Contraception, Contraception Behavior, Reproductive Behavior
Conditions
Keywords
tubal sterilization, permanent contraception, intrauterine device, contraceptive implant, vasectomy
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.
Interventions
BEHAVIORALControl arm: Existing educational website
Information about tubal sterilization currently provided on the Planned Parenthood website
BEHAVIORALAdvancing Access Website
A website comparing tubal sterilization to long-acting reversible contraceptives informed by recent patient centered outcomes research.
Sponsors
University of California, San Francisco
Essential Access Health
Agency for Healthcare Research and Quality (AHRQ)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Access to Long Acting Contraceptives | Immediately after introduction to website and at 3 months follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Person-Centered Contraceptive Counseling Measure | 3 month follow-up | 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. |
| Consumer Assessment of Healthcare Providers and Systems | 3 months follow-up | 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. |
| Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI) | immediately after introduction to website and 3 months follow-up | 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. |
| Knowledge of Long-Acting Contraceptives | Immediately after introduction to website and at 3 month follow-up | 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. |
| Use of preferred method of contraception | 3 month follow-up | 3 items detailed in prior publication (PUBMED Number: 27710196) |
| Would recommend website to a friend | Immediately after introduction to website, and at 3 month follow up | 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)" |
Countries
United States
Contacts
CONTACTEleanor Schwarz, MD, MS
CONTACTAgatha Okobi
PRINCIPAL_INVESTIGATOREleanor Schwarz, MD, MS
University of California, San Francisco
Outcome results
None listed