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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
743
case/self management for COPD vs usual care
usual care for COPD
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
Hospitalization or Emergency Department Visit for COPD
Time frame: 1 yr
Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)
Time frame: 1 yr
All Cause Hospitalizations
Time frame: 1 year
Quality of Life
Time frame: 1 year
COPD Exacerbations Requiring Antibiotics or Corticosteroids
Time frame: 1 year
All Cause Mortality
Time frame: 1 year
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Sioux Falls VAMC
Sioux Falls, South Dakota, United States