NCT01079000

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
367

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

3.8 years

First QC Date

March 1, 2010

Last Update Submit

November 17, 2016

Conditions

Acute Asthma

Keywords

asthmaexacerbationemergency departmentrelapse

Outcome Measures

Primary Outcomes (1)

  • Relapses within 90 days after discharge

    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.

    90 days

Secondary Outcomes (3)

  • Time to relapse

    90 days

  • Primary care provider follow-up

    30 days

  • Health related quality of life (HRQoL)

    Baseline, 30 and 90 days

Study Arms (3)

Control - usual care (UC)

ACTIVE COMPARATOR

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

Opinion leader (OL) guidance to patients' PCPs

EXPERIMENTAL

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.

Behavioral: Opinion Leader letterBehavioral: Usual care

Care manager education to patients

EXPERIMENTAL

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.

Behavioral: Opinion Leader letterBehavioral: Involvement of a care managerBehavioral: Usual care

Interventions

Opinion Leader letterBEHAVIORAL

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.

Care manager education to patientsOpinion leader (OL) guidance to patients' PCPs
Involvement of a care managerBEHAVIORAL

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

Care manager education to patients
Usual careBEHAVIORAL

Usual care provided to asthma patients when discharged from the ED

Care manager education to patientsControl - usual care (UC)Opinion leader (OL) guidance to patients' PCPs

Eligibility Criteria

Age17 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 17-55 years old;
  • Patients treated and discharged from one of the four study sites with acute asthma (not simply for a prescription refill) during the study period;
  • 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;
  • Patients must have evidence of airflow obstruction on presentation at the ED, defined as an FEV1 or PEF \<80% of predicted;
  • Patients must not have a history of more than 20 pack-years of smoking;
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, T6G2B7, Canada

Location

MeSH Terms

Conditions

AsthmaEmergenciesRecurrence

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2010

First Posted

March 2, 2010

Study Start

June 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

November 21, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)