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Integrating Care After Exacerbation of COPD (InCasE)

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.
 
ClinicalTrials.gov Identifier: NCT02021955
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date March 8, 2019
Actual Study Start Date  ICMJE February 11, 2015
Actual Primary Completion Date November 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
hospital re-admission and mortality [ Time Frame: 6 months post-discharge ]
Our primary outcome measure is a composite measure of hospital readmission for any cause at 6 months and all-cause mortality.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
patient quality-of-life [ Time Frame: 6 weeks post-discharge ]
self-report survey of patients' quality-of-life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Integrating Care After Exacerbation of COPD
Official Title  ICMJE Integrating Care After Exacerbation of COPD (InCasE)
Brief Summary 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.
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, reviewed the medical record for each patient discharged from hospital for COPD. The team looked for gaps in care for COPD and key co-morbidities such as obesity, hypertension, diabetes, and cardiovascular disease. They focused on immediate care processes associated with the hospital admission and comorbid disease treatment. For providers in the intervention group, the team placed any patient care recommendations into the medical record using a non-visit consult note and pre-filled order sets. The patient's provider then accepted, modified, or declined 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Behavioral: guideline treatment recommendations
Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: guideline treatment recommendations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2019)
362
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2013)
200
Actual Study Completion Date  ICMJE January 31, 2019
Actual Primary Completion Date November 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021955
Other Study ID Numbers  ICMJE IIR 12-130
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David H. Au, MD MS VA Puget Sound Health Care System Seattle Division, Seattle, WA
PRS Account VA Office of Research and Development
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP