Patient understanding and use of oral contraceptive pills in a southern public health family planning clinic.

Objective: To assess patient understanding and use of oral contraceptive pills (OCPs) and determine if these are associated with literacy.

Methods: Four hundred OCP users from a southern public health family planning clinic were orally tested post visit for literacy, demographics, contraceptive knowledge, OCP use, side effects, and adherence.

Results: Patients were predominately African American (86%); 78% had completed high school and 42% read below a 9th grade level. Most (94%) understood what to do when they missed one pill, yet few knew the correct action to take after missing two or three pills (19% and 3% respectively); 33% reported missing one or more pills in the past 2 weeks. Literacy was not associated with OCP use, knowledge, or adherence.

Conclusion: Patients of all literacy levels had limited understanding of OCP side effects and what to do about multiple missed pills. This puts them at risk for misuse.

Key Words: literacy, health literacy, oral contraceptive use, side effects, missed pills

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In the United States, oral contraceptive pills (OCPs) have been the leading method of contraception for more than two decades. (1) Eighty-two percent of all women who have had sexual intercourse have used OCPs at some time. Use has climbed from 25% of women using contraception in 1995 to 31% in 2002. (2) OCPs are more than 99% effective if taken as prescribed; pill failure is almost always due to incorrect or inconsistent use. (2,3) Approximately one million unintended pregnancies a year in the US are related to OCP misuse or discontinuation. (4) One quarter to one-third of OCP users are probably using OCPs incorrectly. (5) The strongest predictors of misuse of OCPs are patients': 1) not establishing a regular routine for taking their pills, 2) failing to read or understand the written information distributed with the pill package and 3) experiencing side effects. (5)

Despite the importance of informed and consistent use, few studies have evaluated patients' understanding of OCP use, side effects and what to do about missed pills. Limited literacy may be an overlooked barrier to women understanding and adhering to OCP instructions. The Institute of Medicine report on health literacy indicated that 90 million US adults have trouble understanding and acting on healthcare information. (6)

In a 1996 review of the literature, Parker and colleagues found no studies on literacy and contraceptive use and called for research on the relationship between literacy and contraceptive knowledge, attitudes and behaviors. (7) A MEDLINE search of the literature from 1996 to 2005 using the search terms literacy or health literacy and birth control pills, oral contraception pills, OCP knowledge, OCP use, OCP adherence, OCP side effects or OCP risks, found only one study that examined literacy and patient knowledge of contraceptive use. Gazmararian and colleagues (1999) found that one in ten women enrolled in a Medicaid program had low literacy skills, and family planning knowledge and practices were worse among these women. (8)

The purpose of this study was to assess the understanding of: 1) contraception, 2) OCP use and what to do about missed pills, 3) OCP side effects and risks and 4) self-reported OCP adherence among OCP users in a public health family planning setting. The secondary purpose was to evaluate the hypothesis that the literacy level of these patients was associated with OCP understanding and use.

Methods

The study design and survey instruments were reviewed and approved by the Louisiana State University Health Sciences Center-Shreveport Institutional Review Board on the Rights of Human Subjects. Patients using or planning to immediately start using OCPs as their primary method of contraception were recruited from the family planning clinic of the Caddo Parish Health Unit in Louisiana from June through August 1998. The clinic averages 450 patient visits a month from a population of low income, predominantly minority patients.

Announcements regarding the study were made by a research assistant (RA) to patients in the family planning clinic waiting room. Women were excluded if they were not using or planning to use OCPs. Four hundred women agreed to participate in the study. Less than 2% of the patients approached refused to participate in the study.

Patient care in the clinic was not altered from the normal one hour protocol before the study. Before receiving OCPs for the first time from any family planning public clinic in Louisiana, state protocol requires that all patients attend a 35-minute class that covers all methods of contraception and includes a 21 -minute film developed by a state medical school. Three minutes of the film are devoted to information about OCPs. The patient education class is augmented by a family planning handout developed by the Louisiana Office of Public Health Family Planning Program. The Family Planning patient handout is written on an 8th grade level according to the Fog Index. (9) The class size averages four to five patients and is taught by a public health nurse.

