Clinical trial NCT02021955: Integrating Care After Exacerbation of COPD
Official title: Integrating Care After Exacerbation of COPD (InCasE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: randomized controlled trial
quality of life
patient readmission
mortality
patient satisfaction
intervention studies
multicenter study
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-12-27
Enrollment: 717
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Number of Patients With Hospital Re-admission and Mortality
timeFrame: 180 days post-discharge
measure: COPD-related Patient Quality-of-life (Clinical COPD Questionnaire)
timeFrame: 6 weeks post-discharge
Secondary outcomes:
measure: Patients Participants' General Health Status (Veterans RAND 12 Item Health Survey ) Physical Component Score (VR-12 PCS)
timeFrame: 6 weeks post-discharge
Other outcomes:
Locations:
city: Boise
country: United States
facility: Boise VA Medical Center, Boise, ID
state: Idaho
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: David H. Au, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
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.