"My Decision" Tubal Sterilization Decision Support Tool

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04097717
• Other study ID #: STUDY20110382
• Secondary ID: R01MD011678-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: April 30, 2024
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Contraception Behavior
• Reproductive Behavior
• Tubal Sterilization
• Women's Health

Intervention

Behavioral:
• "My Decision" tubal sterilization decision aid
The "My Decision" tubal sterilization decision aid is a web-based decision aid designed to help women make informed decisions about tubal sterilization.

Other:
• Usual Care
Usual medical care will vary among participants.

Locations

Country	Name	City	State
United States	University of Tennessee	Knoxville	Tennessee
United States	University of California, San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Minority Health and Health Disparities (NIMHD), University of California, San Francisco, University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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%. Participant knowledge will be measured at Time 2 to assess the sustained impact of the decision aid on knowledge.	32-36 weeks gestation (Time 2)
Other	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). Decisional conflict will be measured at Time 2 to assess the sustained impact of the decision aid on decisional conflict.	32-36 weeks gestation (Time 2)
Other	Contraceptive Method Selected	Will determine the proportion of women who select sterilization versus another method of contraception at Time 2. Assessed by participant responses to an item asking which contraceptive method they are planning to use after delivery.	32-36 weeks gestation (Time 2)
Other	Contraceptive Method(s) Used	Assessed by participant responses to a multiple choice item asking which methods of contraception they have used or received since their pregnancy ended.	Three months postpartum (Time 3)
Other	Ease in Contraceptive Decision Making	Assessed by participant responses to a 10 point scale about ease of decision making with regards to contraceptive method selection. Response options range from 0 ("Strongly Disagree" that this is an easy decision to make) to 10 ("Strongly Agree" that this an easy decision to make").	Less than 24 weeks gestation (Time 1)
Other	Ease in Contraceptive Decision Making	Assessed by participant responses to a 10 point scale about ease of decision making with regards to contraceptive method selection. Response options range from 0 ("Strongly Disagree" that this is an easy decision to make) to 10 ("Strongly Agree" that this an easy decision to make").	32-36 weeks gestation (Time 2)
Other	Certainty about Tubal Sterilization Decision	Assessed by participant responses to a 10 point scale indicating certainty in desire to obtain or not obtain a tubal sterilization. Response options range from 0 ("Very Certain that I Do Not Want") to 10 ("Very Certain that I Do Want").	Less than 24 weeks gestation (Time 1)
Other	Certainty about Tubal Sterilization Decision	Assessed by participant responses to a 10 point scale indicating certainty in desire to obtain or not obtain a tubal sterilization. Response options range from 0 ("Very Certain that I Do Not Want") to 10 ("Very Certain that I Do Want").	32-36 weeks gestation (Time 2)
Other	Participant Satisfaction with Current Contraceptive Method(s)	Assessed by participant responses to a 5-point Likert scale regarding satisfaction with current contraceptive method(s). Response options range from 1 ("Very Unsatisfied") to 5 ("Very Satisfied").	Three months postpartum (Time 3)
Other	Participant Confidence in Contraceptive Method Selection	Assessed by participant responses to a 5-point Likert scale regarding participant confidence that the method(s) is/are "right for me". Response options range from 1 ("Not at All Confident") to 5 ("Completely Confident").	Three months postpartum (Time 3)
Other	Number of Pregnancies Since Delivery	Assessed by participant-reported survey responses to a Yes/No item about whether a pregnancy has occurred since delivery.	Three months postpartum (Time 3)
Other	Participant Satisfaction with Sterilization Counseling	Participant responses to an 8-item patient-provider communication scale created by the PI to assess participant satisfaction with the sterilization counseling experience. Response options range from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). Items will be examined individually. In addition, a summary score will be created with items 2,3,6 reverse coded such that the range will be 8-40 with a higher score reflecting greater satisfaction with sterilization counseling.	Three months postpartum (Time 3)
Primary	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)
Primary	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	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)
Secondary	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)