Clinical trial NCT01079000: Emergency Department (ED)-Directed Interventions to Improve Asthma Outcomes
Official title: Emergency Department (ED)-Directed Interventions to Improve Outcomes After Asthma Exacerbations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Asthma
Keywords: asthma
exacerbation
emergency department
relapse
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 367
Sex: ALL
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Relapses within 90 days after discharge
timeFrame: 90 days
Secondary outcomes:
measure: Time to relapse
timeFrame: 90 days
measure: Primary care provider follow-up
timeFrame: 30 days
measure: Health related quality of life (HRQoL)
timeFrame: Baseline, 30 and 90 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Brian H Rowe, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Cristina Villa-Roel, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Eddy Lang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Mohit Bhutani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Bjug Borgundvaag, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Richard Leigh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Sumit Majumdar, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Christopher McCabe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Rhonda Rosychuk, PhD
role: PRINCIPAL_INVESTIGATOR
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