Tubal SterilizationNCT04097717
"My Decision" Tubal Sterilization Decision Support Tool
A study testing "My Decision" tubal sterilization decision aid in people with Tubal Sterilization and Women's Health, run by University of Pittsburgh at 2 sites in United States.
Trial summary
This study seeks to test a web-based decision support tool developed to enhance low-income women's ability to make informed decisions about tubal sterilization that align with their preferences, values and reproductive goals. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Tubal Sterilization, Women's Health, Contraception
- What is being tested?
- "My Decision" tubal sterilization decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 549 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Feb 2020to 30 Apr 2024
- Phase
- Interventional
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women
- 21-45 years of age
- Fluently speak English or Spanish
- Fluently read English or Spanish
- Considering tubal sterilization
- < 24 weeks gestation
- Continuing current pregnancy
- Using Medicaid insurance
Who cannot join
- Unable to consent to study participation
- Unable to interact with the content of the web-based decision aid
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Tennessee
Knoxville, Tennessee, 37920
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Developing and Testing a Decision Support Tool for Women Making Tubal Sterilization Decisions
This study seeks to test a web-based decision support tool developed to enhance low-income women's ability to make informed decisions about tubal sterilization that align with their preferences, values and reproductive goals. Half of participants will receive usual care, while the other half will use the web-based decision aid plus usual care. The investigators hypothesize that compared to women who receive usual care alone, women randomized to the decision aid arm will have greater knowledge about sterilization and alternative options, lower decisional conflict, and will be more satisfied with their contraceptive decision at 3-month follow-up.
Read the detailed description
Female surgical sterilization is the second most commonly used contraceptive method in the US and is disproportionately used by low-income women and women of color. Whether the higher use of sterilization in these populations reflects inappropriate overutilization is unclear. On one hand, low-income and racial minority women frequently misunderstand the permanent nature of sterilization, are often unaware of reversible contraceptive alternatives, and commonly experience regret after the procedure- suggesting suboptimal decision making. On the other hand, there is evidence of substantial unmet demand for sterilization among low-income women, due to unique access barriers posed by Medicaid sterilization regulations, putting them at high risk for unintended pregnancy and the adverse health and social consequences associated with unintended pregnancy.
Medicaid sterilization policy currently requires that all women requesting a federally-funded procedure complete a standardized consent form at least 30 days prior to sterilization. This policy was originally instituted in the 1970s to protect vulnerable women from coercive sterilization practices by attempting to ensure informed and voluntary consent. However, there is growing consensus that the policy is incapable of ensuring informed consent, and that the mandatory 30-waiting period impedes access to desired sterilization for many low-income women. The lack of a process that can ensure both informed consent and timely access for sterilization procedures hampers progress toward reproductive health equity for low-income women.
This study seeks to test a novel, web-based decision support tool to support low-income women's ability to make informed and value-concordant decisions about surgical sterilization. A decision support tool may be particularly useful in the context of sterilization decisions because this is a preference-sensitive decision with permanent implications and because there is a high level of misunderstanding about sterilization and limited awareness of alternative options among women who have undergone the surgery, indicating critical gaps in the quality of pre-sterilization counseling. Furthermore, patient-provider interactions may be complicated by a broader social and historical context in which poor and minority women's reproductive choices have not always been valued.
The study is a multi-site randomized controlled trial to test the effect of the decision aid plus usual care compared to usual care alone on decision quality among 350 racially-diverse, low-income pregnant women considering a post-partum sterilization procedure. Participant surveys will be utilized at three assessments points to evaluate outcomes.
In addition to its potential clinical utility, this research also has important policy implications, as it can inform ongoing efforts to transform the current Medicaid policy by offering a decision aid that is able to ensure informed decision making in vulnerable populations, thereby allowing the investigators to ultimately replace the current Medicaid consent form with this scalable tool. Once there is a tool to safeguard women with an evidence-based process for ensuring informed consent, further progress can be made in potentially shortening or waiving the mandatory 30-day waiting period that has restricted access to desired sterilization for many low-income women.
- Conditions
- Tubal Sterilization, Women's Health, Contraception, Contraception Behavior, Reproductive Behavior
- Being tested
- "My Decision" tubal sterilization decision aid, Usual Care
- Keywords
- Tubal Ligation, Decision Aid
- Medical subject headings
- Contraception Behavior, Reproductive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"My Decision" tubal sterilization decision aidBehavioural
The "My Decision" tubal sterilization decision aid is a web-based decision aid designed to help women make informed decisions about tubal sterilization.
Usual CareOther
Usual medical care will vary among participants.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid Arm | Experimental | Participants will use the web-based decision aid plus usual medical care. Receives: Behavioral: "My Decision" tubal sterilization decision aid; Other: Usual Care |
| Usual Care Arm | Other | Participants will receive usual medical care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Knowledge about Tubal Sterilization
Participant responses to 10 True/False items adapted from previously published studies of tubal sterilization knowledge and informed by in-depth interviews with women about sterilization decision making. Items assess knowledge about tubal sterilization and alternative contraception options and will be coded as correct vs. incorrect, with "Don't Know" being coded as an incorrect response. The percentage of correct responses across the 10 questions will be calculated for each participant. The score range is 0 to 100%.
