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

VISN 23 Lung Disease Self Management/Case Management Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00126776
Enrollment
743
Registered
2005-08-04
Start date
2004-07-31
Completion date
2008-07-31
Last updated
2009-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease, case management, self management

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).

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.

Interventions

BEHAVIORALcase management

case/self management for COPD vs usual care

BEHAVIORALusual care

usual care for COPD

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Hospitalization or Emergency Department Visit for COPD1 yr
Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)1 yr

Secondary

MeasureTime frame
All Cause Hospitalizations1 year
Quality of Life1 year
COPD Exacerbations Requiring Antibiotics or Corticosteroids1 year
All Cause Mortality1 year

Countries

United States

Participant flow

Recruitment details

recruited by VA mailing lists July 2004-June 2006

Participants by arm

ArmCount
Disease Management for COPD
disease management for COPD
372
Usual Care
usual care
371
Total743

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studyfollow up complete on all patients00

Baseline characteristics

CharacteristicUsual CareDisease Management for COPDTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
268 Participants245 Participants513 Participants
Age, Categorical
Between 18 and 65 years
103 Participants127 Participants230 Participants
Age Continuous70.1 years
STANDARD_DEVIATION 9.7
69.1 years
STANDARD_DEVIATION 9.4
70.1 years
STANDARD_DEVIATION 9.1
Region of Enrollment
United States
371 participants372 participants743 participants
Sex: Female, Male
Female
6 Participants9 Participants15 Participants
Sex: Female, Male
Male
365 Participants363 Participants728 Participants

Outcome results

Primary

Hospitalization or ED Visit for COPD (Mean Cumulative Frequency)

Time frame: 1 yr

ArmMeasureValue (MEAN)
Disease Management for COPDHospitalization or ED Visit for COPD (Mean Cumulative Frequency)0.48 events per year
Usual CareHospitalization or ED Visit for COPD (Mean Cumulative Frequency)0.82 events per year
Comparison: primary outcome is mean cumulative frequency of COPD related hospitlaizations and ED visits ;ver 1 yr: 0.48 for disease management; 0.82 for usual care, difference 0.34 (95% CI 0.15 to 0.52; P\<0.001)p-value: <0.001mean cumulative frequency
Primary

Hospitalization or Emergency Department Visit for COPD

Time frame: 1 yr

Secondary

All Cause Hospitalizations

Time frame: 1 year

Secondary

All Cause Mortality

Time frame: 1 year

Secondary

COPD Exacerbations Requiring Antibiotics or Corticosteroids

Time frame: 1 year

Secondary

Quality of Life

Time frame: 1 year

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026