Written Asthma Actions Plans Versus No Written Instructions In Specialty Care

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Columbia University

Status

Completed

Conditions

Asthma

Treatments

Behavioral: Written Asthma Action Plan

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00149461
AAAA0864
R01HL073955 (U.S. NIH Grant/Contract)
R01HL073955-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

407 patients

Sex

All

Ages

5 to 80 years old

Volunteers

No Healthy Volunteers

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])

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

407 participants in 2 patient groups

Written Asthma Action Plan Group
Experimental group
Description:
Participants randomized to the written asthma action plan group received an asthma action plan form along with asthma education from their specialist physician.
Treatment:
Behavioral: Written Asthma Action Plan
No Written Instructions Group
No Intervention group
Description:
Participants randomized to the usual care group received no written instructions other than prescriptions from their specialist physician.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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