Integrating Care After Exacerbation of COPD (InCasE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02021955
First received: December 20, 2013
Last updated: September 15, 2014
Last verified: September 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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 Department of Veterans Affairs:

Primary Outcome Measures:
  • hospital re-admission and mortality [ Time Frame: 6 months post-discharge ] [ Designated as safety issue: No ]
    Our 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 ] [ Designated as safety issue: No ]
    self-report survey of patients' quality-of-life


Estimated Enrollment: 200
Study Start Date: November 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: April 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. We will target the intervention to Patient Aligned Care Team (PACT) providers who will be randomized to receive the intervention or not receive the intervention. For the intervention, study clinicians, consisting of experienced primary care providers and pulmonary specialists, will review the medical record for each patient discharged from hospital for COPD. The team will look for gaps in care for COPD and key co-morbidities such as obesity, hypertension, diabetes, and cardiovascular disease. They will focus on immediate care processes associated with the hospital admission and comorbid disease treatment. For providers in the intervention group, the team will place any patient care recommendations into the medical record using a non-visit consult note and pre-filled order sets. The patient's provider then may accept, modify, or decline any or all of the recommendations based on personal knowledge of the patient's history. We 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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021955

Contacts
Contact: Margaret P Collins, PhD MS (206) 764-2085 margaret.collins@va.gov
Contact: Brianna Moss (206) 277-4166 ext 64166 brianna.moss@va.gov

Locations
United States, Idaho
Boise VA Medical Center, Boise, ID Not yet recruiting
Boise, Idaho, United States, 83702
Contact: Paula Carvalho    208-891-6247    Paula.Carvalho@va.gov   
United States, Washington
VA Puget Sound Health Care System, Seattle Not yet recruiting
Seattle, Washington, United States, 98101
Contact: Jane E Summerfield, MA    206-764-2848    jane.summerfield@va.gov   
Contact: Charles G Keelin    (206) 764-2028    charles.keelin2@va.gov   
Principal Investigator: David H Au, MD MS         
Sponsors and Collaborators
Investigators
Principal Investigator: David H Au, MD MS VA Puget Sound Health Care System, Seattle
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02021955     History of Changes
Other Study ID Numbers: IIR 12-130
Study First Received: December 20, 2013
Last Updated: September 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
randomized controlled trial
quality of life
patient readmission
mortality
patient satisfaction
intervention studies
multicenter study

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

ClinicalTrials.gov processed this record on September 16, 2014