Both new and returning patients are also seen by a physician for an examination before receiving a year's supply of OCPs (14 pill packets). New patients, as well as returning patients who are having problems or are switching OCPs, then see a nurse for brief counseling about OCP use, missed pills and side effects. Each pill packet contains an insert written on a 10th grade level as measured by the Fog Index. (9) Patients who had agreed to participate in the study were individually interviewed in a private room at the conclusion of the clinic encounter and were paid $10.00 for their time. Enrollment was halted upon reaching 400 patients.

After RAs obtained informed consent, they verbally administered a structured survey and the Rapid Estimate of Adult Literacy in Medicine (REALM). (10) The interview and testing took approximately 15 minutes. Patient reading ability was assessed using the REALM, an individually administered literacy screening test that is the most frequently used measure of adult literacy in medical settings. (11) The REALM is highly correlated with standardized reading tests and the Test of Functional Health Literacy in Adults. (12) The REALM raw score can be converted into reading grade levels: low (0-6th grade), moderate (7th-8th grade), and high ([greater than or equal to]9th grade). (10)

A structured survey developed by the authors assessed demographics, sexual history and current sexual activity, parity, knowledge of contraception and of how OCPs work, understanding of OCP use and what to do about missed pills, knowledge of OCP side effects and risks, and self-reported OCP adherence. The survey was designed to capture important items critical for proper OCP use. These were all covered by the written, oral and video education provided at all Louisiana public health family planning clinics. The questionnaire was reviewed by public health nurses and subsequently pilot-tested, undergoing multiple revisions to enhance comprehension and cultural sensitivity. The questionnaire is available from the study authors.

Patients' knowledge and self-reported adherence were assessed with open-ended questions. Answers were recorded verbatim by RAs. For example, women were asked whether they understood the meaning of contraception, and, if they responded positively, they were asked what it meant to them. To assess knowledge of common side effects and risks, they were asked if OCPs have side effects or risks, and if they said "yes," they were asked to name all they knew.

Women's knowledge of what to do about missed pills was assessed in a vignette format; three scenarios were presented in which "Tanya" missed one pill, two pills in a row and three pills in a row. For each vignette, the patient was given a pill pack that was identical with the one she would be using and asked what she should do to avoid getting pregnant.

The responses to the open-ended knowledge questions were scored by two OB-GYN faculty and one OB-GYN senior resident. The answers to questions about missed pills were rated as correct/incorrect according to the OCP package insert. Unanimity by the three raters occurred with 84% of responses. In cases of rater disagreement, the majority opinion was used to code each item as correct or incorrect.

Univariate statistics (proportion, or mean and standard deviation) were used to describe the demographics, self-reported adherence, and knowledge of contraception, how OCPs work, OCP use, side effects, and what to do about missed pills. In addition, bivariate analyses (Chi square for categorical variables) were used to describe demographic and OCP variables by literacy levels and class attendance. Data analyses were performed using SAS V9.1 (SAS Institute, Cary, NC).

Results

The results are reported on 400 patients ranging in age from 11 to 41. Demographics, education and literacy levels appear in Table 1. Almost one third (29%) were adolescents; 86% were African American. Patients' education level (last grade completed in school) ranged from first grade through postgraduate level. Reading grade level was lower than years of education would suggest. Seventy-eight percent had completed 12 or more years of education, yet 42% could not read above an 8th grade level. Only seven patients (2%) were age 14 or younger and would not be expected to read on a high school level. Such a small proportion would not explain the relatively low reading levels found.

Seventy-eight percent of the women were single, and 38% had never been pregnant (Table 2). Almost all (97%) were sexually active (Table 2), and 91% said it was important not to get pregnant "right now." All planned to take OCPs after their clinic visit; 299 (75%) were current users and 356 (89%) were current or former users (Table 2). Twelve percent reported obtaining elective abortions in the past.

Almost all patients (97%) reported that they knew enough information to take their pills correctly, and 99% reported they were somewhat or very satisfied with the information they had been given. Satisfaction with information given and confidence in knowledge did not vary by literacy, age, or parity.

Despite their confidence, patients' knowledge of contraception and OCP use was poor. Although 74% said they knew the meaning of contraception, only 62% of all patients were able to actually give the most basic layman's explanation such as "preventing pregnancy." Only about one third (31%) were able to describe how OCPs work in a basic nontechnical way. and 16% incorrectly thought that OCPs prevented disease. When stratified by literacy, analysis showed that basic understanding of these health concepts was poor, although it improved with literacy (Table 3).

Almost all patients (96%) understood to start their pills on Sunday and knew what action must be taken after missing one pill (94%). However, only 19% knew what to do after missing two pills in a row, and only 3% knew what to do after missing three pills. There was no significant difference in knowledge of these items by patient literacy level.

Patients' recall of common side effects and risks was extremely limited. On average, patients were able to name 2.1 common side effects and 1.6 risks. Of the 56% who could name at least one common side effect, the most frequently named were weight gain (27%), nausea (20%), headaches (10%) and irregular bleeding (4%). Fewer patients (42%) could name at least one risk. The most frequently named risks were cancer (16%) and clots (9%). Patient literacy was associated with patients being able to name one or more risks; however, it was not associated with naming at least one common mild side effect (Table 3).

Among the 299 patients who were currently using OCPs, most (84%) thought they were good to excellent pill takers (Table 2), yet one third (33%) reported missing one or more pills at some time in the past two weeks. Among the 46 women who reported missing two or more pills in the last two weeks, 61% considered themselves to be good or excellent pill takers. Among the 98 women who reported missing one or more pills, 27% had sexual intercourse within seven days after missing the pill; importantly, over one third said they did not use a backup contraceptive method. No significant association was found between patient literacy and missing any pills in the two weeks before the interview.

Discussion

This study demonstrates a gap between OCP education and patient knowledge in a southern public health family planning clinic. Patient education is important in the 7,683 federally funded family planning clinics in the US (13) which serve approximately 6.7 million low income women, many of whom are teenagers. (14) In Louisiana, all public health family planning OCP users receive a one hour multifaceted education which includes a contraception class, a film, individual OCP counseling with a physician and a nurse, a handout written on an 8th grade level and a supply of pills. After receiving the education, OCP users had high self-efficacy but relatively limited OCP knowledge regardless of literacy level. Despite patients' satisfaction with the contraception class and counseling, and their confidence in their ability to take birth control pills correctly, patients of all literacy levels knew substantially less about contraception and effective use of OCPs than they believed. Patients' limited understanding of OCP side effects and what to do about missed pills puts them at risk for misuse and unintended pregnancy.

Understanding correct use of OCPs, including what to do about multiple missed pills and side effects, may involve more complex health literacy skills than providers or patients realize. The recent Institute of Medicine report A Prescription to End Confusion notes the importance of recognizing that most adults in America may lack the health literacy necessary to take care of their health. (6) Our findings reveal that health literacy--defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions--may be a potentially overlooked problem in family planning clinics.

