Patient-centered Information on Permanent Contraception

Официальное название

Disseminating PCOR Findings to Reduce Racial Disparities in Surgical Sterilization

Обзор

The goal of this study is to understand whether providing information to women with a strong desire to avoid future pregnancy about how tubal sterilization compares to long-acting reversible contraceptives improves perceived access to available contraceptives. Participants will: * Complete a baseline survey * Receive access to web-based educational resources * Complete a brief follow up survey immediately after exploring these web-based resources * Complete a follow-up survey 3 months after enrolling The investigators will compare outcomes among participants provided with access to a new website (intervention) summarizing recent patient-centered outcomes research (PCOR) comparing interval laparoscopic tubal sterilization and long-acting reversible contraception (LARC) to control participants provided with access to the existing Planned Parenthood website on tubal sterilization.

Подробное описание

This study evaluates the potential benefits of web-based resources to prepare patients considering tubal sterilization to effectively communicate their personal values and priorities to their clinicians, informed by recent patient centered outcomes research (PCOR) comparing interval tubal sterilization to long-acting reversible contraceptives. The investigators hypothesize that patients provided with information on the comparative safety and effectiveness of all available long acting contraceptives will be more likely to obtain contraceptive care that aligns with their personal preferences. The short-term goal of this work is to support patient-centered contraceptive care by increasing knowledge of and perceived access to all available long acting contraceptives among those who wish to avoid future pregnancy. The long-term goal of this work is to increase the proportion of women who are using a method of contraception that aligns with their personal preferences, reduce the proportion of women who regret having undergone a permanent contraceptive procedure, and reduce racial disparities in surgical sterilization.

Вмешательства

• Поведенческое Control arm: Existing educational website
  Information about tubal sterilization currently provided on the Planned Parenthood website
• Поведенческое Advancing Access Website
  A website comparing tubal sterilization to long-acting reversible contraceptives informed by recent patient centered outcomes research.

Первичные конечные точки

• Perceived Access to Long Acting Contraceptives [Срок оценки: Immediately after introduction to website and at 3 months follow-up]

Вторичные конечные точки (6)

• Person-Centered Contraceptive Counseling Measure [Срок оценки: 3 month follow-up]
• Consumer Assessment of Healthcare Providers and Systems [Срок оценки: 3 months follow-up]
• Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI) [Срок оценки: immediately after introduction to website and 3 months follow-up]
• Knowledge of Long-Acting Contraceptives [Срок оценки: Immediately after introduction to website and at 3 month follow-up]
• Use of preferred method of contraception [Срок оценки: 3 month follow-up]
• Would recommend website to a friend [Срок оценки: Immediately after introduction to website, and at 3 month follow up]

Критерии участия

Критерии включения

• Self-reported fertility
• Have a strong desire to avoid future pregnancy
• Speak English or Spanish

Критерии исключения

• Current pregnancy
• The inability to speak English or Spanish
• Prior tubal sterilization or "Essure" procedure
• Menopause
• Infertility
• Hysterectomy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Публикации

• Schwarz EB, Lewis CA, Dove MS, Murphy E, Zuckerman D, Nunez-Eddy C, Tancredi DJ, McDonald-Mosley R, Sonalkar S, Hathaway M, Gariepy AM. Comparative Effectiveness and Safety of Intrauterine Contraception and Tubal Ligation. J Gen Intern Med. 2022 Dec;37(16):4168-4175. doi: 10.1007/s11606-022-07433-4. Epub 2022 Feb 23. PMID 35194746

Идентификаторы

NCT: NCT06296797 · 5R18HS029432-02 · R18HS029432

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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