Patient-centered Information on Permanent Contraception
Disseminating PCOR Findings to Reduce Racial Disparities in Surgical Sterilization
2 other identifiers
interventional
650
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2024
CompletedFirst Posted
Study publicly available on registry
March 6, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
January 26, 2026
January 1, 2026
2.3 years
January 2, 2024
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perceived Access to Long Acting Contraceptives
A 9-item, multi-dimensional measure assessing awareness, availability, accessibility, affordability, and acceptability of contraceptive options including tubal sterilization, vasectomy, the subdermal implant, hormonal intrauterine device, and hormone-free intrauterine device. A summative score ranging from 0 to 48 points will be calculated for each participant at baseline and follow up. Investigators hypothesize there will be greater improvements from baseline to follow up in the intervention than control arm.
Immediately after introduction to website and at 3 months follow-up
Secondary Outcomes (6)
Person-Centered Contraceptive Counseling Measure
3 month follow-up
Consumer Assessment of Healthcare Providers and Systems
3 months follow-up
Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI)
immediately after introduction to website and 3 months follow-up
Knowledge of Long-Acting Contraceptives
Immediately after introduction to website and at 3 month follow-up
Use of preferred method of contraception
3 month follow-up
- +1 more secondary outcomes
Other Outcomes (1)
Suggestions for how to improve web-based resources for people considering permanent contraception.
immediately following introduction to website and at 3 months follow-up
Study Arms (2)
Comparative information on tubal sterilization and other long-acting contraceptives
EXPERIMENTALA new website comparing tubal sterilization to vasectomy and long-acting reversible contraceptives
Information on tubal sterilization
ACTIVE COMPARATORParticipants will be shown an existing web page developed by Planned Parenthood for people considering tubal sterilization
Interventions
Information about tubal sterilization currently provided on the Planned Parenthood website
A website comparing tubal sterilization to long-acting reversible contraceptives informed by recent patient centered outcomes research.
Eligibility Criteria
You may qualify if:
- Self-reported fertility
- Have a strong desire to avoid future pregnancy
- Speak English or Spanish
You may not qualify if:
- Current pregnancy
- The inability to speak English or Spanish
- Prior tubal sterilization or "Essure" procedure
- Menopause
- Infertility
- Hysterectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Essential Access Healthcollaborator
- Agency for Healthcare Research and Quality (AHRQ)collaborator
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
Related Publications (1)
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: 35194746BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eleanor Schwarz, MD, MS
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2024
First Posted
March 6, 2024
Study Start
April 1, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
January 26, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share