The Role of Opinion Leaders in Enhancing Evidence-based Care After Chronic Obstructive Pulmonary Disease (COPD) Emergency Department (ED) Visits (TLAL)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Alberta.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT01107613
First received: April 12, 2010
Last updated: May 4, 2010
Last verified: April 2010
  Purpose

This study will enroll patients who present to Emergency Departments (EDs) and have an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD) at discharged in 2 Edmonton EDs. Patients will all be provided with evidence-based discharge (prednisone and an antibiotic) 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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Other: Opinion leader educational letter
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Lung Attack Alert Study

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Follow-up with primary care provider [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    The follow-up of the patient by their primary care provider for review of the acute and chronic management of their COPD and addressing any issues on the Lung Attack Alert, within the first 90 days after discharge from the ED.


Secondary Outcome Measures:
  • Relapse [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    An unscheduled visit for worsening COPD symptoms. relapse will be sub-divided into various categories (relapse- no change in management; relapse- change in management; relapse-ED visit change in management and discharged; relapse-ED visit change in management and admission; relapse-death)

  • Adjusted management [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    The TLAL letter will identify patients who need review and adjustment of the management of their COPD (e.g., medication change, smoking cessation strategies, pulmonary rehabilitation, etc). This assessment will document all of the actions taken by the primary care provider after ED discharge.

  • Length of ED Stay [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
    The length of stay from the triage to the departure from the ED.

  • Quality of life [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Change in patients' health-related quality of life, within 90 days of discharge from the ED.

  • Referrals [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    The numbers of referrals for pulmonary rehabilitation, spirometry, Pulmonary Clinic.

  • Follow-up with primary care provider [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The follow-up of the patient by their primary care provider for review of the acute and chronic management of their COPD and addressing any issues on the Lung Attack Alert, within the first 30 days after discharge from the ED.


Estimated Enrollment: 110
Study Start Date: April 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Arm
All patients will receive prednisone X 10 days and antibiotics X 5 days, as well as an opinion leader letter sent to the primary care provider outlining the needs of this patient.
Other: Opinion leader educational letter
All patients will receive prednisone X 10 days and antibiotics X 5 days, as well as an opinion leader letter sent to the primary care provider outlining the needs of this patient.
No Intervention: Control/Standard Care
All patients will receive prednisone X 10 days and antibiotics X 5 days. This group will receive educational handouts on AECOPD.

Detailed Description:

Chronic Obstructive Pulmonary Disease (COPD) is the 4th leading cause of morbidity and mortality worldwide. COPD is now seen as a disease that is both preventable and treatable. In order to better facilitate treatment for these patients, a number of consensus guidelines have been developed to help physicians in the diagnosis and chronic management of these patients. However, a number of studies have shown that implementation and adherence to the guidelines by physicians, both at the primary care and specialist level, remains poor.

Patients who experience an Acute Exacerbation of COPD (AECOPD) have an increased risk of mortality, and therefore, must have their management optimized to improve survival. These patients most often are evaluated and treated in their local emergency departments (EDs) for the acute episode; however, follow up care is often left to their primary care physician (PCP). The national rate of patient compliance for follow up with their PCP within the first month following an AECOPD is unknown, however, locally, it is only 30%. From this, it could be inferred that there is a poor rate for any adjustment in chronic management after an AECOPD and therefore an increased risk of future exacerbations.

It is our belief that informing the PCP that their patient experienced an AECOPD, with a form that provides details of the acute management along with an update of the current guideline recommendations, will improve follow up, compliance with current guidelines and the quality of life for patients with COPD.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107613

Contacts
Contact: Brian H Rowe, MD, MSc 780-407-6761 brian.rowe@ualberta.ca
Contact: Tracy Stasiw, BScN 780-407-1092 tmstasiw@telus.net

Locations
Canada, Alberta
Northeaset Community Health Clinic Not yet recruiting
Edmonton, Alberta, Canada
Contact: Debbie Boyko, RN    780-407-3742    debbie.boyko@ualberta.ca   
Principal Investigator: Michelle Rico, MD, CCFP(EM)         
University of Alberta Hospital Emergency Department Not yet recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Brian R Holroyd, MD, FRCPC    780-407-6740    brian.holroyd@ualberta.ca   
Contact: Peggy Foster    780-407-6740    Peggy.Foster@albertahealthservices.ca   
Principal Investigator: Brian H Rowe, MD, MSc         
Principal Investigator: Mohit Bhutani, MD, FCRCPC         
Sponsors and Collaborators
University of Alberta
GlaxoSmithKline
Investigators
Principal Investigator: Brian H Rowe, MD, MSc University of Alberta
Principal Investigator: Mohit Bhutani, MD, FRCPC University of Alberta
  More Information

No publications provided

Responsible Party: Brian Rowe (Professor, University of Alberta) and Mohit Bhutani (Assistant Professor, University of Alberta), University of Alberta
ClinicalTrials.gov Identifier: NCT01107613     History of Changes
Other Study ID Numbers: Pro00011325
Study First Received: April 12, 2010
Last Updated: May 4, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
opinion leader
COPD
Emergency Department
relapse
follow-up
evidence-based guidelines
Exacerbation of COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014