Measured: Less than 24 weeks gestation (Time 1)
Participant Decisional Conflict in Postpartum Contraceptive Choice
Assessed by participant responses to the low literacy version of the Decisional Conflict Scale (DCS). The DCS is a validated measure to assess participants' decisional conflict in medical decision-making. The DCS low literacy version includes 10 items about experience of conflict, with "Yes" = 0, "unsure" = 2 and "No" = 4. All 10 items are a) summed; b) divided by 10; and c) multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Measured: Less than 24 weeks gestation (Time 1)
Secondary outcomes (2)
Contraceptive Method Selected
Will determine the proportion of women who select sterilization versus another method of contraception at Time 1. Assessed by participant responses to an item asking which contraceptive method they are planning to use after delivery.
Measured: Less than 24 weeks gestation (Time 1)
Participant Satisfaction with Decision Making
Assessed by participant responses to the Satisfaction with Decision Scale (SWD), a validated 6-item scale measuring participants' satisfaction with healthcare decision making. The SWD uses a 5-point Likert scale where 1 is "Strongly Disagree" and 5 is "Strongly Agree." A summary score is calculated as an average of all items with a range of 1-5, with a higher score reflecting a higher level of satisfaction with the decision.
Measured: Three months postpartum (Time 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start24 Feb 2020
- Primary completion6 Jan 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tubal SterilizationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled trial in which participants will be assigned to one of two groups (intervention arm or usual care arm) in parallel for the duration of the study. All participants will be asked to complete assessments at three separate time points \[immediately after using the decision aid (for those in the intervention arm) when participants are less than 24 weeks gestation (Time 1); in the 3rd trimester between 32-36 weeks gestation (Time 2); and three months postpartum (Time 3)\].
- Masking
- None (open label)
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee, University of California, San Francisco, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Elizabeth Mosley, University of Pittsburgh
- Investigators
- Sonya Borrero, MD MS, Principal investigator, University of PittsburghElizabeth Mosley, PhD MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097717
- Sponsor's protocol ID
- STUDY20110382
- Other IDs
- R01MD011678-01
- Status last verified
- Oct 2024
- First submitted
- 19 Sep 2019
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be used for publication.
Publications
Borrero S, Mosley EA, Wu M, Dehlendorf C, Wright C, Abebe KZ, Zite N. A Decision Aid to Support Tubal Sterilization Decision-Making Among Pregnant Women: The MyDecision/MiDecision Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e242215. doi: 10.1001/jamanetworkopen.2024.2215.
PubMed 38502127
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Decision Support Tool for Women Making Tubal Sterilization Decisions
- ClinicalTrials.gov ID
- NCT04097717
- Acronym / sponsor ID
- STUDY20110382
- Conditions
- Tubal Sterilization, Women's Health, Contraception, Contraception Behavior, Reproductive Behavior
- Keywords
- Tubal Ligation, Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Tennessee, University of California, San Francisco, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Sep 2019 (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.
This study seeks to test a web-based decision support tool developed to enhance low-income women's ability to make informed decisions about tubal sterilization that align with their preferences, values and reproductive goals. Half of participants will receive usual care, while the other half will use the web-based decision aid plus usual care. The investigators hypothesize that compared to women who receive usual care alone, women randomized to the decision aid arm will have greater knowledge about sterilization and alternative options, lower decisional conflict, and will be more satisfied with their contraceptive decision at 3-month follow-up.
Detailed description
Female surgical sterilization is the second most commonly used contraceptive method in the US and is disproportionately used by low-income women and women of color. Whether the higher use of sterilization in these populations reflects inappropriate overutilization is unclear. On one hand, low-income and racial minority women frequently misunderstand the permanent nature of sterilization, are often unaware of reversible contraceptive alternatives, and commonly experience regret after the procedure- suggesting suboptimal decision making. On the other hand, there is evidence of substantial unmet demand for sterilization among low-income women, due to unique access barriers posed by Medicaid sterilization regulations, putting them at high risk for unintended pregnancy and the adverse health and social consequences associated with unintended pregnancy.
Medicaid sterilization policy currently requires that all women requesting a federally-funded procedure complete a standardized consent form at least 30 days prior to sterilization. This policy was originally instituted in the 1970s to protect vulnerable women from coercive sterilization practices by attempting to ensure informed and voluntary consent. However, there is growing consensus that the policy is incapable of ensuring informed consent, and that the mandatory 30-waiting period impedes access to desired sterilization for many low-income women. The lack of a process that can ensure both informed consent and timely access for sterilization procedures hampers progress toward reproductive health equity for low-income women.
