Abstract
Objective:
We evaluated the efficacy of two educational tools for patients with rheumatoid arthritis (RA). A newly developed video tool including storylines and testimonials combined with a written booklet was compared with the same written booklet alone.
Methods:
We conducted a randomized controlled trial. Our primary outcome was disease knowledge. Secondary outcomes were decisional conflict, self-efficacy, effective healthcare management, and satisfaction.Outcomes were measured before and after reviewing the materials, and 3 and 6 months later. Linear mixed effects models were performed to evaluate changes over time.
Results:
Two hundred and twenty-one participants received an educational video and booklet (n=111) or a booklet alone (n=110). The mean age was 50.8 years, mean disease duration was 4.8 years, 85% were female, and 24% had limited health literacy levels. Within groups, most outcomes improved between baseline and follow-up, but there were no statistically significant differences across groups. Patients receiving the video and booklet were more likely than those receiving the booklet alone to rate the presentation as “excellent” for providing information about the impact of RA, medication options, evidence about medications, benefits of medication, and self-care options. Factors significantly associated with greater improvements in knowledge and decisional conflict from baseline to 6 months included limited health literacy, lower educational level, and shorter disease duration.
Conclusion:
Regardless of the delivery method, outcomes were improved up to 6 months after educational materials were delivered. Our findings support the implementation of self-administered educational materials in clinical settings as they can result in sustained improvements in disease knowledge and decisional conflict.
Keywords: Patient education, educational intervention, video tool, randomized controlled trial, rheumatoid arthritis
Patient education is an integral part of clinical practice in rheumatology. It enables patients to adapt and cope with the effects of rheumatic diseases and treatments. However, patient education is not always a routine part of practice. Few controlled trials of educational materials for people with rheumatoid arthritis (RA) have been reported, and the findings have varied (1–8).
Behavioral interventions, group education, and provider-led patient education may be difficult to implement in clinical settings, and for simpler, self-administered tools, there is uncertainty about which educational delivery formats (ranging from written material to individualized web-based information) are most effective in improving health outcomes in chronic disease (9). Presenting information to patients may not lead to improvements in knowledge if the materials are not engaging or suited for the individual patient. Furthermore, the vast majority of printed educational materials are not suited for populations with limited health literacy because most are written at a higher level than that recommended by governmental guidelines (10). Greater rates of limited health literacy are observed in minority groups and elderly patients, requiring more careful attention to the content, format, and mode of administration of educational materials (11, 12).
Entertainment education, and in particular, video modeling, has been evaluated in various health conditions (13–16). Video modeling demonstrates health behaviors that are considered desirable through visual presentations including soap operas or serial dramas using actors with narratives that permit audiences to identify and relate with the characters and the changes they undergo. This technique is reported to increase positive self-care behaviors, improve short-term knowledge, decrease anxiety, and increase cooperation (17). Additionally, video modeling can be useful in educating populations with limited health literacy or with impairments affecting their ability to read printed materials (18, 19).
For this study, we compared the efficacy of a multimedia patient education tool about therapeutic options for patients with RA, incorporating video modeling combined with written materials, versus written materials alone in improving knowledge. We also evaluated the effects in decisional conflict, self-efficacy, behaviors to participate in own healthcare and satisfaction with the materials. We hypothesized that the combination of video with written materials would lead to better outcomes.
METHODS
To report the results we used the extension of the CONSORT statement that addresses randomized trials of non-pharmacologic treatments (20).
Study design and oversight
The current study was a randomized controlled trial with a 6-month follow-up. Participants were recruited from five outpatient clinics in three Houston area medical facilities (Kelsey-Seybold, Harris Health System and MD Anderson Cancer Center) and through local newspaper advertisements from March 2013 through January 2014.
The study was approved by the Institutional Review Board or relevant Research Committee at each participating center.
Participants
Participants were patients aged 18 years or older with a diagnosis of RA made by a rheumatologist and disease duration of less than 10 years. The disease duration criterion was chosen because patients with longstanding disease are more likely to have acquired specific knowledge about their disease, and have a number of other issues, such as surgical needs and comorbidities, not specifically discussed in the tools.
