My Decision Tubal Sterilization Decision Support Tool

Study Overview
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Brief Summary
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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
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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.

Official Title
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Developing and Testing a Decision Support Tool for Women Making Tubal Sterilization Decisions

Conditions
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Tubal Sterilization, Women's Health, Contraception, Contraception Behavior, Reproductive Behavior

Intervention / Treatment
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* Behavioral: My Decision tubal sterilization decision aid
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision Aid Arm<br>Participants will use the web-based decision aid plus usual medical care. | Behavioral: My Decision tubal sterilization decision aid<br>* The My Decision tubal sterilization decision aid is a web-based decision aid designed to help women make informed decisions about tubal sterilization.<br>Other: Usual Care<br>* Usual medical care will vary among participants.<br>|
| Other: Usual Care Arm<br>Participants will receive usual medical care. | Other: Usual Care<br>* Usual medical care will vary among participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%. | 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). | Less than 24 weeks gestation (Time 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Three months postpartum (Time 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tubal Ligation, Decision Aid