Figure. Group randomization and study schema flow diagram. AD indicates atopic dermatitis; EAP, eczema action plan; Pt, patient.
Shi VY, Nanda S, Lee K, Armstrong AW, Lio PA. Improving patient education with an eczema action plan: a randomized controlled trial. JAMA Dermatol. Published online March 20, 2013. doi:10.1001/jamadermatol.2013.2143
eAppendix 1. Baseline Demographic Questionnaire 8
eAppendix 2. Sample Eczema Action Plan 9
eAppendix 3. Post-Consultation Assessment Survey 10
eAppendix 4. Post-EAP Assessment Survey
Shi VY, Nanda S, Lee K, Armstrong AW, Lio PA. Improving Patient Education With an Eczema Action Plan: A Randomized Controlled Trial. JAMA Dermatol. 2013;149(4):481-483. doi:10.1001/jamadermatol.2013.2143
Author Affiliations: University of Illinois, College of Medicine (Dr Shi), Chicago; Departments of Dermatology and Pediatrics (Dr Lio), Feinberg School of Medicine, Northwestern University (Dr Nanda), Chicago; Department of Dermatology, Brown University, Providence, Rhode Island (Dr Lee); and Department of Dermatology, University of California, Davis, Health System, Sacramento (Dr Armstrong).
A major challenge to atopic dermatitis (AD) management lies in its complex treatment, which must be tailored for both acute exacerbations and long-term maintenance. The addition of a written eczema action plan (EAP) to the routine verbal instruction (VI) may enhance patients' understanding of AD and facilitate treatment adherence.1 This randomized controlled study was designed to evaluate the effect of a written EAP on patient and caregiver understanding of AD, distress level regarding treatment regimen, and preference for the addition of an EAP compared with those receiving traditional in-office VI.
The study was approved by the New England Institutional Review Board (IRB No. 11-137; IORG registration No. IRB00000755), registered at ClinicalTrials.gov (NCT01660217), and conducted at a private dermatology office. The study schema flow diagram is shown in the Figure. Thirty-seven participants were randomized to receiving either VI or EAP (eAppendix 2) at the end of a clinic visit. The EAPs were tailored to each patient given their age, location, and disease severity. After receiving either VI or EAP, the participants completed surveys (eAppendixes 3 and 4) on their self-perceived understanding, comfort, and anxiety level regarding AD management. The initial VI group then crossed over and received an EAP, and their outcomes were assessed again. The effect of the EAP on participants' perception of AD management was compared with that of VI. Their responses were recorded on a numeric scale of 0 to 10, with 10 indicating the most positive self-perception. The control group participants were asked whether they preferred VI alone, the EAP alone, or both, and to list reasons for their preference.
The baseline demographic features of the study population are summarized in Table 1. The mean patient self-perception scores indicated that, compared with VI only, an EAP significantly improved the participants' understanding of their individualized treatment plan (8.0 vs 9.4) (P = .02), benefits and risks of the prescribed medication (7.1 vs 8.7) (P = .02), anatomic location of medication use (8.3 vs 9.7) (P = .03), duration of treatment (7.6 vs 9.7) (P < .01), recognizing AD exacerbating factors (7.0 vs 8.8) (P = .02), and adjusting treatment based on disease severity (6.6 vs 9.1) (P < .01). The interventional group participants also reported feeling significantly more comfortable about their treatment plan (8.2 vs 9.7) (P < .01) and less anxious about caring for AD at home (0.7 vs 3.5) (P < .01). Mean patient response scores indicated no statistical differences in the understanding of eczema (7.2 vs 8.4) (P = .07) or the ability to recognize disease remission (8.6 vs 7.5) (P = .10) between the 2 groups.
The control group that initially received VI crossed over to receive EAP 10 minutes after receiving VI. These participants reported similar improvement in all aspects of AD management compared with receiving VI alone (Table 2). All control group participants preferred to have their providers use both VI and a written EAP during their in-office visits. Most indicated that an EAP provides helpful visualization, a stepwise treatment approach (n = 13, 68%), and a daily reminder (n = 15, 80%). Sixteen participants (84%) also believed that an EAP decreases confusion on treatment modification with respect to disease fluctuation.
Improvement in methods for patient education needs to parallel the rising disease burden of AD. Though some authors have proposed the use of a written action plan to improve AD outcome,1- 3 this is the first randomized controlled study on the utility of an EAP as an instruction tool. This is also an EAP interventional study that examined both an adult and pediatric population.
Evaluation of the VI vs EAP understanding scores confirmed the use of an EAP as an effective education tool. Participants who received an EAP reported a significant decrease in anxiety and increase in comfort about AD self-management. This finding is in concordance with a previous quality improvement study on the clinical utility of EAPs for parents of children with AD.3
The EAP may bring even greater educational and psychosocial benefits to a less educated population or where comprehension may be impaired due to language barriers. Additionally, since patients with more severe disease often require more complicated management plans, EAPs may be especially helpful in those cases.
In our experience, the use of an EAP lengthens the initial office visit by 3 to 5 minutes, but improves understanding and comfort with the plan. This has potential to reduce future consultation time, improve treatment outcomes and quality of life, and reduce economic burden. However, determining whether the self-reported benefits of an EAP from this study lead to long-term clinical success will require future studies with longer follow-up, expanded measurement parameters, and methods that separate the EAP from the educational material to fully answer these questions.
Correspondence: Dr Lio, 1455 N Milwaukee Ave, Second Floor, Chicago, IL 60622 (firstname.lastname@example.org).
Accepted for Publication: October 24, 2012.
Published Online: March 20, 2013. doi:10.1001/jamadermatol.2013.2143
Author Contributions: All authors had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Shi, Nanda, Lee, Armstrong, and Lio. Acquisition of data: Shi, Nanda, and Lio. Analysis and interpretation of data: Shi, Lee, Armstrong, and Lio. Drafting of the manuscript: Shi and Lee. Critical revision of the manuscript for important intellectual content: Shi, Nanda, Armstrong, and Lio. Statistical analysis: Lee and Armstrong. Obtained funding: Shi and Lio. Administrative, technical, and material support: Shi, Nanda, Lee, and Lio. Study supervision: Armstrong and Lio.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was supported in part by Research and Education Grant, Fondation Pour La Dermatite Atopique, Toulouse, France.
Role of the Sponsors: The sponsors had no role in the design and conduct of the study; in the collection, analysis, and interpretation of data; or in the preparation, review, or approval of the manuscript.
Additional Contributions: We thank Khiem Tran, PhD, for his critical reading of the manuscript. We also thank Keren Horn, MD, Meyer Horn, MD, and Neha Robinson, MD, for generously allowing us to conduct this study in their office.