Written Asthma Actions Plans Versus No Written Instructions In Specialty Care

January 16, 2014 updated by: David Evans PhD, Columbia University

The Efficacy of Written Treatment Plans in Asthma

The overall goal of this randomized, controlled study is to compare a model written treatment plan with the usual care that is provided by a group of adult and pediatric pulmonologists and allergists in their practice settings. The written treatment plan is a form that allows a treatment regimen that is consistent with National Heart, Lung, and Blood Institute (NHLBI) guidelines to be conveyed to patients. Barriers to the use of written plans will be identified to better understand why some patients and physicians use written treatment plans more frequently and effectively than others. An additional goal is to assess how patients from different racial/ethnic backgrounds utilize treatments plans. Because asthma disproportionately affects African American and Latino patients, another goal of this study is to better understand if there are fundamental differences in the way patients from racial/ethnic minority groups self-manage asthma in comparison to their white counterparts. The study will also try to determine if differences exist in the way physicians care for minority patients. If there are differences, it is important to determine if the disparities can be overcome with the use of a written treatment plan form.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

Effective self-management of asthma requires that patients, or their caregivers, recognize the early symptoms of an exacerbation and initiate appropriate interventions aimed at preventing the progression of symptoms. Most asthma clinical guidelines suggest that the incorporation of a written self-management plan is essential. Patients must possess, understand, and follow a written plan if they are to respond appropriately to changes in asthma status. Nevertheless, there are no controlled studies examining the efficacy of the written plan itself. Furthermore, even if written plans are an essential and effective component of successful self-management, the data suggest that few patients receive these plans. If patients and physicians are to increase their use of written plans, the barriers to the use of these plans need further investigation.

DESIGN NARRATIVE:

The three primary outcome measures of this study are as follows: 1) reduction in asthma symptom frequency; 2) reduction in urgent, unscheduled, and emergency visits for asthma; and 3) improved quality of life. These outcomes will be measured over a 12-month period.

The following four secondary outcome measures will also be examined: 1) hospitalizations due to asthma; 2) days with activity restriction; 3) the proportion of patients in the intervention group who are given the model written plan form during the initial visit; and 4) the proportion of patients in the intervention group who have the model treatment plan at the end of the follow-up period. These outcomes will be measured over a 12-month period.

Study Type

Interventional

Enrollment (Actual)

407

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • This study will enroll parents of children (ages 5-17 years) with asthma and adult patients with asthma (ages 18-80 years) who receive care at one of 4 New York Ciry medical centers (New York Presbyterian Hospital-Columbia campus, New York Presbyterian Hospital-Cornell campus, Harlem Hospital Center, and Jacobi Medical Center)
  • Diagnosis of persistent asthma (as defined by NHLBI guidelines)
  • All participants are new patients to the practice
  • Had never been seen by a specialist physician for asthma care
  • Had never received a written asthma action plan

Exclusion Criteria:

  • Co-morbidity with conditions that affect lung function (e.g, congenital or acquired heart disease, neuromuscular disease, sickle cell disease, or chronic lung disease [bronchopulmonary dysplasia, emphysema, or cystic fibrosis])

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Written Asthma Action Plan Group
Participants randomized to the written asthma action plan group received an asthma action plan form along with asthma education from their specialist physician.
Behavioral: Written Asthma Action Plan
Other Names:
  • Asthma Treatment Plans
  • Action Plans
NO_INTERVENTION: No Written Instructions Group
Participants randomized to the usual care group received no written instructions other than prescriptions from their specialist physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in asthma symptom frequency
Time Frame: Measured at 3 month intervals for 12 months
Using a 2-week recall period, asthma symptom frequency was measured in 3 ways: (a) the average number of days with asthma symptoms; (b) the average number of nights with symptoms; and (c) the average number of days the participant used a short-acting bronchodilator.
Measured at 3 month intervals for 12 months
Reduction in urgent, unscheduled, and emergency visits for asthma
Time Frame: Measured at 3 month intervals for 12 months
Emergency, urgent, and unscheduled visits for asthma were combined into a single measure and assessed using a 3-month recall.
Measured at 3 month intervals for 12 months
Improved quality of life
Time Frame: Measured at 6 and 12 months
Asthma QOL, using the Juniper Mini Asthma QOL Scale (MiniAQLQ) for adult participants and the Juniper Pediatric Asthma Caregivers QOL Questionnaire (PACQLQ) for parents, was assessed at 6 and 12-months follow-up.
Measured at 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalizations due to asthma
Time Frame: Measured at 3 month intervals for 12 months
Assessed the number of hospital admissions over the previous 3 months.
Measured at 3 month intervals for 12 months
Days with activity restriction
Time Frame: Measured at 3 month intervals for 12 months
Days with activity limitations were defined as the number of days missed from school or work due to asthma.
Measured at 3 month intervals for 12 months
Proportion of participants in the intervention group who are given the written asthma action plan form during the initial visit
Time Frame: Measured at the exit interview after the initial visit with the specialist physician
Participants in each group show the research assistant all written materials they received from the physician during the visit.
Measured at the exit interview after the initial visit with the specialist physician
Proportion of patients in the intervention group who have the model treatment plan at the end of the follow-up period
Time Frame: Measured at 12 month interview
Assessed retention of the written asthma action plan (WAAP) by asking participants to read a specific line from the written asthma action plan to demonstrate that they had the WAAP in their possession.
Measured at 12 month interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Jacobi Medical Center
Harlem Hospital Center
New York Presbyterian Hospital-Cornell

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (ESTIMATE)

September 8, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 17, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAA0864
  • R01HL073955-01 (NIH)
  • R01HL073955 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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