By Katie Hansen, MD, MPH, and Lisa Bayer, MD, MPH
Dr. Hansen is a Clinical Fellow, Complex Family Planning Division, Department of Obstetrics and Gynecology, Oregon Health & Science University. Dr. Bayer is Associate Professor, Complex Family Planning Division, Department of Obstetrics and Gynecology, Oregon Health & Science University.
A patient-centered decision aid that improves tubal sterilization knowledge and decision-making quality may be able to fill gaps in counseling and supplement the existing Medicaid sterilization consent process.
Borrero S, Mosley EA, Wu M, et al. A decision aid to support tubal sterilization decision-making among pregnant women: The MyDecision/MiDecisión randomized clinical trial. JAMA Netw Open 2024;7:e242215.
Tubal sterilization is the most common form of contraception in the United States among pregnancy-capable individuals aged 15-49 years (18.1%).1 Given the well-documented history of contraceptive coercion and forced sterilization in the United States, the provision of patient-centered counseling that supports patient autonomy is critical.2-4 However, widespread misinformation about the procedure exists, and people’s preferences and subsequent decisions about permanent contraception are not always well-informed. This study examined the efficacy of a web-based decision aid for improving tubal sterilization decision quality among low-income pregnant people considering tubal sterilization.
This was a randomized controlled trial across outpatient obstetric clinics in three U.S. cities between March 2020 and November 2023. The researchers recruited a total of 365 cisgender pregnant women ages 21-45 years who were less than 24 weeks’ pregnant, were considering a tubal ligation procedure after delivery, had Medicaid insurance, and were fluent in English or Spanish. All participants were randomized in a 1:1 allocation ratio. Those randomized to the control group received usual care only, while those in the intervention group were asked to complete a web-based decision aid, the MyDecision/MiDecisíon tool. This tool includes multimedia information about tubal sterilization procedures, value-clarifying exercises, and knowledge checks. An assessment of tubal sterilization knowledge and decisional conflict was completed by all participants at baseline prior to 24 weeks’ gestation and during the third trimester to determine durability of the intervention.
The coprimary outcomes of tubal sterilization knowledge and participant decisional conflict were assessed to evaluate the efficacy of the decision aid. Sterilization knowledge was assessed using 10 true/false questions. Decisional conflict was measured using the low-literacy version of the validated Decision Conflict Scale, with a lower score indicating lower conflict.
These outcomes were analyzed as continuous variables and reported as mean differences with 97.5% confidence intervals (CIs). Using an intention-to-treat analysis, both knowledge and decisional conflict differences between the two groups were tested via multivariable logistic and linear regression, controlling for study site. Effect sizes (Cohen’s d) of the intervention were calculated for both outcomes. Subgroup analyses also were performed using linear regression models to identify any differences based on race/ethnicity, age, language spoken, mode of decision aid completion (virtual or in person), recruitment site, education level, and whether they received any permanent contraception counseling from a provider during their pregnancy. For the two primary comparisons, P < 0.025 was used to define statistical significance. For all other comparisons, a P < 0.05 was considered statistically significant.
The study included 172 participants in the intervention group and 178 participants in the control group. Baseline characteristics were similar between the two groups, with a mean age of 29.7 years, mean gestational age of 16.1 weeks, 47.1% completed high school or their GED, 64% were married or cohabiting, 39.1% were non-Hispanic white, and 46.3% reported receiving sterilization counseling during this pregnancy. Tubal sterilization knowledge was significantly higher among participants in the intervention group; the mean percentage of 10 knowledge items answered correctly was 76.5% for the decision aid group and 55.5% for the control group (mean difference 20.8% [97.5% CI, 16.2% to 25.4%]; Cohen’s d, 1.05 [97.5% CI, 0.79-1.31]; P < 0.001).
The items with the largest differences in knowledge scores between the two groups were questions related to how permanent the procedure is; compared to the control group, participants who completed the decision aid were far more likely to know that tubal sterilization is not easily reversible (90.1% vs. 39.3%, P < 0.001) and that tubes will not “come untied” (86.6% vs. 33.7%, P < 0.001). Additionally, decisional conflict scores were a mean 5.8 percentage points lower (97.5% CI, -10.0 to -1.6 percentage points) for participants in the intervention group compared to those in the control group (Cohen’s d, -0.31 [97.5%CI, -0.55 to -0.07]; P = 0.002).
These findings did not significantly differ by race/ethnicity, language, age, mode of decision aid completion, or study site. However, Spanish speakers did experience a greater reduction in decisional conflict than those who spoke English (mean difference, -18.2 points [95% CI, -31.6 to -4.9 points] vs. -3.7 points [95% CI, -7.0 to 0.3 points]; P = 0.003).
When knowledge and decisional conflict were reassessed in the third trimester (on average, four months later), 85% of participants in both groups had received clinician counseling about contraception and/or sterilization. Knowledge scores continued to be significantly higher among those who had completed the decision aid earlier in pregnancy; those in the intervention group answered 67.9% of questions correctly compared to 61.4% in the control group (Cohen’s d, 0.33 [97.5% CI, 0.12-0.54] P = 0.003).
