MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879745
• Other study ID #: STUDY20060240
• Secondary ID: K23AR075057-01A1
• Status: Completed
• Phase: N/A
• Start date: July 29, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Collagen Diseases
• Contraception
• Physician-Patient Relations
• Rheumatic Diseases

Intervention

Other:
• MyVoice:Rheum
Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
• Pamphlet
Participants in this arm will be given a copy of an existing patient pamphlet

Locations

Country	Name	City	State
United States	UPMC Falk Rheumatology Clinic	Pittsburgh	Pennsylvania
United States	UPMC Lupus Center of Excellence	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (31)

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Birru Talabi M, Callegari LS, Borrero S. Redefining Primum Non Nocere to Include Reproductive Autonomy: A New Paradigm in Subspecialty Medicine. Womens Health Rep (New Rochelle). 2021 Oct 26;2(1):497-499. doi: 10.1089/whr.2021.0079. eCollection 2021. — View Citation

Birru Talabi M, Callegari LS, Kazmerski TM, Krishnamurti T, Mosley EA, Borrero S. A blueprint for a new model of sexual and reproductive health care in subspecialty medicine. Health Serv Res. 2023 Feb;58(1):216-222. doi: 10.1111/1475-6773.14074. Epub 2022 Oct 11. No abstract available. — View Citation

Birru Talabi M, Clowse MEB, Blalock SJ, Hamm M, Borrero S. Perspectives of Adult Rheumatologists Regarding Family Planning Counseling and Care: A Qualitative Study. Arthritis Care Res (Hoboken). 2020 Mar;72(3):452-458. doi: 10.1002/acr.23872. — View Citation

Birru Talabi M, Clowse MEB, Blalock SJ, Switzer G, Yu L, Chodoff A, Borrero S. Development of ReproKnow, a reproductive knowledge assessment for women with rheumatic diseases. BMC Rheumatol. 2019 Oct 21;3:40. doi: 10.1186/s41927-019-0091-6. eCollection 20 — View Citation

Birru Talabi M, Clowse MEB, Schwarz EB, Callegari LS, Moreland L, Borrero S. Family Planning Counseling for Women With Rheumatic Diseases. Arthritis Care Res (Hoboken). 2018 Feb;70(2):169-174. doi: 10.1002/acr.23267. No abstract available. — View Citation

Birru Talabi M, Eudy AM, Jayasundara M, Haroun T, Nowell WB, Curtis JR, Crow-Hercher R, White CW, Ginsberg S, Clowse MEB. Pregnancy, Periods, and "The Pill": Exploring the Reproductive Experiences of Women with Inflammatory Arthritis. ACR Open Rheumatol. 2019 Apr 15;1(2):125-132. doi: 10.1002/acr2.1016. eCollection 2019 Apr. — View Citation

Birru Talabi M, Eudy AM, Jayasundara M, Haroun T, Nowell WB, Curtis JR, Crow-Hercher R, White W, Ginsberg S, Clowse MEB. Tough Choices: Exploring Medication Decision-Making During Pregnancy and Lactation Among Women With Inflammatory Arthritis. ACR Open Rheumatol. 2021 Jul;3(7):475-483. doi: 10.1002/acr2.11240. Epub 2021 Jun 11. — View Citation

Borrero S, Talabi MB, Dehlendorf C. Confronting the Medical Community's Complicity in Marginalizing Abortion Care. JAMA. 2022 Nov 1;328(17):1701-1702. doi: 10.1001/jama.2022.18328. — View Citation

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Kazmerski TM, Stransky OM, Wright CE, Albanowski M, Pilewski JM, Talabi MB, Callegari LS, Chang JC, Abebe KZ, Miller E, Deal A, O'Leary R, Borrero S. Feasibility Testing of a Web-Based Reproductive Decision Support Tool for Cystic Fibrosis. J Cyst Fibros. — View Citation

