Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
VISN 23 Lung Disease Self Management/Case Management Program
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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