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Obstetrics & Gynecology:
doi: 10.1097/AOG.0b013e318213cbb1
Original Research

Use of a Low-Literacy Informed Consent Form to Improve Women's Understanding of Tubal Sterilization: A Randomized Controlled Trial

Zite, Nikki B. MD, MPH; Wallace, Lorraine S. PhD

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Author Information

From the Departments of Obstetrics and Gynecology and Family Medicine, University of Tennessee Graduate School of Medicine, Knoxville, Tennessee.

Funded by the Physicians Medical Education Research Fund at the University of Tennessee Medical Center, Knoxville.

Corresponding author: Nikki B. Zite, MD, MPH, Associate Professor, University of Tennessee Graduate School of Medicine, Department of Obstetrics & Gynecology, 1924 Alcoa Highway, U-27, Knoxville, TN 37920; e-mail: nzite@mc.utmck.edu.

Financial Disclosure The authors did not report any potential conflicts of interest.

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Abstract

OBJECTIVE: To estimate whether the Medicaid-Title XIX Sterilization Consent Form (SCF) format—“standard” compared with “low-literacy”—is associated with women's understanding of tubal sterilization.

METHODS: This study was a randomized trial that took place in an obstetrics and gynecology residency clinic in the southeastern United States. Women, aged 21 to 45 years, were randomly allocated to receive a copy of either the standard or the low-literacy Medicaid-Title XIX SCF. A research assistant assessed women's sociodemographic characteristics, health-literacy skills, and understanding of sterilization using items from the Postpartum Tubal Sterilization Knowledge questionnaire. Women were also queried regarding their preferences for either version of the Medicaid-Title XIX SCF.

RESULTS: We included 201 women in the study. Compared with women in the standard group (n=99), women in the low-literacy group (n=102) with no additional counseling better understood the length of time required between signing the form and undergoing sterilization (23.6% difference between groups, P<.01), the time interval until the form expired (33.7% difference between groups, P<.01), permanence of sterilization (15.7% difference between groups, P=.01), and that nonpermanent contraceptive options as effective as sterilization are available (8.2% difference between groups, P=.02). When given the choice to select either Medicaid-Title XIX SCF, 189 (94%) preferred the low-literacy version.

CONCLUSION: Our results support replacing the standard Medicaid-Title XIX SCF with the low-literacy version to foster increased understanding of sterilization.

LEVEL OF EVIDENCE: I

Although more than 10 million reproductive-aged American women depend on sterilization for contraception,1 rates of tubal sterilization are highest among African Americans, those with no or public insurance,2 and those with a history of unintended pregnancy.3 Misinformation about sterilization and limited awareness of contraceptive alternatives are common. For example, 62% of African American and 36% of white women thought that sterilization reversal could easily restore fertility.4

In the 1970s, concerns about coercion and forced sterilization of illiterate women in the southern United States5 led the Department of Health, Education, and Welfare to create regulations related to federally funded sterilization.6 From 1976 forward, women requesting publicly funded sterilization were required to complete a Medicaid-Title XIX Sterilization Consent Form (SCF), in most cases, at least 30 days before being sterilized. Additionally, women must have a signed copy of the Medicaid-Title XIX SCF available or verified or both at the time of the procedure. Women most likely to consent to and undergo publicly funded sterilization—those in an ethnic minority, with low socioeconomic status, and with limited formal educational attainment—are at particularly high risk of having limited general and health-literacy skills.7

The deficits—excessively high reading demands, poor layout features, tiny text point size—of the current Medicaid-Title XIX SCF8 have been described. Although a low-literacy version of the Medicaid-Title XIX SCF8 was previously created using plain language guidelines,9,10 the utility of this document in aiding patient understanding of tubal sterilization has yet to be evaluated. Therefore, the primary purpose of this study was to estimate whether Medicaid-Title XIX SCF format—“standard” compared with “low-literacy”—was associated with women's understanding of tubal sterilization. The secondary purpose of the study was to estimate women's preferences for either the standard or the low-literacy Medicaid-Title XIX SCF.

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MATERIALS AND METHODS

Participants were recruited to partake in a randomized controlled trial from an outpatient obstetrics and gynecology residency clinic in the southeastern United States between May and July 2010. Eligibility criteria included being 21–45 years of age, English-speaking, and currently enrolled in TennCare (Medicaid). Approximately 80% of patients presenting at this clinic are seen for obstetric-related care. Potential participants who appeared too acutely ill or had poor visual acuity were excluded. A research assistant approached patients while they were in the waiting room or at the check-out counter after their scheduled appointment. The research assistant explained the purpose of the study and informed each participant that her responses would be anonymous and that she would be given a $10 gift card to compensate her for participating in the study. The Institutional Review Board at the University of Tennessee Graduate School of Medicine approved the research methods of this study.

Upon receiving written informed consent from each participant, the research assistant orally administered six sociodemographic items (age, race, educational attainment, marital status, number of children, and self-reported health status) from the 2010 Behavioral Risk Factor Surveillance Survey.11 Similar sociodemographic items from this survey have shown to have both excellent validity and reliability.12

Next, the research assistant asked each participant three established health literacy screening items,13 each with five possible response options: 1) “How often do you have problems learning about your medical condition because of difficulty understanding written information? [always, often, sometimes, occasionally, or never]”; 2) “How often do you have someone help you read hospital materials? [always, often, sometimes, occasionally, or never]”; and 3) “How confident are you filling out medical forms by yourself? [extremely, quite a bit, somewhat, a little bit, or not at all].” On the basis of previous testing of these screening items,13,14 participants were considered to be at risk of having inadequate health-literacy skills if they responded either “always, often, or sometimes” to items 1 and 2 or “somewhat, a little bit, or not at all” to item 3. A health literacy composite was calculated based on participants' responses to these three items combined. Participants were categorized as having adequate (responded positively to zero items), marginal (responded positively to one item), or inadequate (responded positively to two or more items) health-literacy skills.

Randomization was created using a computer-generated sequence with permuted blocks of 10. Assignment was concealed by placing a photocopy of either the standard or the low-literacy Medicaid-Title XIX SCF into a beige manila file folder. The research assistant always opened the next manila file folder in the prerandomized stack, which allocated participants to one of the two study groups in accordance with the randomization sequence. Once the research assistant opened each file folder, she provided each participant with a laminated copy of either the standard or the low-literacy Medicaid-Title XIX SCF to review. The research assistant and participants could not be blinded to group assignment.

The standard Medicaid-Title XIX SCF is a one-page document, currently used throughout the United States, written at a high school reading level.8 A low-literacy version of the Medicaid-Title XIX SCF, written at the 6th grade reading level and meeting established guidelines for optimal formatting (eg, at least 12-point font size, increased use of white space),9,10 was previously developed.8 For this study, minor revisions (eg, slight wording changes, reduced margin sizes) were made to the original low-literacy Medicaid-Title XIX SCF to allow for all information to fit on a single page (available upon request from the first author). Patient-relevant content presented on both the standard and the low-literacy Medicaid-Title XIX SCFs was identical; however, as described above, the information was presented at a lower reading level and increased font size throughout the low-literacy version.

Upon distributing either the standard or the low-literacy Medicaid-Title XIX SCF, the research assistant asked each participant to read her version of the Medicaid-Title XIX SCF at her own pace. Next, participants were asked five closed-ended questions, addressing content outlined on both the standard and the low-literacy Medicaid-Title XIX SCF, to assess sterilization-related knowledge. First, the research assistant orally administered four items (scored as “true,” “false,” or “don't know,” with “don't know” responses categorized as incorrect) from the valid and reliable Postpartum Tubal Sterilization Knowledge questionnaire,15 including the following: 1) “Now that I've signed the form, I can get my tubes tied in 30 days (or about one month). [true]”; 2) “Now that I signed the consent form, I must have my tubes tied. [false]”; 3) “In a few years, if I change my mind, doctors can easily fix my tubes so that I can have another baby. [false]”; and 4) “There are forms of birth control that work as well as having my tubes tied, but can be stopped or removed if I decide to have another baby. [true]” In addition to completing the aforementioned four Postpartum Tubal Sterilization Knowledge questionnaire items, participants were also asked the following knowledge-related item: “How many months after you sign this form will your ‘consent’ (signature) expire?” Responses to this question were coded as correct (answer of 6 months) or incorrect (answer other than 6 months).

An overall sterilization-related knowledge composite was calculated based on participants' total number of correct responses to these five close-ended items. Participants were categorized as having limited (zero to three correct responses) or adequate (four or more correct responses) sterilization-related knowledge based on their responses to these items. Additionally, participants were also asked to rate how easy or difficult it was to read the version of the Medicaid-Title XIX SCF they received on a 5-point Likert-type scale (1=very easy; 2=easy; 3=average; 4=difficult; 5=very difficult).

Lastly, the research assistant presented each participant with a laminated copy of the version of the Medicaid-Title XIX SCF that she did not initially receive. Participants were given a few minutes to compare and contrast the standard and low-literacy versions of the Medicaid-Title XIX SCF. Finally, participants were asked, “If you could receive either form, which one would you prefer? Why?” The research assistant recorded verbatim responses to these items. Preferences for both versions of the Medicaid-Title XIX SCF were tallied. Responses to this question (why?) were categorized as follows: 1) format-related comments (eg, larger font, not as “busy,” better layout, better paragraphs, important information is bolded, shorter); 2) literacy-related comments (eg, “my” language, not physician language, information is explained more clearly, less complicated); 3) both format- and literacy-related comments; or 4) don't know, other, or did not provide a response. Initially, both authors coded all responses independently, with initial agreement at 97.5%. During the coding process, both authors were blinded to participants' Medicaid-Title XIX SCF group. All coding discrepancies were identified and resolved through discussion, with final codes for each response assigned. Both authors identified illustrative comments to capture overall impressions regarding preferences for either the standard or the low-literacy Medicaid-Title XIX SCF.

A priori, based on a previous pilot study, we estimated that there would be approximately a 20% difference in the proportion of participants categorized as having adequate sterilization-related knowledge based on their responses to Postpartum Tubal Sterilization Knowledge questionnaire items and the consent expiration item (standard Medicaid-Title XIX SCF group=estimated 55% identifying four or more correct responses; low-literacy Medicaid-Title XIX SCF group=estimated 75% identifying four or more correct responses). To obtain a significant difference (20%) in sterilization knowledge between the two groups, with an α (two-sided) of .05 and β of .20, a total of 196 participants (98 women per group) were necessary.16

Sociodemographic characteristics, health-literacy skills, and scores on tubal sterilization knowledge–related questions were compared (mean plus or minus standard deviation, frequencies, percentages) between the two study groups. Continuous variables were compared using independent Student t tests, and categorical variables were compared using χ2 tests. Responses to the open-ended item was categorized with frequencies tallied. All statistical analyses were performed using SPSS 17.0. All statistical tests were two-sided; P<.05 was considered significant.

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RESULTS

Between May and July 2010, we screened 210 women, of whom 203 were randomly assigned to receive either the standard or the low-literacy Medicaid-Title XIX SCF (Fig. 1). However, during the course of the oral interviews, the research assistant discovered that two of the women (one from each the standard and the low-literacy Medicaid-Title XIX SCF groups) did not speak or understand English or both well enough to warrant their inclusion in the study sample. Therefore, the final study sample was composed of 201 participants (standard Medicaid-Title XIX SCF group [n=99] and low-literacy Medicaid-Title XIX SCF group [n=102]). Sociodemographic characteristics and health-literacy skills did not differ between women randomized to the standard or the low-literacy Medicaid-Title XIX SCF group (Table 1).

Fig. 1
Fig. 1
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Table 1
Table 1
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A greater percentage of women who received the low-literacy Medicaid-Title XIX SCF answered three of the four Postpartum Tubal Sterilization Knowledge questionnaire items correctly compared with those who received the standard version (Table 2). The most notable difference between the two groups was with regard to the proportion of women—low-literacy (52.9%) compared with standard (19.2%) group—correctly indicating that the Medicaid-Title XIX SCF expired 6 months after signing it (33.7% difference between the groups, P<.01). Compared with women in the standard group, women in the low-literacy group also better understood the length of time required between signing the form and undergoing sterilization (23.6% difference between groups, P<.01), the permanence of sterilization (15.7% difference between groups, P=.01), and that nonpermanent contraceptive options as effective as sterilization are available (8.2% difference between groups, P=.02).

Table 2
Table 2
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A greater proportion of women randomized to the low-literacy (50.0%) compared with the standard (28.3%) group indicated that the Medicaid-Title XIX SCF was “very easy” to read (Fig. 2). However, in both groups, relatively few participants rated either Medicaid-Title XIX SCF as “difficult” or “very difficult” to read.

Fig. 2
Fig. 2
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When given the choice to select either Medicaid-Title XIX SCF, the majority of women (n=189, 94.0%) preferred the low-literacy version. Illustrative comments to capture overall impressions regarding preferences for the low-literacy Medicaid-Title XIX SCF are presented in Table 3.

Table 3
Table 3
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DISCUSSION

The most important finding from our study was that, without additional counseling or clarification by a physician, Medicaid-Title XIX SCF format—standard compared with low-literacy—was associated with women's understanding of the tubal sterilization process. Specifically, women randomized to the low-literacy Medicaid-Title XIX SCF group better understood the length of time required between signing the form and undergoing sterilization, when the form expired after signing it, the permanence of sterilization, and that nonpermanent contraceptive options as effective as sterilization are available.

The low-literacy Medicaid Title XIX SCF resulted in significant knowledge gains. Perhaps the most significant difference between the two groups that emerged was participants' understanding of the permanent nature of tubal sterilization. Presenting this vital information using simplified language (“If I decide to have my tubes tied, I know that I will NOT be able to have a baby now or later on.”) resulted in increased understanding of the significance of the procedure. These findings are critical because evidence suggests that many women do not fully understand the permanence of tubal sterilization4 and later in life may regret having had the procedure.17 By design, the Medicaid Title XIX SCF was not intended to be signed by a patient without additional counseling by a physician or other healthcare provider or both. Ideally, the combination of written content presented in the Medicaid Title XIX SCF and the oral exchange between the patient and physician should provide the patient with understandable and comprehensive information needed to make an informed decision regarding tubal sterilization. However, in actuality this is not always the case. For example, a recent study found that even when a clinician was involved in the consent process for obstetric and gynecologic procedures, many women did not adequately understand all of the treatment options available to them.18 Therefore, there is a need to ensure that written informed consent documents, including the Medicaid Title XIX SCF, are designed to meet the informational needs of patients.

Mirroring previous studies, participants overwhelmingly preferred the low-literacy over the standard version of the Medicaid Title XIX SCF. For example, when given the choice, patients consistently selected revised or simplified versions of advanced directives19 and pneumococcal vaccination educational tools.20 Importantly, mounting evidence also suggests that both comprehension and activation can be improved by presenting information in a format that patients can understand.21,22

Several limitations need to be considered when interpreting our results. First, the generalizability of our findings may be limited by the fact that participants were recruited from a single obstetrics and gynecology residency clinic in the southeastern United States. Recognizing that there are known racial differences in sterilization utilization,2,3 we were unable to adequately address these variations in our largely homogenous population. Second, women were recruited to participate in this study while waiting for an appointment unrelated to sterilization counseling. As a result, their review of the Medicaid Title XIX SCF did not occur within the context of an actual clinical encounter. Therefore, our study sample may not be completely representative of our target population (ie, women who are interested in tubal sterilization). Third, our sample was limited to women who were fluent in English and literate, which could limit generalization of the results. Fourth, health literacy was estimated using three previously validated screening items13 shown to be highly correlated with more extensive measures of health literacy.13,14 However, our assessment of health literacy may not be as sensitive as more robust assessment tools (ie, Rapid Estimate of Adult Literacy in Medicine23 or Test of Functional Health Literacy in Adults24).

Fifth, although evidence and expert opinion indicate that patient education–related materials should be designed to adhere to low-literacy guidelines, it is unlikely that a patient will ever read, sign, or read and sign a Medicaid Title XIX SCF without additional counseling from a physician or other health professional. Similarly, we do not know whether any of these women had requested or discussed sterilization with a physician in the past. However, given that our study was randomized, we are confident that previous exposure and knowledge of sterilization or the Medicaid Title XIX SCF or both would be similar across the two study groups. Lastly, the research assistant was not blinded to randomization status, therefore raising the possibility of measurement bias.

In conclusion, our findings have considerable implications for patients, obstetricians and gynecologists, and those responsible for instituting public health–related policies. Strategies such as presenting pertinent information in a user-friendly format are needed to increase patient understanding and promote informed decision-making, especially in the case of a permanent procedure such as tubal sterilization. Policy makers should consider replacing the standard (current) Medicaid-Title XIX SCF with the low-literacy version to foster increased understanding of the process of obtaining and permanence of tubal sterilization.

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REFERENCES

1. Mosher WD, Jones J. Use of contraception in the United States: 1982–2008. Vital Health Stat 2010;23:1–44.

2. Borrero S, Schwarz EB, Reeves MF, Bost JE, Creinin MD, Ibrahim SA. Race, insurance status, and tubal sterilization. Obstet Gynecol 2007;109:94–100.

3. Borrero S, Moore CG, Qin L, Schwarz EB, Akers A, Creinin MD, et al. Unintended pregnancy influences racial disparity in tubal sterilization rates. J Gen Intern Med 2010;25:122–8.

4. Borrero S, Abebe K, Dehlendorf C, Schwarz EB, Creinin MD, Nikolajski C, et al. Racial variation in tubal sterilization rates: role of patient-level factors. Fertil Steril 2011;95:17–22.

5. Walker v Pierce, 46, USLW 2069. US Court of Appeals 4th circuit, July 26, 1977.

6. US Department of Health, Education, and Welfare. 45 Code of Federal Regulations 1976;205:35.

7. National Center for Education Statistics. National Assessment of Adult Literacy. A first look at the literacy of America's adults in the 21st century. NCES Publication No. 2006470. December 2005.

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10. Weiss BD. Health literacy: a manual for clinicians. Chicago (IL): AMA Press; 2003.

11. Centers for Disease Control and Prevention. Office of Surveillance, Epidemiology, and Laboratory Services. Behavioral Risk Factor Surveillance Survey. Available at: http://www.cdc.gov/brfss/questionnaires/english.htm. Retrieved October 13, 2010.

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15. Zite NB, Wallace LS. Development and validation of a Medicaid Postpartum Tubal Sterilization Knowledge Questionnaire. Contraception 2007;76:287–91.

16. Browner WS, Newman TB, Cummings SR, et al. Estimating sample size and power: the nitty-gritty. In: Hulley SB, Cummings SR, Browner WS, Grady D, Hearst N, Newman TB, editors. Designing clinical research. 2nd ed. Philadelphia (PA): Lippincott Williams & Wilkins; 2001. p. 65–85.

17. Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol 1999;93:889–95.

18. Touqmatchi D, Boret T, Nicopoullous J. The quality of operative consenting against RCOG advice as standard. J Obstet Gynaecol 2010;30:159–65.

19. Sudore RL, Landefeld CS, Barnes DE, Lindquist K, Williams BA, Brody R, et al. An advance directive redesigned to meet the literacy level of most adults: a randomized trial. Patient Educ Couns 2007;69:165–95.

20. Jacobson TA, Thomas DM, Morton FJ, Offutt G, Shevlin J, Ray S. Use of a low-literacy patient education tool to enhance pneumococcal vaccination rates. A randomized controlled trial. JAMA 1999;282:646–50.

21. DeWalt DA, Malone RM, Bryant ME, Kosnar MC, Corr KE, Rothman RL, et al. A heart failure self-management program for patients of all literacy levels: a randomized, controlled trial [ISRCTN11535170]. BMC Health Serv Res 2006;6:30.

22. Kripalani S, Sharma J, Justice E, Justice J, Spiker C, Laufman LE, et al. Low-literacy interventions to promote discussion of prostate cancer: a randomized controlled trial. Am J Prev Med 2007;33:83–90.

23. Davis TC, Long SW, Jackson RH, Mayeaux EJ, George RB, Murphy PW, et al. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med 1993;25:391–5.

24. Parker RM, Baker DW, Williams MV, Nurss JR. The test of functional health literacy in adults: a new instrument for measuring patients' literacy skills. J Gen Intern Med 1995;10:537–41.

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© 2011 by The American College of Obstetricians and Gynecologists.

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