MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

Study Overview
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Brief Summary
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This is a pilot trial to assess feasibility and acceptability of MyVoice vs. a patient pamphlet among female patients ages 18-44 (n=50) who receive rheumatology care. • Hypothesis: MyVoice will be feasible and acceptable to patients who receive rheumatology care.

Detailed Description
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The pilot will demonstrate if the MyVoice 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 decision aid (n=38). Women in the control arm (n=12) will receive a widely-accessible paper-based pamphlet about pregnancy, which, similarly to MyVoice, targets women with a broad range of rheumatic diseases. Rheumatologists will have no obligatory actions; however, if one or more of their patients completed the study, they will be emailed an anonymous survey about their experiences with the study and related patient encounters. This will occur 2 weeks after the final patient participant completes the study. Rheumatologists will not be informed by study personnel which of their patients participated in the study.

Official Title
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A Pilot Study of the MyVoice:Rheum Decision Aid to Address the Reproductive Health Needs of Women With Rheumatic Diseases

Conditions
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Contraception, Rheumatic Diseases, Physician-Patient Relations

Intervention / Treatment
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* Other: MyVoice:Rheum
* Other: Pamphlet
* Other: Provider Experience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have at least one of four rheumatic diseases diagnosed by a rheumatologist: rheumatoid arthritis (RA), systemic sclerosis (SSc), myositis, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision Aid Users<br>Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid | Other: MyVoice:Rheum<br>* Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).<br>|
| Active Comparator: Pamphlet Users<br>Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning | Other: Pamphlet<br>* Participants in this arm will be given a copy of an existing patient pamphlet<br>|
| Experimental: Rheumatologists<br>Rheumatologists who interact with patients who have used the MyVoice: Rheum decision aid | Other: Provider Experience<br>* Rheumatologists will take a survey to assess their experiences with MyVoice and/or the pamphlet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Intervention | Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher acceptability. | T2 (within 24 hours of intervention and appointment) | 
| Intervention Appropriateness Measure | Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater acceptability. | T2 (within 24 hours of intervention and appointment) | 
| System Usability Scale | Ten-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater usability. | T2 (within 24 hours of intervention and appointment) | 
| Perceived Value of Tool to Providers | 7-item questionnaire assessing providers' reactions to the MyVoice tool. Each statement is answered with a 5-point Likert scale from Strongly Agree (1) to Strongly Disagree (5). | T4 (2 weeks after final patient study visit is completed) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatic diseases, shared decision-making, sexual and reproductive health, decision aids