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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.
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:
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:
The methods used for this study could be translated into clinic practice and possibly generalized to other chronic life-threatening conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Audit and Feedback |
|
| Control | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audit and Feedback | Behavioral | Intervention patients and clinicians received a one-page patient-specific individualized summary, based on questionnaire responses, to stimulate conversations. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed 2 weeks after targeted clinic visit |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David H Au, MD MS | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16334970 | Result | 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. | |
| 21145201 | Result | 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. |
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Patients gave written informed consent before enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention (Audit and Feedback) | We solicited patients' preferences for health care communication and treatment in order to generate individualized summary reports of patient's preferences. These individualized summaries of patient's preferences regarding communication about end-of-life care and preferences for end-of-life care were used to activate patients, family members, and healthcare providers. |
| FG001 | Control (Usual Care) | We solicited control patients' preferences but did not deliver study generated summary reports to patients, surrogates or providers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
42 clinicians were randomized to the intervention group. 50 clinicians were randomized to the control group. 376 patients were enrolled and assigned to their clinician's treatment group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Audit and feedback |
| BG001 | Control | Usual care |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patient age in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Measured at enrollment and 2 weeks after targeted clinic visit |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Audit and Feedback |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David H. Au, MD, MS | Department of Veterans Affairs, Health Services Research and Development | 206-764-2430 | david.au@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 11, 2007 | Oct 1, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| D004646 | Emphysema |
| D003142 | Communication |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| 21233263 | Result | 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. |
| 22497533 | Result | 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. |
| 21809909 | Result | 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. |
| 21940765 | Result | 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. |
| 21631367 | Result | 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. |
| 23298873 | Result | 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. |
| Total |
Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Patient gender reported as percent. | Number | percent |
|
| Race/Ethnicity, Customized | Patient race reported as percent. | Number | percent |
|
| Smoking Status | Patient smoking status reported as percent. | Number | percent |
|
| Male Clinicians | Clinician gender reported as percent. | Number | percent |
|
| Clinician clinic | Clinician clinic reported as percent. | Number | percent |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | Proportion of participants reporting | Assessed 2 weeks after targeted clinic visit |
|
|
|
| 0 |
| 194 |
| 0 |
| 194 |
| EG001 | Control | Usual care | 0 | 182 | 0 | 182 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D001519 | Behavior |