Comparing Written Versus Pictorial Asthma Action Plans to Improve Asthma Management and Health Outcomes Among Children and Adolescents: Protocol of a Pilot and Feasibility Randomized Controlled Trial (Preprint)

Abstract

BackgroundAsthma is an important focal point for health-focused research as ineffective symptom management and control can lead to significant morbidity and mortality. Current treatment guidelines for asthma recommend the use of a written asthma action plan (WAAP) to include individualized instruction for daily care and medication use. However, WAAPs are typically written at a 7 th to 9 th grade reading level, which can be a barrier to patients understanding their treatment, having confidence in using a WAAP, and engaging in asthma education during clinic visits. ObjectiveUtilizing a feasibility and pilot Randomized Controlled Trial (RCT) design, the objective of the Take Action for Asthma Control (TAAC) study is to test a symptom-based, computer-generated pictorial asthma action plan (PAAP) in contrast to a standard WAAP, and assess the feasibility and acceptability of the AAP intervention and study procedures. The study has three primary aims: (1) estimate the effect sizes of PAAPs compared to WAAPs, (2) evaluate feasibility and acceptability from the perspectives of key stakeholders, and (3) establish whether parent and youth literacy levels are associated with treatment outcomes. MethodsThis feasibility and pilot RCT is a block randomized, 2-arm, parallel-group clinical trial, lasting 6-months in duration. At baseline, participants are randomly assigned to receive a PAAP or WAAP, which is generated for them and review with them by their asthma physician. Study procedures take place over four separate time points, including a baseline clinic appointment, 1-month telephone follow-up, and 3-and 6-month clinic-based follow-ups. At each time point date are collected related to the main outcomes of AAP knowledge, AAP satisfaction, asthma control, pulmonary function, and adherence to daily asthma medication. A sample size of up 60 participants (ages 8-17 years) is being recruited. Feasibility and acceptability data are collected via one-to-one qualitative interviews with providers involved in the study, and a sub-group of families that participate in the study. ResultsRecruitment for the current phase of the study began in May 2017. It is anticipated that recruitment will continue through May 2018. Full results will immediately follow follow-up data collection. ConclusionsAn asthma action plan is an individualized, evidence-based strategy for patient education and asthma management. The standard WAAP, however, is dense and may be a barrier for families with lower literacy levels. Due to these concerns, many families are not prescribed a WAAP despite national guidelines encouraging its use. Moreover, pictorial asthma action plans (PAAPs) may be an acceptable and feasible alternative for these families.