NCT01107613

Brief Summary

This study will enroll patients who present to Emergency Departments (EDs) and have an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) or asthma at discharged in one Edmonton ED. Patients will all be provided with evidence-based discharge (prednisone and an antibiotic for COPD and prednisone and inhaled corticosteroids for asthma) and will be randomized to receive enhanced education to the primary care provider or standard care. The investigators' goal is to determine if an opinion leaders' advice will improve chronic care in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

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

Timeline
Completed

Started Jan 2011

Typical duration 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

April 12, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 11, 2022

Status Verified

November 1, 2017

Enrollment Period

1.4 years

First QC Date

April 12, 2010

Last Update Submit

July 7, 2022

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

opinion leaderCOPDEmergency Departmentrelapsefollow-upevidence-based guidelinesExacerbation of COPD

Outcome Measures

Primary Outcomes (1)

  • Follow-up with primary care provider

    The follow-up of the patient by their primary care provider for review of the acute and chronic management of their COPD or asthma and addressing any issues on the Lung Attack Alert, within the first 90 days after discharge from the ED.

    90 days

Secondary Outcomes (6)

  • Relapse

    90 days

  • Adjusted management

    90 days

  • Length of ED Stay

    Up to 24 hours

  • Quality of life

    90 days

  • Referrals

    90 days

  • +1 more secondary outcomes

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Opinion leader educational letter

Behavioral: Opinion leader educational letter

Control/Standard Care

NO INTERVENTION

Regular care

Interventions

Opinion leader educational letterBEHAVIORAL

All patients will receive prednisone X 10 days and antibiotics X 5 days, as well as an opinion leader educational letter sent to the primary care provider outlining the needs of this patient.

Intervention Arm

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Appropriately signed and dated informed consent has been obtained;
  • ED patients presenting with an acute exacerbation of COPD requiring treatment in the ED;
  • Previous physician-diagnosis of COPD (e.g., emphysema, chronic bronchitis or COPD) either previously or within the ED;
  • Age \> 40 years of age;
  • Current or former smokers of more than 10 pack years (number of packs of cigarettes {or pipe and/or cigars) smoked per day X the number of years of smoking);
  • FEV1/FVC ratio \< 0.7 for age, sex and height (either known or determined within the ED);
  • Patients can read and comprehend English language.

You may not qualify if:

  • Patients presenting for prescription renewal;
  • Patients who require hospitalization;
  • Patients who do not have a primary care physician or patients for whom a family physician cannot be found;
  • Patients who have already been enrolled in the study;
  • Patients with a ED physician-diagnosis of primary asthma, pneumonia, HIV/AIDS, immuno-compromise, or life expectance of \< 90 days;
  • Patients who, in the opinion of the investigator, should be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta Hospital Emergency Department

Edmonton, Alberta, T6G2B7, Canada

Location

Northeaset Community Health Clinic

Edmonton, Alberta, Canada

Location

Related Publications (1)

  • Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.

    PMID: 35514131DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmergenciesRecurrence

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brian H Rowe, MD, MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR

  • Mohit Bhutani, MD, FRCPC

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 21, 2010

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

January 1, 2013

Last Updated

July 11, 2022

Record last verified: 2017-11

Locations

CA(2)