Patient-centered Information on Permanent Contraception

Disseminating PCOR Findings to Reduce Racial Disparities in Surgical Sterilization

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Contraception; Contraception Behavior; Reproductive Behavior
• Intervention / Treatment: Behavioral: Advancing Access Website; Behavioral: Control arm: Existing educational website

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.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eleanor Schwarz, MD, MS; Phone Number: 415-502-1826; Email: eleanor.schwarz@ucsf.edu
• Study Contact Backup: Name: Hannah Begna, MS; Phone Number: (510) 660-0915; Email: hannah.begna@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
      • Contact: Eleanor Schwarz, MD, MS; Email: eleanor.schwarz@ucsf.edu
      • Contact: Hannah Begna, MS; Email: hannah.begna@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comparative information on tubal sterilization and other long-acting contraceptives; A new website comparing tubal sterilization to vasectomy and long-acting reversible contraceptives	Behavioral: Advancing Access Website; A website comparing tubal sterilization to long-acting reversible contraceptives informed by recent patient centered outcomes research.; Other Names: Comparisons of tubal sterilization to long-acting reversible contraceptives
Active Comparator: Information on tubal sterilization; Participants will be shown an existing web page developed by Planned Parenthood for people considering tubal sterilization	Behavioral: Control arm: Existing educational website; Information about tubal sterilization currently provided on the Planned Parenthood website

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 IUD, and hormone-free IUD. A summative score ranging from 0 to 48 points will be calculated for each participant at baseline and follow up. We 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"). We hypothesize there will be greater improvements from baseline in the intervention than control arm.	3 month follow-up
Consumer Assessment of Healthcare Providers and Systems	Response options on a 10-point Likert scale, ranging from poor (0) to excellent (10). We hypothesize there will be greater improvements from baseline in the intervention than control arm.	3 months follow-up
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 you in your 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" We 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
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. We will calculate change in knowledge scores on follow up surveys compared to baseline. We 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
Use of preferred method of contraception	3 items detailed in prior publication PMID 27710196	3 month follow-up
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Agency for Healthcare Research and Quality (AHRQ); Essential Access Health
• Investigators: Principal Investigator: Eleanor Schwarz, MD, MS, University of California, San Francisco

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: contraceptive implant; IUD; permanent contraception; vasectomy; tubal sterilization
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: 5R18HS029432-02 (U.S. AHRQ Grant/Contract); R18HS029432 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No