Clinical trial NCT06296797: Patient-centered Information on Permanent Contraception
Official title: Disseminating PCOR Findings to Reduce Racial Disparities in Surgical Sterilization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contraception
Reproductive Behavior
Contraception Behavior
Keywords: tubal sterilization
permanent contraception
intrauterine device
contraceptive implant
vasectomy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Essential Access Health
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-03-06
Enrollment: 650
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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

Primary outcomes:
measure: Perceived Access to Long Acting Contraceptives
timeFrame: Immediately after introduction to website and at 3 months follow-up
Secondary outcomes:
measure: Person-Centered Contraceptive Counseling Measure
timeFrame: 3 month follow-up
measure: Consumer Assessment of Healthcare Providers and Systems
timeFrame: 3 months follow-up
measure: Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI)
timeFrame: immediately after introduction to website and 3 months follow-up
measure: Knowledge of Long-Acting Contraceptives
timeFrame: Immediately after introduction to website and at 3 month follow-up
measure: Use of preferred method of contraception
timeFrame: 3 month follow-up
measure: Would recommend website to a friend
timeFrame: Immediately after introduction to website, and at 3 month follow up
Other outcomes:
measure: Suggestions for how to improve web-based resources for people considering permanent contraception.
timeFrame: immediately following introduction to website and at 3 months follow-up
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Eleanor Schwarz, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.