MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

University of Pittsburgh45 enrolled

Overview

This is a pilot trial to assess feasibility and acceptability of MyVoice:Rheum vs. a patient pamphlet among female patients ages 18-44 (n=40) who receive rheumatology care. • Hypothesis: MyVoice:Rheum will be feasible and acceptable to patients who receive rheumatology care.

The pilot will demonstrate if the MyVoice:Rheum decision aid can be feasibly and acceptably implemented into the rheumatology context and inform operational procedures for a future hybrid effectiveness-implementation trial. Women in the intervention arm will receive the MyVoice:Rheum decision aid (n=30). Women in the control arm (n=9) will receive a widely-accessible paper-based pamphlet about pregnancy, which, similarly to MyVoice:Rheum, targets women with a broad range of rheumatic diseases.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Rheumatic Diseases Physician-Patient Relations Contraception

Interventions

MyVoice:RheumOTHER

Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).

PamphletOTHER

Participants in this arm will be given a copy of an existing patient pamphlet

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 44 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients must have at least one of four rheumatic diseases diagnosed by a rheumatologist: rheumatoid arthritis (RA), systemic sclerosis (SSc), myositis, Sjogren's syndrome, vasculitis, spondyloarthritis, and systemic lupus erythematosus (SLE). Patients must read and speak in English as a Spanish-language version of the tool has not yet been developed Access to a smart phone, personal computer, or tablet. Exclusion Criteria: * Women who have had prior hysterectomy or sterilization, or are pregnant.

Locations (2)

UPMC Falk Rheumatology Clinic

Pittsburgh, Pennsylvania, United States

UPMC Lupus Center of Excellence

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Acceptability of Intervention

Acceptability of Intervention Measure (AIM) consist of Four- item measure, Likert scales ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean of scores, with a higher score indicating higher acceptability. We assigned a feasibility threshold of ≥ 3.5 of 5, for which higher scores indicate more positive responses.

Time frame: T2 (within 24 hours of intervention and appointment)

Intervention Appropriateness Measure

The validated Intervention Appropriateness Measure (IAM) consist of Four-item Likert scales ranging from 1 (completely disagree) to 5 (completely agree); we assigned a feasibility threshold of ≥ 3.5 of 5 for IAM scores, for which higher scores indicate more positive responses. Score is determined by calculating the mean, with a higher score indicating greater appropriateness.

Time frame: T2 (within 24 hours of intervention and appointment)

System Usability Scale

Usability was assessed via summary scores from the System Usability Scale (SUS), which consists of a 10-item Likert scale with scores ranging from 0-100; overall score calculated by finding the mean of items on scale. We set a threshold of scores \>80.3 as 'A'/excellent and 68-80.3 as 'B'/very good, consistent with standard rating for the SUS.

Time frame: T2 (within 24 hours of intervention and appointment)

Data from ClinicalTrials.gov

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