Patient knowledge of OCP use varied by the complexity of the instructions. Understanding of simple, one-step instructions was very high for women of all literacy levels, but understanding of more complex, multistep instructions was extremely low, regardless of literacy skills. Similar trends were found in the UK, where over 90% of OCP users knew to take the pills for 21 days and to take them at the same time every day. However, less than half knew which factors could lessen the pill's effectiveness or for how long they were unprotected if they missed pills. (15) In the US, Ross and colleagues found that, after specific instructions for what to do about missing two or more pills in a row were read to patients in federally-funded family planning clinics, 21% could still not correctly explain in their own words what should be done. (16)

In our study, knowledge of common side effects was low. Almost half (42%) could not name a single common side effect of OCP use. Side effects such as nausea and bleeding are the primary reasons for early discontinuation of the pill. (4,5) In our study, only 20% of women identified nausea as a common side effect, and merely 4% named irregular bleeding. In the US, fear and misunderstanding of OCP side effects result in at least half of women discontinuing the pill within the first year, often failing to substitute another method or adopting a less effective method. (5) Patient compliance might improve if users better knew and understood side effects. Understanding and acting on complex multistep instructions or understanding potential previously inexperienced side effects may require a higher level of health literacy than that of many users.

Despite most patients believing that they were good pill takers, one in three reported inconsistent OCP use, having missed one or more pills in the previous two weeks. Of note, almost one-third of the women had sex during episodes of missed pills (27%), and 35% did not use a backup contraceptive method. In a US family planning study using electronic surveillance, only 13% of OCP users reported consistently using pills correctly. (17) The incidence of missed pills was more widespread than rates self-reported by patients. (17)

Previous studies found that patients rarely discuss OCP use or subsequent problems with their providers; clinicians are often not aware that patients are having problems with OCP use or side effects. (5) Ideally, OCP users need to be able to call the clinic when they have questions and should be encouraged to do so. Clear and frequently reviewed provider-patient communication to inform patients about OCP use, missed pills and side effects is needed. Using a 'teach-back' method where patients are asked to tell the provider what they understand may improve patient understanding and outcomes without significantly increasing the length of the visit. (18-20)

In addition to using teach-back to confirm comprehension of important points, OCP patient education classes and counseling in public health family planning clinics need to-the-point messages focused on what patients need to know and do about side effects and missed pills. Health literacy literature indicates that providers need to use plain language and limit information to 3 to 5 key points which are repeated. (18-21) Patient education may also be improved with demonstrations and drawings, use of stories to illustrate key points and repeated sessions. (18-19,22-24)

The findings from this study should be cautiously interpreted and may not be generalizable to some sites. The study was conducted in a single public family planning clinic in a southern city, and the study population did not include any Hispanics or immigrants. Nevertheless, the population demographics are similar to many public clinics in the United States. Care was taken to construct and administer data collection instruments that were appropriate for patients with low literacy skills. However, all data concerning OCP practices were self-reported and would likely overestimate OCP compliance.

Patients reported that they were well informed and confident about OCP use, but testing revealed limited knowledge of OCP side effects, risks and what to do about missed pills. Basic understanding about how to use OCPs in a practical manner may involve more detailed knowledge than patients or providers realize. One-third reported recently missing pills which is consistent with national estimates. (5) The fact that some of the women in this study had sex during episodes of missed pills and did not use a back up method of contraception indicates that many patients may not adequately understand information that family planning providers and policy makers may assume they know. More attention needs to be paid to delivering clear, understandable messages focused on what patients need to do to prevent pregnancy. In addition, patient education classes and provider counseling need to include interactive techniques where patients teach back what they have learned. Further work on improved patient education and counseling that adequately meets the needs of all pill users is urgently needed.

Acknowledgment 

The authors would like to acknowledge Drs. Gary Brooks and Sabrina Hollomon for help in scoring patient responses to open-ended questions and Eileen Shoup, nursing supervisor, for help in pilot testing the questionnaire and insuring all items were covered in the family planning clinic patient education. We also thank research assistants Claire Bocchini, Kristin Green and Sara Bess Lee for data collection and entry.

References

1. Mosher WD, Martinez GM, Chandra A, et al. Use of contraception and use of family planning services in the United States: 1982-2002. Adv Data 2004;350:1-36.

2. Piccinino LJ, Mosher WD. Trends in contraceptive use in the United States. Fam Plann Perspect 1998;30:4-10.

3. Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology, 18th Revised Ed. New York: Ardent Media, 2004.

