Written Treatment Plan Versus Usual Care for Treating Individuals With Asthma - Full Text View

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) Columbia University
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00149461

Purpose

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.

Condition	Intervention
Asthma	Behavioral: Written Treatment Plan

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	The Efficacy of Written Treatment Plans in Asthma

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Reduction in asthma symptom frequency [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Reduction in urgent, unscheduled, and emergency visits for asthma [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Improved quality of life [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hospitalizations due to asthma [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Days with activity restriction [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Proportion of patients in the intervention group who are given the model written plan form during the initial visit [ Time Frame: Measured at Year 4 ] [ Designated as safety issue: No ]
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 Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	512
Study Start Date:	August 2003
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients will receive a written treatment plan from their physician.	Behavioral: Written Treatment Plan Patients will receive a written treatment plan from their physician.
2: No Intervention Patients will not receive a written treatment plan from their physician.

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.

Eligibility

Ages Eligible for Study:	3 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

This study will enroll parents of children (ages 3-17 years) with asthma and adult patients with asthma (ages 18-75 years) whe receive care at one of 3 centers (New York Presbyterian Hospital-Columbia campus, New York Presbyterian Hospital-Cornell campus, and Harlem Hospital Center)
Diagnosis of persistent asthma (as defined by NHLBI guidelines)
Diagnosis of asthma was made using commonly accepted clinical criteria (episodic symptoms of airflow obstruction, airflow obstruction that is at least partially reversible, and reasonable alternative diagnoses have been excluded)
Evidence of at least mild persistent asthma, based on the finding of at least one of the following clinical features before treatment:
1. Presence of symptoms (3 or more days a week)
2. Nocturnal asthma symptoms (3 or more times a month)
3. PEF variability of at least 20% to 30%

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])

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149461

Contacts

Contact: David Evans, PhD

212-305-6732

de8@columbia.edu

Locations

United States, New York
Columbia University	Recruiting
New York, New York, United States, 10032
Contact: Beverley J. Sheares, MD, MS bjs4@columbia.edu
Principal Investigator: David Evans, PhD

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Columbia University

Investigators

Principal Investigator:

David Evans, PhD

Columbia University

More Information

Publications of Results:

Sheares BJ, Du Y, Vazquez TL, Mellins RB, Evans D. Use of written treatment plans for asthma by specialist physicians. Pediatr Pulmonol. 2007 Apr;42(4):348-56.

Responsible Party:	Columbia University ( David Evans, PhD )
Study ID Numbers:	256, R01 HL073955
Study First Received:	September 6, 2005
Last Updated:	January 31, 2008
ClinicalTrials.gov Identifier:	NCT00149461
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009