search
Back to results

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

Primary Purpose

Pulmonary Disease, COPD, Chronic Bronchitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audit and Feedback
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulmonary Disease focused on measuring Communication, Palliative Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Audit and Feedback

Usual care

Outcomes

Primary Outcome Measures

Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale
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.
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.

Full Information

First Posted
March 18, 2005
Last Updated
October 10, 2019
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT00106080
Brief Title
Improving the Quality of End-of-Life Communication for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Improving the Quality of End-of-Life Communication for Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, COPD, Chronic Bronchitis, Emphysema
Keywords
Communication, Palliative Care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
376 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Audit and Feedback
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Audit and Feedback
Intervention Description
Intervention patients and clinicians received a one-page patient-specific individualized summary, based on questionnaire responses, to stimulate conversations.
Primary Outcome Measure Information:
Title
Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale
Description
The quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers.
Time Frame
Measured at enrollment and 2 weeks after targeted clinic visit
Secondary Outcome Measure Information:
Title
Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit.
Description
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.
Time Frame
Assessed 2 weeks after targeted clinic visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Au, MD MS
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16334970
Citation
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.
Results Reference
result
PubMed Identifier
21145201
Citation
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.
Results Reference
result
PubMed Identifier
21233263
Citation
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.
Results Reference
result
PubMed Identifier
22497533
Citation
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.
Results Reference
result
PubMed Identifier
21809909
Citation
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.
Results Reference
result
PubMed Identifier
21940765
Citation
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.
Results Reference
result
PubMed Identifier
21631367
Citation
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.
Results Reference
result
PubMed Identifier
23298873
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs