Objective
We developed a standardized educational tool to inform women about preeclampsia. The objective of this study was to assess whether exposure to this tool led to superior understanding of the syndrome.
Study Design
This was a randomized controlled trial in which 120 women were assigned to (1) a newly developed preeclampsia educational tool, (2) a standard pamphlet addressing preeclampsia that had been created by the American College of Obstetricians and Gynecologists, or (3) no additional information. Preeclampsia knowledge was assessed with the use of a previously validated questionnaire.
Results
There were no demographic differences among the groups. Patients who received the tool scored significantly better on the preeclampsia questionnaire than those who received the American College of Obstetricians and Gynecologists pamphlet or no additional information (71%, 63%, 49%, respectively; P < .05). This improved understanding was evident equally among women with and without adequate health literacy (interaction: P > .05).
Conclusion
Patients who were exposed to a graphics-based educational tool demonstrated superior preeclampsia-related knowledge, compared with those patients who were exposed to standard materials or no education.
Preeclampsia is a pregnancy-specific condition that affects between 5% and 8% of the pregnant population. The syndrome is characterized by hypertension and proteinuria and is a leading cause of maternal morbidity and death in the United States. In the developed world, the frequency of adverse maternal and perinatal events remains markedly lower than that in developing countries, largely because of the greater number of available resources. To benefit maximally from these resources, however, women must first seek medical care in a timely fashion.
The possibility that women do not seek timely care is increased if they have a poor understanding of the signs and symptoms of preeclampsia. Indeed, 1 recent study supports the concept that women, regardless of literacy level, often have a poor understanding of preeclampsia. Importantly, this knowledge deficit appeared to be modifiable, because women who had acknowledged receiving information about the disease (such as from their healthcare provider) demonstrated greater preeclampsia-specific knowledge. Because the most severe forms of preeclampsia often are associated with maternal symptoms, it has been suggested that nearly one-half of the most serious outcomes that occur as a result of preeclampsia may be prevented with additional patient education and counseling. This hypothesis is further supported by studies in which women who are diagnosed with preeclampsia and receive timely and proper surveillance have fewer adverse events than those with delayed diagnosis.
Despite the association between timely medical care and improved outcomes for women with preeclampsia, little research has been done to understand how best to educate pregnant women about the disease and the actions that they should take when it is suspected. Correspondingly, no standardized and simple tool for this education exists. The objective of the current study was to test whether patients who were exposed to a tool that had been developed specifically for educating pregnant women about preeclampsia would demonstrate superior knowledge relevant to clinical care about the disease when compared with patients who received standard educational materials or no education.
Materials and Methods
This study was a randomized controlled trial that was designed to assess whether exposure to a newly developed standardized and simple educational tool could lead to superior knowledge about concepts that are clinically relevant to preeclampsia. This trial was registered at clinicaltrials.gov ( NCT01119183 ).
The first phase of the study involved the development of the preeclampsia educational tool. With the guidance of 2 maternal-fetal medicine physicians and a health services researcher with expertise in health literacy, key concepts pertaining to the signs and symptoms and the potential consequences of preeclampsia were identified. The team also selected relevant patient-initiated actions that should be undertaken when preeclampsia is suspected. Then, with the assistance of a graphic designer, these key concepts were translated into images and simple text and placed onto a single-sided card. This card was the initial iteration of the preeclampsia educational tool. Two focus groups, both consisting of pregnant women with their partners or family members, were then convened. The participants were recruited from a university-based obstetrics and gynecology clinic that primarily serves low-income patients. This population was chosen because the participants were more likely to have relatively low literacy skills. The objective of the focus groups was to gain insight into whether and how the tool should be altered to assure the appropriate messages were being relayed to the patient population of interest. Creating and tailoring the educational tool to a population with low literacy would allow for the broadest application. Based on these focus groups, the tool was further modified. An image of the final graphics-based tool is presented in the Figure .
After the development of the tool, we began a 3-arm randomized controlled trial to evaluate the newly created preeclampsia educational tool. For this trial, participants were recruited at outpatient facilities of an urban tertiary care hospital in which women from a range of socioeconomic strata received care. Women were eligible for inclusion if they were at least 18 years of age, English-speaking, and at least 12 weeks pregnant. Women with visual or uncorrected hearing impairment or women who had been diagnosed with preeclampsia in the current pregnancy were not eligible for participation. Eligible women who agreed to be enrolled gave written consent and were assigned randomly to 1 of the following 3 educational exposures: no educational intervention, the American College of Obstetricians and Gynecologists (ACOG) preeclampsia pamphlet, or the novel graphics-based tool. Randomization was accomplished with a computer-generated random number table.
