Bronchitis and Emphysema Advice and Training to Reduce Hospitalization
NCT ID: NCT00395083
Last Updated: 2014-09-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
426 participants
INTERVENTIONAL
2006-07-31
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention incorporating self-management education, an action plan, and case-management to decrease the risk of hospitalizations due to chronic obstructive pulmonary disease (COPD) among veterans with severe COPD.
Hypotheses:
Primary Hypothesis:
Veterans with COPD who receive a self-management program incorporating education sessions, development of an action plan, and case-management will have a decreased risk of COPD hospitalization compared to standardized COPD care.
Primary Objective:
In an intent-to-treat analysis, determine the efficacy of a comprehensive self-management program for reducing the risk of COPD hospitalization in veterans with severe COPD in comparison to patients receiving standardized COPD care.
Secondary Hypotheses:
Compared with standardized COPD care, veterans with COPD who receive a comprehensive self-management intervention will have: A) decreased health-related costs resulting from decreased hospitalizations and outpatient utilization, B) decreased hospitalization rates and average length of stay due to both COPD and all-cause admissions, and C) improvement in a set of outcomes including mortality, health-related quality of life, medication adherence, patient satisfaction, disease knowledge, skill acquisition and self-efficacy.
Secondary Objectives:
To evaluate the healthcare costs, hospitalization days, mortality, adherence, and health outcomes of a comprehensive self-management program compared to standardized COPD care among patients with severe COPD measured by:
A)Healthcare-related costs B)Health services use due to COPD and to all causes C)Clinical outcome measures
1. Mortality
2. Health-related quality of life measured by generic and COPD-specific measures
3. Patient satisfaction
4. Medication adherence
5. Disease knowledge, skill acquisition and self-efficacy
In the proposed study, 960 veterans with severe COPD hospitalized in the previous year will be randomly assigned to either a comprehensive case management program or standardized COPD care. The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. Patients allocated to the control arm will receive standardized care that incorporates guideline-based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
The study will be conducted in 2 phases, a 12-month feasibility study conducted at 6 VA sites followed by the full study in which an additional 8 sites will enroll patients over the next 24 months. As a result, 180 patients will be initially enrolled in the feasibility study over the first year and the remaining 780 patients will be enrolled in the second and third years of the study when the full study is implemented. Subjects will be followed until the completion of the study, for at least one, and up to four years. The primary outcome is time to first COPD hospitalization.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Understanding Patient Management of COPD Exacerbations
NCT02725294
Effect of Educational Intervention in Patients With Low-Risk Chronic Obstructive Pulmonary Disease
NCT00932711
Randomized Controlled Trial of Exercise Training in Patients With COPD
NCT00012792
Veterans Integrated Service Network (VISN) 23 Lung Disease Self Management/Case Management Program
NCT00126776
At Home Spirometry and Video Module Education for COPD Patients
NCT03834350
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention incorporating self-management education, an action plan, and case-management to decrease the risk of hospitalizations due to chronic obstructive pulmonary disease (COPD) among veterans with severe COPD.
Hypotheses:
Primary Hypothesis:
Veterans with COPD who receive a self-management program incorporating education sessions, development of an action plan, and case-management will have a decreased risk of COPD hospitalization compared to standardized COPD care.
Primary Objective:
In an intent-to-treat analysis, determine the efficacy of a comprehensive self-management program for reducing the risk of COPD hospitalization in veterans with severe COPD in comparison to patients receiving standardized COPD care.
Secondary Hypotheses:
Compared with standardized COPD care, veterans with COPD who receive a comprehensive self-management intervention will have: A) decreased health-related costs resulting from decreased hospitalizations and outpatient utilization, B) decreased hospitalization rates and average length of stay due to both COPD and all-cause admissions, and C) improvement in a set of outcomes including mortality, health-related quality of life, medication adherence, patient satisfaction, disease knowledge, skill acquisition and self-efficacy.
Secondary Objectives:
To evaluate the healthcare costs, hospitalization days, mortality, adherence, and health outcomes of a comprehensive self-management program compared to standardized COPD care among patients with severe COPD measured by:
A)Healthcare-related costs B)Health services use due to COPD and to all causes C)Clinical outcome measures
1. Mortality
2. Health-related quality of life measured by generic and COPD-specific measures
3. Patient satisfaction
4. Medication adherence
5. Disease knowledge, skill acquisition and self-efficacy
In the proposed study, 960 veterans with severe COPD hospitalized in the previous year will be randomly assigned to either a comprehensive case management program or standardized COPD care. The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care. Patients allocated to the control arm will receive standardized care that incorporates guideline-based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
The study will be conducted in 2 phases, a 12-month feasibility study conducted at 6 VA sites followed by the full study in which an additional 8 sites will enroll patients over the next 24 months. As a result, 180 patients will be initially enrolled in the feasibility study over the first year and the remaining 780 patients will be enrolled in the second and third years of the study when the full study is implemented. Subjects will be followed until the completion of the study, for at least one, and up to four years. The primary outcome is time to first COPD hospitalization.
