Asthma Patient Education in the Emergency Room

Asthma Clinical Trial

Official title:

Trial of Asthma Patient Education in the Emergency Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110409
• Other study ID #: 173
• Secondary ID: R01HL075893
• Status: Completed
• Phase: N/A
• First received: May 6, 2005
• Last updated: June 7, 2013
• Start date: January 2005
• Est. completion date: February 2010

Study information

• Verified date: June 2013
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• Standard Emergency Room Asthma Education
Participants will receive standard emergency room education about asthma.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		Measured at 8 weeks	No
Secondary	Rescue inhaled beta agonist use		Measured at 8 weeks	No
Secondary	Peak flow meter rates		Measured at 8 weeks	No
Secondary	Number of days lost from work or school due to asthma		Measured at 8 weeks	No
Secondary	Decreasing urgent resource utilization for asthma		Measured at 16 weeks and 1 year	No
Secondary	Cost effectiveness		Measured at 16 weeks and 1 year	No