Veterans Integrated Service Network (VISN) 23 Lung Disease Self Management/Case Management Program

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: case management; Behavioral: usual care

• Registration Number: NCT00126776
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

The purpose of this study is to determine if a program of self management and case management reduces hospitalizations and urgent care visits for patients with chronic obstructive pulmonary disease (COPD).

Detailed Description

Study design and plan:

This is a one-year, 5-site randomized trial. High-risk patients will be randomized to usual care or a case/self management intervention. The frequency of urgent care visits or admission to a hospital for COPD will be compared.

Study procedures: visit 1 Patient informed consent will be obtained prior to patient participation in the trial.

Patients will also sign a release of information form to obtain outside records of COPD admissions or urgent care visits.

Demographic data, inclusion/exclusion data, medications and problem list will be obtained.

Post-albuterol forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) will be performed using calibrated spirometers in accordance with guidelines established by the American Thoracic Society. A uniform set of nomograms (NHANES III) will be used at all sites. The best of three efforts will be defined as the highest FEV1 and the highest FVC obtained on any of the three blows (even if not from the same curve with a maximum of 5 attempts).

Patients who meet all above criteria and who agree to participation will be randomized to usual care or the case/self management intervention, by means of sealed sequentially numbered envelopes at each site.

Patients who are randomized to case/self management intervention will receive 1-2 hours of education (appendix 1). These patients will be given instructions for self-management of exacerbation and a telephone care contact number. Coordinators will confirm that the patient has been instructed about, and is in possession of, standard pharmacologic treatment of exacerbation, including a 10 day supply of oral prednisone and an oral antibiotic. Prednisone dose regimens and specific antibiotics will be determined by the site PI according to local sensitivities and practice patterns, with access to current disease management recommendations and information.

Study procedures: treatment period All patients will be contacted by telephone every 6 weeks by a blinded centralized study staff member who will inquire about interim urgent care visits and hospitalizations and COPD exacerbations according to a scripted case report form.

Patients in the intervention arm will be contacted by the site coordinator monthly to reinforce educational principles and assist patients with disease management questions or concerns.

Study procedures: end of trial At the end of one year quality of life scores (SF36 and St. George's Respiratory Questionnaire, a VISN 23 patient satisfaction survey, and a brief questionnaire regarding current influenza and pneumococcal vaccination status, smoking status, and average number of minutes of exercise per day will be mailed to all patients.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-08-03
• Study First Submitted QC: 2005-08-03
• Study First Posted: 2005-08-04
• Primary Completion: 2007-12
• Study Completion: 2008-07
• Status Verified: 2009-07
• Results First Submitted: 2009-07-14
• Results First Submitted QC: 2009-07-14
• Last Update Submitted: 2009-07-14
• Results First Posted: 2009-08-25
• Last Update Posted: 2009-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 743

Inclusion Criteria

One or more of the following:

• Hospital admission for COPD within the prior year
• Unscheduled visit for COPD within the prior year
• Home oxygen use for COPD
• Systemic steroid use for COPD within the prior year
• Post bronchodilator FEV1 < 70% predicted
• Post bronchodilator FEV1/FVC < 70% predicted

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Exclusion Criteria

• Any unstable medical condition that would preclude effective participation in the study, or which would be expected to reduce life expectancy to < 1 year
• Inability to contact patient by telephone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	case management	CAse/self management for COPD
2	usual care	usual care

Primary Outcome Measures

Name	Time	Method
Hospitalization or Emergency Department Visit for COPD	1 yr
Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)	1 yr

Secondary Outcome Measures

Name	Time	Method
All Cause Hospitalizations	1 year
Quality of Life	1 year
COPD Exacerbations Requiring Antibiotics or Corticosteroids	1 year
All Cause Mortality	1 year

Trial Locations

Locations (5)

Des Moines VA; 🇺🇸 Des Moines, Iowa, United States

IA City VA; 🇺🇸 Iowa City, Iowa, United States

Minneapolis VAMC; 🇺🇸 Minneapolis, Minnesota, United States

Omaha VAMC; 🇺🇸 Omaha, Nebraska, United States

Sioux Falls VAMC; 🇺🇸 Sioux Falls, South Dakota, United States