Clinical trial NCT06447233: Patient Perspectives Medicaid Title XIX Sterilization Consent Form
Official title: An Exploratory Analysis of Patient Perspectives Regarding the Medicaid Title XIX Sterilization Consent Form
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Satisfaction
Keywords: Sterilization
Coercion
Understanding
Satisfaction
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2024-06-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study participants will be patients seeking care at Columbia University affiliated OBGYN practices. The Columbia University affiliated OBGYN practices serve the Washington Heights and Inwood communities of New York City. The patient population is majority Hispanic and foreign-born. Approximately half of patients seeking permanent contraception are Spanish speaking.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient experience with the Medicaid Title XIX Sterilization consent form
timeFrame: Day 1, up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Erika Levi, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: