NCT00268580

Brief Summary

The purpose of the study is to evaluate whether the Emergency Department (ED) Asthma Care Project (ACP) leads to improved asthma care delivery and patient outcomes in the ED setting. Hypothesis: Implementation of a multi-disciplinary asthma strategy/clinical pathway for the treatment of asthma in the ED, based upon the 1999 Canadian Asthma Consensus Guidelines (and subsequent updates), will increase adherence with published management guidelines in the ED setting, reduce variations in the emergency management of acute asthma, increase utilization of specialized asthma services and improve outcomes for patients following ED visits. Methods: This observational, pre- post-intervention study will compare a stratified sample of 10 Ontario hospital EDs (5 intervention and 5 control sites). Chart abstractions will be performed on all adult visits for acute asthma over a 3 month period before and after implementation of the Ontario Hospital Associations (OHA)'s (now Ontario Lung Association's (OLA's) ED Asthma Care Map. Patient and provider surveys and provider focus group post intervention will also be conducted. Primary outcome measures are hospitalizations and repeat ED visit rates. Secondary outcome measures include: length of stay in ED, self-reported adherence with referral to specialized asthma services made during index ED visit, self-reported asthma control, and use of self-management strategies (including use of action plan), use of asthma management strategies promoted by the care map (such as use of objective measure of airflow rates, use of steroids, education, referral to specialized asthma services on discharge). Ease of implementation and barriers to implementation will also be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

Same day

First QC Date

December 20, 2005

Last Update Submit

March 28, 2016

Conditions

Keywords

AsthmaCare mapClinical pathwayEducationEmergency department

Outcome Measures

Primary Outcomes (2)

  • % of ED visitors admitted to hospital for asthma

    The patient is either admitted or not at the end of the ED visit.

    At the end of the index ED visit (this is a dichotomous outcome. It is not possible to specify a "time frame").

  • Repeat Emergency Department visit rate for asthma

    Within 24, 72h, 1 month

Secondary Outcomes (16)

  • Hospitalization length of stay

    From ED presentation to hospital discharge

  • Length of stay in ED

    From ED presentation to ED discharge

  • Self-reported adherence with referral to specialized asthma services made during index ED visit

    At folllowup questionnaire

  • Self-reported asthma control, and use of self-management strategies (including use of action plan)

    At followup questionnaire

  • Use of Asthma Management Strategies Promoted by the ED ACP: use of objective measure of airflow rates (PEFR or spirometry), and gas exchange (oxygen saturation, arterial blood gases)

    During index ED visit (between ED presentation and ED discharge).

  • +11 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Asthma care provided using care pathway

Behavioral: Asthma Care Pathway

Control

NO INTERVENTION

Standard of care provided

Interventions

Asthma care provided using standardized asthma care pathway

Intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • asthma plus or minus chronic obstructive pulmonary disease (COPD)
  • ED visit for acute asthma treatment
  • age 19 years or greater

You may not qualify if:

  • COPD without asthma
  • ED visit for asthma prescription renewal only

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Chatham Kent Health Alliance

Chatham, Ontario, N7M 5L9, Canada

Location

Sudbury Regional Hospital

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Lake of the Woods District Hospital

Kenora, Ontario, P9N 3W7, Canada

Location

Lakeridge Health Hospital

Oshawa, Ontario, L1J 8R2, Canada

Location

Grey Bruce Health Services

Owen Sound, Ontario, N4K 6M9, Canada

Location

Prince Edward County Hospital

Picton, Ontario, Canada

Location

Renfrew Victoria Hospital

Renfrew, Ontario, K7V 1P6, Canada

Location

MeSH Terms

Conditions

AsthmaEmergencies

Condition Hierarchy (Ancestors)

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

Study Officials

  • Diane Lougheed, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

January 1, 2006

Primary Completion

January 1, 2006

Study Completion

June 1, 2006

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations