Improving Parent Understanding of Instructions About Asthma Care

Overview

Asthma has an especially great impact on poor urban children and their families. In addition to higher asthma prevalence and morbidity, those in low SES urban areas are at risk for low health literacy. Low health literacy is associated with poorer asthma outcomes. The provision of a written asthma action plan has been shown to help with asthma management and to reduce hospitalizations and ER visits. Poor urban families who may have low literacy may need an alternative asthma action plan to convey the treatment plan. This pilot study proposes to investigate whether a plain language asthma action plan can improve parent understanding and adherence with medication instructions, compared to standard written materials, among parents of children with asthma. This is an RCT in which parents of children with asthma will be randomized to either receive a pictogram-based low literacy asthma action plan, or a standard action plan (AAAAI), to examine whether those who receive the low literacy plan have improved asthma action plan knowledge when presented with a hypothetical scenario. A second part of the study is to examine whether providers who are given the pictogram-based low literacy asthma action plan will be more likely to counsel about certain aspects of asthma management (eg. need for daily medications even when sick, spacer use, confusion between everyday and rescue inhaler)compared to providers who receive use a standard action plan (AAAAI). This is an RCT in which pediatric providers are randomized to counsel a hypothetical patient using the pictogram-based action plan or the standard action plan (AAAAI).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2018

Interventions

  • Other: Pictogram-based asthma action plan
    • Asthma action plan using plain language, pictograms, and photographs
  • Other: AAAAI standard of care written action plan

Arms, Groups and Cohorts

  • Active Comparator: AAAAI Action Plan
    • Asthma Action Plan from the American Academy of Allergy, Asthma, and Immunology
  • Experimental: Asthma pictogram written action plan
    • Cartoon/pictogram-based written action plan sheet

Clinical Trial Outcome Measures

Primary Measures

  • Asthma Action Plan knowledge (parent)
    • Time Frame: 1 day (on same day of enrollment; no outcome assessment after day of enrollment)
    • Outcome measure will be assessed on the day of enrollment only, using a hypothetical scenario. No outcome assessments will be performed after the day of enrollment.

Secondary Measures

  • Asthma action plan content (provider)
    • Time Frame: same day as presentation of hypothetical counseling scenario
    • Provider coverage of green/yellow/red zone concepts, spacer use, medication information, symptoms; use of low literacy principles

Participating in This Clinical Trial

Parent study: Inclusion Criteria:

  • Primary caregiver / parent / legal guardian of child 2-12 years old – Child with diagnosis of asthma Exclusion Criteria:

  • Parent not English or Spanish-speaking Provider study: Inclusion Criteria:

  • Health providers who care for children with asthma

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • NYU Langone Health
  • Collaborator
    • Northwestern University Feinberg School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Suzy Tomopoulos, MD, Principal Investigator, NYU School of Medicine
    • Shonna (Hsiang) Yin, MD, Principal Investigator, NYU School of Medicine

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