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

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ClinicalTrials.gov Identifier: NCT03735238
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : July 10, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Jasvinder Singh, MD, MPH, University of Alabama at Birmingham

Study Description
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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).

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Other: SMILE Computerized Decision-Aid

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 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Implementing the Decision-Aid for Lupus (IDEAL Strategy)
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Lupus Patients
All lupus patients, regardless of if they are having an active flare
 Other: SMILE 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.
Other Names:
  • SMILE
  • Decision-Aid
  • DA


Outcome Measures
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Primary Outcome Measures :
  1. Penetration [ Time Frame: 24 months ]
    This is measured using study records (# of patients viewed the Decision Aid (DA)/ # of eligible patients)


Secondary Outcome Measures :
  1. Perceived Acceptability of Intervention Measure (IAM) for Decision Aid (DA) [ Time Frame: 12 months ]
    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).

  2. Perceived DA Implementation Success [ Time Frame: 12 months ]
    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).

  3. Perceived DA Permanence [ Time Frame: 12 months ]
    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).

  4. Patient perception of DA Usefulness [ Time Frame: 0 months ]
    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.

  5. Patient Satisfaction for Decision Aid (DA) [ Time Frame: 0 months ]
    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.

  6. Perceived Intervention Appropriateness Measure (IAM) for Decision Aid (DA) [ Time Frame: 12 Months ]
    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).

  7. Perceived Feasibility of Intervention Measure (FIM) for Decision Aid (DA) [ Time Frame: 12 Months ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinic personnel and patients will be derived from lupus clinics at 16 sites throughout the country.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735238


Contacts
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Contact: Candace Green, BA 205-975-2405 candacegreen@uabmc.edu
Contact: Deztanity Tatum, BS 205-934-0315 dtatum@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Candace Green, BA    205-975-2405    candacegreen@uabmc.edu   
Contact: Deztanity Tatum, BS    205-934-0315    dtatum@uabmc.edu   
Principal Investigator: Jasvinder Singh, MD, MPH         
Sponsors and Collaborators
University of Alabama at Birmingham
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Jasvinder A Singh, MD, MPH University of Alabama at Birmingham
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jasvinder Singh, MD, MPH, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03735238    
Other Study ID Numbers: 300002272
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jasvinder Singh, MD, MPH, University of Alabama at Birmingham:
lupus
decision making
implementation
 SLE
decision-aid
decision conflict
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases