Improving Parent Understanding of Instructions About Asthma Care

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: AAAAI standard of care written action plan; Other: Pictogram-based asthma action plan

• Study Type: Interventional
• Enrollment (Actual): 449
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AAAAI Action Plan; Asthma Action Plan from the American Academy of Allergy, Asthma, and Immunology	Other: AAAAI standard of care written action plan
Experimental: Asthma pictogram written action plan; Cartoon/pictogram-based written action plan sheet	Other: Pictogram-based asthma action plan; Asthma action plan using plain language, pictograms, and photographs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Action Plan knowledge (parent)	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.	1 day (on same day of enrollment; no outcome assessment after day of enrollment)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Northwestern University Feinberg School of Medicine
• Investigators: Principal Investigator: Suzy Tomopoulos, MD, NYU School of Medicine; Principal Investigator: Shonna (Hsiang) Yin, MD, NYU School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: July 26, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (Estimate): July 29, 2011

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Asthma; Health literacy; Parent knowledge of appropriate action plan steps
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 09-0358

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No