Written Treatment Plan Versus Usual Care for Treating Individuals With Asthma
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Efficacy of Written Treatment Plans in Asthma |
- 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 ]
- 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 ]
| Enrollment: | 496 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | February 2013 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Patients will receive a written treatment plan from their physician.
|
Behavioral: Written Treatment Plan
Patients will receive a written treatment plan from their physician.
|
|
No Intervention: 2
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 |
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:
- Presence of symptoms (3 or more days a week)
- Nocturnal asthma symptoms (3 or more times a month)
- 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 More Information
Publications:
| Responsible Party: | David Evans PhD, Professor of Emeritus of Clinical Sociomedical Sciences (In Pediatrics), Columbia University |
| ClinicalTrials.gov Identifier: | NCT00149461 History of Changes |
| Other Study ID Numbers: | AAAA0864, R01HL073955-01, R01 HL073955 |
| Study First Received: | September 6, 2005 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013