PEDIATRICS Vol. 102 No. 2 August 1998, p. e26
,
From the * Departments of Pediatrics/Human Development and
Epidemiology, *
College of Human Medicine, and § College of Natural
Science, Michigan State University, East Lansing, Michigan.
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ABSTRACT |
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Objective. To study the effect of an educational videotape about poliovirus vaccines and choices of schedules for parents/guardians of children starting the polio vaccination series.
Design. Prospective, randomized trial comparing two educational interventions.
Setting. Five pediatric offices (two university-based, two health maintenance organization staff models, and one private practice) and a local health department immunization clinic in the greater Lansing, MI, area.
Participants. A total of 287 parents/guardians of 2- to 3-month-olds presenting for well-child care and due for the first set of immunizations including poliovirus vaccine.
Interventions. Parents/guardians were randomized to read the vaccine information statement (VIS) alone or to read the VIS and view a 15-minute videotape about polio vaccination and choices of schedules produced by Michigan State University. The intervention groups were similar by race/ethnicity, education, and relationship to the child.
Outcome Measures. Change in knowledge about the risk of poliomyelitis in the United States, transmission of poliomyelitis, characteristics of the two poliovirus vaccines, and choices of polio vaccination schedules; and parent opinion on effectiveness of the interventions, as measured by pre- and postintervention questionnaires.
Results. Both interventions resulted in increased test scores of knowledge. However, videotape viewers scored significantly higher on their posttest compared with parents/guardians assigned to VIS only. This significant increase was noted across all practice types, two of three major racial/ethnic groups, and educational levels. (The increase for Hispanic parents/guardians approached significance). Reading the VIS did not improve posttest scores for videotape viewers. Reading the VIS did improve posttest scores for those assigned to VIS only, but these scores still were not as high as for videotape viewers who did not read the VIS.
Conclusions. This study demonstrated that a complicated discussion of risks/benefits of two vaccines and their schedules of administration could be communicated effectively via a videotaped presentation. In addition, the videotape was more effective than VIS alone in increasing short-term knowledge, regardless of practice type, race/ethnicity, or educational level. As immunization schedules increase in complexity and parents are asked to make more choices, videotaped information may be a better method to achieve the goal of truly informed consent.
Key words: poliovirus, vaccine, videotape, informed consent, parent education.
In January 1997, a significant change took place in the
recommended routine childhood immunization schedule for polio
vaccination. The Advisory Committee on Immunization Practices of the
Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians recommended a greater role for the use of inactivated poliovirus vaccine (IPV).1,2 This recommendation came about
because of the small risk of paralytic poliomyelitis associated with
receipt of oral poliovirus vaccine (OPV), which has been the only cause of indigenous paralytic poliomyelitis in the United States since 1979. Although the three organizations differ somewhat in the recommended
approach, each calls for informing parents/guardians of three choices
of polio vaccination schedules: two doses of IPV followed by two doses
of OPV, four doses of OPV, or four doses of IPV.
As with most new vaccines and vaccination schedule changes, health care
providers have raised concerns about this change. Among them are
whether it is possible in a busy office practice to include a
discussion about this choice of schedule with parents/guardians; whether parents/guardians will be able to understand the choices and
make a decision about which schedule they want for their child; and
what effect the introduction of additional injections into the routine
schedule will have on timely administration of other needed
vaccines.3-7
Knowing that a change in the polio vaccination recommendation was
imminent, Michigan State University Department of Pediatrics/Human Development and Extension Service wrote and produced a 15-minute videotape about polio vaccination choices, targeted to
parents/guardians of 2- to 3-month-old children starting their primary
vaccination series. The purpose of the videotape was to facilitate
implementation of the recommendation to inform parents/guardians of the
choice of polio vaccination schedule available to them. The script was written to closely match the language used in the CDC and AAP (interim)
polio vaccine information statements (VIS), and was reviewed for
accuracy and clarity by an epidemiologist in the National Immunization
Program at CDC as well as by a local advisory group of health care
providers and parents.
The videotape script was not written to support any one choice. The
educational messages about the three polio vaccine schedules and risks
and benefits are delivered in two different styles. In the first part
of the videotape, the messages are delivered using narration, visual
graphics, and on-camera comments. In the second part, three vignettes
are presented in which parents discuss their questions and decision
with their child's health care provider. A different choice of vaccine
schedule is made in each of the vignettes.
The educational messages are presented in the following order:
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INTRODUCTION
Top
Abstract
Introduction
Methods
Results
Discussion
References
The objectives of the study were to address the following:
This article describes the results of the study pertaining to enhancement of parent knowledge.
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METHODS |
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Study Design
The study was a prospective, randomized, nonblinded cohort design conducted in five pediatric offices and a local health department immunization clinic. The study took place between May and August 1997. The pediatric offices included two university-based practices, two health maintenance organization (HMO) staff model offices, and a private practice. Parents/guardians were eligible to participate if they were presenting their 2- to 3-month-old child for a health maintenance visit and the child was due to begin the polio vaccination series. Parents/guardians needed to be able to understand spoken English because the videotape was only available in English. If two parents/guardians accompanied the child, only one was asked to complete the study. Similarly, only one study was completed if the parent/guardian had twins.
At the five pediatric practices, parents/guardians were recruited to participate during an office visit before the 2-month health maintenance visit. Parents/guardians were told that this was a study of ways to help them understand vaccine choices. Randomization and administration of the intervention then took place at the 2-month appointment. At the local health department clinic, because patients were seen on a walk-in basis only, parents/guardians were recruited and studied on the same day.
Parents/guardians were randomized to receive the updated CDC-produced polio VIS (February 6, 1997) only or to receive the VIS and view the videotape before being seen by the practitioner. All participants completed a preintervention questionnaire in the waiting room. If randomized to videotape + VIS, parents/guardians then were taken to one of the patient examination rooms to view the videotape.
All practices distributed the CDC polio VIS during the 2-month health maintenance visit, but five used an additional information sheet. At university-based practices A and B, a practice-developed information page on polio vaccination and pertussis vaccination choices was handed out at the time of registration to be seen at the 2-month health maintenance visit. At HMO staff models A and B, the interim AAP VIS (November 1996) was provided at the 2-week health maintenance visit. The private practice provided the AAP and CDC VIS during the 2-month visit. Because the intention was to study the use of the interventions in "real-life practice," offices were permitted to carry on their usual routines with respect to presentation of VIS and vaccine discussions and recommendations with the parent/guardian.
For both interventions, the parent/guardian was asked to complete a postintervention questionnaire after the practitioner had met with the parent/guardian and child, but before leaving the office.
Randomization schedules were created by designating half-days as "videotape + VIS" or "VIS only"; ie, all patients for a given half-day were assigned to one intervention arm or the other. This scheme was developed to optimize assignment of approximately equal numbers of subjects in each study arm and to simplify the study process for the participating practices. To minimize assignment bias by the office scheduling staff, randomization schedules differed week by week and were stored in a file away from the registration area. Staff were requested not to schedule appointments based on anticipation of the randomization scheme. All clinics indicated that there were no important differences in types of patients scheduled for a particular day or half-day of the week.
The preintervention questionnaire was the same for both intervention groups and included six questions of knowledge about poliomyelitis, poliovirus vaccines, and choices of schedule; two questions about decision of polio vaccination schedule; and three demographic questions. The postintervention questionnaire for both groups included the same knowledge and decision-making questions. (See Appendix for list of knowledge questions.) In addition, all participants were asked whether they read the VIS and what their opinion was of the intervention(s) to which they were exposed.
Analysis
Sample size was calculated based on the results of previous
comparison studies of video versus nonvideo interventions. To detect at
least a 20% difference between intervention groups with 95%
confidence interval (CI) (
< = 0.05) and 80% power (
= 0.20), an enrollment of at least 182 parents/guardians, 91 in each group, was
required. Because we were interested in evaluating differences within
groups, we targeted enrollment to at least 250, 125 in each group.
Data from the questionnaires were entered into and analyzed using Epi Info.8 A mean score was calculated for questions dealing with knowledge of poliomyelitis, poliovirus vaccines, and vaccination schedules. (The highest score possible was 15.) Differences between mean test scores were calculated using analysis of variance. Where variances of the means were not homogeneous, the Kruskal-Wallis H test was used.
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RESULTS |
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A total of 399 parents/guardians were recruited to participate in the study. Of these, 318 (79.7%) consented to participate and 287 (90.3%) completed the study. Reasons for noncompletion included not keeping the scheduled 2-month health maintenance visit and no rescheduled appointment during the study period; leaving the practice before the 2-month health maintenance visit; previous poliovirus vaccine administration to the child; difficulty understanding spoken English; or failure to complete the second questionnaire.
There were no significant differences of race/ethnicity, education, or relationship to the child between the two randomized groups (Table 1). There were differences in the distribution of race/ethnicity and educational level among parents/guardians in the six practices (Table 2).
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Mean preintervention test scores did not differ significantly by practice, race/ethnicity, or education between the two intervention groups. All groups but one had better test scores after the intervention (Table 3). Posttest improvement was significantly greater for the videotape + VIS group compared with the VIS group for all practices.
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Among African-American and white parents/guardians, postintervention test scores were increased for both interventions, but were significantly greater for the videotape + VIS group (Table 3). Postintervention test scores also significantly increased among Hispanic parents/guardians, with the mean difference among videotape + VIS versus VIS approaching significance (P = .07).
Improvements in posttest scores were noted across all educational levels, and the mean postintervention test score increased with increasing educational level for both intervention groups. Mean differences did not differ significantly between educational levels for either intervention.
Data were available from the private practice to examine the effect on test scores of having older children. The mean difference in scores for first-time parents versus parents with other children was not statistically significant for either intervention group.
Of parents/guardians assigned to videotape + VIS, 58 (41%) stated that they read the VIS (Table 4). There were no differences across practice, race/ethnicity, or educational level in the proportion of parents/guardians in this intervention group who read the VIS. VIS readers did not have statistically different posttest scores or mean difference in scores compared with nonreaders.
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Among participants in the VIS-only group, 89 (62%) read the VIS. The proportion of participants who read the VIS was similar by race/ethnicity and educational level. Overall, parents/guardians in the VIS-only group who read the VIS had a significant increase in their posttest score compared with nonreaders, but the mean difference was less than that for parents in the videotape + VIS group, including those who had not read the VIS.
In the videotape + VIS group, 95 participants (66%) provided written comments about the videotape. Parents/guardians stated most often that the videotape was "clear," "concise," "easy to understand," "very informative," or "explained everything." Of 58 (41%) parents/guardians in the videotape + VIS group who read the VIS, 25 (43%) stated that the videotape was more helpful than the VIS, and 31 (53%) said videotape and VIS were equally helpful. An additional 11 (9%) parents/guardians who did not read the VIS stated that they preferred the videotape. Of 89 (62%) parents/guardians in the VIS-only group who read the VIS, 83 (93%) indicated that the VIS was an effective means of providing information.
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DISCUSSION |
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Published studies have reported on the use of videotape for increasing patient knowledge in disease prevention, health behavior change, diagnostics, and home care; for reducing anxiety about treatments, tests, or test results; and for providing informed consent for invasive procedures.9-19 In most studies, videotape was found to be more effective, either alone or in combination with other educational interventions, compared with nonvideo interventions in improving patient short-term knowledge. The use of role modeling seems to be a strength of educational videotape because it enhances viewer knowledge while decreasing anxiety.9 Additionally, its use in the polio videotape was intended to reinforce important messages that may have been missed or unclear during the first segment. This study appears to be the first that evaluates videotape for education or informed consent about vaccination.