4. Rosenberg MJ, Waugh MS, Long S. Unintended pregnancies and use, misuse and discontinuation of oral contraceptives. J Reprod Med 1995;40:355-360.

5. Rosenberg M, Waugh MS. Causes and consequences of oral contraceptive noncompliance. Am J Obstet Gynecol 1999;180:S276-S279.

6. Institute of Medicine. Health Literacy: A Prescription to End Confusion. Nielsen-Bohlman L, Panzer A, Kindig DA, eds. Washington, DC: National Academy Press, 2004.

7. Parker RM, Williams MV, Baker DW, et al. Literacy and contraception: exploring the link. Obstet Gynecol 1996;88:72S-77S.

8. Gazmararian JA, Parker RM, Baker DW. Reading skills and family planning knowledge and practices in a low-income managed-care population. Obstet Gynecol 1999;93:239-244.

9. Gunning R. The Technique of Clear Writing. New York: Harper & Row; 1974.

10. Davis TC, Long SW, Jackson RH, et al. Rapid estimate of adult literacy in medicine: a shortened screening instrument. Fam Med 1993;25:391-395.

11. Davis TC, Marin E, Gazmararian J, et al. Literacy testing in health care research. In: Schwartzberg JG, VanGeest JB, Wang CC, eds. Understanding Health Literacy: Implications for Medicine and Public Health. Chicago: American Medical Association Press; 2005.

12. Parker RM, Baker DW, Williams MV, et al. The test of functional health literacy in adults (TOFHLA): a new instrument for measuring patient's literacy skills. J Gen Intern Med 1995;10:537-541.

13. Frost JJ, Frohwith L, Purell A. The availibility and use of publicly funded family planning clinics: US trends, 1994-2001. Perspect Sex Reprod Health 2004;36:206-215.

14. Guttmacher Institute. Contraceptive Needs and Services, 2001-2002 [Internet]. 2001 [2006 Jan 10]. Table 1, Total number of women aged 13-44 and number of women in need of contraceptive services and supplies, by age, poverty status and race/ethnicity, 2002-national, regional, and state summary; [about 1 screen]. Availaible at: http://www.guttmacher.org/pub/win/index.html. Accessed January 9, 2006.

15. Brook SJ, Smith C. Do combined oral contraceptive pill users know how to take their pill properly? Br J Fam Plann 1991;17:18-20.

16. Ross BS, Potter LS, Armstrong KA. Improving patient educational literature: an understandable patient package insert for "the pill." J Obstet Gynecol Neonatal Nurs 2004;33:198-208.

17. Oakley D, Potter L, de Leon-Wong E, et al. Oral contraceptive use use and protective behavior after mised pills. Fam Plann Perspect 1997;29:277-279.

18. Doak CC, Doak LG, Root JH. Teaching Patients With Low-Literacy Skills, 2nd ed. Philadelphia: JB Lippincott; 1996.

19. Weiss BD. Health Literacy: A Manual for Clinicians. Chicago, American Medical Association Foundation and American Medical Association, 2003.

20. Schillinger D, Piette J, Grumbach K, et al. Closing the loop: physician communication with diabetic patients who have low health literacy. Arch Intern Med 2003;163:83-90.

21. Oakley D. Rethinking patient counseling techniques for changing contraceptive use behavior. Am J Obstet Gynecol 1994;170:1585-1590.

22. Davis TC, Williams MV, Marin E, et al. Health literacy and cancer communication. CA Cancer J Clin 2002;52:134-149.

23. Houts PS, Witmer JT, Egeth HE, et al. Using pictographs to enhance recall of spoken medical instructions, II. Patient Educ Couns 2001;43:231-242.

