Development of injury prevention materials for people with low literacy skills

Results REALM results for n = 59 parents sampled from the PED indicated that 27% ( n = 16) read below 9th grade reading level. Cloze results demonstrate that materials were appropriate for 71% ( n = 21) when written for 8th grade reading level and 80% ( n = 23) when rewritten for 6th grade reading level. Conclusion Others designing similar interventions can use these methods to develop interventions for low literacy populations. Practice implications When developing injury prevention materials for use with PED populations, health professionals should consider reading ability, reading level, content, and design of materials. Abbreviations FK Flesch-Kincaid HALS Health Activities Literacy Scale NICHD National Institute of Child Health and Human Development PED Pediatric Emergency Department REALM Rapid Estimate of Adult Literacy in Medicine SAM Suitability Assessment of Materials Keywords Literacy Injury prevention Emergency Department Materials development SAM Cloze FK Children Urban Pediatric 1 Introduction Injuries to children are a major public health problem resulting in thousands of Pediatric Emergency Department (PED) visits each year [1] . There has been movement toward addressing injury prevention in an emergency department setting [2] . To be effective, issues of literacy must be considered when designing injury prevention materials. The growing awareness of the importance of the connection between literacy and health is demonstrated by the U.S. Department of Health and Human Services including a call to improve literacy among the health goals and objectives for the nation [3] . In addition, the Institute of Medicine of the National Academies of Science convened a committee to examine issues and definitions associated with literacy. They concluded health care systems should develop and support programs to reduce the negative effects of limited literacy [4] . The National Assessment of Adult Literacy Survey is the most comprehensive report of English literacy among US adults [5] . The National Adult Literacy Survey (NALS) assesses a broad range of tasks that adults perform in order to function at work, at home, and in the community. The NALS is a nationally representative and continuing assessment of the English language conducted in 1992 and 2003. In the 2003 NALS, the Health Activities Literacy Scale (HALS) [6] was added to assess the ability of adults to apply literacy skills to understand health-related materials and forms. The HALS found that 12% of the US population has skills in the lowest levels (Level 1 of a possible 3) indicating an inability to effectively use health information. The average proficiency of White adults on the HALS is significantly higher than the average proficiency of Black, Hispanic, and other adults living in the United States [6] . A growing body of literature supports that adults with limited literacy skills face health-related disadvantages [7] . A number of studies have used the Rapid Estimate of Adult Literacy in Medicine (REALM) [8] or the Test of Functional Health Literacy in Adults [9] to compare literacy levels and health outcomes. Such studies have found a relationship between low literacy and lack of screening for health issues, as well as low literacy and more frequent hospitalizations. Additionally, those with low literacy have been found to have more difficulty managing their chronic diseases [10–18] . To date, we could find no studies of how literacy is related to unintentional injury prevention or the relationship between literacy among parents/caregivers and their ability to adopt health behaviors that would improve children's health or protect their children from injury. Because research has shown an increased risk for injury among lower socioeconomic status and minority populations [19,20] and because these groups have been shown to also be at elevated risk for literacy problems [6] it is logical to assume that there will be a link between literacy issues and the adoption of safety behaviors in the low income, predominantly African-American population being served by a injury prevention intervention entitled, Safety in Seconds™. This ongoing research is significant, as no prior research has specifically targeted a population at high risk for low literacy and injury with an intervention tailored for a low literacy population. This intervention may provide a pathway to reach those with low literacy and help to close the disparity gap. Therefore, to design safety behavior interventions it was first necessary to establish literacy and comprehension levels among this population. The research presented in this paper was conducted as part of a larger National Institutes of Child Health and Human Development-funded trial (Grant No. 5R01 HD042777), the aim of which is to evaluate the effects of a brief, computer-tailored intervention on home and motor vehicle safety practices among parents with children from birth through 5 years of age being seen in a PED. To develop