Interventions
One group received a newly developed video tool and similar written information in a paper booklet (video + booklet), whereas the other group only received the booklet. The booklet was a consumer guide developed by the Health Care Program from the Agency for Healthcare Research and Quality (21). All materials (video and written materials) were available in English and Spanish. Details about the development, content, process to ensure the use of lay language, and pilot testing of the video are published elsewhere (22, 23). Briefly, the video tool was structured as a series of dramatized episodes (24) within a common storyline depicting a main character with RA. Each episode was linked to a learning module providing patients with factual information about their condition and treatment options, similar to the information in the booklet. Total length of time of the video was 20 minutes. The video is available to the public (English: https://www.youtube.com/watch?v=oK6pCoYT_rk&t=570s; Spanish: https://mediaplayer.mdanderson.org/video-full/D2F7AF2B-B725-4E17-B282-AC777F6F3504).
Randomization
After completion of a baseline questionnaire, participants were randomly assigned in unequal allocation blocks to one of two study groups, using an automated web-based institutional system. Participants were randomly assigned in a 1:1 ratio, stratified by site and by language preference of the participant. The random sequence was concealed from the four research staff who enrolled participants and the statistician conducting the analysis up until the implementation of the intervention due to the open label nature of the study.
Implementation
After randomization and baseline assessment, patients were given time on site to review the materials before the clinical encounter. They completed a questionnaire either immediately after on site, or within one week of participation, mailing the questionnaire back. Participants were allowed to take with them the educational materials.
Follow-up assessments were conducted 3 and 6 months after inclusion. Patients were mailed self-report questionnaires, along with a stamped envelope for questionnaire return. An attempt was made to remind patients who had not returned their questionnaires at least once by phone, to complete them. To ensure questionnaire completion, we offered patients not completing their questionnaires within two weeks to either complete the questionnaires over the phone or be met at the clinic or at their home by study personnel to collect the questionnaires. A modest monetary reimbursement was offered to all participants to compensate them for their time after each questionnaire completion.
Outcomes
The primary efficacy endpoint was knowledge about RA and therapeutic options immediately after reviewing the educational materials and at 3 and 6 months follow-up, compared with baseline. We adapted a RA knowledge questionnaire to reflect the key learner content covered in the video tool. The knowledge questionnaire has good psychometric properties (internal consistency r=0.72 to 0.94 and test/re-test r=0.81) and has been previously validated (25–28). It includes 10 questions and the score is the sum of correct items (final scores ranging from 0 to 10). We used the effect size approach (a distribution-based method) to calculate the minimal clinically important difference (MCID). A standardized mean difference of 0.50 (a moderate effect size) was considered the MCID.”
Secondary efficacy endpoints were also assessed at baseline, 3 months, and 6 months, and included:
Decisional Conflict Scale (DCS), which measures the degree to which someone is conflicted or unclear about a particular health care choice. In our study, we used the decisional conflict scale to learn if after being exposed to the educational materials patients felt more informed and clear about what was most important to them when making decisions about their treatment. We used the low literacy version of the instrument and modified it to assess only the subscales relevant to our study, ‘informed’ and ‘values clarity’ as our intervention did not involve making a healthcare decision. Scores range from 0 (feels extremely informed/clear about personal values) to 100 (feels extremely uninformed/unclear about personal values) (29). This scale was also measured immediately after review.
Arthritis Self-Efficacy Scale which measures the belief of one’s own capability to perform tasks or cope with adversity (30, 31). It is an 8-item scale, with scores ranging from 0 to 100, higher values indicating greater self-efficacy.
Effective Consumer Scale, a 17-item instrument that measures individuals’ perception of their skills and behaviors to effectively manage their healthcare (32). The scores range from 0 to 100, wherein higher scores indicate better health care management (33–35).
Patients rated the acceptability and their satisfaction with the educational tools immediately after reviewing the materials.
(i) Acceptability of the materials, was measured with the Ottawa Acceptability Scale, including clarity, balance, length, and ease of use (36).
(II) Patients’ satisfaction with the content, ease of use, and format of the materials, was assessed with an instrument, consisting of 9 items asking patients to rate the video tool on the basis of its content, ease of use, transportability and format (37, 38).
