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Improving the Quality of End-of-Life Communication for Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00106080
First received: March 18, 2005
Last updated: November 7, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to evaluate a multifaceted intervention to improve the quality of end-of-life communication between patients with COPD and their primary care providers using information about patients preferences for end of life care and how to communicate and use this information to activate patients, family members, and healthcare providers.


Condition Intervention
Pulmonary Disease
COPD
Chronic Bronchitis
Emphysema
Behavioral: Audit and Feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Official Title: Improving the Quality of End-of-Life Communication for Patients With COPD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale [ Time Frame: Measured at enrollment and 2 weeks after targeted clinic visit ] [ Designated as safety issue: No ]
    The quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers.


Secondary Outcome Measures:
  • Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit. [ Time Frame: Assessed 2 weeks after targeted clinic visit ] [ Designated as safety issue: No ]
    We measured the difference between intervention and control group patients reporting having had a discussion with their clinician about treatment preferences at their last clinic visit.


Enrollment: 376
Study Start Date: November 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Audit and Feedback
Behavioral: Audit and Feedback
Intervention patients and clinicians received a one-page patient-specific individualized summary, based on questionnaire responses, to stimulate conversations.
No Intervention: Control
Usual care

Detailed Description:

This project builds on previous work that described preferences important to patients at end-of-life and desire for life-sustaining therapy by incorporating these attributes into a multifaceted intervention designed to improve the quality of end-of-life communication.

Our specific aim was to evaluate a multifaceted intervention to improve the quality of end-of-life communication between patients with moderate or severe COPD and their primary care providers. The intervention is based on self-efficacy theory and includes provider education, local champions and role models, determination of patients individual barriers and facilitators regarding communication about end-of-life care, preferences for communication about end-of-life care and preferences for end-of-life care and using this information to activate patients, family members, and healthcare providers.

For both control and intervention patients we collected the following information which was incorporated into a one-page summary report:

  1. Preferences about cardiopulmonary resuscitation (CPR) and mechanical ventilation
  2. Preferences for communication with provider
  3. Measure of severity of airflow obstruction
  4. Barriers and facilitators to communication
  5. Preferences for end-of-life care

The intervention was incorporated into a usual clinic visit. For the upcoming clinic visit, we generated an individualized one-page patient specific feedback form for intervention group patients and providers. Patients and providers in the control group did not receive the form.

The generated one-page feedback form was:

  1. Mailed to the patient to share with their surrogate
  2. Sent to their provider prior to the clinic visit
  3. Provided to the patient prior to their clinic visit

The methods used for this study could be translated into clinic practice and possibly generalized to other chronic life-threatening conditions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

One or more of the following:

  1. Have 3 or more outpatient clinics visits for COPD (ICD-9) in the two years prior to enrollment.
  2. Have been hospitalized with a primary discharge diagnosis (ICD-9) for COPD in the two years prior to enrollment.
  3. Active use of inhaled beta-agonist and ipratropium bromide (or equivalent in combination inhalers like Combivent) in the 12 months prior to enrollment.

Plus

  1. Have a future visit scheduled in one of the eligible primary care or chest clinics; and
  2. Have airflow limitation

Exclusion Criteria:

  1. If they have cognitive dysfunction, language barriers or severe psychiatric disorder that would preclude them from completing the questionnaires. This was assessed initially by the patients provider and by the research assistant during in-person interviews.
  2. The provider taking care of their COPD does not participate.
  3. Have a new diagnosis of COPD within the last month.
  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: NCT00106080

Locations
United States, Washington
VA Health Services Research and Development
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Investigators
Principal Investigator: David H Au, MD MS VA Puget Sound Health Care System, Seattle
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00106080     History of Changes
Other Study ID Numbers: IIR 02-292
Study First Received: March 18, 2005
Results First Received: August 6, 2014
Last Updated: November 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Communication
Palliative Care

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 27, 2014