the intervention, a tailored parent report, a study of literacy and comprehension was conducted and is described here. The specific aims of this paper were to: (1) describe the development of injury prevention materials for people with low literacy skills (i.e., parent report); and (2) describe literacy and comprehension abilities among a sample of parents from the PED. 2 Methods There were four phases to this project: Phase 1—development and testing of materials; Phase 2—literacy testing with the PED population for whom the intervention was being developed; Phase 3—revision of the materials; and Phase 4—pilot testing and solicitation of qualitative feedback from parents. Each phase is described below. All data were collected from convenience samples of participants identified in the PED waiting room, as described below. All research activities for this study were approved by the Institution's Committee on Human Research. 2.1 Setting and population The Johns Hopkins Pediatric Emergency Department serves predominately low income urban children. The Johns Hopkins PED, the site for this research, is one of the largest providers of emergency care for Baltimore City children, with approximately 1000 patient visits per month among 0–5 year olds, 20% of which are due to an injury. According to the Emergency Department Director (AW), 52% of the PED population receive Medical Assistance benefits or have no health insurance. Seventy-eight percent of the patients cared for are African-American and most live in the surrounding East Baltimore neighborhood, which is one of the most economically disadvantaged areas of the city. Nearly two-thirds of Baltimore City's adult population has not completed high school; one in three families lives below the poverty level [21] . 2.2 Phase 1: development and testing of materials Injury prevention materials were delivered in the form of a parent report (see Fig. 1 ). The Safety in Seconds™ intervention relies on reading skills of the recipient. In about 15 min an assessment is completed and a colorful, four-page booklet (or parent report) is produced. This parent report can be taken with the recipient and shared with the family or health care provider. The messages (text) inserted into the parent report were developed using rules of plain language [22] and with consideration of the needs of a low literacy population. Approximately 400 different safety messages (one for each stage and profile of a behavior change theory, the Precaution Adoption Process Model, PAPM) [23] were written and revised by the study team and expert health communications consultants from the Saint Louis University's Health Communication Research Laboratory. 2.2.1 Precaution Adoption Process Model (PAPM) The PAPM explains the adoption of health-related behavior as a developmental process through distinct behavioral stages which culminate in the adoption and maintenance of a precautionary behavior [24,25] . The PAPM's utility as applied to safety practices is intuitively appealing because it provides more information about how close parents are to adopting recommended safety practices than simply asking parents if they ‘do’ or ‘do not do’ these practices, which is beneficial in determining the need for tailored messages to facilitate behavior change. A pre-determined PAPM staging algorithm was used to classify parents according to their safety profiles and stages. Parents were staged so that profile and stage-tailored messages could be provided in the parent report. 2.2.2 Flesch-Kincaid (FK) All messages in the library were assessed by the authors (WS or LT) for reading level using the Flesch-Kincaid [26] grade level. The readability of sample text was measured with the use of the Flesch-Kincaid readability scale (grade level range 0–12), which is automated and readily available in Microsoft Word or other word processing packages and has been demonstrated to be reliable and valid [27] . The Flesch-Kincaid scale assesses readability on the basis of average number of syllables per word and the average number of words per sentence [28] . Reading grade level was assessed for each of the 400 potential messages in the library to make sure they were all below a certain reading grade level (initially set at 8th grade reading level). Flesch-Kincaid [26] grade level is an index that gives the years of education required to comprehend a document. The FK grade level is calculated using average sentence length and average syllables per word. This measure rates text on a US school grade level, e.g., a score of 8.0 means that the document was written on the 8th grade level as defined by educators. 2.2.3 Suitability Assessment of Materials (SAM) Because readability formulas do not identify all of the content, organization, and format factors that contribute to level of reading difficulty [29] the materials were assessed with the Suitability Assessment of Materials [28] . Parent reports were assessed for design, presentation, and motivating qualities by two authors from the study team (WS and EM) and one external literacy expert (DR). SAM score was assessed by evaluating the printed message booklet in six areas: content, literacy demand, graphics, layout and typography, learning stimulation, motivation, and cultural appropriateness. Within each of the six factors there are 22 criteria for which an evaluator gives a score. Validation of the SAM instrument has been conducted with health care providers from several cultures [28] . Points are assigned in each area, a score of 2 points for superior rating, 1 point for adequate rating, 0 points for not suitable rating, or N/A if the factor does not apply to the material. The SAM instrument systematically assesses the appropriateness of health care instruction or materials by providing a numerical score (in percent) that falls in one of three categories: superior (70–100%), adequate (40–69%), or not suitable (0–39%). Scored items are summed to create a raw score that is converted into a percentage (excluding N/A items). The SAM can be completed in a brief time ‘at your desk’ and used to pinpoint deficiencies in materials that reduce their suitability. The SAM instrument is for use with print material and illustrations, but it has also been applied to video- and audio-taped instructions. Despite the subjective interpretation of evaluators, the SAM instrument provides a systematic, structured approach to evaluating materials. Evaluators use the guidelines set forth for each of the six factors. 2.3 Phase 2: literacy testing A study investigator (WS) and two research assistants attended the PED on several occasions to enroll the desired sample size ( n = 30). The investigator or research assistant approached each parent with a child less than 6 years old and explained the purpose of the data collection activity (i.e., “we are asking parents to complete one or two reading tests to help us prepare materials that parents might be given when their child visits the emergency department”). Any parent in the waiting room who spoke English and was accompanying a child less than 6 years old was eligible to participate. We did not record names or any identifying information on participants other than highest grade level completed. 2.3.1 Rapid Estimate of Adult Literacy in Medicine (REALM) Currently the most time-efficient way to assess a patient's reading grade level is the REALM [8] . A participant's reading grade level can be easily measured in about 2 min. The REALM is a word recognition test (or reading ability instrument), in which participants read aloud from a list of 66 medically-related words. The words are arranged in three columns in order of complexity by the number of syllables and pronunciation difficulty beginning with short easy words like fat , flu , and pill , proceeding to more difficult words like medication and osteoporosis . Participants were asked to read aloud as many words as they could, beginning with the first word and continuing through the list as far as possible until they reach words they could not pronounce correctly. The tester used a corresponding word list to check correct pronunciation. The raw score is the total number of words pronounced correctly. The raw score is then converted into reading grade range (i.e., grades 0–3, 4–6, 7–8, and grade 9 and above). Participants who score in grades 0–3 and 4–6 have literacy skills that correspond approximately to National Adult Literacy Survey Levels 1 and 2, respectively. 2.3.2 The Cloze The Cloze [30] is a paper-and-pencil test of comprehension that determines the fit between reader and material. The Cloze is only appropriate for persons who read at a 6th grade reading level or higher. Participants who scored at or above a 6th grade reading level on the REALM (REALM raw score ≥ 36) were asked to take the Cloze. The Cloze asks participants to fill in a series of 54 blanks, where every fifth word was deleted from a passage, with exact replacements ( Fig. 2 ). The ability of readers to fill in missing words correctly is a valid indicator of how well they understood the passage. The Cloze is scored by calculating the number of correctly filled in blanks, divided by the total number of blanks. Scores on the Cloze are summarized into three levels: Level 1 (appropriate) yields a score between 60 and 100%, Level 2 (suitable, but requires supplemental teaching) yields a score between 40 and 59%, and Level 3 (not appropriate) yields a score between 0 and 39%. The Cloze text used in this study was a message excerpted from the parent report. This message was selected as text for the Cloze because it is included in all parent reports. The text used for the Cloze featured childhood safety issues and a hospital-based safety resource center for parents, the Children's Safety Center [31,32] . When this message appeared in the parent report it included a picture of the center as well as information on hours of operation and contact numbers. 