24. McMahon SR, Rimsza ME, Bay RC. Parents can dose liquid medication accurately. Pediatrics 1997;100 (3 Pt 1):330-333.

We read to train the mind, to fill the mind, to rest the mind, to
recreate the mind, or to escape the mind.
--Holbrook Jackson

Terry C. Davis, PHD, Doren D. Fredrickson, MD, PHD, Linda Potter, DRPH, Rose Brouillette, MD, Anna C. Bocchini, BA, Mark V. Williams, MD, and Ruth M. Parker, MD

From the Departments of Pediatrics, Medicine and Obstetrics and Gynecology. Louisiana State University Health Sciences Center. Shreveport, LA; the Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Wichita, KS; the University of Medicine and Dentistry of New Jersey School of Public Health. Piscataway, NJ; and the Department of Medicine, Emory University School of Medicine, Atlanta. GA.

Reprint requests to Terry Davis PhD, Department of Medicine, LSUHSC-Shreveport, 1501 Kings Highway, Shreveport, LA 71130. Email: [e-mail]

This research was funded by the Department of Obstetrics and Gynecology at Louisiana State University Health Sciences Center-Shreveport.

The study design and survey instruments were reviewed and approved by the Louisiana State University Health Sciences Center-Shreveport Institutional Review Board on the Rights of Human Subjects.

Accepted April 13, 2006.

RELATED ARTICLE: Key Points

* There is a gap between oral contraceptive pill (OCP) education and patient knowledge in a southern public health family planning clinic.

* After receiving a contraceptive education class and individual OCP counseling, patients had high satisfaction and self-efficacy but relatively limited knowledge of contraception and OCP use, regardless of literacy level.

* Patients' poor understanding of OCP side effects and what to do about multiple missed pills puts them at risk for misuse.

* Understanding correct usage of OCPs and avoiding unintended pregnancy may involve more complex health literacy skills than providers or patients realize.

Table 1. Demographics of family planning oral contraceptive pills (OCP)
patients

Demographic variable                 n    %

Female sex                           400  100
Race
  African American                   345   86
  White/other                         55   14
Age
  11-14                                7    2
  15-19                              108   27
  20-24                              115   29
  25-9                                94   23
  30-51                               76   19
Highest grade completed
   1-6                                 2    1
   7-8                                 9    2
   9-11                               78   19
  12                                 161   40
  13-15                              118   30
  16+                                 32    8
REALM reading grade level (a)
   0-6th grade                        40   10
   7-8th grade                       127   32
  [greater than or equal to]9 grade  231   58
Marital status
  Single/never married               311   78
  Married                             46   11
  Divorced/widowed/separated          43   11

(a) REALM reading grade results sum to 398 instead of 400 because 2
patients declined REALM testing.

Table 2. Oral contraceptive pills (OCP)/sexual experience among family
planning OCP patients (N=400)

                                                             n    %

Age at first sexual intercourse (years)
   6-13                                                       37   9
  14-15                                                      106  26
  16-19                                                      231  58
  20-37                                                       15   4
  Never had sex                                               11   3
Parity
   0                                                         153  38
   1                                                         139  35
   2-3                                                        90  22
   4-7                                                        18   5
Elective abortions
   0                                                         352  88
   1                                                          35   9
   2-6                                                        13   3
Current use of OCPs (n=299)
   1-6 months                                                 52  17
   7-12 months                                                45  15
  [greater than or equal to]12 months                        202  68
Among previous OCP users (n-356), self-described compliance
  An excellent pill taker                                    131  37
  A good pill taker                                          168  47
  A fair pill taker                                           47  13
  A poor pill taker                                           10   3

Table 3. Proportion of patients with understanding of oral contraceptive
pills (OCP) concepts by literacy (N=400)

                                Reading grade    Literacy level
                                0-6     7-8      9+
                                (n=40)  (n=127)  (n=231)  P

Knows meaning of                23      54       74       <0.0001
  "contraception"
Knows OCP mechanisms of action  15      21       39       <0.001
Knows at least 1 mild side      45      54       59       NS
  effect
Knows at least 1 risk           18      41       47       <0.01

NS. not significant.