Clinical trial NCT04097717: "My Decision" Tubal Sterilization Decision Support Tool
Official title: Developing and Testing a Decision Support Tool for Women Making Tubal Sterilization Decisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tubal Sterilization
Women's Health
Contraception
Contraception Behavior
Reproductive Behavior
Keywords: Tubal Ligation
Decision Aid
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Tennessee
name: University of California, San Francisco
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-09-20
Enrollment: 549
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 \[immediately after using the decision aid (for those in the intervention arm) when participants are less than 24 weeks gestation (Time 1); in the 3rd trimester between 32-36 weeks gestation (Time 2); and three months postpartum (Time 3)\].
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Unable to consent to study participation
* Unable to interact with the content of the web-based decision aid

Primary outcomes:
measure: Participant Knowledge about Tubal Sterilization
timeFrame: Less than 24 weeks gestation (Time 1)
measure: Participant Decisional Conflict in Postpartum Contraceptive Choice
timeFrame: Less than 24 weeks gestation (Time 1)
Secondary outcomes:
measure: Contraceptive Method Selected
timeFrame: Less than 24 weeks gestation (Time 1)
measure: Participant Satisfaction with Decision Making
timeFrame: Three months postpartum (Time 3)
Other outcomes:
measure: Participant Knowledge about Tubal Sterilization
timeFrame: 32-36 weeks gestation (Time 2)
measure: Participant Decisional Conflict in Postpartum Contraceptive Choice
timeFrame: 32-36 weeks gestation (Time 2)
measure: Contraceptive Method Selected
timeFrame: 32-36 weeks gestation (Time 2)
measure: Contraceptive Method(s) Used
timeFrame: Three months postpartum (Time 3)
measure: Ease in Contraceptive Decision Making
timeFrame: Less than 24 weeks gestation (Time 1)
measure: Ease in Contraceptive Decision Making
timeFrame: 32-36 weeks gestation (Time 2)
measure: Certainty about Tubal Sterilization Decision
timeFrame: Less than 24 weeks gestation (Time 1)
measure: Certainty about Tubal Sterilization Decision
timeFrame: 32-36 weeks gestation (Time 2)
measure: Participant Satisfaction with Current Contraceptive Method(s)
timeFrame: Three months postpartum (Time 3)
measure: Participant Confidence in Contraceptive Method Selection
timeFrame: Three months postpartum (Time 3)
measure: Number of Pregnancies Since Delivery
timeFrame: Three months postpartum (Time 3)
measure: Participant Satisfaction with Sterilization Counseling
timeFrame: Three months postpartum (Time 3)
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
Study officials:
affiliation: University of Pittsburgh
name: Sonya Borrero, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Elizabeth Mosley, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: