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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 : June 28, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Jasvinder Singh, MD, MPH, University of Alabama at Birmingham

Tracking Information
First Submitted Date October 31, 2018
First Posted Date November 8, 2018
Last Update Posted Date June 28, 2019
Actual Study Start Date December 15, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 26, 2018)
Penetration [ Time Frame: 24 months ]
This is measured using study records (# of patients viewed the Decision Aid (DA)/ # of eligible patients)
Original Primary Outcome Measures
 (submitted: November 6, 2018)
Penetration [ Time Frame: 24 months ]
This is measured using study records (# of patients viewed the DA/ # of eligible patients)
Change History Complete list of historical versions of study NCT03735238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 26, 2018)
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures
 (submitted: November 6, 2018)
  • Perceived DA Acceptability: validated scale [ Time Frame: 12 months ]
    Clinic personnel's perception of the acceptability of the decision-aid, measured using a validated scale with eight (8) items with responses ranging from 1 ("Not at all") to 5 ("To a very great extent). The eight 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).
  • 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).
  • 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).
  • 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.
  • Patient Satisfaction: validated single item scale [ 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 audio satisfaction.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Implementing the Decision-Aid for Lupus (IDEAL Strategy)
Official Title Implementing the Decision-Aid for Lupus (IDEAL Strategy)
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 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Clinic personnel and patients will be derived from lupus clinics at 16 sites throughout the country.
Condition Systemic Lupus Erythematosus
Intervention 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
Study Groups/Cohorts Lupus Patients
All lupus patients, regardless of if they are having an active flare
Intervention: Other: SMILE Computerized Decision-Aid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 6, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 15, 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Candace Green, BA 205-975-2405 candacegreen@uabmc.edu
Contact: Deztanity Tatum, BS 205-934-0315 dtatum@uabmc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03735238
Other Study ID Numbers 300002272
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jasvinder Singh, MD, MPH, University of Alabama at Birmingham
Study Sponsor University of Alabama at Birmingham
Collaborators Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Jasvinder A Singh, MD, MPH University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date June 2019