Several measures were collected at baseline to serve as analytic covariates, including demographic information (age, sex, race/ethnicity, education, employment status, and marital status), and disease duration in years. Health literacy was assessed using a single item, “How confident are you filling out medical forms by yourself?”, which was developed by Chew et al to measure health literacy. The responses range from “extremely” to “not at all”. For limited health literacy level, we used a cutoff point of at least “somewhat” in English-speaking participants and at least “a little bit” in Spanish-speaking participants, as has been proposed previously (39, 40). Lastly, we administered the Health Assessment Questionnaire, a measure of physical function widely used in studies of patients with RA (41).
Sample size
The target sample size was estimated a priori to be 220 (110 per group). This sample size allowed for 81% power to detect a difference of 0.46 points on a scale of 0 to 10 (Cohen’s d=0.33, i.e., a small effect size) in a design with 3 repeated measurements having a compound symmetry covariance structure when the standard deviation is 1.41, the correlation between observations on the same subject is 0.6, and two-sided tests (alpha=0.05). The parameters employed were derived from a Cochrane systematic review of decision aids, using knowledge as the outcome measure (42).
Statistical analyses
All analyses were done on an intent-to-treat (ITT) basis, i.e., all patients who were randomized to receive educational materials were accounted for in the analysis according to the intervention they were scheduled to receive. Missing data of the outcome measures at a time point were imputed by the mean of the observed data at the corresponding time point.
Given the longitudinal nature of the outcome measures, linear mixed effect models were used to study the changes of the outcome measures over time to take the intra patient correlation into account, and to compare the changes in the outcome scores (follow up period – pre randomization) between the groups (43).
Linear regression models were used to assess the relationship between the intervention and changes in outcome scores, and the effect of covariates of interest. Analyses were conducted for differences before and immediately after reviewing the educational materials, and before and after 6 months. The interactions between the group allocation and covariates (age, sex, race/ethnicity, educational level, language in which the questionnaire was answered, health literacy, disease duration) were examined first. All seven independent variables and interaction terms with p<0.10 from above were included in the initial step of model selection. Subgroup analyses were performed in the presence of interaction between independent variable and group allocation. For all analyses, two-sided p < 0.05 was considered statistically significant. Statistical Analysis System software (SAS Institute, North Carolina State University, Cary, NC) was used to perform the analyses.
Role of the funding agency
The funding agency had no role in study design, in the collection, analysis and interpretation of the data, or in the writing of the report and decision to submit the manuscript for publication.
RESULTS
Of 504 patients that were approached, 283 refused to participate. Two hundred and twenty-one patients were randomized to receive the video tool combined with the booklet (n=111) or the booklet only (n=110). The flow of participants through each stage is shown in Figure 1. Specifically, 23 were recruited through advertisements, 160 from county clinics, and 38 from other hospitals. A total of 116 patients (52%) (64 from the video + booklet group and 52 from the booklet only group) returned their questionnaires at 3 months and 144 patients (65%) (69 from the video + booklet group and 75 from the booklet only group) returned their questionnaires at 6 months.
Figure 1.
CONSORT 2010 flow diagram
Baseline demographic and clinical characteristics
Table 1 shows baseline characteristics of the patients. No statistically significant differences were found between groups. The mean (±standard deviation) age was 50.8 (±13.3) years, mean disease duration was 4.8 (±2.7) years, 85% were female, 24% had limited health literacy levels, and 54% answered the questionnaire in English. The time taken to review the video and the booklet in the group receiving both tools ranged from 25 to 45 minutes compared to 10 to 30 minutes taken to read the booklet alone in the other group.
Table 1.
