- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00106080
Improving the Quality of End-of-Life Communication for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Improving the Quality of End-of-Life Communication for Patients With COPD
Study Overview
Status
Conditions
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:
- Preferences about cardiopulmonary resuscitation (CPR) and mechanical ventilation
- Preferences for communication with provider
- Measure of severity of airflow obstruction
- Barriers and facilitators to communication
- 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:
- Mailed to the patient to share with their surrogate
- Sent to their provider prior to the clinic visit
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
- Have a future visit scheduled in one of the eligible primary care or chest clinics; and
- Have airflow limitation
Exclusion Criteria:
- 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.
- The provider taking care of their COPD does not participate.
- Have a new diagnosis of COPD within the last month.
Study Plan
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
Investigators
- Principal Investigator: David H Au, MD MS, VA Puget Sound Health Care System Seattle Division, Seattle, WA
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.
- Reinke LF, Slatore CG, Udris EM, Moss BR, Johnson EA, Au DH. The association of depression and preferences for life-sustaining treatments in veterans with chronic obstructive pulmonary disease. J Pain Symptom Manage. 2011 Feb;41(2):402-11. doi: 10.1016/j.jpainsymman.2010.05.012. Epub 2010 Dec 8.
- Janssen DJ, Curtis JR, Au DH, Spruit MA, Downey L, Schols JM, Wouters EF, Engelberg RA. Patient-clinician communication about end-of-life care for Dutch and US patients with COPD. Eur Respir J. 2011 Aug;38(2):268-76. doi: 10.1183/09031936.00157710. Epub 2011 Jan 13.
- Cecere LM, Slatore CG, Uman JE, Evans LE, Udris EM, Bryson CL, Au DH. Adherence to long-acting inhaled therapies among patients with chronic obstructive pulmonary disease (COPD). COPD. 2012 Jun;9(3):251-8. doi: 10.3109/15412555.2011.650241. Epub 2012 Apr 12.
- Cecere LM, Littman AJ, Slatore CG, Udris EM, Bryson CL, Boyko EJ, Pierson DJ, Au DH. Obesity and COPD: associated symptoms, health-related quality of life, and medication use. COPD. 2011 Aug;8(4):275-84. doi: 10.3109/15412555.2011.586660. Epub 2011 Aug 2.
- Au DH, Udris EM, Engelberg RA, Diehr PH, Bryson CL, Reinke LF, Curtis JR. A randomized trial to improve communication about end-of-life care among patients with COPD. Chest. 2012 Mar;141(3):726-735. doi: 10.1378/chest.11-0362. Epub 2011 Sep 22.
- Reinke LF, Slatore CG, Uman J, Udris EM, Moss BR, Engelberg RA, Au DH. Patient-clinician communication about end-of-life care topics: is anyone talking to patients with chronic obstructive pulmonary disease? J Palliat Med. 2011 Aug;14(8):923-8. doi: 10.1089/jpm.2010.0509. Epub 2011 Jun 1.
- Reinke LF, Uman J, Udris EM, Moss BR, Au DH. Preferences for death and dying among veterans with chronic obstructive pulmonary disease. Am J Hosp Palliat Care. 2013 Dec;30(8):768-72. doi: 10.1177/1049909112471579. Epub 2013 Jan 8.
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 02-292
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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