Patient-centered Information on Permanent Contraception

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-45
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Self-reported fertility

Have a strong desire to avoid future pregnancy

Speak English or Spanish

Disqualifiers

Current pregnancy

The inability to speak English or Spanish

Prior tubal sterilization or "Essure" procedure

Menopause

Trial design

Design model

Parallel

Treatments tested in this trial

  • Control arm: Existing educational website

    Behavioral

    Information about tubal sterilization currently provided on the Planned Parenthood website

  • Advancing Access Website

    Behavioral

    A website comparing tubal sterilization to long-acting reversible contraceptives informed by recent patient centered outcomes research.

Treatment groups

650 Participants
are divided into 2 treatment groups
Group A: Comparative information on tubal sterilization and other long-acting contraceptivesExperimental treatment 1 intervention
Group B: Information on tubal sterilizationActive comparator 1 intervention

Trial outcomes

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.

Time frame
Immediately after introduction to website and at 3 months follow-up

Secondary outcomes

1

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.

Time frame
3 month follow-up
2

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.

Time frame
3 months follow-up
3

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.

Time frame
immediately after introduction to website and 3 months follow-up
4

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.

Time frame
Immediately after introduction to website and at 3 month follow-up

Other outcomes

1

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.

Time frame
immediately following introduction to website and at 3 months follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Essential Access Health

Collaborator

Agency for Healthcare Research and Quality (AHRQ)

Collaborator