Exacerbations among patients with COPD result in costly emergency room visits and hospitalizations. The overall direct and indirect medical costs of COPD for the United States in 2000 were estimated to be in excess of $30 billion. In the VA health care system, there were 16,073 discharges for COPD in fiscal year 2003 at an average cost of $9,400 (2005 dollars). Disease management programs for COPD may improve patient self-care, improving symptoms and resulting in decreased exacerbations. However, implementing the types of published programs that use self-management education and case-management require additional resources for the VA. The COPD disease management program described in this proposal was developed by extensive modification of existing programs using the strongest theory-based and evidence-based elements, and takes advantage of existing VA systems. By targeting patients at high risk for exacerbations, this study focuses on the population in which the needs and potential impact are the greatest.
The intervention is designed to enable patients with COPD to manage their disease more effectively, by monitoring their symptoms and initiating appropriate action when their symptoms worsen. The elements of the program are developed using self-efficacy theory, a recognized and powerful predictor of health-related behavior change. The goal of the intervention is an informed and activated patient working with an informed, skilled case manager to improve self-management of COPD and ultimately clinical outcomes. Case-management programs are used to improve outcomes and to reduce health care utilization among patients with other chronic diseases such as diabetes, congestive heart failure and asthma, suggesting that this approach may be successful in COPD.
A study conducted in Canada by Dr. Bourbeau, a co-investigator for this proposal, suggests that an intensive home-based self-management education program and case-management reduce the risk of COPD hospitalizations by 35% over 1-year, and reduced average hospital days by 42%. Cost-savings resulting from decreased hospitalizations offset the cost of the intervention, and the intervention was potentially cost-saving. Relying on home visits, the intervention is not practical or affordable in the VA, and therefore this study evaluates whether a novel case-management intervention for COPD developed specifically for the VA will reduce hospitalizations without increasing overall health-care costs.
Because the majority of health care costs for patients with COPD are due to hospitalizations for exacerbations, COPD admissions are the primary outcome and the principal self-management goal. Assessing the cost-effectiveness of this intervention is a critical component of the proposed study, and will provide data for evidence-based decisions by VA physicians and managers regarding the management of COPD.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
No interventions assigned to this group
Group 2
The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.
COPD Self-management Education
The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
COPD Self-management Education
The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
The study population consists of VA patients with COPD who receive some of their medical care at Veterans Affairs medical centers and were hospitalized for COPD in the last 12 months. To ensure that patients enrolled in the study receive regular care at the participating VA, we will include only patients enrolled in either the primary care or pulmonary clinic at the VA medical center and were seen at least once in the last year. This criterion should not significantly decrease the number of eligible patients because 90% of patients admitted for COPD in the VA had at least 1 outpatient visit to the VA primary care clinic in the year prior to their hospitalization based on data from the VA OPC in FY03.
1. Diagnosis of COPD confirmed by all of the following:
1. FEV1/FVC \< 0.70
2. FEV1 \< 80%
3. Age \> 40 years
4. A current or past history of cigarette smoking (\> 10 pack-years)
2. COPD hospitalization in the previous year
3. Receives care at participating VA medical center
1. Enrolled in either primary care or pulmonary clinic at the VA
2. Seen at least once in the past year in either primary care or pulmonary clinic
4. No COPD exacerbations in last 4 weeks
5. English-speaking
6. Access to telephone
Exclusion Criteria
2. Medical conditions affecting the ability to participate in the study such as:
1. Comorbid illness likely to limit life expectancy \< 1 year
2. Decompensated heart failure
3. Dementia
4. Uncontrolled psychiatric illness
3. Participation in another clinical intervention trial in the previous 30 days
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
US Department of Veterans Affairs
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vincent S. Fan, MD MPH
Role: STUDY_CHAIR
VA Puget Sound Health Care System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States
VA Medical Center, Loma Linda
Loma Linda, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
VA Medical Center, Bay Pines
Bay Pines, Florida, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States
Robert J. Dole VAMC & ROC, Wichita
Wichita, Kansas, United States
VA Medical Center, Lexington
Lexington, Kentucky, United States
VA Medical Center, Kansas City MO
Kansas City, Missouri, United States
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, United States
VA Western New York Healthcare System at Buffalo
Buffalo, New York, United States
New York Harbor HCS
New York, New York, United States
VA Medical Center, Cincinnati
Cincinnati, Ohio, United States
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States
VA Medical Center, Providence
Providence, Rhode Island, United States
VA North Texas Health Care System, Dallas
Dallas, Texas, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
VA Puget Sound Health Care System
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fan VS, Gaziano JM, Lew R, Bourbeau J, Adams SG, Leatherman S, Thwin SS, Huang GD, Robbins R, Sriram PS, Sharafkhaneh A, Mador MJ, Sarosi G, Panos RJ, Rastogi P, Wagner TH, Mazzuca SA, Shannon C, Colling C, Liang MH, Stoller JK, Fiore L, Niewoehner DE. A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial. Ann Intern Med. 2012 May 15;156(10):673-83. doi: 10.7326/0003-4819-156-10-201205150-00003.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
560
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.