Baseline patient characteristics.
| Characteristic | No. (%)* | ||
|---|---|---|---|
|
| |||
| Total cohort, n = 221 | Video + Booklet n = 111 | Booklet Only n = 110 | |
| Mean age (standard deviation) | 50.8 years (13.3) years) | 49.8 years (13.0) years) | 51.8 years (13.5 years) |
| Sex | |||
| Female | 187 (85) | 95 (86) | 92 (84) |
| Race/ethnicity | |||
| White | 44 (20) | 25 (23) | 19 (17) |
| Black or African American | 44 (20) | 19 (17) | 25 (23) |
| Hispanic | 124 (56) | 60 (54) | 64 (58) |
| Other | 8 (4) | 6 (5) | 2 (2) |
| Marital status | |||
| Married/living together | 119 (54) | 65 (59) | 54 (49) |
| Educational attainment | |||
| Less than high school diploma or equivalent | 81 (37) | 40 (36) | 41 (37) |
| High school diploma or equivalent or associate degree | 102 (46) | 51 (46) | 51 (46) |
| Bachelor degree or higher | 36 (16) | 19 (17) | 17 (15) |
| Language of questionnaire | |||
| English | 119 (54) | 60 (54) | 59 (54) |
| Employment status | |||
| Employed | 78 (35) | 35 (32) | 43 (39) |
| Mean disease duration (standard deviation) | 4.8 years (2.7) | 4.5 years (2.7) | 5.1 years (2.7) |
| Health literacy | |||
| Limited health literacy | 54 (24) | 24 (22) | 30 (27) |
| Mean number of medications (standard deviation) | 2.7 (1.4) | 2.7 (1.3) | 2.7 (1.5) |
| Mean Health Assessment Questionnaire‡ (standard deviation) | 0.6 (0.6) | 0.6 (0.6) | 0.7 (0.6) |
Percentages may not add up to 100% owing to rounding.
Higher score indicates more difficulty with physical function
Disease knowledge
Outcomes across time points are shown in Table 2. Knowledge scores significantly increased immediately after reviewing the educational materials (video+booklet 5.5 (±2.1) to 7.6 (±1.5), p<.0001 and booklet only 5.5 (±2.1) to 7.2 (±2.0), p <.0001), and at 3 and at 6 months compared with baseline in both groups (Table 2). Both groups achieved the MCID (the standardized mean differences were 0.86 and 0.81, for the video+booklet and booklet alone groups, respectively). However, no significant differences were observed in improvement in knowledge scores between the groups immediately after reviewing the educational material (video+booklet 7.6 (±1.5) vs booklet only 7.2 (±2.0), p=0.07), and at 3 and 6 months (p=0.73 and 0.74, respectively).
Table 2.
Unadjusted means and standard deviations (SD) of outcome measures across time.*
| Outcome | Group | Baseline Mean (SD) | After Intervention | 3 months* | 6 months* | p value* |
|---|---|---|---|---|---|---|
| Knowledge questionnaire‡ | Video+Booklet | 5.5 (2.1) | 7.6 (1.5) | 7.2 (1.3) | 7.3 (1.3) | <.0001 |
| Booklet Only | 5.5 (2.1) | 7.2 (2.0) | 7.3 (1.0) | 7.2 (1.2) | <.0001 | |
| p † | 0.07 | 0.73 | 0.74 | |||
| Total score decisional conflict score (higher score, higher decisional conflict) | Video+Booklet | 42.9 (34.6) | 13.6 (21.9) | 24.8 (22.8) | 23.0 (19.7) | <.0001 |
| Booklet Only | 45.5 (34.3) | 22.7 (27.2) | 25.4 (19.5) | 25.2 (20.9) | <.0001 | |
| p † | 0.13 | 0.70 | 0.94 | |||
| “Informed” decisional conflict subscore (higher score, more uninformed) | Video+Booklet | 45.2 (36.0) | 14.3 (22.1) | 25.9 (23.7) | 23.2 (20.6) | <.0001 |
| Booklet Only | 49.6 (36.6) | 26.4 (30.5) | 27.8 (20.7) | 25.4 (21.3) | <.0001 | |
| p † | 0.09 | 0.63 | 0.67 | |||
| “Values clarity” decisional conflict subscore (higher score, more unclear about personal values) |
Video+Booklet | 39.4 (37.9) | 12.6 (25.0) | 23.0 (24.5) | 22.5 (21.7) | <.0001 |
| Booklet Only | 39.3 (39.3) | 17.3 (28.2) | 21.8 (21.3) | 24.8 (23.2) | ≤.0002 | |
| p † | 0.34 | 0.85 | 0.67 | |||
| Self-efficacy (higher score, higher confidence) | Video+Booklet | 56.3 (27.0) | 55.5 (21.5) | 62.9 (16.7) | 0.76 | |
| Booklet Only | 55.5 (24.1) | 56.1 (15.9) | 61.3 (17.2) | 0.78 | ||
| p † | 0.68 | 0.79 | ||||
| Effective Consumer Scale to 100 (higher score, better disease management) | Video+Booklet | 74.8 (17.4) | 77.4 (12.3) | 79.1 (10.9) | 0.83 | |
| Booklet Only | 76.4 (17.1) | 76.6 (9.7) | 77.9 (12.9) | 0.32 | ||
| p † | 0.25 | 0.23 |
Analysis based on intention-to-treat population.
