NCT02021955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
717

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 11, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

June 4, 2021

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

3.8 years

First QC Date

December 20, 2013

Results QC Date

June 2, 2021

Last Update Submit

July 19, 2023

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

randomized controlled trialquality of lifepatient readmissionmortalitypatient satisfactionintervention studiesmulticenter study

Outcome Measures

Primary Outcomes (2)

  • Number of Patients With Hospital Re-admission and Mortality

    Composite measure of hospital readmission for any cause at 180 days and all-cause mortality.

    180 days post-discharge

  • 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.

    6 weeks post-discharge

Secondary Outcomes (1)

  • Patients Participants' General Health Status (Veterans RAND 12 Item Health Survey ) Physical Component Score (VR-12 PCS)

    6 weeks post-discharge

Study Arms (2)

usual care

NO INTERVENTION

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

guideline treatment recommendations

EXPERIMENTAL

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

Behavioral: guideline treatment recommendations

Interventions

guideline treatment recommendationsBEHAVIORAL

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

guideline treatment recommendations

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Providers: none
  • Patients:
  • Having previously participated in the study.
  • Significant cognitive dysfunction, language barrier, or severe psychiatric disorder that would preclude completing the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boise VA Medical Center, Boise, ID

Boise, Idaho, 83702, United States

Location

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

Seattle, Washington, 98108-1532, United States

Location

Related Publications (1)

  • 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.

    PMID: 35333140DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePatient Satisfaction

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Margaret Collins
Organization
VA Puget Sound Health Care Sysem
margaret.collins@va.gov
206.764.2085

Study Officials

  • David H. Au, MD MS

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2013

First Posted

December 27, 2013

Study Start

February 11, 2015

Primary Completion

November 29, 2018

Study Completion

January 31, 2019

Last Updated

July 27, 2023

Results First Posted

June 4, 2021

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)