Clinical trial NCT00149461: Written Asthma Actions Plans Versus No Written Instructions In Specialty Care
Official title: The Efficacy of Written Treatment Plans in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma Action Plans
African Americans
Latinos
Health Literacy
Asthma Education
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: New York Presbyterian Hospital-Cornell
name: Harlem Hospital Center
name: Jacobi Medical Center
First posted: 2005-09-08
Enrollment: 407
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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 \[bronchopulmonary dysplasia, emphysema, or cystic fibrosis\])

Primary outcomes:
measure: Reduction in asthma symptom frequency
timeFrame: Measured at 3 month intervals for 12 months
measure: Reduction in urgent, unscheduled, and emergency visits for asthma
timeFrame: Measured at 3 month intervals for 12 months
measure: Improved quality of life
timeFrame: Measured at 6 and 12 months
Secondary outcomes:
measure: Hospitalizations due to asthma
timeFrame: Measured at 3 month intervals for 12 months
measure: Days with activity restriction
timeFrame: Measured at 3 month intervals for 12 months
measure: Proportion of participants in the intervention group who are given the written asthma action plan form during the initial visit
timeFrame: Measured at the exit interview after the initial visit with the specialist physician
measure: Proportion of patients in the intervention group who have the model treatment plan at the end of the follow-up period
timeFrame: Measured at 12 month interview
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: David Evans, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/ppul.20586.
citation: Sheares BJ, Mellins RB, Dimango E, Serebrisky D, Zhang Y, Bye MR, Dovey ME, Nachman S, Hutchinson V, Evans D. Do Patients of Subspecialist Physicians Benefit from Written Asthma Action Plans? Am J Respir Crit Care Med. 2015 Jun 15;191(12):1374-83. doi: 10.1164/rccm.201407-1338OC.