NCT00106080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

November 11, 2014

Completed
Last Updated

October 11, 2019

Status Verified

October 1, 2019

Enrollment Period

3.5 years

First QC Date

March 18, 2005

Results QC Date

August 6, 2014

Last Update Submit

October 10, 2019

Conditions

Pulmonary DiseaseCOPDChronic BronchitisEmphysema

Keywords

CommunicationPalliative Care

Outcome Measures

Primary Outcomes (1)

  • 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.

    Measured at enrollment and 2 weeks after targeted clinic visit

Secondary Outcomes (1)

  • Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit.

    Assessed 2 weeks after targeted clinic visit

Study Arms (2)

Intervention

EXPERIMENTAL

Audit and Feedback

Behavioral: Audit and Feedback

Control

NO INTERVENTION

Usual care

Interventions

Audit and FeedbackBEHAVIORAL

Intervention patients and clinicians received a one-page patient-specific individualized summary, based on questionnaire responses, to stimulate conversations.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One or more of the following:
  • Have 3 or more outpatient clinics visits for COPD (ICD-9) in the two years prior to enrollment.
  • \. Have been hospitalized with a primary discharge diagnosis (ICD-9) for COPD in the two years prior to enrollment.
  • \. 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seattle, Washington, 98108, United States

Location

Related Publications (8)

  • 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.

    PMID: 16334970RESULT

  • 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.

    PMID: 21145201RESULT

  • 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.

    PMID: 21233263RESULT

  • 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.

    PMID: 22497533RESULT

  • 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.

    PMID: 21809909RESULT

  • 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.

    PMID: 21940765RESULT

  • 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.

    PMID: 21631367RESULT

  • 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.

    PMID: 23298873RESULT

MeSH Terms

Conditions

Lung DiseasesPulmonary Disease, Chronic ObstructiveBronchitis, ChronicEmphysemaCommunication

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesBehavior

Results Point of Contact

Title
David H. Au, MD, MS
Organization
Department of Veterans Affairs, Health Services Research and Development
david.au@va.gov
206-764-2430

Study Officials

  • David H Au, MD MS

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2005

First Posted

March 21, 2005

Study Start

November 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 11, 2019

Results First Posted

November 11, 2014

Record last verified: 2019-10

Locations

US(1)