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

This study is currently recruiting patients.
Verified by Department of Veterans Affairs August 2005

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00126776

Purpose

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).
Condition Intervention
Chronic Obstructive Pulmonary Disease
 Behavior: self management/case management

MedlinePlus related topics:  COPD (Chronic Obstructive Pulmonary Disease)

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title: VISN 23 Lung Disease Self Management/Case Management Program

Further Study Details: 
Primary Outcomes: hospitalization or urgent care visits for COPD
Secondary Outcomes: all cause hospitalizations; resource utilization; quality of life; patient satisfaction; COPD exacerbations requiring antibiotics or corticosteroids; influenza and pneumococcal vaccination rates; smoking status; time spent exercising daily; all cause mortality; local choice of antibiotics; frequency
Expected Total Enrollment:  800

Study start: July 2004;  Expected completion: December 2006
Last follow-up: December 2006;  Data entry closure: December 2006

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

Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00126776

Michael Caldwell, RN, RRT      (402) 346-8800  Ext. 3312    Michael.Caldwell@med.va.gov

Iowa
      IA City VA, Iowa City,  Iowa,  52246,  United States; Recruiting
Jaymie Ransford, RT  319-338-0581  Ext. 5830    Jaymie.Ransford@med.va.gov 
Lois Geist, MD,  Principal Investigator

      Des Moines VA, Des Moines,  Iowa,  50310,  United States; Recruiting
Lucinda Jacobs, RT  515-699-5999  Ext. 4758    Lucinda.Jacobs@med.va.gov 
Sarita Kumari, MD,  Principal Investigator

Minnesota
      Minneapolis VAMC, Minneapolis,  Minnesota,  55417,  United States; Recruiting
Carrie Beaner, RT  612-725-2000  Ext. 2109    Caroline.Beaner@med.va.gov 
Kathryn L Rice, MD,  Principal Investigator

Nebraska
      Omaha VAMC, Omaha,  Nebraska,  68105,  United States; Recruiting
Michael Caldwell, RN, RRT  402-346-8800  Ext. 3312    Micheal.Caldwell@med.va.gov 
Naresh Dewan, MD,  Principal Investigator

South Dakota
      Sioux Falls VAMC, Sioux Falls,  South Dakota,  57117,  United States; Recruiting
Nancy Thum, RN  605-336-3230  Ext. 6706    Nancy.Thum@med.va.gov 
Mel Thomas, MD,  Principal Investigator

Study chairs or principal investigators

Kathryn L Rice, MD,  Principal Investigator,  Minneapolis VA Medical Center   
Naresh Dewan, MD,  Principal Investigator,  Omaha VA Medical Center   

More Information

Study ID Numbers:  VISN 23 PC-SI 0401
Last Updated:  August 18, 2005
Record first received:  August 3, 2005
ClinicalTrials.gov Identifier:  NCT00126776
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23



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