This study seeks to test a novel, web-based decision support tool to support low-income women's ability to make informed and value-concordant decisions about surgical sterilization. A decision support tool may be particularly useful in the context of sterilization decisions because this is a preference-sensitive decision with permanent implications and because there is a high level of misunderstanding about sterilization and limited awareness of alternative options among women who have undergone the surgery, indicating critical gaps in the quality of pre-sterilization counseling. Furthermore, patient-provider interactions may be complicated by a broader social and historical context in which poor and minority women's reproductive choices have not always been valued.
The study is a multi-site randomized controlled trial to test the effect of the decision aid plus usual care compared to usual care alone on decision quality among 350 racially-diverse, low-income pregnant women considering a post-partum sterilization procedure. Participant surveys will be utilized at three assessments points to evaluate outcomes.
In addition to its potential clinical utility, this research also has important policy implications, as it can inform ongoing efforts to transform the current Medicaid policy by offering a decision aid that is able to ensure informed decision making in vulnerable populations, thereby allowing the investigators to ultimately replace the current Medicaid consent form with this scalable tool. Once there is a tool to safeguard women with an evidence-based process for ensuring informed consent, further progress can be made in potentially shortening or waiving the mandatory 30-day waiting period that has restricted access to desired sterilization for many low-income women.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized controlled trial in which participants will be assigned to one of two groups (intervention arm or usual care arm) in parallel for the duration of the study. All participants will be asked to complete assessments at three separate time points [immediately after using the decision aid (for those in the intervention arm) when participants are less than 24 weeks gestation (Time 1); in the 3rd trimester between 32-36 weeks gestation (Time 2); and three months postpartum (Time 3)].
| Arm | Type | Receives |
|---|---|---|
| Decision Aid Arm | Experimental | Behavioral: "My Decision" tubal sterilization decision aid, Other: Usual CareParticipants will use the web-based decision aid plus usual medical care. |
| Usual Care Arm | Other | Other: Usual CareParticipants will receive usual medical care. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Pregnant women
- 21-45 years of age
- Fluently speak English or Spanish
- Fluently read English or Spanish
- Considering tubal sterilization
Key exclusion criteria (2 listed)
- Unable to consent to study participation
- Unable to interact with the content of the web-based decision aid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "My Decision" tubal sterilization decision aidThe "My Decision" tubal sterilization decision aid is a web-based decision aid designed to help women make informed decisions about tubal sterilization. | Behavioural | Decision Aid Arm |
| Usual CareUsual medical care will vary among participants. | Other | Decision Aid Arm, Usual Care Arm |
Primary outcome
Participant Knowledge about Tubal Sterilization
Time frame: Less than 24 weeks gestation (Time 1)
Participant responses to 10 True/False items adapted from previously published studies of tubal sterilization knowledge and informed by in-depth interviews with women about sterilization decision making. Items assess knowledge about tubal sterilization and alternative contraception options and will be coded as correct vs. incorrect, with "Don't Know" being coded as an incorrect response. The percentage of correct responses across the 10 questions will be calculated for each participant. The score range is 0 to 100%.
Participant Decisional Conflict in Postpartum Contraceptive Choice
Time frame: Less than 24 weeks gestation (Time 1)
Assessed by participant responses to the low literacy version of the Decisional Conflict Scale (DCS). The DCS is a validated measure to assess participants' decisional conflict in medical decision-making. The DCS low literacy version includes 10 items about experience of conflict, with "Yes" = 0, "unsure" = 2 and "No" = 4. All 10 items are a) summed; b) divided by 10; and c) multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
2 secondary outcomes
Contraceptive Method Selected
Time frame: Less than 24 weeks gestation (Time 1)
Participant Satisfaction with Decision Making
Time frame: Three months postpartum (Time 3)
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 1 Nov 2024.
- Derived from this study: PubMed 38502127Borrero S, Mosley EA, Wu M, Dehlendorf C, Wright C, Abebe KZ, Zite N. A Decision Aid to Support Tubal Sterilization Decision-Making Among Pregnant Women: The MyDecision/MiDecision Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e242215. doi: 10.1001/jamanetworkopen.2024.2215.
- Individual participant dataSharing planned: Yes. De-identified participant data will be used for publication.
Related trials for Tubal Sterilization
Recruiting
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Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix)
Active, not recruiting
SALpingectomy for STERilization (SALSTER)
Sterilization Tubal, Salpingectomy
Enrolling by invitationObservational study
Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
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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.
Sonya Borrero, MD MS principal investigator
University of Pittsburgh
Elizabeth Mosley, PhD MPH principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "My Decision" tubal sterilization decision aid in people with Tubal Sterilization and Women's Health, run by University of Pittsburgh at 2 sites 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 8 inclusion and 2 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Participant Knowledge about Tubal Sterilization (time frame: Less than 24 weeks gestation (Time 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04097717, which also lists 1 linked publication.
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 1 Nov 2024.