Integrating Care After Exacerbation of COPD (InCasE)

• ClinicalTrials.gov Identifier: NCT02021955
• Recruitment Status: Completed
• First Posted: December 27, 2013
• Results First Posted: June 4, 2021
• Last Update Posted: June 4, 2021
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Behavioral: guideline treatment recommendations	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 717 participants
• Allocation: Randomized
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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

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

  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] December 18, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Au DH, Collins MP, Berger DB, Carvalho PG, Nelson KM, Reinke LF, Goodman RB, Adamson R, Woo DM, Rise PJ, Coggeshall SS, Plumley RB, Epler EM, Moss BR, McDowell JA, Weppner WG. Health System Approach to Improve Chronic Obstructive Pulmonary Disease Care after Hospital Discharge: Stepped-Wedge Clinical Trial. Am J Respir Crit Care Med. 2022 Jun 1;205(11):1281-1289. doi: 10.1164/rccm.202107-1707OC.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02021955
• Other Study ID Numbers: IIR 12-130
• First Posted: December 27, 2013
• 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

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, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes