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Integrating Care After Exacerbation of COPD (InCasE)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
guideline treatment recommendations
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease focused on measuring randomized controlled trial, quality of life, patient readmission, mortality, patient satisfaction, intervention studies, multicenter study

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boise VA Medical Center, Boise, ID
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

usual care

guideline treatment recommendations

Arm Description

Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.

Primary care clinicians receive treatment recommendations for their patients discharged from hospital for a COPD exacerbation.

Outcomes

Primary Outcome Measures

Number of Patients With Hospital Re-admission and Mortality
Composite measure of hospital readmission for any cause at 180 days and all-cause mortality.
COPD-related Patient Quality-of-life (Clinical COPD Questionnaire)
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

Patients Participants' General Health Status (Veterans RAND 12 Item Health Survey ) Physical Component Score (VR-12 PCS)
self-report survey of patients' general physical health quality-of-life scored from 0-100 with higher scores indicating better health.

Full Information

First Posted
December 20, 2013
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02021955
Brief Title
Integrating Care After Exacerbation of COPD
Acronym
InCasE
Official Title
Integrating Care After Exacerbation of COPD (InCasE)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 11, 2015 (Actual)
Primary Completion Date
November 29, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
randomized controlled trial, quality of life, patient readmission, mortality, patient satisfaction, intervention studies, multicenter study

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
717 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care
Arm Type
No Intervention
Arm Description
Primary care providers treat their patients discharged from hospital for a COPD exacerbation as usual.
Arm Title
guideline treatment recommendations
Arm Type
Experimental
Arm Description
Primary care clinicians receive treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
Intervention Type
Behavioral
Intervention Name(s)
guideline treatment recommendations
Intervention Description
Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
Primary Outcome Measure Information:
Title
Number of Patients With Hospital Re-admission and Mortality
Description
Composite measure of hospital readmission for any cause at 180 days and all-cause mortality.
Time Frame
180 days post-discharge
Title
COPD-related Patient Quality-of-life (Clinical COPD Questionnaire)
Description
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.
Time Frame
6 weeks post-discharge
Secondary Outcome Measure Information:
Title
Patients Participants' General Health Status (Veterans RAND 12 Item Health Survey ) Physical Component Score (VR-12 PCS)
Description
self-report survey of patients' general physical health quality-of-life scored from 0-100 with higher scores indicating better health.
Time Frame
6 weeks post-discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H. Au, MD MS
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boise VA Medical Center, Boise, ID
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1532
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35333140
Citation
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.
Results Reference
derived

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Integrating Care After Exacerbation of COPD

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