Asthma Patient Education in the Emergency Room

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The objective of this randomized trial is to assess the effectiveness of an intervention involving education, self-efficacy, and social support in improving quality of life outcomes among 296 adult asthma patients treated in the emergency room. The main outcome will be a comparison of within-patient change in quality of life between enrollment and 8 weeks. Secondary objectives will be to assess the effectiveness of the intervention in decreasing the need for rescue inhaled beta agonists, in improving peak flow meter rates, and in decreasing the number of days lost from work or school due to asthma. These outcomes will be measured again at 16 weeks to determine if benefits are sustained. Additional outcomes at 16 weeks and 1 year will be to assess the effectiveness of the intervention in decreasing urgent resource utilization for asthma and cost effectiveness.

Condition or disease	Intervention/treatment	Phase
Asthma	Behavioral: Asthma Education in Adults; Behavioral: Standard Emergency Room Asthma Education	Not Applicable

Detailed Description:

BACKGROUND:

Many urban asthma emergency room patients lack effective self-management. Most current training programs are administered in outpatient settings and have low attendance rates for emergency room patients. There is a great need to develop effective programs that can be easily administered in the emergency room for patients who, in many cases, are not present in other settings to receive education. This proposal builds on preliminary studies and is tailored to provide emergency room patients with basic education during "a teachable moment" when they may be most receptive to asthma information.

DESIGN NARRATIVE:

Patients will be recruited from two New York City urban emergency rooms or inpatient settings and randomized to the intervention or control groups. Intervention patients will receive a protocol focusing on asthma self-management, education, self-efficacy, and social support, with telephone reinforcement for 8 weeks. Control patients will receive standard emergency room education about asthma.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	296 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Trial of Asthma Patient Education in the Emergency Room
Study Start Date :	January 2005
Actual Primary Completion Date :	February 2010
Actual Study Completion Date :	February 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; Intervention participants will receive information focusing on asthma self-management, education, self-efficacy, and social support while in the hospital emergency room. Telephone reinforcement will occur for 8 weeks following study entry.	Behavioral: Asthma Education in Adults; The intervention involves enhancing asthma education, asthma self-efficacy and asthma-related social support and is administered during a single in-person session in the ED (or hospital for admitted patients) followed by telephone reinforcement.
Active Comparator: 2; Participants in the control group will receive standard emergency room education about asthma.	Behavioral: Standard Emergency Room Asthma Education; Participants will receive standard emergency room education about asthma.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Quality of life [ Time Frame: Measured at 8 weeks ]

Secondary Outcome Measures :

1. Rescue inhaled beta agonist use [ Time Frame: Measured at 8 weeks ]
2. Peak flow meter rates [ Time Frame: Measured at 8 weeks ]
3. Number of days lost from work or school due to asthma [ Time Frame: Measured at 8 weeks ]
4. Decreasing urgent resource utilization for asthma [ Time Frame: Measured at 16 weeks and 1 year ]
5. Cost effectiveness [ Time Frame: Measured at 16 weeks and 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 95 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients will be eligible if they are 18 years of age or older
• Fluent in English
• Have a known diagnosis of asthma
• Will receive treatment for asthma during the current hospitalization or emergency room visit.

Exclusion Criteria:

• Cognitive deficits
• Other pulmonary diseases or severe comorbidity
• Do not have out-patient access to a telephone

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New York
New York, New York, United States

Sponsors and Collaborators

Hospital for Special Surgery, New York

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Study Chair:	Carol A. Mancuso, MD	Hospital for Special Surgery, New York

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Mancuso CA, Peterson MG. Different methods to assess quality of life from multiple follow-ups in a longitudinal asthma study. J Clin Epidemiol. 2004 Jan;57(1):45-54.

Mancuso CA, Rincon M, Robbins L, Charlson ME. Patients' expectations of asthma treatment. J Asthma. 2003 Dec;40(8):873-81.

Mancuso CA, Rincon M, Charlson ME. Adverse work outcomes and events attributed to asthma. Am J Ind Med. 2003 Sep;44(3):236-45.

Mancuso CA, Rincon M, McCulloch CE, Charlson ME. Self-efficacy, depressive symptoms, and patients' expectations predict outcomes in asthma. Med Care. 2001 Dec;39(12):1326-38.

Mancuso CA, Peterson MG, Charlson ME. Effects of depressive symptoms on health-related quality of life in asthma patients. J Gen Intern Med. 2000 May;15(5):301-10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Peterson MG, Gaeta TJ, Birkhahn RH, Fernández JL, Mancuso CA. History of symptom triggers in patients presenting to the emergency department for asthma. J Asthma. 2012 Aug;49(6):629-36. doi: 10.3109/02770903.2012.690480. Epub 2012 Jun 28.

Responsible Party:	Carol A. Mancuso, MD, Hospital for Special Surgery
ClinicalTrials.gov Identifier:	NCT00110409 History of Changes
Other Study ID Numbers:	173; R01HL075893 ( U.S. NIH Grant/Contract )
First Posted:	May 9, 2005
Last Update Posted:	June 10, 2013
Last Verified:	June 2013

Additional relevant MeSH terms:

Asthma; Emergencies; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases	Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes