Integrating Care After Exacerbation of COPD (InCasE)
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|ClinicalTrials.gov Identifier: NCT02021955|
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : June 4, 2021
Last Update Posted : June 4, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Behavioral: guideline treatment recommendations||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||717 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Integrating Care After Exacerbation of COPD (InCasE)|
|Actual Study Start Date :||February 11, 2015|
|Actual Primary Completion Date :||November 29, 2018|
|Actual Study Completion Date :||January 31, 2019|
No Intervention: usual care
Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.
Experimental: guideline treatment recommendations
Primary care clinicians receive treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
Behavioral: guideline treatment recommendations
Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
- Number of Patients With Hospital Re-admission and Mortality [ Time Frame: 180 days post-discharge ]Composite measure of hospital readmission for any cause at 180 days and all-cause mortality.
- COPD-related Patient Quality-of-life (Clinical COPD Questionnaire) [ Time Frame: 6 weeks post-discharge ]self-report survey of patients' quality-of-life with scores ranging from 0-6 with lower scores representing better health; not all participants completed surveys.
- Patients Participants' General Health Status (Veterans RAND 12 Item Health Survey ) Physical Component Score (VR-12 PCS) [ Time Frame: 6 weeks post-discharge ]self-report survey of patients' general physical health quality-of-life scored from 0-100 with higher scores indicating better health.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Primary care provider (MD, NP, PA) from VA Puget Sound or Boise VA.
- Willingness to participate in the informed consent process and complete interviews and questionnaires.
- Having a provider that is participating in this clinical trial.
- Discharged alive with either a primary discharge diagnosis of COPD or acute respiratory failure with a secondary diagnosis of COPD.
- Willing and able to participate in the informed consent process and complete interviews and questionnaires.
- Having previously participated in the study.
- Significant cognitive dysfunction, language barrier, or severe psychiatric disorder that would preclude completing the questionnaires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021955
|United States, Idaho|
|Boise VA Medical Center, Boise, ID|
|Boise, Idaho, United States, 83702|
|United States, Washington|
|VA Puget Sound Health Care System Seattle Division, Seattle, WA|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||David H. Au, MD MS||VA Puget Sound Health Care System Seattle Division, Seattle, WA|
Documents provided by VA Office of Research and Development:
|Responsible Party:||VA Office of Research and Development|
|Other Study ID Numbers:||
|First Posted:||December 27, 2013 Key Record Dates|
|Results First Posted:||June 4, 2021|
|Last Update Posted:||June 4, 2021|
|Last Verified:||June 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
randomized controlled trial
quality of life
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases