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

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: case management; Behavioral: usual care

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 Type: Interventional
• Enrollment (Actual): 743
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 2; usual care	Behavioral: usual care; usual care for COPD
Active Comparator: 1; CAse/self management for COPD	Behavioral: case management; case/self management for COPD vs usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospitalization or Emergency Department Visit for COPD	1 yr
Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)	1 yr

Secondary Outcome Measures

Outcome Measure	Time Frame
All Cause Mortality	1 year
Quality of Life	1 year
All Cause Hospitalizations	1 year
COPD Exacerbations Requiring Antibiotics or Corticosteroids	1 year

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Kathryn L Rice, MD, Minneapolis Veterans Affairs Medical Center; Principal Investigator: Naresh Dewan, MD, VA Nebraska Western Iowa Health Care System

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: August 3, 2005
• First Submitted That Met QC Criteria: August 3, 2005
• First Posted (Estimate): August 4, 2005

Study Record Updates

• Last Update Posted (Estimate): August 25, 2009
• Last Update Submitted That Met QC Criteria: July 14, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: self management; chronic obstructive pulmonary disease; case management
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: VISN 23 PC-SI 0401