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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Behavioral: case management; Behavioral: usual care	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	743 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	VISN 23 Lung Disease Self Management/Case Management Program
Study Start Date :	July 2004
Actual Primary Completion Date :	December 2007
Actual Study Completion Date :	July 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 1; CAse/self management for COPD	Behavioral: case management; case/self management for COPD vs usual care
2; usual care	Behavioral: usual care; usual care for COPD

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Hospitalization or Emergency Department Visit for COPD [ Time Frame: 1 yr ]
2. Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) [ Time Frame: 1 yr ]

Secondary Outcome Measures :

1. All Cause Hospitalizations [ Time Frame: 1 year ]
2. Quality of Life [ Time Frame: 1 year ]
3. COPD Exacerbations Requiring Antibiotics or Corticosteroids [ Time Frame: 1 year ]
4. All Cause Mortality [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Iowa
Des Moines VA
Des Moines, Iowa, United States, 50310
IA City VA
Iowa City, Iowa, United States, 52246
United States, Minnesota
Minneapolis VAMC
Minneapolis, Minnesota, United States, 55417
United States, Nebraska
Omaha VAMC
Omaha, Nebraska, United States, 68105
United States, South Dakota
Sioux Falls VAMC
Sioux Falls, South Dakota, United States, 57117

Sponsors and Collaborators

VA Office of Research and Development

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Kathryn Rice MD, Minneapolis VA Medical Center
ClinicalTrials.gov Identifier:	NCT00126776 History of Changes
Other Study ID Numbers:	VISN 23 PC-SI 0401
First Posted:	August 4, 2005
Results First Posted:	August 25, 2009
Last Update Posted:	August 25, 2009
Last Verified:	July 2009

Keywords provided by VA Office of Research and Development:

chronic obstructive pulmonary disease; case management; self management

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases