Evaluation of the Emergency Department Asthma Care Project

This study has been completed.
Sponsor:
Collaborators:
Ontario Hospital Association
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Dr. Diane Lougheed, Queen's University
ClinicalTrials.gov Identifier:
NCT00268580
First received: December 20, 2005
Last updated: March 28, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Asthma Care Pathway

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of the Emergency Department Asthma Care Project

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • % of ED visitors admitted to hospital for asthma [ Time Frame: At the end of the index ED visit (this is a dichotomous outcome. It is not possible to specify a "time frame"). ] [ Designated as safety issue: No ]
    The patient is either admitted or not at the end of the ED visit.

  • Repeat Emergency Department visit rate for asthma [ Time Frame: Within 24, 72h, 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospitalization length of stay [ Time Frame: From ED presentation to hospital discharge ] [ Designated as safety issue: No ]
    It is not possible to specify a 'time frame'; the length of stay is the outcome

  • Length of stay in ED [ Time Frame: From ED presentation to ED discharge ] [ Designated as safety issue: No ]
  • Self-reported adherence with referral to specialized asthma services made during index ED visit [ Time Frame: At folllowup questionnaire ] [ Designated as safety issue: No ]
  • Self-reported asthma control, and use of self-management strategies (including use of action plan) [ Time Frame: At followup questionnaire ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: During index ED visit (between ED presentation and ED discharge). ] [ Designated as safety issue: No ]
    These are dichotomous outcomes describing actual care received during the ED visit.

  • ; types of asthma medications prescribed (bronchodilators, corticosteroids) in ED and upon discharge; route of medications prescribed (IV vs oral vs. inhaled steroids; MDI vs nebulized bronchodilators) [ Time Frame: During index ED visit (between presentation and discharge, including discharge orders and instructions). ] [ Designated as safety issue: No ]
    These are dichotomous outcomes describing actual care received during the ED visit.

  • ; documentation of assessment and teaching of device technique [ Time Frame: During index ED visit (between ED presentation and ED discharge) ] [ Designated as safety issue: No ]
    During index ED visit (between presentation and discharge, including discharge orders and instructions).

  • ; documentation of asthma action plan provision or revision [ Time Frame: During index ED visit (between ED presentation and ED discharge) ] [ Designated as safety issue: No ]
  • ; type of asthma education provided (e.g. environmental trigger avoidance, warning signs, medication use) [ Time Frame: During index ED visit (between ED presentation and ED discharge) ] [ Designated as safety issue: No ]
  • ; follow-up care recommendations or referrals (AEC, Asthma Clinic, Respirology Clinic, family physician) [ Time Frame: During index ED visit (between ED presentation and ED discharge) ] [ Designated as safety issue: No ]
  • Utilization of Specialized Asthma Services [ Time Frame: After discharge (within 12 months) ] [ Designated as safety issue: No ]
    Self-reported by patient on the followup questionnaire

  • ; referral rates (#/year) to local AECs and Asthma Clinics [ Time Frame: After discharge (within 12 months) ] [ Designated as safety issue: No ]
  • ; types of providers involved in emergency asthma care [ Time Frame: During index visit (between ED presentation and ED discharge) ] [ Designated as safety issue: No ]
  • Proportion of patients enrolled on the ED ACP (Overall, by patient age category and by physician specialty) [ Time Frame: During index visit (between ED presentation and ED discharge) ] [ Designated as safety issue: No ]
  • Differences in patient demographics, physician demographics, day of week, time of day between patients enrolled vs. not enrolled [ Time Frame: During index visit (between ED presentation and ED discharge) ] [ Designated as safety issue: No ]
  • Perceived utility of pathway (overall, by site, and by profession) [ Time Frame: At time of followup survey (wihtin 12 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2006
Study Completion Date: June 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Asthma care provided using care pathway
Behavioral: Asthma Care Pathway
Asthma care provided using standardized asthma care pathway
No Intervention: Control
Standard of care provided

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • COPD without asthma
  • ED visit for asthma prescription renewal only
  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: NCT00268580

Locations
Canada, Ontario
Chatham Kent Health Alliance
Chatham, Ontario, Canada, N7M 5L9
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Lake of the Woods District Hospital
Kenora, Ontario, Canada, P9N 3W7
Lakeridge Health Hospital
Oshawa, Ontario, Canada, L1J 8R2
Grey Bruce Health Services
Owen Sound, Ontario, Canada, N4K 6M9
Prince Edward County Hospital
Picton, Ontario, Canada
Renfrew Victoria Hospital
Renfrew, Ontario, Canada, K7V 1P6
Sudbury Regional Hospital
Sudbury, Ontario, Canada, P3E 5J1
Sponsors and Collaborators
Queen's University
Ontario Hospital Association
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Diane Lougheed, MD Queen's University
  More Information

Responsible Party: Dr. Diane Lougheed, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00268580     History of Changes
Other Study ID Numbers: DMED-782-04  ORS # 2003-342 
Study First Received: December 20, 2005
Last Updated: March 28, 2016
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
Asthma
Care map
Clinical pathway
Education
Emergency department

Additional relevant MeSH terms:
Asthma
Emergencies
Bronchial Diseases
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 July 28, 2016