Implementing the Decision-Aid for Lupus (IDEAL Strategy)

Systemic Lupus Erythematosus Clinical Trial

— IDEAL  

Official title:

Implementing the Decision-Aid for Lupus (IDEAL Strategy)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03735238
• Other study ID #: 300002272
• Status: Active, not recruiting
• Start date: December 15, 2018
• Est. completion date: December 15, 2025

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 15, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penetration	This is measured using study records (# of patients viewed the Decision Aid (DA)/ # of eligible patients)	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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