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Written Asthma Actions Plans Versus No Written Instructions In Specialty Care

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Asthma Action Plan
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma Action Plans, African Americans, Latinos, Health Literacy, Asthma Education

Eligibility Criteria

5 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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])

Sites / Locations

  • Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Written Asthma Action Plan Group

No Written Instructions Group

Arm Description

Participants randomized to the written asthma action plan group received an asthma action plan form along with asthma education from their specialist physician.

Participants randomized to the usual care group received no written instructions other than prescriptions from their specialist physician.

Outcomes

Primary Outcome Measures

Reduction in asthma symptom frequency
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.
Reduction in urgent, unscheduled, and emergency visits for asthma
Emergency, urgent, and unscheduled visits for asthma were combined into a single measure and assessed using a 3-month recall.
Improved quality of life
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.

Secondary Outcome Measures

Hospitalizations due to asthma
Assessed the number of hospital admissions over the previous 3 months.
Days with activity restriction
Days with activity limitations were defined as the number of days missed from school or work due to asthma.
Proportion of participants in the intervention group who are given the written asthma action plan form during the initial visit
Participants in each group show the research assistant all written materials they received from the physician during the visit.
Proportion of patients in the intervention group who have the model treatment plan at the end of the follow-up period
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.

Full Information

First Posted
September 6, 2005
Last Updated
January 16, 2014
Sponsor
Columbia University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), New York Presbyterian Hospital-Cornell, Harlem Hospital Center, Jacobi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00149461
Brief Title
Written Asthma Actions Plans Versus No Written Instructions In Specialty Care
Official Title
The Efficacy of Written Treatment Plans in Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), New York Presbyterian Hospital-Cornell, Harlem Hospital Center, Jacobi Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma Action Plans, African Americans, Latinos, Health Literacy, Asthma Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Written Asthma Action Plan Group
Arm Type
Experimental
Arm Description
Participants randomized to the written asthma action plan group received an asthma action plan form along with asthma education from their specialist physician.
Arm Title
No Written Instructions Group
Arm Type
No Intervention
Arm Description
Participants randomized to the usual care group received no written instructions other than prescriptions from their specialist physician.
Intervention Type
Behavioral
Intervention Name(s)
Written Asthma Action Plan
Other Intervention Name(s)
Asthma Treatment Plans, Action Plans
Primary Outcome Measure Information:
Title
Reduction in asthma symptom frequency
Description
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.
Time Frame
Measured at 3 month intervals for 12 months
Title
Reduction in urgent, unscheduled, and emergency visits for asthma
Description
Emergency, urgent, and unscheduled visits for asthma were combined into a single measure and assessed using a 3-month recall.
Time Frame
Measured at 3 month intervals for 12 months
Title
Improved quality of life
Description
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.
Time Frame
Measured at 6 and 12 months
Secondary Outcome Measure Information:
Title
Hospitalizations due to asthma
Description
Assessed the number of hospital admissions over the previous 3 months.
Time Frame
Measured at 3 month intervals for 12 months
Title
Days with activity restriction
Description
Days with activity limitations were defined as the number of days missed from school or work due to asthma.
Time Frame
Measured at 3 month intervals for 12 months
Title
Proportion of participants in the intervention group who are given the written asthma action plan form during the initial visit
Description
Participants in each group show the research assistant all written materials they received from the physician during the visit.
Time Frame
Measured at the exit interview after the initial visit with the specialist physician
Title
Proportion of patients in the intervention group who have the model treatment plan at the end of the follow-up period
Description
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.
Time Frame
Measured at 12 month interview

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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])
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Evans, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17352397
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.
Results Reference
result
PubMed Identifier
25867075
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.
Results Reference
derived

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Written Asthma Actions Plans Versus No Written Instructions In Specialty Care

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