Large knowledge differences remained for the two questions about permanence, with the intervention group remaining more likely to know that tubal sterilization is not easily reversible (76.0% vs. 54.4%; odds ratio [OR], 2.7 [95% CI, 1.6-4.4]; P < 0.001) and that tubes will not “come untied” (69.5% vs. 40.9%; OR, 3.3 [95% CI, 2.1-5.4]; P < 0.001). Decisional conflict scores were a mean of 4.1 points (95% CI, 7.8-0.4 points) lower for the intervention group compared with the control (Cohen’s d, -0.23 [95% CI, -0.44 to -0.02]; P = 0.03).
COMMENTARY
Tubal sterilization is a safe, common, and highly effective method of birth control. However, there are significant historical and ethical considerations that can complicate the provision of permanent contraception. Between 1909 and 1979, physicians performed more than 60,000 forced sterilization procedures in state-organized programs.5 These practices disproportionately affected immigrants, the working class, and people of color.
In an effort to protect these vulnerable populations, the federal government created the Medicaid Title XIX “Consent to Sterilization” form.6 For a patient on Medicaid to receive a tubal sterilization procedure, they must be at least 21 years of age and the Medicaid consent form must be signed at least 30 days, but no more than 180 days, before the procedure is performed. This policy remains in place today and is required to receive payment for any sterilization procedure of a patient covered by medical assistance.
There is growing concern that the Medicaid sterilization consent process establishes barriers to care rather than protecting patients. About 50% of patients requesting a postpartum sterilization procedure are unable to obtain one, often because of issues with the Medicaid consent form.7 Strikingly, one-half of those with unfulfilled postpartum permanent contraception requests become pregnant within the following year.8 The consent form also has been criticized for being difficult to read and comprehend, especially for those with lower health literacy.9
Previous studies have demonstrated that Medicaid recipients seeking sterilization often are unaware of the procedure’s permanence or equally effective alternatives.10 Results of the current study highlight the persistence of this knowledge gap among this population regarding sterilization permanence and lack of reversibility. Clinicians should be aware of this knowledge gap and ensure full comprehension of sterilization permanence during the consent process. To promote patients’ reproductive autonomy, the American College of Obstetricians and Gynecologists has called for reform of the Medicaid consent policy, including redefining the consent form’s validity time frame, using a low-health literacy consent form in multiple languages, and developing a standardized, validated decision support tool.11
In this study, the use of a web-based decision aid was associated with significant improvements in both tubal sterilization knowledge and decisional conflict compared to usual care only among pregnant people enrolled in Medicaid. With Cohen’s d interpreted as large (0.8), medium (0.5), and small (0.3) effect sizes, we see that the decision aid was associated with a large improvement in knowledge and a small to medium improvement in decisional conflict.12 While the MyDecision/MiDecisión tool has not been widely implemented nor studied in different populations, findings from this study point to shortcomings of counseling about tubal sterilization and highlight the need for decision support. By providing an evidence-based and patient-centered process for obtaining informed consent prior to tubal sterilization, this tool could both fill gaps in counseling and potentially replace the existing Medicaid consent process.
REFERENCES
- Daniels K, Abma JC. Current contraceptive status among women aged 15-49: United States, 2015-2017. NCHS Data Brief 2018;327:1-7.
- Stern AM. Sterilized in the name of public health: Race, immigration, and reproductive control in modern California. Am J Public Health 2005;95:1128-1138.
- Liddon N, Steiner RJ, Martinez GM. Provider communication with adolescent and young females during sexual and reproductive health visits: Findings from the 2011-2015 National Survey of Family Growth. Contraception 2018;97:22-28.
- Brandi K, Woodhams E, White KO, Mehta PK. An exploration of perceived contraceptive coercion at the time of abortion. Contraception 2018;97:329-334.
- Harris LH, Wolfe T. Stratified reproduction, family planning care and the double edge of history. Curr Opin Obstet Gynecol 2014;26:539-544.
- Block-Abraham D, Arora KS, Tate D, Gee RE. Medicaid consent to sterilization forms: Historical, practical, ethical, and advocacy considerations. Clin Obstet Gynecol 2015;58:409-417.
- Hahn TA, McKenzie F, Hoffman SM, et al. A prospective study on the effects of Medicaid regulation and other barriers to obtaining postpartum sterilization. J Midwifery Womens Health 2019;64:186-193.
- Thurman AR, Janecek T. One-year follow-up of women with unfulfilled postpartum sterilization requests. Obstet Gynecol 2010;116:1071-1077.
- Zite NB, Philipson SJ, Wallace LS. Consent to sterilization section of the Medicaid-Title XIX form: Is it understandable? Contraception 2007;75:256-260.
- Leung A, Loh A, Pentlicky S, Gurney EP. Knowledge and attitudes about sterilization and long-acting reversible contraception. Matern Child Health J 2021;25:1336-1344.
- [No authors listed]. Access to postpartum sterilization: ACOG Committee Opinion Summary, Number 827. Obstet Gynecol 2021;137:1146-1147.
- Lakens D. Calculating and reporting effect sizes to facilitate cumulative science: A practical primer for t-tests and ANOVAs. Front Psychol 2013;4:863.