Participants who were assigned to either the ACOG pamphlet or the newly developed educational tool were given time to review the material and then underwent a structured interview. No additional information regarding preeclampsia was provided by the interviewer. Those women who were assigned to the “no educational tool” arm received no additional counseling or education; they underwent only the interview. The interview gathered demographic information, assessed health literacy, and ascertained participant knowledge about preeclampsia. Demographic information was obtained with questions that were adapted from the Literacy and Health Among Medicare Managed Care Enrollees questionairre. Health literacy was measured with the Newest Vital Sign assessment tool. This validated assessment tool uses a nutritional label and 6 associated questions to evaluate whether patients have limited health literacy. Preeclampsia knowledge was assessed with a preeclampsia knowledge questionnaire that had been validated previously with a Cronbach alpha of .86. The questionnaire consists of a series of 24 closed-ended questions regarding the implications of preeclampsia, the symptoms associated with the syndrome, and the proper actions that should be taken should a woman experience such symptoms. The questionnaire was scored by calculation of the percentage of correct responses. Participants, at this time, were not told whether their responses were correct and were not given the educational tool to keep. One to 2 weeks after the completion of the interview, we attempted to contact the participants and again administered the preeclampsia knowledge questionnaire to determine whether any enhancement of knowledge was retained, even for the short term.
All statistical analyses were performed with SPSS software (version 19.0; SPSS, Chicago, IL). Descriptive statistics were calculated for each variable. The Kolmogorov-Smirnov test was used to assess normality of data. Demographic characteristics of the groups were compared with the use of analysis of variance and χ 2 analysis, as appropriate. Analysis of variance, with the Tukey pairwise multiple comparison test, was used to evaluate whether the form of educational exposure (none, ACOG pamphlet, graphics-based tool) that patients received was associated with women’s mean scores on the preeclampsia questionnaire (the primary outcome). All tests were 2-sided, and the level of significance was set at .05. An a priori power calculation revealed that 40 participants in each group provided 80% power, at an alpha of .05, to detect a 15% difference in the mean preeclampsia questionnaire score assuming and mean score of 50% with an SD of 10% among women who were unexposed to any educational intervention.
The study was approved by the institutional review board at Northwestern University, and informed consent was obtained from all participants.
Results
One hundred twenty patients were recruited during the period of study. Most of the participants were African American (52.2%), with a mean age of 27.2 ± 5.9 (SD) years. Of the participants, 74% had at least a high school education; 52% had adequate literacy, and 45% were employed. Demographic characteristics of this population stratified by group assignment are presented in Table 1 . As illustrated, there were no differences noted among groups on the basis of their characteristics to include health literacy.
| Variable | Group 1: educational tool (n = 40) | Group 2: American College of Obstetricians and Gynecologists pamphlet (n = 39) | Group 3: no education (n = 41) | P value |
|---|---|---|---|---|
| Age, y a | 26.7 ± 6.0 | 28.4 ± 6.0 | 26.5 ± 5.8 | .32 |
| Multiparous, n (%) | 24 (60.0) | 28 (71.8) | 22 (53.7) | .24 |
| Race/ethnicity, n (%) | .50 | |||
| White | 4 (10.0) | 5 (12.8) | 7 (17.1) | |
| African American | 21 (52.5) | 21 (53.8) | 19 (46.3) | |
| Hispanic | 11 (27.5) | 12 (30.8) | 13 (31.7) | |
| Other | 4 (10.0) | 1 (2.6) | 2 (4.9) | |
| Presently employed, n (%) | 11 (27.5) | 18 (46.2) | 14 (33.3) | .22 |
| Completed high school, n (%) | 29 (72.5) | 22 (56.4) | 23 (56.1) | .23 |
| Annual household income <$25,000, n (%) | 26 (65.0) | 29 (74.4) | 25 (61.0) | .43 |
| History of preeclampsia, n (%) | 2/24 (8.3) | 2/28 (7.1) | 2/22 (9.1) | .97 |
| Adequate literacy, n (%) | 23 (57.5) | 21 (53.8) | 18 (43.9) | .45 |
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