Integrating Care After Exacerbation of COPD

NCT ID: NCT02021955

Last Updated: 2023-07-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

717 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-11

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

guideline treatment recommendations

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

Group Type EXPERIMENTAL

guideline treatment recommendations

Intervention Type BEHAVIORAL

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

Interventions

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guideline treatment recommendations

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David H. Au, MD MS

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Locations

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Boise VA Medical Center, Boise, ID

Boise, Idaho, United States

Site Status

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35333140 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IIR 12-130

Identifier Type: -

Identifier Source: org_study_id

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