Community Based Self Management of COPD Facilitated by a Palliative Care Team:Impact on Health Care Utilization and QOL

This study has been completed.
Sponsor:
Collaborator:
Medica Sur Clinic & Foundation
Information provided by:
Essentia Health
ClinicalTrials.gov Identifier:
NCT00648609
First received: March 27, 2008
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Pulmonary Disease Chronic Obstructive
Other: Palliative home care in advanced COPD
Other: Standard of care

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Community Based Self Management of COPD Facilitated by a Palliative Care Team:Impact on Health Care Utilization and QOL

Resource links provided by NLM:


Further study details as provided by Essentia Health:

Primary Outcome Measures:
  • Health service utilization, symptom scores, and patient quality of life [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 23
Study Start Date: March 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Palliative home care in advanced COPD
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.
Other: Standard of care
Usual care for COPD patients

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with advanced COPD from St. Mary's Duluth Clinic Health Systrem population in Duluth Minnesota

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648609

Locations
United States, Minnesota
Essentia Health
Duluth, Minnesota, United States, 55805
Sponsors and Collaborators
Essentia Health
Medica Sur Clinic & Foundation
Investigators
Principal Investigator: Dean Fox, MD Essentia Health
  More Information

Publications:
Responsible Party: Dean Fox MD, St. Mary's Duluth Clinic Health System
ClinicalTrials.gov Identifier: NCT00648609     History of Changes
Other Study ID Numbers: 080801
Study First Received: March 27, 2008
Last Updated: June 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Essentia Health:
Community based self management of COPD with palliative care

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014