- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00648609
Community Based Self Management of COPD Facilitated by a Palliative Care Team:Impact on Health Care Utilization and QOL
The purpose of this study is to compare in home support services for patients with COPD with usual care. The study is designed to evaluate the impact of an interdisciplinary palliative care team on community based self management of advanced COPD.
A total of thirty patients will be enrolled into this study. Twenty patients will be randomly assigned to receive usual care, and ten patients will be randomly assigned to usual care plus in home support services. This study will use objective criteria to identify patients with COPD likely to benefit from home based palliative care services. The patients will undergo initial assessment by medical, social work, and spiritual care personnel followed by a family meeting to establish a care plan. Periodic scheduled visits, and as needed unscheduled visits to address urgent needs will occur over one year's time in an attempt to return patients with COPD to the center of decision making regarding their care, avoid acute exacerbations and thereby avoid unscheduled clinic and ER visits. Patients will complete the QOL survey and symptom assessment scale upon initial intervention. After obtaining information from all patients who qualify for the study, participants will be randomized into cohorts. Those who are randomized to serve as cases will be provided with community based self management services by an interdisciplinary palliative care team. The control group will receive standard care. At the conclusion of 12 months both cases and controls will again complete the QOL survey,medical utilization, and symptom assessment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Minnesota
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Duluth, Minnesota, United States, 55805
- Essentia Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 60 or greater
- Dx of COPD
- Received 2 or more unscheduled acute care visits during the 12 months from Jan 2007-Dec 2007
- SMDC primary care provider
- Lives within 50 miles of Duluth Minnesota
- Informed consent
Exclusion Criteria:
- Non English speaking
- Too ill or cognitively impaired to provide baseline data or informed consent
- Lives more than 50 miles from Duluth
- Nursing home resident
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Home-based palliative care services
Patients who are 60 or more years of age and have a diagnosis of COPD.Patients who have received two or more unscheduled acute care visits during the 12 months prior to the start of the study.
|
Interdisciplinary palliative care team on community based self care management of advanced COPD.
|
Standard of care
Patients who are 60 or more years of age and have a diagnosis of COPD.Patients who have received two or more unscheduled acute care visits during the 12 months prior to the start of the study.
|
Usual care for COPD patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health service utilization, symptom scores, and patient quality of life
Time Frame: Baseline and 12 months
|
Health care utilization: over 12 months while enrolled on study vs. 12 months prior to enrollment.
For symptom scores and quality of life: at the time of enrollment and at the end of 12 months study period.
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Baseline and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dean Fox, MD, Essentia Health
Publications and helpful links
General Publications
- Curtis JR, Engelberg RA, Wenrich MD, Au DH. Communication about palliative care for patients with chronic obstructive pulmonary disease. J Palliat Care. 2005 Autumn;21(3):157-64.
- Halpern MT, Stanford RH, Borker R. The burden of COPD in the U.S.A.: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S81-9. doi: 10.1016/s0954-6111(03)80028-8.
- Rocker GM, Sinuff T, Horton R, Hernandez P. Advanced chronic obstructive pulmonary disease: innovative approaches to palliation. J Palliat Med. 2007 Jun;10(3):783-97. doi: 10.1089/jpm.2007.9951.
- American Academy of Hospice and Palliative Medicine; Center to Advance Palliative Care; Hospice and Palliative Nurses Association; Last Acts Partnership; National Hospice and Palliative Care Organization. National Consensus Project for Quality Palliative Care: Clinical Practice Guidelines for quality palliative care, executive summary. J Palliat Med. 2004 Oct;7(5):611-27. doi: 10.1089/jpm.2004.7.611. No abstract available.
- Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592. Erratum In: Am J Respir Crit Care Med 1997 Jan;155(1):386.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 080801
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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