Emergency Department (ED)-Directed Interventions to Improve Asthma Outcomes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01079000
First received: March 1, 2010
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to determine if evidence-based guidance on follow-up care and self-management provided to PCPs and patients, respectively, reduces relapses within 90 days for acute asthma (primary outcome). Secondary outcomes will include follow-up visits with the primary care provider, patients' quality of life and cost-effectiveness indicators.


Condition Intervention
Acute Asthma
Behavioral: Opinion Leader letter
Behavioral: Involvement of a care manager
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Emergency Department (ED)-Directed Interventions to Improve Outcomes After Asthma Exacerbations

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Relapses within 90 days after discharge [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Any unscheduled medical visit to a walk-in clinic, family doctor's office or an emergency department resulting from the patient's perceived need for further asthma treatment within 90 days after discharge.


Secondary Outcome Measures:
  • Time to relapse [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Time from Emergency Department (ED) discharge to first asthma relapse.

  • Primary care provider follow-up [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    A patient having a face-to-face meeting with their PCP within 30 days after discharge. Telephone interactions with the office will be classified as "no PCP follow-up".

  • Health related quality of life (HRQoL) [ Time Frame: Baseline, 30 and 90 days ] [ Designated as safety issue: Yes ]
    A disease specific, validated instrument for asthma patients (AQLQ) will be used. We will also employ the EQ-5D.


Estimated Enrollment: 366
Study Start Date: June 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control - usual care (UC)
Usual care after an ED visit for asthma will include the provision of discharge instructions/plan, and action plan, and verbal instructions for follow-up with their PCP, and a faxed copy of the ED chart to the patient's PCP.
Behavioral: Usual care
Usual care provided to asthma patients when discharged from the ED
Experimental: UC+personalized fax to patients' PCPs
The OL letter will encourage follow-up within two weeks and provide management suggestions. Opinion leaders are influential, respected, and local clinical leader who provides guidance about appropriate and optimal patient care.
Behavioral: Opinion Leader letter
The patients' PCP will be notified by fax about the ED visit and management. This notification sheet will contain a summary of the current asthma guidelines for ambulatory care (including: asthma education, long-term recommendations, smoking cessation, and action plan) signed by a local opinion leader. A review of the patient's management within a week of the ED visit will be recommended. The patient will also receive information regarding their acute exacerbation and will be told to review the current management of their disease with their PCP.
Experimental: UC+personalized fax to patients' PCPs+case manager
A care manager will encourage patients' to pursue follow-up, provide management review and offer brief education via telephone within a week of being discharged.
Behavioral: Involvement of a care manager
A care manager will encourage patients' to pursue follow-up, provide management review and offer brief education via telephone within a week of being discharged.

Detailed Description:

This prospective, randomized, open label study will include asthmatics 17-55 years of age with no evidence of chronic obstructive pulmonary disease. Patients will be eligible if they visit one of four Emergency Departments (EDs) in Edmonton or Calgary and receive treatment for acute asthma resulting in discharge home. All patients should have a primary care provider (PCP: Family Physician, Internist or Nurse Practitioner) with whom to follow-up or one will be found for them. At discharge patients will be randomized into three groups: A: Usual care; PCPs will receive a faxed copy of the ED chart and patients will receive a discharge plan and a paper-based educational pamphlet (treatment in the ED and at discharge will be left to ED physicians' discretion); B: Usual care + personalized fax to the patients' PCP including a copy of the ED chart and a opinion-leader (OL) letter encouraging follow-up within two weeks and providing management suggestions; or C: Usual care + personalized fax to the patients' PCP including the OL letter as described above + involvement of a case manager who will encourage patients' to pursue follow-up, provide management review and offer brief education within the next week. Outcomes will be ascertained blinded to treatment allocation through telephone follow-up at 30 and 90 days. A sample of 366 patients (122 per group) is required based on the proportion with relapse at 90 days (40%) and a chi-square test of association and post-hoc tests (groups A vs. B, groups B vs. C). This sample will allow for the detection of an moderate effect size of at least 0.171, and a difference between groups A and B of 50% (i.e., 40% vs. 20%) and between groups B and C of 75% (i.e., 20% vs. 5%) using two-sided z-tests, 80% power, α=0.025. Intention to treat analyses will be conducted. Relapse rates by group and associated 95% confidence intervals (CI) will be calculated. Proportions among groups will be compared using chi-square tests and if statistically significant, separate proportion tests will compare pairs of groups adjusting for multiple testing. A multivariable logistic regression model will adjust effect estimates for potential baseline imbalances and site-specific differences in effectiveness.

  Eligibility

Ages Eligible for Study:   17 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 17-55 years old;
  2. Patients treated and discharged from one of the four study sites with acute asthma (not simply for a prescription refill) during the study period;
  3. Patients must have had a previous physician-diagnosis of asthma and an exacerbation diagnosed by the ED physician (e.g., past asthma history, recorded response to β-agonists in the ED, and increased asthma symptoms). In the event of a new diagnosis, the patient is still eligible for the study if the treating physician feels that the history is compatible with a diagnosis of asthma;
  4. Patients must have evidence of airflow obstruction on presentation at the ED, defined as an FEV1 or PEF <80% of predicted;
  5. Patients must not have a history of more than 20 pack-years of smoking;
  6. All patients should have a PCP (FP, nurse practitioner or internist) with whom to follow-up or attempts will be made to find one for them.

Exclusion criteria:

These criteria ensure the exclusion of suspected COPD patients and patients who require different treatments:

  1. Patients with asthma who are primarily cared for by a Respirologist/Pulmonologist;
  2. Patients not seen by an emergency physician in the ED (e.g., direct referrals);
  3. Physician diagnosis of acute COPD (e.g., failure of FEV1 or PEF to respond to ED treatment and a FEV1/FVC ratio ≤ 70%);
  4. Radiologically confirmed pneumonia during the 10 days preceding trial entry;
  5. Patients with an active history of bronchiectasis, cystic fibrosis, or lung cancer;
  6. Clinically confirmed congestive heart failure at ED presentation;
  7. Patients not able/unwilling to perform spirometry assessment;
  8. Inability to provide informed consent or comply with the study protocol due to cognitive impairment, language barrier, or no contact details;
  9. Patient has previously participated in the study;
  10. Patients who in the opinion of the investigator are unsuitable for enrolment.
  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: NCT01079000

Contacts
Contact: Brian H Rowe, MD, MSc 780-407-6761 brian.rowe@ualberta.ca
Contact: Cristina Villa-Roel, MD, MSc 780-492-9671 villaroe@ualberta.ca

Locations
Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada
Contact: Eddy Lang, MD    403-944-8430    eddy.lang@albertahealthservices.ca   
Principal Investigator: Eddy Lang, MD         
Sub-Investigator: Richard Leigh, MD, FRCPC         
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Brian H Rowe, MD, MSc    780-407-6760    brian.rowe@ualberta.ca   
Contact: Jennifer Victor, RN    780-407-3742    Jennifer.Victor2@albertahealthservices.ca   
Sub-Investigator: Mohit Bhutani, MD, FRCPC         
Principal Investigator: Brian H Rowe, MD, MSc         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Brian H Rowe, MD, MSc University of Alberta
Principal Investigator: Cristina Villa-Roel, MD, MSc University of Alberta
Principal Investigator: Eddy Lang, MD University of Calgary
Principal Investigator: Mohit Bhutani, MD University of Alberta
Principal Investigator: Bjug Borgundvaag, MD University of Toronto
Principal Investigator: Richard Leigh, MD University of Calgary
Principal Investigator: Sumit Majumdar, MD, MSc University of Alberta
Principal Investigator: Christopher McCabe, PhD University of Alberta
Principal Investigator: Rhonda Rosychuk, PhD University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01079000     History of Changes
Other Study ID Numbers: CIHR operating grant # 201109, CIHR Grant
Study First Received: March 1, 2010
Last Updated: April 24, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
asthma
exacerbation
emergency department
relapse

Additional relevant MeSH terms:
Bronchial Diseases
Asthma
Emergencies
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014