VIS that describe the risks/benefits of each vaccine and its recommended schedule are intended to assist the practitioner in providing informed consent. They are required by federal law to be distributed to parents/guardians or recipients for each vaccine given. Studies have found that parents' reading ability is lower than that required for many patient information materials, including the VIS.20-22 One study to evaluate a university-prepared VIS for poliovirus vaccines showed that shorter, simpler materials written at a 6th-grade level did not ensure good comprehension, even among parents/guardians who could read above that level.22
There may be other reasons that parents do not read the VIS. Anecdotal information provided by parents in this study suggested that they are not given adequate time to read the VIS before being asked to consent to vaccinations, they cannot read and attend to their child or children at the same time, they feel they know the information already because they have been through the process before with an older child, or they rely on the practitioner to inform them verbally and consider the VIS a back-up document should they have questions later. Regardless of the reason, this study showed that a significant number of parents did not read the VIS, which puts into question whether this is the optimal means of providing adequate informed consent.
One aspect of this study design limits some of the conclusions that can be drawn. To facilitate office practice participation in this study, we did not restrict practitioners in how they chose to discuss poliovirus vaccines and vaccine choices with parents/guardians, nor did we regulate when or how the VIS or other written materials were presented. It is not clear how or whether these differences affected parent motivation to read the VIS or to seek clarification from the practitioner on points discussed in the VIS. This variability in information-sharing could account for practice-level differences in the proportion of parents who read the VIS or what they learned from the reading. However, this lack of regulation may enhance the generalizability of these study results to most pediatric practices.
In conclusion, this study demonstrated that a complicated discussion of
the risks/benefits of two poliovirus vaccines and three polio
vaccination schedules could be effectively communicated via a videotape
presentation. In addition, the videotape
with or without having read
the VIS
was universally more effective than the VIS alone in
increasing knowledge across different practice types, racial/ethnic
groups, and educational levels of parents/guardians. Given the
variability in which VIS are used by parents and office practices and
clinics, a videotaped presentation appears to be a more consistent,
informative, and enjoyable source of information about childhood
vaccines and vaccine choices.
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FOOTNOTES |
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Short clips of this videotape may be viewed on the MSU extension web site (http://www.msue.msu.edu/msue/cyf/family/immune.html).
Received for publication Jan 1, 1998; accepted Apr 8, 1998.
Reprint requests to (R.A.D.) B401 Clinical Center, 138 Service Rd, East Lansing, MI 48824-1313.
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ACKNOWLEDGMENTS |
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This project was funded by a grant from the Associate Dean for Research and Graduate Programs and the Office of Medical Education, Research, and Development, Michigan State University, and support from the Michigan Department of Community Health and the Gerber Foundation of Fremont, MI.
We gratefully acknowledge the participation of the following clinical practices: Blue Care Network Mid-Michigan Cedar Street; Blue Care Network Mid-Michigan West; Ingham County Health Department; Meridian Pediatric Associates; Okemos Pediatric Associates; and Westside Pediatric Associates. We also acknowledge the contribution of on-site research assistants Leigh Ann Bremer, Chris Donnelly, Eric Duffy, Breanna Gauthier, Sean Grimes, Jason Grove, Anthony Howard, NiJuanna Irby, Tammon Nash, Shannon Sykes, and Delphine Walker. Candy Decker, RN, provided assistance and consultation with protocol development and training. Karen Pace (MSU Extension 4-H Youth Programs) produced the videotape, assisted by Dawn Contreras (MSU Extension Children, Youth, and Family Program). D. Rebecca Prevots, PhD, MPH (CDC) provided critical review of the videotape script and the manuscript. Jane L. Turner, MD, and Marsha D. Rappley, MD, also provided critical review of the manuscript.
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ABBREVIATIONS |
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CDC, Centers for Disease Control and Prevention. AAP, American Academy of Pediatrics. IPV, inactivated poliovirus vaccine. OPV, oral poliovirus vaccine. VIS, vaccine information statement(s). HMO, health maintenance organization. CI, confidence interval. SD, standard deviation.
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REFERENCES |
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time for a change.
Pediatrics.
1996;
98:116-117 This article has been cited by other articles:
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