MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Decision Aid Users Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid |
Other: MyVoice:Rheum
Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
|
| Active Comparator: Pamphlet Users Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning |
Other: Pamphlet
Participants in this arm will be given a copy of an existing patient pamphlet
|
| Experimental: Rheumatologists Rheumatologists who interact with patients who have used the MyVoice: Rheum decision aid |
Other: Provider Experience
Rheumatologists will take a survey to assess their experiences with MyVoice and/or the pamphlet
|
Outcome Measures
Primary Outcome Measures
- Acceptability of Intervention [T2 (within 24 hours of intervention and appointment)]
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.
- Intervention Appropriateness Measure [T2 (within 24 hours of intervention and appointment)]
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.
- System Usability Scale [T2 (within 24 hours of intervention and appointment)]
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.
- Perceived Value of Tool to Providers [T4 (2 weeks after final patient study visit is completed)]
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).
Other Outcome Measures
- Reproductive knowledge assessment for women with rheumatic diseases (ReproKnow) [T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)]
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.
- Shared Decision-Making (collaboRATE) [T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)]
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.
- Perceived Efficacy in Patient-Physician Interactions [T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)]
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
- Reproductive Self Efficacy [T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)]
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.
- Change in Pregnancy Intention [T3 (three months post-intervention) compared to T0 (baseline)]
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
- Participant feedback to tool [T2 (within 24 hours of intervention and appointment); T3 (three months post-intervention)]
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.
- Receipt of family planning care [T3 (three months post-intervention) compared to T0 (baseline)]
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.
- Participant receipt of preconception care [T3 (three months post-intervention) compared to T0 (baseline)]
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
- Participant number of pregnancies during study [T3 (three months post-intervention)]
Assessed by participant-reported survey responses to a Yes/No item about whether a pregnancy has occurred since enrollment.
- Participant Change in Contraceptive Use [T3 (three months post-intervention) compared to T0 (baseline)]
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.
- Patient satisfaction with family planning conversation [T2 (within 24 hours of intervention and appointment)]
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.
- Quantity and quality of reproductive health conversation with rheumatologist [T2 (within 24 hours of intervention and appointment)]
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?
- Decisional Conflict [T2 (within 24 hours of intervention and appointment)]
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
- Interpersonal Quality of Care [T3 (3 months post intervention)]
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
- Attitudes on rheumatic medications and pregnancy [T3 (three months post-intervention) compared to T0 (baseline)]
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).
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UPMC Falk Rheumatology Clinic | Pittsburgh | Pennsylvania | United States | 15213 |
| 2 | UPMC Lupus Center of Excellence | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Pittsburgh
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
- Principal Investigator: Mehret S Birru Talabi, MD, PhD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY20060240
- K23AR075057-01A1