Implementing the Decision-Aid for Lupus (IDEAL Strategy)

Study Overview
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Brief Summary
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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).

Detailed Description
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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 16 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 at least 500 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.

Official Title
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Implementing the Decision-Aid for Lupus (IDEAL Strategy)

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Other: SMILE Computerized Decision-Aid


Participation Criteria
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Eligibility Criteria
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Clinic Personnel Inclusion Criteria: Aim 1: clinic personnel involved in the care of lupus patients Aim 2: clinic personnel involved in the care of lupus patients Aim 3: clinic personnel involved in the care of lupus patients Clinic Personnel Exclusion Criteria: Aim 1: none Aim 2: none Aim 3: none Patient Inclusion Criteria: Aim 2: Adults with a diagnosis of lupus Aim 3: Adults with a diagnosis of lupus Patient Exclusion Criteria: Aim 2: No diagnosis of lupus, not English or Spanish speaking, visually impaired, altered mental status Aim 3: No diagnosis of lupus, not English or Spanish speaking, visually impaired, altered mental status

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lupus Patients<br>All lupus patients, regardless of if they are having an active flare | Other: SMILE Computerized Decision-Aid<br>* 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.<br>* Other names: DA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penetration | This is measured using study records (# of patients viewed the Decision Aid (DA)/ # of eligible patients) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Acceptability of Intervention Measure (IAM) for Decision Aid (DA) | Clinic personnel's perception of the acceptability of the decision-aid, 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). | 12 months | 
| Perceived DA Implementation Success | Clinic personnel's perception of the implementation success of the decision-aid, 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). | 12 months | 
| Perceived DA Permanence | Clinic personnel's perception of the permanence of the decision-aid, 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). | 12 months | 
| Patient perception of DA Usefulness | Patient perception of the effect of the decision-aid on preparing the patient for decision making measured using the 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). For scoring, sum the score of the 10 items and divide by 10. Scores can then be converted to a 0-100 scale by subtracting 1 from this summed score and multiplying by 25. | 0 months | 
| Patient Satisfaction for Decision Aid (DA) | Patient satisfaction with the ease of the use of the decision-aid 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. | 0 months | 
| Perceived Intervention Appropriateness Measure (IAM) for Decision Aid (DA) | Clinic personnel's perception of the appropriateness of the decision-aid, 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). | 12 Months | 
| Perceived Feasibility of Intervention Measure (FIM) for Decision Aid (DA) | Clinic personnel's perception of the feasibility of the decision-aid, 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). | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lupus, decision making, implementation, SLE, decision-aid, decision conflict