| Marital status | 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) | Count of Participants | Participants | No |
|
| Residence | 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) | Count of Participants | Participants | No |
|
| OG001 | University of Alabama at Birmingham (UAB), Birmingham | Penetration of DA at University of Alabama at Birmingham, Birmingham, Alabama |
| OG002 | Vanderbilt University, Nashville | Penetration of DA at Vanderbilt University, Nashville, Tennessee |
| OG003 | University of Chicago, Chicago | Penetration of DA at the University of Chicago, Chicago (UChicago), Illinois |
| OG004 | University of Mississippi Medical Center (UMMC), Jackson | Penetration of DA at the University of Mississippi Medical center, Jackson, Mississippi |
| OG005 | Cedars Cedars-Sinai Medical Center, Los Angeles | Penetration of DA at Cedars-Sinai Medical Center, Los Angeles, California |
| OG006 | Baylor College of Medicine, Houston | Penetration of DA at the Baylor College of Medicine, Houston, Texas |
| OG007 | Northwestern University, Chicago | Penetration of DA at the Northwestern University, Chicago, Illinois |
| OG008 | Emory University, Atlanta | Penetration of DA at the Emory University, Atlanta, Georgia |
| OG009 | Medical University of South Carolina (MUSC), Charleston | Penetration of DA at the Medical University of South Carolina (MUSC), Charleston, SC |
| OG010 | Northwell Health, New York | Penetration of DA at the Northwell Health, New York, New York |
| OG011 | University of California (UCLA), Los Angeles | Penetration of DA at the University of California (UCLA), Los Angeles, California |
| OG012 | Ohio State University (OSU), Columbus | Penetration of DA at the Ohio State University (OSU), Columbus, Ohio |
| OG013 | 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 |
| OG014 | Washington University, St. Louis | Penetration of DA at the Washington University, St. Louis, Missouri |
|
|
|
| Secondary | Perceived Acceptability of Intervention Measure (AIM) by Clinic Personnel for the SLE Patient Decision-aid | Clinic personnel's perception of the acceptability of the SLE Patient decision-aid (PtDA), measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater acceptability (i.e., better outcome). | 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. | Posted | Mean | Standard Deviation | score on a scale (range 1-5) | 24 months |
|
|
|
| Secondary | Perceived DA Implementation Success by Clinic Personnel for the SLE Patient Decision-aid | Clinic personnel's perception of the implementation success of the SLE Patient decision-aid (PtDA), measured using a validated scale with three (3) items with responses ranging from 1 ("Disagree") to 5 ("Agree"). These three items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater implementation success (i.e., better outcome). | 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. | Posted | Mean | Standard Deviation | score on a scale (range 1-5) | 24 months |
|
|
|
| Secondary | Perceived DA Permanence by Clinic Personnel for the SLE Patient Decision-aid | Clinic personnel's perception of the permanence of the SLE Patient decision-aid (PtDA), measured using one validated item that is scored ranging from 1 ("Not at all permanent") to 5 ("Extremely permanent"). This item will be examined by itself, where higher scores indicate perceptions of greater permanence of the decision-aid in the clinic (i.e., better outcome). | 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. | Posted | Mean | Standard Deviation | score on a scale (range 1-5) | 24 months |
|
|
|
| Secondary | Perceived Intervention Appropriateness Measure (IAM) by Clinic Personnel for the SLE Patient Decision-aid | Clinic personnel's perception of the appropriateness of the SLE Patient decision-aid (PtDA), measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater appropriateness (i.e., better outcome). | 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. | Posted | Mean | Standard Deviation | score on a scale (range 1-5) | 24 Months |
|
|
|
| Secondary | Perceived Feasibility of Intervention Measure (FIM) by Clinic Personnel for the SLE Patient Decision-aid | Clinic personnel's perception of the feasibility of the SLE Patient decision-aid (PtDA), measured using a validated scale with four (4) items with responses ranging from 1 ("completely disagree") to 5 ("completely agree"). The four items will be averaged to create one composite mean scale score (range 1-5), where higher scores reflect perceptions of greater feasibility (i.e., better outcome). | 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. | Posted | Mean | Standard Deviation | score on a scale (range 1-5) | 24 Months |
|
|
|
| Secondary | Patient Decisional Conflict Scale Related to Medication Treatment Decision-making for SLE Medications Including the Immunosuppressive Medications and Biologics After Viewing the SLE Patient Decision-aid | Decisional conflict was measured using the low literacy version of the Decisional Conflict Scale (DCS), a well-validated self-administered instrument, after viewing the SLE Patient decision-aid (PtDA). The low literacy version has 10 items with 3 response categories: yes, unsure, and no. Four subscale scores consisting of uncertainty about choice, feeling informed, values clarity, and feeling supported in decision-making were also calculated. DCS (and subscale) scores range from 0 (best) to 100 (worst) and scores >= 25 are consistent with clinically significant residual decisional conflict | Posted | Mean | Standard Deviation | score on a scale (DCS; 0-100) | 6 Months |
