Patient SatisfactionNCT06447233
Patient Perspectives Medicaid Title XIX Sterilization Consent Form
An observational study of Patient Satisfaction, run by Columbia University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Patient Satisfaction
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 20 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- Seeking permanent contraception procedure through a Columbia University practice
- English or Spanish speaking
- Completed the Medicaid Title XIX Consent Form
Who cannot join
- -Currently pregnant and seeking immediate postpartum permanent contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Analysis of Patient Perspectives Regarding the Medicaid Title XIX Sterilization Consent Form
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.
Read the 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.
- Conditions
- Patient Satisfaction
- Keywords
- Sterilization, Coercion, Understanding, Satisfaction
- Medical subject headings
- Patient Satisfaction, Personal Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start29 Apr 2024
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Erika Levi, MD MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447233
- Sponsor's protocol ID
- AAAU9746
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Analysis of Patient Perspectives Regarding the Medicaid Title XIX Sterilization Consent Form
- ClinicalTrials.gov ID
- NCT06447233
- Acronym / sponsor ID
- AAAU9746
- Conditions
- Patient Satisfaction
- Keywords
- Sterilization, Coercion, Understanding, Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Seeking permanent contraception procedure through a Columbia University practice
- English or Spanish speaking
- Completed the Medicaid Title XIX Consent Form
Key exclusion criteria (1 listed)
- -Currently pregnant and seeking immediate postpartum permanent contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient experience with the Medicaid Title XIX Sterilization consent form
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Levi, MD MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient experience with the Medicaid Title XIX Sterilization consent form (time frame: Day 1, up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.