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| ID | Type | Description | Link |
|---|---|---|---|
| K23AR075057-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Aid Users | Experimental | Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid |
|
| Pamphlet Users | Active Comparator | Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyVoice:Rheum | Other | Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Mehret S Birru Talabi, MD, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Falk Rheumatology Clinic | Pittsburgh | Pennsylvania | 15213 | United States | ||
| UPMC Lupus Center of Excellence |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31284305 | Background | Mehta B, Luo Y, Xu J, Sammaritano L, Salmon J, Lockshin M, Goodman S, Ibrahim S. Trends in Maternal and Fetal Outcomes Among Pregnant Women With Systemic Lupus Erythematosus in the United States: A Cross-sectional Analysis. Ann Intern Med. 2019 Aug 6;171(3):164-171. doi: 10.7326/M19-0120. Epub 2019 Jul 9. | |
| 28437837 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Decision Aid Users | Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA). |
| FG001 | Pamphlet Users | Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Decision Aid Users | Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA). |
| BG001 | Pamphlet Users |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 30 of 31 decision aid users completed the AIM. | Posted | Mean | Standard Deviation | score on a scale | T2 (within 24 hours of intervention and appointment) |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decision Aid Users | Patients with a rheumatic disease who are given access to the MyVoice:Rheum decision aid MyVoice:Rheum: Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA). |
Not provided
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Due to an increase in telemedicine utilization over the COVID-19 pandemic, most recruitment was conducted remotely instead of in-person as originally intended. The COVID-19 pandemic coincided with our study, which may account for the low number of participants recruited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mehret Birru Talabi | University of Pittsburgh Medical Center | 412-383-8000 | birrums@upmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2021 | Mar 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 27, 2021 | Jan 19, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012725 | Sexual Behavior |
Not provided
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| Pamphlet | Other | Participants in this arm will be given a copy of an existing patient pamphlet |
|
| T2 (within 24 hours of intervention and appointment) compared to T0 (baseline) |
| 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) |
| 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) |
| 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) |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| 33509066 | Background | 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. |
| 34970654 | Background | 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. |
| 31777789 | Background | 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. |
| 33181126 | Background | 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. |
| 32374928 | Background | Wolgemuth T, Stransky OM, Chodoff A, Kazmerski TM, Clowse MEB, Birru Talabi M. Exploring the Preferences of Women Regarding Sexual and Reproductive Health Care in the Context of Rheumatology: A Qualitative Study. Arthritis Care Res (Hoboken). 2021 Aug;73(8):1194-1200. doi: 10.1002/acr.24249. Epub 2021 Jul 14. |
| 30875455 | Background | 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. |
| 19909547 | Background | Frosch DL, Legare F, Fishbein M, Elwyn G. Adjuncts or adversaries to shared decision-making? Applying the Integrative Model of behavior to the role and design of decision support interventions in healthcare interactions. Implement Sci. 2009 Nov 12;4:73. doi: 10.1186/1748-5908-4-73. |
| 28402085 | Background | Stacey D, Legare F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4(4):CD001431. doi: 10.1002/14651858.CD001431.pub5. |
| 15471770 | Background | O'Connor AM, Llewellyn-Thomas HA, Flood AB. Modifying unwarranted variations in health care: shared decision making using patient decision aids. Health Aff (Millwood). 2004;Suppl Variation:VAR63-72. doi: 10.1377/hlthaff.var.63. |
| 34114738 | Background | 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. |
| 32090480 | Background | 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. |
| 35482371 | Background | 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. |
