Written Asthma Actions Plans Versus No Written Instructions In Specialty Care

NCT00149461 | Completed DMC

• 3 other identifiers: AAAA0864R01HL073955-01R01HL073955
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma Action Plans; African Americans; Latinos; Health Literacy; Asthma Education

Outcome Measures

Primary Outcomes (3)

• 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.

  Measured at 3 month intervals for 12 months

• 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.

  Measured at 3 month intervals for 12 months

• 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.

  Measured at 6 and 12 months

Secondary Outcomes (4)

• Hospitalizations due to asthma

  Measured at 3 month intervals for 12 months

• Days with activity restriction

  Measured at 3 month intervals for 12 months

• Proportion of participants in the intervention group who are given the written asthma action plan form during the initial visit

  Measured at the exit interview after the initial visit with the specialist physician

• Proportion of patients in the intervention group who have the model treatment plan at the end of the follow-up period

  Measured at 12 month interview

Study Arms (2)

Written Asthma Action Plan Group

EXPERIMENTAL

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

Behavioral: Written Asthma Action Plan

No Written Instructions Group

NO INTERVENTION

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

Interventions

Written Asthma Action Plan BEHAVIORAL

Also known as: Asthma Treatment Plans, Action Plans

Written Asthma Action Plan Group

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Co-morbidity with conditions that affect lung function (e.g, congenital or acquired heart disease, neuromuscular disease, sickle cell disease, or chronic lung disease \[bronchopulmonary dysplasia, emphysema, or cystic fibrosis\])

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• New York Presbyterian Hospital-Cornell: collaborator
• Harlem Hospital Center: collaborator
• Jacobi Medical Center: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 17352397 RESULT

• 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.

  PMID: 25867075 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David Evans, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emeritus of Clinical Sociomedical Sciences (In Pediatrics)

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: September 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2009
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

US (1)