Asthma Clinical Trial
Official title:
Evaluation of the Emergency Department Asthma Care Project
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.
Study findings may be used to support implementation of a standardized ED clinical pathway
and related ED provider education program throughout Ontario.
Specific Objectives:
- To evaluate the impact of the pathway on patients.
- To evaluate the impact of the pathway on health care providers.
- To evaluate the ease of implementation of the pathway.
Study Design:
- Observational, pre- post-intervention study design.
- Comparison between intervention and control sites.
- Patient and provider surveys and provider focus group post intervention
Key Components:
1. Pre- and post- intervention chart abstraction of key elements of the process of asthma
care in ED setting
2. Post-intervention telephone survey of patients
3. Post-intervention self-administered survey of health care providers
4. Post-intervention focus group
Methodology:
Background The Ontario Respiratory Outcomes Research Network (ORORN) is completing a
Canadian Institutes of Health Research (CIHR)-funded study on "Determinants of Regional
Variation in Emergency Department Utilization and Hospitalizations for Asthma in Ontario".
This study included detailed chart abstractions on the process of care in the ED as well as
detailed telephone questionnaires of adults and children who presented to EDs for treatment
of acute asthma in a stratified sample of 14 hospitals across Ontario between March 2001 and
Feb 2002. Data are available on over 5,000 ED visits. It is proposed that a number of these
sites be approached to participate in ED ACP. A sub-set of data from these sites will
provide baseline (pre-intervention) data, and some or all of the intervention and control
sites for the ED ACP could be selected from the ORORN study sites. This would minimize (or
potentially eliminate) costs of primary baseline data collection, and expedite collection of
post-intervention data given the familiarity of sites and research personnel with the
previous study instruments and protocol.
Selection of Intervention and Control Sites
Five intervention (Kingston General Hospital, Belleville General Hospital, Sudbury Regional
Hospital, Renfrew Victoria Hospital, and Lake of the Woods District Hospital [Kenora]) and 5
control sites ( Prince Edward County Memorial Hospital, Lakeridge Hospital [Oshawa], St.
Joseph's Hospital [Hamilton], Chatham District Hospital, and Owen Sound District Hospital)
were selected. To ensure the sites are representative of Ontario, sites will be selected
based upon a sampling frame which takes into consideration:
- Hospital/community size and location (urban/rural; geographic setting)
- Level of care (community/academic -tertiary/quaternary setting)
- Hospitalization rates for asthma in adults and children
- Presence of local specialized asthma services
- Access to quality baseline (pre-intervention) data from the ORORN ED study database
- Willingness of site to participate
- Location of other Asthma Plan of Action initiatives which might confound or be
confounded by this intervention
Case identification within each ED will be performed by the method used by ORORN in a
previous asthma ED study. This involves reviewing ED log books of presenting complaints
potentially indicative of asthma OR electronically available data on disposition diagnoses
of asthma. Potentially eligible patients will be approached as outlined below to obtain
informed consent.
ED records (log books) from participating hospitals will be reviewed by a local research
assistant for the preceding 24 to 72 hrs on a daily basis (Monday through Friday). Patient
records with a chief complaint potentially indicative of an acute asthma exacerbation will
be reviewed to capture all patients with a discharge diagnosis of an acute exacerbation of
asthma. ED records with the following complaints in the logbook will be reviewed: asthma,
shortness of breath, wheeze, cough, chest tightness, difficulty breathing. To be eligible
the disposition diagnosis on the ED sheet must be asthma. Patients with a history of asthma
presenting for reasons other than an acute exacerbation of asthma (such as prescription
renewal or unrelated complaint) will be excluded.
Eligible patients will be mailed:
1. An introductory letter (Appendix A) outlining the purpose of the study, and informing
them that they will be contacted by a research assistant within one week of their
presentation to the hospital and invited to participate in the study and
2. A consent form (Appendix B). The Research assistant will contact patients by telephone
to obtain informed consent. A telephone contact sheet (Appendix C) outlines the script
to be used by the research assistant when speaking to potential participants. Once
consent has been obtained the participant will answer a questionnaire (by telephone or
in person). The questionnaire will be entered into a computerized version of a paper
copy (Appendix D). The patient chart will then be abstracted also using a computerized
version of the paper copy (Appendix E).
If the patient re-presents to the ED within 14 days of first visit the research assistant
will contact the participant to obtain consent again. Any visit within the 14day period will
be considered the same episode and repeat consent will not be required.
Pre-Intervention Chart Abstraction
Pre-intervention chart abstraction data will be obtained from either:
1. the ORORN ED study database, for sites that participated in the previous ORORN study,
which contains data on adult and pediatric ED visits between March 2001 and February
2002, OR
2. retrospective primary data collection of ED visits for asthma between March 2001 and
February 2002 for sites selected that did not participate in the previous ORORN ED
study, utilizing the ORORN chart abstraction tool (or an abbreviated audit using
specific components of that tool). (NOTE: If this is necessary, the research team and
advisory committee will need to determine an appropriate abbreviated time-period to
audit (eg. 3 months rather than a full 12 months) to remain within budget and meet
target time-lines.)
Post-Intervention Chart Abstraction Post-intervention chart abstraction data will be
obtained by primary data collection, using the ORORN chart abstraction tool (or an
abbreviation thereof).
Post-Intervention Collection of Administrative Outcomes Hospitalization rates, readmission
rates, and ED repeat visit rates for asthma and asthma-related conditions (as defined by the
OHA Report Cards) will be obtained for each site directly or from national administrative
databases (CIHI, NACRS). Referral rates to local specialized services will be collected
where relevant and possible in small communities directly from the community resource
involved.
Post-intervention Survey of Patients Patients eligible to participate will be mailed an
introductory letter outlining the purpose of the study and a consent form. Subsequently,
potential participants will be contacted by telephone by a research associate. After
obtaining informed consent, a brief (5-10 minute maximum) telephone interview will be
performed. A questionnaire for this purpose will be developed, including data elements from
the ORORN regional variation study questionnaire to enable comparisons. It will also
included whether the patient received education or referrals during their ED visit, whether
they complied with referrals, and questions regarding the impact of the patient's visit on
their asthma self-management skills and confidence.
Post-intervention Self-administered Survey of Health Care Providers A sample of ED health
care providers involved in the delivery of aspects of the clinical pathway will be contacted
at each site, and invited to complete a self-administered survey. A questionnaire for this
purpose will be developed, to include perceived change in practice, perceived change in
knowledge of recommended asthma management, perceived utility of the pathway, barriers to
pathway implementation, and recommendations for improvement.
Post-intervention Site Representatives Focus Group
A post-intervention focus group including representatives from each participating site will
be convened to gain additional insight into the site specific and aggregate outcomes and
barriers that would be unlikely to emerge without the interaction found in a group.
Aggregate data will be distributed to all sites, and site specific data to individual sites.
The focus group will be invited to:
- assist with interpretation of quantitative findings;
- obtain perceptions of project outcomes and impacts;
- identify project strengths, weaknesses, and recommendations;
- identify solutions related to project implementation; and
- generate new ideas.
Ethical Considerations This study has been approved by the Queen's University Health
Sciences and Affiliated Teaching Hospital's Research Ethics Board (REB) (Appendix F). Ethics
is also being sought at all participating sites. The Queen's submission will be shared with
sites and study coordinator will assist sites, where necessary, to facilitate the process.
Access to medical records will be sought from each institution. As this study involves
questionnaire data collected by interview, stress may occur as a result of perceived
pressure to answer specific questions. Participants will be informed during consent process
that participation is voluntary, they may chose to not answer specific questions, and may
withdraw from the study at any time without affecting their future medical care. Patient
confidentiality will be ensured at all times. Confidential individual identification numbers
will be randomly generated and sequentially by the web based data entry system, and used to
link the abstracted data and questionnaire data.
Privacy officers have been contacted at each of the participating sites to ensure that the
protocol meets the sites privacy protocol.
Potential Outcome Measures:
A. Impact of pathway on patients:
1. Hospitalization rate and length of stay
2. Length of stay in ED
3. Relapse rate to the ED for asthma, within 24 and 72 hours of ED visit
4. Self-reported adherence with referral to specialized asthma services made during index
ED visit
5. Self-reported asthma control, and use of self-management strategies (including use of
action plan)
B. Impact of the pathway on providers:
a. Use of Asthma Management Strategies Promoted by the ED ACP i. use of objective measure of
airflow rates (PEFR or spirometry), and gas exchange (oxygen saturation, arterial blood
gases) ii. types of asthma medications prescribed (bronchodilators, corticosteroids) in ED
and upon discharge iii. route of medications prescribed (IV vs oral vs. inhaled steroids;
metered-dose inhaler (MDI) vs nebulized bronchodilators) iv. documentation of assessment and
teaching of device technique v. documentation of asthma action plan provision or revision
vi. type of asthma education provided (e.g. environmental trigger avoidance, warning signs,
medication use) vii. follow-up care recommendations or referrals (AEC, Asthma Clinic,
Respirology Clinic, family physician) b. Utilization of Specialized Asthma Services i.
referral rates (#/year) to local AECs and Asthma Clinics ii. types of providers involved in
emergency asthma care
C. Ease of implementation of the pathway/ Barriers to implementation:
1. Proportion of patients enrolled on the ED ACP (Overall, by patient age category and by
physician specialty)
2. Differences in patient demographics, physician demographics, day of week, time of day
between patients enrolled vs. not enrolled
3. Perceived utility of pathway (overall, by site, and by profession)
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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