Clinical trial NCT03735238: Implementing the Decision-Aid for Lupus (IDEAL Strategy)
Official title: Implementing the Decision-Aid for Lupus (IDEAL Strategy)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: lupus
decision making
implementation
SLE
decision-aid
decision conflict
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2018-11-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinic personnel and patients will be derived from lupus clinics at 16 sites throughout the country.

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.

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

Primary outcomes:
measure: Penetration
timeFrame: 24 months
Secondary outcomes:
measure: Perceived Acceptability of Intervention Measure (IAM) for Decision Aid (DA)
timeFrame: 12 months
measure: Perceived DA Implementation Success
timeFrame: 12 months
measure: Perceived DA Permanence
timeFrame: 12 months
measure: Patient perception of DA Usefulness
timeFrame: 0 months
measure: Patient Satisfaction for Decision Aid (DA)
timeFrame: 0 months
measure: Perceived Intervention Appropriateness Measure (IAM) for Decision Aid (DA)
timeFrame: 12 Months
measure: Perceived Feasibility of Intervention Measure (FIM) for Decision Aid (DA)
timeFrame: 12 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jasvinder A Singh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh JA, Hearld LR, Hall AG, Beasley TM. Implementing the DEcision-Aid for Lupus (IDEAL): study protocol of a multi-site implementation trial with observational, case study design : Implementing the DEcision-Aid for Lupus. Implement Sci Commun. 2021 Mar 11;2(1):30. doi: 10.1186/s43058-021-00118-9.