2.4 Phase 3: revision of materials and retesting Based on initial results of REALM and Cloze testing, the parent report was rewritten at a lower reading grade level. All messages in the library were rewritten at the lower grade level and FK and SAM scores were recalculated on the 400 revised messages. Rewritten materials were retested on a different convenience sample using the REALM and Cloze with a second sample of 29 adults recruited from the PED following the same procedures described above. 2.5 Phase 4: pilot testing and solicitation of qualitative feedback Qualitative feedback from parents was sought in the development of the injury prevention materials for this project. In-depth interviews were conducted with a total of 18 parent participants as part of the pilot testing for the larger RCT. Parents were recruited from the ED waiting area and were first asked to answer questions on the computer kiosk and read the parent report. A study interviewer then asked parents to describe their experience using the kiosk and their opinions about the parent report. Questions solicited reactions to and understanding of the parent report, whether the report was culturally sensitive and appealing, and what parents liked most and least about the report. Parent responses were audio-taped and transcribed. 2.6 Data analysis Analysis consisted of descriptive statistics (frequencies and percentages) and score distributions for REALM and Cloze results. Due to the anonymous nature of the data collection, no socio-demographic data, other than highest grade completed, were collected. One author (LT) read all transcripts for themes and summarized the results. 3 Results 3.1 Phase 1: materials development Initially messages in the original 400 message library were written with the goal of keeping all the reading grade levels below the 8th grade reading level for several reasons: first, injury prevention content was prioritized over literacy target level; and second, this level is consistent with the graduation rate among our ED users and finally, 8th grade reading level is the Institutions convention for consent documents. At first pass, the messages were at an 8.5 FK reading grade level. All three reviewers assessed the materials in the superior range using SAM, average rating 87%. 3.2 Phase 2: literacy testing 3.2.1 REALM Literacy testing was completed with a convenience sample of n = 30 participants during Phase 2. Results (number and percent) are presented in Table 1 for the reading grade level score from the REALM test. A total of 63% ( n = 19) read at a 9th grade or above grade level. No one scored in the lowest grade level, 0–3rd grade. A total of 28 participants in Group 1 indicated the highest grade level completed in school. Most completed high school ( n = 18), additionally, n = 9 reported less than high school, only n = 1 reported more than high school. 3.2.2 Cloze A total of 87% ( n = 26) scored at least 6th grade or higher on the REALM, making them eligible for the Cloze. Table 2 presents Cloze results (number and percent) for 26 participants tested during Phase 2. Materials were appropriate (Level 1) for 42% ( n = 11). Materials were characterized as suitable, but would require supplemental teaching for 38% ( n = 10). For a total of 19% ( n = 15) the materials were not appropriate. Four participants out of 30 (13%) from Group 1 were not tested with the Cloze because they scored below 6th grade on the REALM. Thus, out of the entire Group 1 sample of 30, our materials were not appropriate for 5 persons scoring at Levels 3 and 4 persons who did not score high enough on the REALM to take the Cloze. However, our materials were either appropriate (Level 1) for 11 persons or suitable, but required supplemental teaching (Level 2) for 10 persons, combined total of 81% ( n = 21). 3.3 Phase 3: revision of materials and retesting The overall FK reading grade level of the messages was initially 8.5 in Phase 1, this was modified and reduced to 6.5 for retesting with the population. The SAM score remained superior after this revision. 3.3.1 REALM Results (number and percent) are presented in Table 3 for the reading grade level score from the second group's REALM test ( n = 29). A total of 83% ( n = 24) read at a 9th grade or above grade level. Again, no participants scored in the lowest grade level, 0–3rd grade. A total of 27 participants in Group 2 indicated the highest grade level completed in school. A total of n = 13 completed high school, additionally, n = 13 reported less than high school, only n = 1 reported completing more than high school. 3.3.2 Cloze In Group 2, a total of 90% (26 out of 29) scored at least 6th grade or higher, making them eligible for the Cloze. Table 4 presents Cloze results (number and percent) for 26 participants tested during Phase 3 (Group 2). Materials were appropriate (Level 1) for 65% ( n = 17). Materials were suitable, but required supplemental teaching (Level 2) for 23% ( n = 6). Materials were not appropriate (Level 3) for three persons (12%). 