p values are from a two-sample t-test comparing the groups in terms of change in outcome between a follow-up period and baseline using ESTIMATE statement in PROC MIXED procedure in SAS, unless stated otherwise.
Within groups, the p-value from t-test comparing baseline with follow-up score in PROC MIXED procedure in SAS was significant for all outcomes (p<.01) except self-efficacy (both at 3 months, p=0.76 and 0.78 for the two groups, respectively) and Effective Consumer scale (at 3 months for both groups, p=0.067 and 0.83 for the two groups, respectively) and 6 months for the booklet group, p=0.32).
Seven of the 10 questions required the patient to check 2 answers. In this case, each correct choice was 0.5. If a patient checked 3 with 2 of them the correct answers, a score of 0.75 was assigned for that particular question. Three questions had only 1 correct answer for a point each. If a patient checked 2 with 1 of them the correct answer, a score of 0.75 was assigned for that particular question.
Decisional conflict
Decisional conflict scores decreased immediately after reviewing the educational materials, at 3 and at 6 months compared with baseline in both groups. There were no differences in score changes in “total” decisional conflict between the two groups immediately after reviewing the educational material, at 3 and 6 months. Similar results were observed with the “informed” and “values clarity” decisional conflict subscales.
Self-efficacy
Compared with the baseline assessment, both groups had a higher mean self-efficacy score at 6 months, but there were no statistically significant differences in the changes of the scores across groups at 3 or 6 months.
Effective Consumer Scale
We observed better scores on the consumer effectiveness scale in both groups 6 months. However, the observed differences in the changes of the scores across groups were not statistically significant.
Acceptability of the materials
Patients in the video + booklet group were more likely than those in the booklet only group to rate the presentation as “excellent” for providing information about the following items: impact of RA (56% vs 37%), medication options (62% vs 43%), evidence about medications (49% vs 32%), benefits of medication (54% vs 37%), and self-care options (48% vs 26%) (p<0.05 for all). Also, more patients receiving the video + booklet found the length of the material presented to be “just right”, compared to those receiving the booklet alone (92% vs 80%, p=0.03).
Satisfaction with educational tool
Most patients in both groups gave favorable responses to all evaluation questions, with no significant differences in response options observed between the two groups.
Determinants of improvement
Knowledge.
Table 3 shows the predictors of knowledge improvement from baseline to immediately after intervention or 6 months found from the regression analysis. Being male, having a shorter disease duration, and being Hispanic (compared with being white), were predictive of greater knowledge improvement immediately after receiving the educational materials. At 6 months, significant predictors of greater knowledge improvement were limited health literacy at baseline, lower educational level, and having a shorter disease duration. Baseline knowledge scores were similar across these subpopulations, except for the health literacy groups and disease duration (Supplementary Figure 1). Participants with limited health literacy and shorted disease duration had lower baseline knowledge scores than their counterparts, but caught up to the others either immediately after reviewing the educational materials or at 6 months.
Table 3.
Factors associated to knowledge improvement (mean difference from baseline in total number of correct answers).
| Greater Knowledge Improvement | ||||
|---|---|---|---|---|
|
| ||||
| Determinant | After Intervention | At 6 months | ||
| B (SE) | p | B (SE) | p | |
| Video tool + Booklet (reference: booklet alone) | 0.44 (0.23) | 0.06 | 0.08 (0.24) | 0.75 |
| Female (reference: male) | −0.77 (0.32) | 0.02 | - | - |
| Disease duration, years | −0.09 (0.04) | 0.04 | −0.12 (0.05) | 0.01 |
| Ethnicity (reference: White) | ||||
| Black or African American | 0.26 (0.36) | 0.47 | - | - |
| Hispanic | 0.78 (0.30) | 0.01 | - | - |
| Other | −0.56 (0.64) | c | ||
| Education level (reference: less than high school) | ||||
| Bachelor’s degree or higher | - | - | −1.9 (0.38) | <0.001 |
| High School Diploma or equivalent | - | - | −0.95 (0.29) | <0.001 |
| Adequate health literacy (reference: limited) | - | - | −0.93 (0.31) | <0.001 |
Immediately after or within a week; SE=standard error
Decisional conflict.