Krishnamurti T, Birru Talabi M, Callegari LS, Kazmerski TM, Borrero S. A Framework for Femtech: Guiding Principles for Developing Digital Reproductive Health Tools in the United States. J Med Internet Res. 2022 Apr 28;24(4):e36338. doi: 10.2196/36338. — View Citation

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Pryor KP, Albert B, Desai S, Ritter SY, Tarter L, Coblyn J, Bermas BL, Santacroce LM, Dutton C, Braaten KP, Pace LE, Rexrode K, Janiak E, Feldman CH. Pregnancy Intention Screening in Patients With Systemic Rheumatic Diseases: Pilot Testing a Standardized Assessment Tool. ACR Open Rheumatol. 2022 Aug;4(8):682-688. doi: 10.1002/acr2.11449. Epub 2022 May 31. — View Citation

Rajendran A, Eudy AM, Balevic SJ, Clowse MEB. The importance of pregnancy planning in lupus pregnancies. Lupus. 2021 Apr;30(5):741-751. doi: 10.1177/0961203321989803. Epub 2021 Jan 28. — View Citation

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Sammaritano LR, Bermas BL, Chakravarty EE, Chambers C, Clowse MEB, Lockshin MD, Marder W, Guyatt G, Branch DW, Buyon J, Christopher-Stine L, Crow-Hercher R, Cush J, Druzin M, Kavanaugh A, Laskin CA, Plante L, Salmon J, Simard J, Somers EC, Steen V, Tedeschi SK, Vinet E, White CW, Yazdany J, Barbhaiya M, Bettendorf B, Eudy A, Jayatilleke A, Shah AA, Sullivan N, Tarter LL, Birru Talabi M, Turgunbaev M, Turner A, D'Anci KE. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020 Apr;72(4):529-556. doi: 10.1002/art.41191. Epub 2020 Feb 23. — View Citation

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Stransky O, Hunt N, Richards JS, Talabi MB. Exploring Family Planning, Parenting, and Sexual and Reproductive Health Care Experiences of Men With Rheumatic Diseases. J Rheumatol. 2022 Mar;49(3):251-255. doi: 10.3899/jrheum.210785. Epub 2021 Nov 15. — View Citation

Stransky OM, Wolgemuth T, Kazmerski T, Chodoff A, Borrero S, Birru Talabi M. Contraception decision-making and care among reproductive-aged women with autoimmune diseases. Contraception. 2021 Feb;103(2):86-91. doi: 10.1016/j.contraception.2020.11.001. Epub 2020 Nov 9. — View Citation

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reproductive Knowledge Assessment for Women With Rheumatic Diseases (ReproKnow)	Rheumatology-specific reproductive health knowledge was assessed via ReproKnow, a measure developed and preliminarily validated by our team that covers domains of contraception safety and efficacy, pregnancy management, pre-conception planning, medication safety, fertility; a score of nine indicates the highest level of reproductive knowledge	T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)
Other	Perceived Efficacy in Patient-Physician Interactions	Self-reported efficacy in communicating with providers was assessed using a modified version of the validated five-item Perceived Efficacy in Patient-Provider Interactions (PEPPI) scale. Five-item measure with 5-point Likert scale questions from 1 (not at all confident) to 5 (very confident). Aggregate score is calculated by taking the individual item scores together and dividing by 5, with higher score indicating higher perceived efficacy in communicating with providers.	T2 (within 24 hours of intervention and appointment) compared to T0 (baseline)
Other	Participant Number of Pregnancies During Study	Assessed by participant-reported survey responses to a Yes/No item about whether a pregnancy has occurred since enrollment.	T3 (three months post-intervention)
Other	Quantity and Quality of Reproductive Health Conversation With Rheumatologist	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? (Not Reported)	T2 (within 24 hours of intervention and appointment)
Primary	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.	T2 (within 24 hours of intervention and appointment)
Primary	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.	T2 (within 24 hours of intervention and appointment)
Primary	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.	T2 (within 24 hours of intervention and appointment)