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

June 16, 2011 updated by: Essentia Health

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

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Dean Fox, MD, Essentia Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

June 20, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

June 1, 2011

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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