Clinical trial NCT00126776: Veterans Integrated Service Network (VISN) 23 Lung Disease Self Management/Case Management Program
Official title: VISN 23 Lung Disease Self Management/Case Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
case management
self management
Lead sponsor: VA Midwest Health Care Network
Sponsor class: FED
First posted: 2005-08-04
Enrollment: 743
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalization or Emergency Department Visit for COPD
timeFrame: 1 yr
measure: Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)
timeFrame: 1 yr
Secondary outcomes:
measure: All Cause Hospitalizations
timeFrame: 1 year
measure: Quality of Life
timeFrame: 1 year
measure: COPD Exacerbations Requiring Antibiotics or Corticosteroids
timeFrame: 1 year
measure: All Cause Mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Des Moines VA
state: Iowa
city: Iowa City
country: United States
facility: IA City VA
state: Iowa
city: Minneapolis
country: United States
facility: Minneapolis VAMC
state: Minnesota
city: Omaha
country: United States
facility: Omaha VAMC
state: Nebraska
city: Sioux Falls
country: United States
facility: Sioux Falls VAMC
state: South Dakota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Kathryn L Rice, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Nebraska Western Iowa Health Care System
name: Naresh Dewan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rice KL, Dewan N, Bloomfield HE, Grill J, Schult TM, Nelson DB, Kumari S, Thomas M, Geist LJ, Beaner C, Caldwell M, Niewoehner DE. Disease management program for chronic obstructive pulmonary disease: a randomized controlled trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):890-6. doi: 10.1164/rccm.200910-1579OC. Epub 2010 Jan 14.