Systemic Lupus Erythematosus
Conditions
Keywords
lupus, decision making, implementation, SLE, decision-aid, decision conflict
Brief summary
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).
Detailed description
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.
Interventions
OTHERSMILE Computerized Decision-Aid
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.
Sponsors
Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * Adults with a diagnosis of Systemic Lupus Erythematosus (SLE) by a rheumatologist Patient
Exclusion criteria
* No diagnosis of lupus, not English or Spanish speaking, visually impaired, altered mental status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 24 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived DA Implementation Success by Clinic Personnel for the SLE Patient Decision-aid | 24 months | 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). |
| Perceived DA Permanence by Clinic Personnel for the SLE Patient Decision-aid | 24 months | 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). |
| Perceived Intervention Appropriateness Measure (IAM) by Clinic Personnel for the SLE Patient Decision-aid | 24 Months | 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). |
| Perceived Feasibility of Intervention Measure (FIM) by Clinic Personnel for the SLE Patient Decision-aid | 24 Months | 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). |
| 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 | 6 Months | Decisional conflict was measured using the low literacy version of the Decisional Conflict Scale (DCS), a well-validated self-administered instrument, after viewing the SLE Patient decision-aid (PtDA). The low literacy version has 10 items with 3 response categories: yes, unsure, and no. Four subscale scores consisting of uncertainty about choice, feeling informed, values clarity, and feeling supported in decision-making were also calculated. DCS (and subscale) scores range from 0 (best) to 100 (worst) and scores \>= 25 are consistent with clinically significant residual decisional conflict |
| Patient-reported Interpersonal Processes of Care for Patient-Physician Communication After Viewing the SLE Patient Decision-aid | 6 Months | The Interpersonal Processes of Care short form (IPC-SF) is a patient-reported, 18-item validated patient-reported patient-physician communication and care processes measure, assessed after viewing the SLE Patient decision-aid (PtDA). Scores range from 18 to 90, with higher scores indicating better patient-physician communication ± care. |
| Perceived Acceptability of Intervention Measure (AIM) by Clinic Personnel for the SLE Patient Decision-aid | 24 months | 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). |
| Patient Time for Reviewing SLE Patient Decision-aid | 6 Months | The SLE Patient Decision-aid (PtDA) review times was expressed in minutes as patient-reported; this was supplemented by study coordinator's record of patient DA review time in-clinic prior to addition of this question. This patient self-reported question was added at the onset of the COVID-19 pandemic, where shelter-in-place orders led to stopping of in-person outpatient visits and all vists were converted to virtual visits using the phone or the video (Telemedicine). |
| Patient Preparation for Decision Making Assessed After Viewing the SLE Patient Decision-aid | Baseline visit after viewing the SLE Patient Decision-Aid (PtDA) | 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). |
| Patient Acceptability of the SLE Patient Decision-Aid | Baseline visit after viewing the SLE PtDA | 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. |
| Patient Feasibility of the SLE Patient Decision-Aid | Baseline visit after viewing the SLE PtDA | 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. |
| Number of Participants Who Perceived the SLE Patient Decision-Aid to be Useful | Baseline visit after viewing the SLE PtDA | 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. |
| Patient Satisfaction for SLE Patient Decision-aid | 6 months | Patient satisfaction with the ease of the use of the SLE Patient Decision-aid (PtDA) measured using a validated single item scale scored on an ordinal scale from (strongly disagree =1) to (strongly agree = 5). This item will be examined by itself, where higher scores indicate greater patient satisfaction with the decision aid (i.e., better outcome). This is a single item scale, and there are no subscales. It was adapted from another study that assessed satisfaction with iPad or interactive voice response. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Lupus Patients All lupus patients, regardless of if they are having an active flare. | 1,855 |
| Total | 1,855 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not want to participate in research | 3 |
| Overall Study | Time constraints, patient preference or percieved burden of survey completion | 26 |
Baseline characteristics
| Characteristic | Lupus Patients |
|---|---|
| Age, Continuous | 44.68 years STANDARD_DEVIATION 14.35 |
| Education level Greater than HS | 827 Participants |
| Education level HS degree or GED | 152 Participants |
| Education level Less than HS | 27 Participants |
| Insurance Payer Type Commercial/Private | 655 Participants |
| Insurance Payer Type Medicaid | 221 Participants |
| Insurance Payer Type Medicare | 340 Participants |
| Insurance Payer Type Other | 234 Participants |
| Marital status Divorced | 87 Participants |
| Marital status Living with partner | 45 Participants |
| Marital status Married | 443 Participants |
| Marital status Other | 7 Participants |
| Marital status Separated | 19 Participants |
| Marital status Single | 372 Participants |
| Marital status Widowed | 33 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 149 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 1685 Participants |
| Race/Ethnicity, Customized Race African American | 827 Participants |
| Race/Ethnicity, Customized Race Asian | 80 Participants |
| Race/Ethnicity, Customized Race Hispanic | 149 Participants |
| Race/Ethnicity, Customized Race Other/Mixed | 22 Participants |
| Race/Ethnicity, Customized Race White | 754 Participants |
| Residence Rural | 218 Participants |
| Residence Suburban | 483 Participants |
| Residence Urban | 305 Participants |
| Sex: Female, Male Female | 1731 Participants |
| Sex: Female, Male Male | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2,005 |
| other Total, other adverse events | 0 / 2,005 |
| serious Total, serious adverse events | 0 / 2,005 |
Outcome results
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).
Time frame: 24 months
Population: Reach/penetration = # of patients viewed DA / # of eligible patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loyola University, Chicago | Penetration/Reach: Number of Eligible Participants at Each Clinical Site Who Enrolled Divided by the Number of Eligible Participants at Each Clinical Site, Expressed as Overall Percent | 96 Participants |
| University of Alabama at Birmingham (UAB), Birmingham | 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 | 725 Participants |
| Vanderbilt University, Nashville | 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 | 121 Participants |
| University of Chicago, Chicago | 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 | 104 Participants |
| University of Mississippi Medical Center (UMMC), Jackson | 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 | 105 Participants |
| Cedars Cedars-Sinai Medical Center, Los Angeles | 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 | 88 Participants |
| Baylor College of Medicine, Houston | 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 | 63 Participants |
| Northwestern University, Chicago | 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 | 79 Participants |
| Emory University, Atlanta | 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 | 73 Participants |
| Medical University of South Carolina (MUSC), Charleston | 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 | 102 Participants |
| Northwell Health, New York | 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 | 124 Participants |
| University of California (UCLA), Los Angeles | 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 | 69 Participants |
| Ohio State University (OSU), Columbus | 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 | 37 Participants |
| University of California at San Diego (UCSD), San Diego, CA | 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 | 28 Participants |
| Washington University, St. Louis | 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 | 81 Participants |
Comparison: This is a single arm implementation trial with no comparison group. This outcome represents the reach/penetration of the implementation at each site over the trial duration. We did not perform power calculation. There was no null hypothesis stated. Our aim was to enroll at least 28 patients per site in this implementation trial during regular outpatient rheumatology clinic visits. No statistical test was performed for this outcome.
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.
Time frame: Baseline visit after viewing the SLE PtDA
Population: All SLE Patients who viewed the SLE PtDA patients, regardless of if they are having an active flare, and responded to this part of the patient survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Loyola University, Chicago | Number of Participants Who Perceived the SLE Patient Decision-Aid to be Useful | Patient perception of DA Usefulness in decision-making | 1640 Participants |
| Loyola University, Chicago | Number of Participants Who Perceived the SLE Patient Decision-Aid to be Useful | Patient perception of DA Usefulness for information adequacy | 1448 Participants |
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.
