Clinical trial NCT00106080: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
COPD
Chronic Bronchitis
Emphysema
Keywords: Communication
Palliative Care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-03-21
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

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 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.

Primary outcomes:
measure: Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale
timeFrame: Measured at enrollment and 2 weeks after targeted clinic visit
Secondary outcomes:
measure: Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit.
timeFrame: Assessed 2 weeks after targeted clinic visit
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: David H Au, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.