| 15471751 | Background | Birru MS, Monaco VM, Charles L, Drew H, Njie V, Bierria T, Detlefsen E, Steinman RA. Internet usage by low-literacy adults seeking health information: an observational analysis. J Med Internet Res. 2004 Sep 3;6(3):e25. doi: 10.2196/jmir.6.3.e25. |
| 26168470 | Background | Ng JY, Ntoumanis N, Thogersen-Ntoumani C, Deci EL, Ryan RM, Duda JL, Williams GC. Self-Determination Theory Applied to Health Contexts: A Meta-Analysis. Perspect Psychol Sci. 2012 Jul;7(4):325-40. doi: 10.1177/1745691612447309. |
| 10435967 | Background | Torgerson DJ, Roberts C. Understanding controlled trials. Randomisation methods: concealment. BMJ. 1999 Aug 7;319(7206):375-6. doi: 10.1136/bmj.319.7206.375. No abstract available. |
| 36151999 | Background | 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. |
| 22297687 | Background | Schwarz EB, Parisi SM, Handler SM, Koren G, Cohen ED, Shevchik GJ, Fischer GS. Clinical decision support to promote safe prescribing to women of reproductive age: a cluster-randomized trial. J Gen Intern Med. 2012 Jul;27(7):831-8. doi: 10.1007/s11606-012-1991-y. |
| 35639495 | Background | 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. |
| 34782452 | Background | 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. |
| 36318120 | Background | Crear-Perry J, Hassan A, Daniel S. Advancing Birth Equity in a Post-Dobbs US. JAMA. 2022 Nov 1;328(17):1689-1690. doi: 10.1001/jama.2022.19468. |
| 36318124 | Background | 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. |
| 36128693 | Background | Bermas BL, Blanco I, Blazer AD, Clowse ME, Edens C, Ramsey-Goldman R, Talabi MB. Overturning Roe v. Wade: Toppling the Practice of Rheumatology. Arthritis Rheumatol. 2022 Dec;74(12):1865-1867. doi: 10.1002/art.42336. Epub 2022 Oct 11. No abstract available. |
| 31660532 | Result | 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 2019. |
| 30550399 | Result | Rocca CH, Ralph LJ, Wilson M, Gould H, Foster DG. Psychometric Evaluation of an Instrument to Measure Prospective Pregnancy Preferences: The Desire to Avoid Pregnancy Scale. Med Care. 2019 Feb;57(2):152-158. doi: 10.1097/MLR.0000000000001048. |
| 28851459 | Result | Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. |
| 37833123 | Result | 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. 2024 May;23(3):404-411. doi: 10.1016/j.jcf.2023.10.003. Epub 2023 Oct 11. |
| 21035130 | Result | Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28. |
| 28935217 | Result | Dehlendorf C, Henderson JT, Vittinghoff E, Steinauer J, Hessler D. Development of a patient-reported measure of the interpersonal quality of family planning care. Contraception. 2018 Jan;97(1):34-40. doi: 10.1016/j.contraception.2017.09.005. Epub 2017 Sep 18. |
| 9670878 | Result | Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x. |
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning
Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pamphlet Users |
Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet |
|
|
| 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. | 30 of the 31 Decision Aid users completed the IAM. | Posted | Mean | Standard Deviation | score on a scale | 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. | 30 of the original 31 Decision Aid Users completed the SUS Measure. | Posted | Mean | Standard Deviation | score on a scale | T2 (within 24 hours of intervention and appointment) |
|
|
|
| Other Pre-specified | 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 | Posted | Mean | Standard Deviation | number of correct responses | T2 (within 24 hours of intervention and appointment) compared to T0 (baseline) |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | score on a scale | T2 (within 24 hours of intervention and appointment) compared to T0 (baseline) |
|
|
|
| Other Pre-specified | 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. | Pamphlet users did not complete T3 assessment. 30 Decision aids users completed T3 assessment. | Posted | Count of Participants | Participants | T3 (three months post-intervention) |
|
|
|
| Other Pre-specified | 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) | Posted | Count of Participants | Participants | T2 (within 24 hours of intervention and appointment) |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Pamphlet Users | Patients with a rheumatic disease who are given access to a widely-accessible pamphlet about family planning Pamphlet: Participants in this arm will be given a copy of an existing patient pamphlet | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
| D001519 | Behavior |
| Did you make a decision related to family planning? |
|