Patient Perspectives Medicaid Title XIX Sterilization Consent Form

Recruiting

• Conditions: Patient Satisfaction

• Registration Number: NCT06447233
• Lead Sponsor: Columbia University

Brief Summary

The goal of this survey and interview study is to learn about patient experience consenting for permanent contraception using the Medicaid Title XIX Sterilization Consent form. The main questions it aims to answer are:

* To explore patient perspectives on and understanding of the current consenting process for obtaining permanent contraception as it relates to the Medicaid Title XIX Sterilization consent form.

* To explore patient experience with the current consenting process, and thoughts regarding the ideal consenting process including how it would differ from the one currently in place, if at all.

Participants will complete a 10-15 minute survey and be offered participation in an in-depth one-on-one interview.

Detailed Description

The United States has a long history of coerced sterilization which was influenced by the eugenics and population control movements of the early and mid-20th century, respectively. The Medicaid Title XIX Sterilization Consent Form was created in response to these forced sterilizations to protect patients, but in recent years there have been questions regarding whether these forms are instead creating barriers to care for already marginalized populations. Prior studies demonstrated decreased rates of completion of postpartum permanent contraception requests secondary to invalid consent forms and negative attitudes among OBGYNs, including concerns regarding the ethics behind the forms. To date, there is very limited literature exploring patient perspectives. This will be a mixed methods study in which bilingual surveys will be distributed via REDCap to patients seeking permanent contraception at Columbia University affiliated OBGYN practices and complete in-depth interviews exploring patient experiences consenting for permanent contraception, and what an ideal consenting process might look like to them.

Study Timeline

• Study Start: 2024-04-29
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Seeking permanent contraception procedure through a Columbia University practice
• English or Spanish speaking
• Completed the Medicaid Title XIX Consent Form

Exclusion Criteria

-Currently pregnant and seeking immediate postpartum permanent contraception

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient experience with the Medicaid Title XIX Sterilization consent form	Day 1, up to 1 hour	Patient perspectives on and understanding of the current consenting process for obtaining permanent contraception as it relates to the Medicaid Title XIX Sterilization consent form. Patients' responses to interview questions will be translated into coded data using Dedoose, and grouped coded data will inform patterns of patient experience. Quantitative software will be used to analyze survey responses using descriptive statistics.

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States