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临床试验/NCT06296797
NCT06296797招募中不适用

Disseminating PCOR Findings to Reduce Racial Disparities in Surgical Sterilization

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
650
试验地点
1
主要终点
Perceived Access to Long Acting Contraceptives

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Self-reported fertility
  • Have a strong desire to avoid future pregnancy
  • Speak English or Spanish

排除标准

  • Current pregnancy
  • The inability to speak English or Spanish
  • Prior tubal sterilization or "Essure" procedure
  • Menopause
  • Infertility
  • Hysterectomy

研究组 & 干预措施

Comparative information on tubal sterilization and other long-acting contraceptives

Experimental

A new website comparing tubal sterilization to vasectomy and long-acting reversible contraceptives

干预措施: Advancing Access Website (Behavioral)

Information on tubal sterilization

Active Comparator

Participants will be shown an existing web page developed by Planned Parenthood for people considering tubal sterilization

干预措施: Control arm: Existing educational website (Behavioral)

结局指标

主要结局

Perceived Access to Long Acting Contraceptives

时间窗: 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.

次要结局

  • Consumer Assessment of Healthcare Providers and Systems(3 months follow-up)
  • Would recommend website to a friend(Immediately after introduction to website, and at 3 month follow up)
  • Person-Centered Contraceptive Counseling Measure(3 month follow-up)
  • Use of preferred method of contraception(3 month follow-up)
  • Knowledge of Long-Acting Contraceptives(Immediately after introduction to website and at 3 month follow-up)
  • Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI)(immediately after introduction to website and 3 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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