MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

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

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.

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.

Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning

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.

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.

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.

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).

Completion of a 10-item multiple choice instrument, ReproKnow, a validated instrument for assessing knowledge of reproductive health in rheumatic diseases. Answers will be coded as correct or incorrect. The percentage of correct responses across the 10 questions will be calculated for each participant. The score range is 0 to 100%. A higher score indicates greater knowledge. Participant knowledge will be measured at baseline and following their use of the tool to assess the sustained impact of the decision aid on knowledge.

Three-item measure with 5-point Likert scale questions of 0 (no effort was made) to 4 (every effort was made) to assess shared decision-making between patients and providers. The mean of all three items is calculated. Higher scores represent more shared decision-making.

Five-item measure with 5-point Likert scale questions from 1 (not at all confident) to 5 (very confident). Score is determined by the sum (possible range of 5 to 25) with higher score indicating higher perceived efficacy in communicating with providers

Five-item measure with 5-point Likert scale questions from 1 (not at all confident) to 5 (very confident). Score is determined by the sum (possible range of 5 to 25) with higher score indicating higher perceived efficacy in communicating with providers.

Desire to Avoid Pregnancy scale- 14-item measure with 5-point Likert scale questions from 0 (strongly agree) to 4 (strongly disagree). Score is determined by calculating the mean (range of 0-4) with higher scores reflecting a higher desire to avoid pregnancy

Informed by in-depth interviews with women about their likes and dislikes of the MyVoice tool, their perceived barriers and facilitators to its use, if/how MyVoice could be used in their own lives. Questions also assess whether their rheumatologists discussed reproductive health and if/how MyVoice influenced those decisions.

Asks whether participant has visited a clinic for any of the following over the course of the study: birth control prescription, birth control counselling, pregnancy test, preconception counseling, prenatal care.

Single item asking whether prior to pregnancy user did any of the following to prepare: Took folic acid Stopped or cut down smoking Stopped or cut down drinking alcohol Ate more healthily Sought medical/health advice Took some other action I did not do any of the above before pregnancy

Assessed by participant-reported survey responses to a Yes/No item about whether a pregnancy has occurred since enrollment.

Assessed by participant responses to a multiple choice item asking which methods of contraception they are currently using (in the past 2 weeks). Reasons for non-use assessed by response to a multiple choice item asking why they are not currently using contraception.

10-item scale adapted from the Interpersonal Quality of Family Planning scale with 5-point Likert scale from 1(poor) to 5 (excellent). A higher score indicates higher satisfaction with the family planning conversation.

Three-item measure. Did you talk to your rheumatologist about family planning today- yes/no; Did you make a decision related to family planning- yes/no; what was the family planning decision you made today?

Administered if participant made a family planning decision with their rheumatologist. Decisional conflict scale- 10-item measure with answer options yes/no/not sure. Answers are given score value of yes=0, unsure=2, no=4. Answers are summed, divided by 10, and multiplied by 25. Score range of 0 to 100 with higher scores indicating higher decisional conflict

10-item measure assessing the quality of the patient-rheumatologist interaction following use of the tool. Items are scored on a 5 point likert scale from poor (1) to excellent (5) with a higher mean score indicating a higher perceived quality of the patient-provider interaction

8-item measure assessing participant's attitude towards medications and disease activity during pregnancy and trust of provider's attitudes towards medications during pregnancy. Each item is ranked on a 5-point Likert scale from strongly agree (1) to strongly disagree (5).

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.