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

October 10, 2019 updated by: VA Office of Research and Development

Improving the Quality of End-of-Life Communication for Patients With COPD

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

376

Phase

  • Not Applicable

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

    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual care
Experimental: Intervention
Audit and Feedback
Intervention patients and clinicians received a one-page patient-specific individualized summary, based on questionnaire responses, to stimulate conversations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers.
Measured at enrollment and 2 weeks after targeted clinic visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit.
Time Frame: Assessed 2 weeks after targeted clinic visit
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.
Assessed 2 weeks after targeted clinic visit

Collaborators and Investigators

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

Investigators

  • Principal Investigator: David H Au, MD MS, VA Puget Sound Health Care System Seattle Division, Seattle, WA

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.

General Publications

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

November 1, 2004

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

March 18, 2005

First Submitted That Met QC Criteria

March 18, 2005

First Posted (Estimate)

March 21, 2005

Study Record Updates

Last Update Posted (Actual)

October 11, 2019

Last Update Submitted That Met QC Criteria

October 10, 2019

Last Verified

October 1, 2019

More Information

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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