Time frame: Baseline visit after viewing the SLE PtDA
Population: All SLE Patients who viewed the SLE PtDA patients, regardless of if they are having an active flare, and responded to this part of the patient survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Patient Acceptability of the SLE Patient Decision-Aid | 3.26 score on a scale (range:1-4) | Standard Deviation 0.63 |
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
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Patient Decisional Conflict Scale Related to Medication Treatment Decision-making for SLE Medications Including the Immunosuppressive Medications and Biologics After Viewing the SLE Patient Decision-aid | 19.48 score on a scale (DCS; 0-100) | Standard Deviation 23.78 |
| University of Alabama at Birmingham (UAB), Birmingham | 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 | 21.77 score on a scale (DCS; 0-100) | Standard Deviation 25.7 |
| Vanderbilt University, Nashville | 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 | 20.23 score on a scale (DCS; 0-100) | Standard Deviation 24.67 |
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.
Time frame: Baseline visit after viewing the SLE PtDA
Population: All SLE Patients who viewed the SLE PtDA patients, regardless of if they are having an active flare, and responded to this part of the patient survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Patient Feasibility of the SLE Patient Decision-Aid | 4.33 score on a scale (range:1-4) | Standard Deviation 0.77 |
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).
Time frame: Baseline visit after viewing the SLE Patient Decision-Aid (PtDA)
Population: All SLE Patients who viewed the SLE PtDA patients, regardless of if they are having an active flare, and responded to this part of the patient survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Patient Preparation for Decision Making Assessed After Viewing the SLE Patient Decision-aid | 74.44 score on a scale (PDM; 0-100) | Standard Deviation 23.76 |
Secondary
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Patient-reported Interpersonal Processes of Care for Patient-Physician Communication After Viewing the SLE Patient Decision-aid | 82.19 score on a scale (IPC; 18-90) | Standard Deviation 9.28 |
| University of Alabama at Birmingham (UAB), Birmingham | Patient-reported Interpersonal Processes of Care for Patient-Physician Communication After Viewing the SLE Patient Decision-aid | 81.88 score on a scale (IPC; 18-90) | Standard Deviation 9.84 |
| Vanderbilt University, Nashville | Patient-reported Interpersonal Processes of Care for Patient-Physician Communication After Viewing the SLE Patient Decision-aid | 82.34 score on a scale (IPC; 18-90) | Standard Deviation 9.36 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Patient Satisfaction for SLE Patient Decision-aid | 4.41 score on a scale (range 1-5) | Standard Deviation 1.08 |
| University of Alabama at Birmingham (UAB), Birmingham | Patient Satisfaction for SLE Patient Decision-aid | 4.44 score on a scale (range 1-5) | Standard Deviation 0.87 |
| Vanderbilt University, Nashville | Patient Satisfaction for SLE Patient Decision-aid | 4.44 score on a scale (range 1-5) | Standard Deviation 0.85 |
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).
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Patient Time for Reviewing SLE Patient Decision-aid | 23 Minutes | Standard Deviation 16.18 |
| University of Alabama at Birmingham (UAB), Birmingham | Patient Time for Reviewing SLE Patient Decision-aid | 22.44 Minutes | Standard Deviation 13.44 |
| Vanderbilt University, Nashville | Patient Time for Reviewing SLE Patient Decision-aid | 21.63 Minutes | Standard Deviation 14.81 |
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).
Time frame: 24 months
Population: The main study flow diagram is for the patient participants who were invited to view the SLE PtDA. We also evaluated clinic personnel reported outcomes, which are provided for outcomes #2-6, including this outcome. As expected, the denominator for the clinic personnel outcomes is different from that for the patient participants. In summary, our implementation study had separate aims focused on patient-reported effectiveness outcomes, and clinic personnel reported implementation outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Perceived Acceptability of Intervention Measure (AIM) by Clinic Personnel for the SLE Patient Decision-aid | 3.53 score on a scale (range 1-5) | Standard Deviation 0.83 |
| University of Alabama at Birmingham (UAB), Birmingham | Perceived Acceptability of Intervention Measure (AIM) by Clinic Personnel for the SLE Patient Decision-aid | 3.84 score on a scale (range 1-5) | Standard Deviation 0.8 |
| Vanderbilt University, Nashville | Perceived Acceptability of Intervention Measure (AIM) by Clinic Personnel for the SLE Patient Decision-aid | 3.63 score on a scale (range 1-5) | Standard Deviation 0.79 |
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).