Significant predictors of less decisional conflict immediately after reviewing the education materials included younger age and lower education. At 6 months, significant predictors of less decisional conflict were limited health literacy, lower educational level (less than high school diploma compared with Bachelor’s degree), and shorter disease duration. Factors associated with the decisional conflict informed and values clarity subscales are shown in Supplementary Table 1. Baseline decisional conflict scores were similar across these subpopulations, except for the health literacy groups (Supplementary Figure 2). Participants with limited health literacy had greater decisional conflict at baseline than participants with adequate health literacy.
Effective Consumer Scale
The predictors of better effective consumer scale scores at 6 months were lower disease duration and limited health literacy (p<0.001 for both covariates) (Supplementary Table 2). Participants with limited health literacy and shorter disease duration had lower baseline effective consumer scales scores than their counterparts, but at 6 months scores were similar across these subpopulations (Supplementary Figure 1).
DISCUSSION
In this study, regardless of the delivery method, patients with RA showed improved outcomes after reviewing educational materials, which persisted up to 6 months later. The video tool combined with the reading material was equally as effective as the reading material alone in improving knowledge scores or decisional conflict; however, patient ratings were significantly higher for the multimedia tool. This finding is important as in the study, all participants were asked, and were given time, to review the materials. Yet, in a clinical setting and when they are on their own, patients may be more likely to review materials that are more appealing. Our study nevertheless was not design to address patients’ adherence with reviewing the materials, but rather to examine the impact of the tools after review.
We found that several patient characteristics were associated with knowledge improvement. While there was some variation across time points, Hispanics, patients with limited health literacy or lower educational status, and those with shorter disease duration were more likely to have greater improvement in knowledge than their counterparts. Independent factors associated with less decisional conflict at 6 months included limited health literacy, lower educational level, and shorter disease duration. Some of these associations could be attributed to lower scores at baseline in patients with specific characteristics compared to their counterparts (i.e., participants with limited health literacy and shorter disease duration). These findings suggest that future patient education tools should take into account baseline patient characteristics for best performance, and that patients at disadvantaged educational levels can ‘catch up’ to others more informed.
Although substantial information on behavioral and nurse-led educational interventions in RA exists (44), there is little knowledge on the effect of self-administered short educational materials, which are the most common materials provided in clinical settings, as they require few resources to administer. Specific findings for self-administered educational tools (books, pamphlets, workbooks, and computerized lessons) for patients with RA are scarce, most comparing an educational tool with no education and primarily showing that educational tools are effective (5, 45). However, when comparing different self-administered educational tools, setting and delivery methods may not be as important. Similar to our results, a trial comparing multimedia educational material versus printed materials in patients with RA reported no differences between groups one month post-intervention in self-reported adherence, illness perception, or functional status (4). Nonetheless, using audiovisual delivery educational tools, may be beneficial in situations where specific behaviors need to be learned, also improving resource utilization. A trial compared a web video on methotrexate self-injection combined with nurse guidance versus nurse guidance alone, found that teaching time was reduced for the group of participants receiving the video intervention (3).