|
|
|
| Secondary | Patient-reported Interpersonal Processes of Care for Patient-Physician Communication After Viewing the SLE Patient Decision-aid | The Interpersonal Processes of Care short form (IPC-SF) is a patient-reported, 18-item validated patient-reported patient-physician communication and care processes measure, assessed after viewing the SLE Patient decision-aid (PtDA). Scores range from 18 to 90, with higher scores indicating better patient-physician communication ± care. | Posted | Mean | Standard Deviation | score on a scale (IPC; 18-90) | 6 Months |
|
|
|
| Secondary | Patient Satisfaction for SLE Patient Decision-aid | Patient satisfaction with the ease of the use of the SLE Patient Decision-aid (PtDA) measured using a validated single item scale scored on an ordinal scale from (strongly disagree =1) to (strongly agree = 5). This item will be examined by itself, where higher scores indicate greater patient satisfaction with the decision aid (i.e., better outcome). This is a single item scale, and there are no subscales. It was adapted from another study that assessed satisfaction with iPad or interactive voice response. | Posted | Mean | Standard Deviation | score on a scale (range 1-5) | 6 months |
|
|
|
| Secondary | Patient Time for Reviewing SLE Patient Decision-aid | The SLE Patient Decision-aid (PtDA) review times was expressed in minutes as patient-reported; this was supplemented by study coordinator's record of patient DA review time in-clinic prior to addition of this question. This patient self-reported question was added at the onset of the COVID-19 pandemic, where shelter-in-place orders led to stopping of in-person outpatient visits and all vists were converted to virtual visits using the phone or the video (Telemedicine). | Posted | Mean | Standard Deviation | Minutes | 6 Months |
|
|
|
| Secondary | Patient Preparation for Decision Making Assessed After Viewing the SLE Patient Decision-aid | Patient perception of the effect of the decision-aid on preparing the patient for decision making measured using the Patient Preparation for Decision Making (PDM) , a validated scale consisting of 10 questions scored on an ordinal scale from (not at all =1) to (a great deal = 5. Score ranged 0-100, 100 representing the highest preparation for decision-making. This was assessed after viewing the SLE Patient decision-aid (PtDA). | 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 | Posted | Mean | Standard Deviation | score on a scale (PDM; 0-100) | Baseline visit after viewing the SLE Patient Decision-Aid (PtDA) |
|
|
|
| Secondary | Patient Acceptability of the SLE Patient Decision-Aid | The patient acceptability survey is for the assessment of patient acceptability of the SLE Patient Decision-Aid (PtDA). Each question was rated from Poor (1) to Excellent (4). Total score ranged 1-4. DA acceptability refers to rating regarding the comprehensibility of component of the decision-aid, its length, pace, amount of the information, and the balance in presentation of the information about the options available and the overall suitability for decision making. | 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 | Posted | Mean | Standard Deviation | score on a scale (range:1-4) | Baseline visit after viewing the SLE PtDA |
|
|
|
| Secondary | Patient Feasibility of the SLE Patient Decision-Aid | The feasibility of the study survey completion and the administration of the lupus decision aid in the busy clinic were assessed with a self-administered patient questionnaire consisting of 4 questions, 2 questions for each, the survey and for the process of viewing ± administering the lupus DA in the busy clinic. Responses ranged from strongly disagree (=1) to strongly agree (=5). Higher scores indicate higher feasibility of the survey and of the SLE Patient Decision-Aid (PtDA) administration respectively. | 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 | Posted | Mean | Standard Deviation | score on a scale (range:1-4) | Baseline visit after viewing the SLE PtDA |
|
|
|
| Secondary | Number of Participants Who Perceived the SLE Patient Decision-Aid to be Useful | Patient perception of the SLE Patient Decision-Aid (PtDA) usefulness was aimed at assessing whether people would consider the the SLE PtDA to be useful at present and when they would think back to the time, they had made decisions about lupus treatments in the past (question 1), and whether the information contained in the lupus DA were adequate (question 2). It measured patient response of Yes vs. no to two simple questions. The tool is not yet a validated assessment but was based on our debriefing of lupus patients in the previous randomized study of lupus decision-aid. | 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 | Posted | Count of Participants | Participants | Baseline visit after viewing the SLE PtDA |
|
|
|
| 0 |
| 2,005 |
| 0 |
| 2,005 |
| 0 |
| 2,005 |
Not provided
Not provided