Time frame: 24 months
Population: The main study flow diagram is for the patient participants. We also evaluated clinic personnel reported outcomes in this study, which are provided for outcomes #2-6, including this outcome. The denominator for the clinic personnel is different from those of the patient participants, as expected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Perceived DA Implementation Success by Clinic Personnel for the SLE Patient Decision-aid | 3.41 score on a scale (range 1-5) | Standard Deviation 0.73 |
| University of Alabama at Birmingham (UAB), Birmingham | Perceived DA Implementation Success by Clinic Personnel for the SLE Patient Decision-aid | 3.54 score on a scale (range 1-5) | Standard Deviation 0.7 |
| Vanderbilt University, Nashville | Perceived DA Implementation Success by Clinic Personnel for the SLE Patient Decision-aid | 3.47 score on a scale (range 1-5) | Standard Deviation 0.91 |
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).
Time frame: 24 months
Population: The main study flow diagram is for the patient participants. We also evaluated clinic personnel reported outcomes in this study, which are provided for outcomes #2-6, including this outcome. The denominator for the clinic personnel is different from those of the patient participants, as expected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Perceived DA Permanence by Clinic Personnel for the SLE Patient Decision-aid | 3.22 score on a scale (range 1-5) | Standard Deviation 0.74 |
| University of Alabama at Birmingham (UAB), Birmingham | Perceived DA Permanence by Clinic Personnel for the SLE Patient Decision-aid | 3.02 score on a scale (range 1-5) | Standard Deviation 0.96 |
| Vanderbilt University, Nashville | Perceived DA Permanence by Clinic Personnel for the SLE Patient Decision-aid | 3.11 score on a scale (range 1-5) | Standard Deviation 1.03 |
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).
Time frame: 24 Months
Population: The main study flow diagram is for the patient participants. We also evaluated clinic personnel reported outcomes in this study, which are provided for outcomes #2-6, including this outcome. The denominator for the clinic personnel is different from those of the patient participants, as expected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Perceived Feasibility of Intervention Measure (FIM) by Clinic Personnel for the SLE Patient Decision-aid | 3.44 score on a scale (range 1-5) | Standard Deviation 0.71 |
| University of Alabama at Birmingham (UAB), Birmingham | Perceived Feasibility of Intervention Measure (FIM) by Clinic Personnel for the SLE Patient Decision-aid | 3.61 score on a scale (range 1-5) | Standard Deviation 0.75 |
| Vanderbilt University, Nashville | Perceived Feasibility of Intervention Measure (FIM) by Clinic Personnel for the SLE Patient Decision-aid | 3.53 score on a scale (range 1-5) | Standard Deviation 0.81 |
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).
Time frame: 24 Months
Population: The main study flow diagram is for the patient participants. We also evaluated clinic personnel reported outcomes in this study, which are provided for outcomes #2-6, including this outcome. The denominator for the clinic personnel is different from those of the patient participants, as expected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Loyola University, Chicago | Perceived Intervention Appropriateness Measure (IAM) by Clinic Personnel for the SLE Patient Decision-aid | 3.43 score on a scale (range 1-5) | Standard Deviation 0.86 |
| University of Alabama at Birmingham (UAB), Birmingham | Perceived Intervention Appropriateness Measure (IAM) by Clinic Personnel for the SLE Patient Decision-aid | 3.76 score on a scale (range 1-5) | Standard Deviation 0.74 |
| Vanderbilt University, Nashville | Perceived Intervention Appropriateness Measure (IAM) by Clinic Personnel for the SLE Patient Decision-aid | 3.64 score on a scale (range 1-5) | Standard Deviation 0.85 |