Although our video had features of decision support, we considered it primarily an education tool because it does not incorporate all elements of the International Patient Decision Aid Standards (IPDAS). For example, we did not provide information about the outcome probabilities associated with the different treatment options or included a step-by-step tool to make a decision. Adding enhanced decision-making tools may also increase benefits. In a study comparing the same consumer guide we used with a written decision aid, participants were assigned to either receive the booklet, an adapted low literacy, multi-lingual medication guide, or a low literacy, multi-lingual medication guide plus a multi-lingual decision aid provided during the medical encounter. Educational materials were seen by the participants prior to their routine clinic visit. Immediately after the visit patients receiving the combination of the adapted guide plus decision aid had higher knowledge scores. However, at 6 months, no significant differences were observed between groups in long-term clinical outcomes (disease activity or functional status), except for worse self-reported adherence in the group receiving the adapted guide alone. In a subgroup analysis of participants in whom a medication change was reported, those receiving the decision aid had significantly improvement in knowledge and reduced decisional conflict (1). Another study comparing a pharmaceutical booklet on etanercept with a long and a short decision aid, found that compared patients receiving any of the decision aid versions had greater knowledge scores immediately after reading the educational materials, than those receiving the simple booklet. No other differences in outcomes were observed (2). Our study did not include a decision aid, as it was primarily designed to evaluate general educational materials on RA, rather than to aid patients facing specific health decisions.
Our patient education tool focused on the optimal use of effective disease-modifying anti-rheumatic drugs (traditional and biologic) and on the acquisition of disease knowledge and management with design considerations for poor readers, using entertainment education. The video tool was developed following a systematic and rigorous process using a innovative approach which incorporated narratives and stories contextualizing the information and engaging the user, with a program that was both didactic and entertaining (22, 23).
Although our findings illustrate how “edutainment” can work in RA, the findings may be limited by the following considerations. First, we did not include patients with longstanding disease, only patients with disease duration of less than 10 years. Patients with longstanding RA are likely to have different educational needs and priorities than those with disease of shorter duration (46). Second, the attrition rate at 3 and 6 months was high, and could have increased the probability of a type II error. However, the non-response rates are consistent with those reported in other educational studies, and in tailored behavioral programs (47, 48). Third, the lack of blinding —i.e., the fact that patients were aware of the assignment—may have affected the results. Educational studies are difficult to blind owing to practical issues, especially with two very distinct delivery methods. It is possible that the interaction between research staff and participants could have influenced the responses, although this interaction only occurred at enrollment as the 3 and 6 months assessments were primarily done by mailed self-response questionnaires. Fourth, as with most educational interventions, results from participants may differ from those of patients who declined to participate, decreasing the generalizability of the findings.
Our study provides evidence that self-administered, patient education materials are effective in improving educational outcomes in patients with RA, regardless of the mode of delivery. The newly developed video incorporating entertainment and education was better liked by participants than the printed booklet, suggesting that patients may be more likely to engage with multimedia tools. These are systematically developed materials following a rigorous method (23) that are easy to implement in clinic. Our findings support the implementation of self-administered educational materials in clinical settings as they can result in sustained improvements in disease knowledge and decisional conflict.
Supplementary Material
SIGNIFICANCE AND INNOVATION.
We compared the efficacy in improving knowledge of a newly developed multimedia patient education tool in English and Spanish about therapeutic options for patients with rheumatoid arthritis, incorporating video modeling combined with written materials, versus written materials alone.
Short, self-administered, patient education materials are effective in improving educational outcomes in patients with rheumatoid arthritis, regardless of the mode of delivery.
Our findings support the implementation of self-administered educational materials in clinical settings, as they require few resources to administer and result in sustained improvements in disease knowledge and decisional conflict.
Acknowledgments
We are grateful to Vincent Richards from The University of Texas, MD Anderson Cancer Center for their contributions during the acquisition of the data and to Kenneth Saag from The University of Alabama at Birmingham School of Public Health and Amye Leong from Healthy Motivation and the Global Alliance for Musculoskeletal Health of the Bone and Joint Decade for the input provided during the development of the multimedia patient education tool.
Funding:
Agency for Health Research and Quality. The Agency had no role in the design or conduct of the study, or on the interpretation of results.
Disclosure
This study was supported by a grant from The Agency for Healthcare Research and Quality (AHRQ) (Award Number: 1R18HS019354). ClinicalTrials.gov Identifier: NCT01698762. The project was also supported in part by a grant from The University of Texas MD Anderson Cancer Center Duncan Family Institute for Cancer Prevention and Risk Assessment to Dr. Volk and the NIH/NCI under award number P30CA016672 using the Biostatistics Resource Group.
Footnotes
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