Patient-centered Information on Permanent Contraception

Contraception Clinical Trial

Official title:

Disseminating PCOR Findings to Reduce Racial Disparities in Surgical Sterilization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296797
• Other study ID #: 5R18HS029432-02
• Secondary ID: R18HS029432
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Eleanor Schwarz, MD, MS
• Phone: 415-502-1826
• Email: eleanor.schwarz[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Contraception Behavior
• Reproductive Behavior

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Agency for Healthcare Research and Quality (AHRQ), Essential Access Health

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Suggestions for how to improve web-based resources for people considering permanent contraception.	Open-ended question regarding ease-of-use and helpfulness of the web-based program. These responses will provide ongoing information to help guide future adaptations and dissemination.	immediately following introduction to website and at 3 months follow-up
Primary	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	Person-Centered Contraceptive Counseling Measure	4-items including: Letting me say what mattered to me about my birth control, Taking my preferences about my birth control seriously, Giving me enough information to make the best decision about my birth control method, Respecting me as a person, with responses range from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). Investigators hypothesize there will be greater improvements from baseline in the intervention than control arm.	3 month follow-up
Secondary	Consumer Assessment of Healthcare Providers and Systems	Response options on a 10-point Likert scale, ranging from poor (0) to excellent (10).; Investigators hypothesize there will be greater improvements from baseline in the intervention than control arm.	3 months follow-up
Secondary	Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI)	To create a score on the 5 item contraceptive "PEPPI scale" ranging from 5 (lowest possible score) to 25 (representing highest patient-perceived self-efficacy), each item begins with "How confident are participants in their ability to… ", and subjects respond to each question on a scale of 1 to 5, with 5 representing "very confident," and 1 representing "not at all confident" Investigators hypothesize there will be greater improvements from baseline to follow up in the intervention than control arm.	immediately after introduction to website and 3 months follow-up
Secondary	Knowledge of Long-Acting Contraceptives	10 items adapted from the previously used Tubal Sterilization Knowledge Questionnaire items developed by Hall et al. Answers will be coded as correct vs. incorrect (with "Don't Know" being coded as an incorrect response) to create a knowledge score. Investigators will calculate change in knowledge scores on follow up surveys compared to baseline. Investigators hypothesize there will be greater improvements from baseline in the intervention than control arm.	Immediately after introduction to website and at 3 month follow-up
Secondary	Use of preferred method of contraception	3 items detailed in prior publication (PUBMED Number: 27710196)	3 month follow-up
Secondary	Would recommend website to a friend	5 items designed to evaluate usability of website and recommendations to friends. E.g., "Using a scale of 0 (not at all) to 10 (extremely likely), participants will indicate how likely they are to recommend this website to a friend who is considering getting her tubes tied? (0-10)"	Immediately after introduction to website, and at 3 month follow up