3.4 Phase 4: pilot testing and solicitation of qualitative feedback Responses from the 18 parents who completed a kiosk assessment and received a parent report as part of the pilot testing for the larger trial were overwhelmingly positive and enthusiastic. When asked what they thought of the parent report, pilot participants (parents) thought the parent report was “interesting”, “colorful”, “right to the point”, and “fun to read”. One participant said, “It's nice, it's got my grandson's name on it and everything, it's like something I made myself.” Another parent said, “I liked the easy questions, nothing complicated, no long paragraphs, just straight to the point.” Responses to whether the report was culturally sensitive and appealing were also positive. Parents said, “… it was appealing, I enjoyed the pictures. It was comfortable reading to me. It should be comfortable for other parents.” Another parent said, “I think it's pretty much for everybody.” Only one parent out of the 18 interviewed felt the report was not culturally sensitive, but “just pretty” (respondent gave no further information). Parents found the report interesting, “The way it was presented in the colorful magazine format and that it was sectioned off—in comparison to a black and white sheet that just has a small font … that you would probably just throw away. Here in the magazine it is sectioned off well where you can read a little bit at a time.” Another said, “I thought it was well put together and well thought out.” 4 Discussion and conclusion 4.1 Discussion There is a call for developing and implementing interventions and communications for all reading levels including low literacy populations [4] . Previous research has demonstrated that health education materials are typically written at levels far above what the general population can understand and greatly exceed what a low literacy population can understand [4] . The overall literacy level of our sample of 59 participants indicated that 28% ( n = 16) read below a 9th grade reading level. This trend has increasing importance particularly for parents and families served in clinic and community settings including the emergency department. Understanding whether parents comprehend communications and interventions provided is important and necessary for successful adoption of any health behavior, including injury prevention. Injury prevention materials for use in a larger randomized controlled trial being conducted in the PED were developed using principles of materials development for low literacy groups [28] . The reading grade level and reading comprehension of a convenience sample from the PED were tested using the REALM and Cloze. As a result of this testing, the injury prevention materials (i.e., the parent report) were rewritten for lower reading grade levels (6.5 grade level) more appropriate for the population. The materials were then retested on a subsequent convenience sample from the PED. It was determined that an estimated 60% of the participants tested would understand the materials. A total of 20% would understand the materials with supplemental teaching. Therefore, we expect 80% to comprehend the materials provided in the larger trial. In order to maximize the number of persons who would comprehend the materials, a protocol for supplemental teaching was developed for use in the larger study. Supplemental teaching is provided to every participant in the larger trial. Supplemental teaching instructs study recruiters to organize and classify the information presented in the feedback report to parents in the following way: You will notice that the report is based on the questions you answered about [child's name]. The report has [child's name] name right at the top as you can see here. The report is four pages long. The first page is an introduction. It tells you about a great resource center that is free for you to use called the Children's Safety Center. It is right around the corner over there. I can show you exactly where if you would like. The second page is everything you need to know about keeping [child's name] safe from poisons in your home. The third page tells you all about keeping your family safe from a house fire. The last page is all about car safety seats. A great thing about this report is that it is designed just for you and [child's name], based on the answers that you just entered into the computer. When another parent uses the computer they will get a completely different report that is designed just for them (excerpted from the Safety in Seconds™, Supplemental Teaching Protocol). The protocol for supplemental teaching can be accomplished in 1–2 min per participant. Another important point to consider is that the 20% who may be unable to read the materials may share the parent report with others who can read it with them or for them. Both possibilities should be considered when interpreting results of interventions and the impact of educational materials. There may be serious practice implications for health care providers, health educators, and staff of having to provide supplemental teaching instructions for other similar low literacy populations. The literacy and comprehension testing reported in the current paper were used to adjust materials so that more of the PED population (participants in the larger randomized controlled trial) would be able to read and comprehend the parent reports printed from the kiosk. Recent work has suggested that tailoring on cultural variables (e.g., spirituality, time orientation, and racial pride) can further enhance the effectiveness of computer-tailored health communication [33,34] . Cultural tailoring on these variables is also included in the parent report. Other factors that contribute to a persons’ understanding of the parent report, which were assessed in this study by the SAM, include the colorfulness of the layout, the inclusion of pictures matching the race and gender of each participant (e.g., the parent–child dyad), and the inclusion of graphics selected to match the topics discussed in the messages (e.g., smoke alarms, poison latches, and car safety seats). The superior SAM scores, average 87%, indicate that other cues presented in the booklet, may help parents better understand the messages presented. Because the general literacy skills of adults are so low, health care professionals, health educators, and injury control professionals should apply literacy testing and materials assessment when developing any communication or educational materials. While there are many types of non-reading interventions available, that is, videos, audiotapes, graphic images, etc., the advantages of the reading intervention presented here should not be overlooked. A personal interaction with a health educator who could tailor specific messages to parents as well as provide demonstration and instruction may be ultimately desirable for a population with low literacy skills, however, the cost and availability of such services are prohibitive. A kiosk used in the waiting room of a busy ED or health care clinic may be more realistic. The costs and feasibility of reading and non-reading interventions must be balanced in comparison with the benefit of more people understanding the messages. As is true with any study, there are limitations in the research presented. The REALM test used to determine a participant's reading grade level and scores derived in Group 2 were higher than Group 1. This could be due to higher functioning in Group 2 and not due to lowering the reading grade level of the messages. However, our results indicate that a significant percentage (71% in Group 1 and 80% in Group 2) would be able to read these materials (with supplemental teaching). The intent of this paper is not to explain the difference in performance between the two groups, but rather to describe a process for developing materials for people with low literacy skills. A second limitation was that this research was conducted on small convenience samples of parents in the waiting area of a large, urban teaching hospital PED. Because no socio-demographic data (other than highest grade in school completed) were collected on participants or on people who refused, it cannot be determined whether the participants are similar or dissimilar with regard to important demographic factors to the overall PED population. However, each participant was a parent or guardian of a child less than 6 years old who was being seen in the PED. 4.2 Conclusions The strengths of this study are significant. The research presented describes a process and tools that others can use for assessing reading grade level of their population and appropriateness of materials rapidly with readily available instruments, REALM, FK, SAM, and Cloze. We learned about our PED population's needs regarding printed injury prevention materials. 4.3 Practice implications These results can apply to many forms of patient education such as discharge instructions in a variety of care settings that serve low income, low literacy populations. We incorporated and addressed literacy concerns while developing our injury prevention intervention. Future research will address the link between literacy issues and actual safety behavior. Acknowledgements The authors would like to acknowledge the Health Communication Research Laboratory at the Saint Louis University School of Public Health for their expertise and participation in the NICHD-funded trial. In addition, the authors would like to also acknowledge Debra Roter of the Johns Hopkins Bloomberg School of Public Health for her participation in completing a SAM assessment of the parent report. This research was funded by a grant from the National Institute of Child Health and Human Development, Grant No. 5R01 HD042777. This study was conducted at and approved by the Johns Hopkins Bloomberg School of Public Health's Committee on Human Research. References [1] M. Heinen M.J. Hall M.A. Boudreault L.A. Fingerhut National trends in injury hospitalisations, 1979–2001 2005 National Center for Health Statistics Hyattsville, Maryland [2] Role of emergency, physicians in the prevention of pediatric injury. American College of Emergency Physicians. Ann Emerg Med 1997;30:125. 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