Patient-centered Information on Permanent Contraception
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Control arm: Existing educational website, Advancing Access Website.
- Who it may be relevant to
- Registry conditions: Contraception, Reproductive Behavior, Contraception Behavior. Basic parameters: 21 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Disseminating PCOR Findings to Reduce Racial Disparities in Surgical Sterilization
Overview
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.
Detailed description
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.
Interventions
- Behavioral Control arm: Existing educational website
Information about tubal sterilization currently provided on the Planned Parenthood website - Behavioral Advancing Access Website
A website comparing tubal sterilization to long-acting reversible contraceptives informed by recent patient centered outcomes research.
Primary outcome measures
- Perceived Access to Long Acting Contraceptives [Time frame: Immediately after introduction to website and at 3 months follow-up]
Secondary outcome measures (6)
- Person-Centered Contraceptive Counseling Measure [Time frame: 3 month follow-up]
- Consumer Assessment of Healthcare Providers and Systems [Time frame: 3 months follow-up]
- Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI) [Time frame: immediately after introduction to website and 3 months follow-up]
- Knowledge of Long-Acting Contraceptives [Time frame: Immediately after introduction to website and at 3 month follow-up]
- Use of preferred method of contraception [Time frame: 3 month follow-up]
- Would recommend website to a friend [Time frame: Immediately after introduction to website, and at 3 month follow up]
Eligibility criteria
Inclusion criteria
- Self-reported fertility
- Have a strong desire to avoid future pregnancy
- Speak English or Spanish
Exclusion criteria
- Current pregnancy
- The inability to speak English or Spanish
- Prior tubal sterilization or "Essure" procedure
- Menopause
- Infertility
- Hysterectomy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Publications
- 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
Identifiers
NCT: NCT06296797 · 5R18HS029432-02 · R18HS029432