Patient Perspectives Medicaid Title XIX Sterilization Consent Form

Patient Satisfaction Clinical Trial

Official title:

An Exploratory Analysis of Patient Perspectives Regarding the Medicaid Title XIX Sterilization Consent Form

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06447233
• Other study ID #: AAAU9746
• Status: Recruiting
• Start date: April 29, 2024
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: Tamara Kurek, MD
• Phone: 7164720180
• Email: tk3018[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Satisfaction

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient experience with the Medicaid Title XIX Sterilization consent form	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.	Day 1, up to 1 hour