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Integrating Care After Exacerbation of COPD (InCasE)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02021955
First Posted: December 27, 2013
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
This clinical trial is designed to determine whether an intervention that provides information to primary care providers about gaps in care for their patients recently discharged from hospital for COPD can reduce hospital re-admissions and mortality and improve their patients' quality-of-life.

Condition Intervention
Chronic Obstructive Pulmonary Disease Behavioral: guideline treatment recommendations

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integrating Care After Exacerbation of COPD (InCasE)

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • hospital re-admission and mortality [ Time Frame: 6 months post-discharge ]
    The primary outcome measure is a composite measure of hospital readmission for any cause at 6 months and all-cause mortality.


Secondary Outcome Measures:
  • patient quality-of-life [ Time Frame: 6 weeks post-discharge ]
    self-report survey of patients' quality-of-life


Estimated Enrollment: 465
Actual Study Start Date: February 11, 2015
Estimated Study Completion Date: May 29, 2018
Estimated Primary Completion Date: May 29, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
Chronic obstructive pulmonary disease (COPD) exacerbations are common among Veterans admitted to hospital, lead to worsening health-related quality of life, and are important drivers of health care expenditures. As many as half of patients discharged for COPD are readmitted within 6 months. An intervention to improve COPD care is needed, not only to treat patients for COPD and their accompanying comorbidities, but also to redesign the care delivery system. The goal of this clinical trial is to test an intervention to improve patient care during the transition from hospital to outpatient setting for patients discharged for COPD. The investigators are targeting the intervention to Patient Aligned Care Team (PACT) providers who are randomized to receive the intervention or not receive the intervention. For the intervention, study clinicians, consisting of experienced primary care providers and pulmonary specialists, review the medical record for each patient discharged from hospital for COPD. The team looks for gaps in care for COPD and key co-morbidities such as obesity, hypertension, diabetes, and cardiovascular disease. They focus on immediate care processes associated with the hospital admission and comorbid disease treatment. For providers in the intervention group, the team places any patient care recommendations into the medical record using a non-visit consult note and pre-filled order sets. The patient's provider then accepts, modifies, or declines any or all of the recommendations based on personal knowledge of the patient's history. The investigators hypothesize that the intervention will: 1) improve patient quality of life; and 2) decrease hospital readmission and mortality after hospital admission for COPD exacerbation.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Providers:

  • 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.

Patients:

  • 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.

Exclusion Criteria:

Providers: none

Patients:

  • Having previously participated in the study.
  • Significant cognitive dysfunction, language barrier, or severe psychiatric disorder that would preclude completing the questionnaires.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: David H. Au, MD MS VA Puget Sound Health Care System Seattle Division, Seattle, WA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02021955     History of Changes
Other Study ID Numbers: IIR 12-130
First Submitted: December 20, 2013
First Posted: December 27, 2013
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by VA Office of Research and Development:
randomized controlled trial
quality of life
patient readmission
mortality
patient satisfaction
intervention studies
multicenter study

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases