Implementing the Decision-Aid for Lupus (IDEAL Strategy)

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Systemic Lupus Erythematosus

Treatments: Other: SMILE Computerized Decision-Aid

Study type: Observational

Funder types: Other

Identifiers

NCT03735238

300002272

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

2,000 participants in 1 patient group

Lupus Patients

Description:

All lupus patients, regardless of if they are having an active flare

Treatment:

Other: SMILE Computerized Decision-Aid