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

NCT ID: NCT01079000

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Acute Asthma

Keywords

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asthma exacerbation emergency department relapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Usual care provided to asthma patients when discharged from the ED

Opinion leader (OL) guidance to patients' PCPs

In addition to UC, OL guidance will be provided to the patients' PCP. A letter signed by an influential, respected, and local clinical leader (Respirologist) will encourage follow-up within two weeks and provide management suggestions.

Group Type EXPERIMENTAL

Opinion Leader letter

Intervention Type BEHAVIORAL

The patients' PCP will be notified by fax about the ED visit and management. The Opinion Leader letter 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.

Usual care

Intervention Type BEHAVIORAL

Usual care provided to asthma patients when discharged from the ED

Care manager education to patients

In addition to UC and OL guidance provided to the patients' PCP, care manager self-management education will be provided to patients. 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.

Group Type EXPERIMENTAL

Opinion Leader letter

Intervention Type BEHAVIORAL

The patients' PCP will be notified by fax about the ED visit and management. The Opinion Leader letter 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.

Involvement of a care manager

Intervention Type BEHAVIORAL

The involvement of 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

Usual care

Intervention Type BEHAVIORAL

Usual care provided to asthma patients when discharged from the ED

Interventions

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Opinion Leader letter

The patients' PCP will be notified by fax about the ED visit and management. The Opinion Leader letter 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.

Intervention Type BEHAVIORAL

Involvement of a care manager

The involvement of 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

Intervention Type BEHAVIORAL

Usual care

Usual care provided to asthma patients when discharged from the ED

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian H Rowe, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Cristina Villa-Roel, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Eddy Lang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Mohit Bhutani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Bjug Borgundvaag, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Richard Leigh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Sumit Majumdar, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Christopher McCabe, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Rhonda Rosychuk, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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CIHR Grant

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CIHR operating grant # 201109

Identifier Type: -

Identifier Source: org_study_id