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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

VISN 23 Lung Disease Self Management/Case Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126776
• Other study ID #: VISN 23 PC-SI 0401
• Status: Completed
• Phase: N/A
• First received: August 3, 2005
• Last updated: July 14, 2009
• Start date: July 2004
• Est. completion date: July 2008

Study information

• Verified date: July 2009
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. completion date: July 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• case management
case/self management for COPD vs usual care
• usual care
usual care for COPD

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization or Emergency Department Visit for COPD		1 yr	Yes
Primary	Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)		1 yr	No
Secondary	All Cause Hospitalizations		1 year	No
Secondary	Quality of Life		1 year	No
Secondary	COPD Exacerbations Requiring Antibiotics or Corticosteroids		1 year	No
Secondary	All Cause Mortality		1 year	Yes