Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268580
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2005-12-20
Brief Title:
Evaluation of the Emergency Department Asthma Care Project
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Evaluation of the Emergency Department Asthma Care Project
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 strategyclinical 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 OHAs now Ontario Lung Associations OLAs 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
Hypothesis Implementation of a multi-disciplinary asthma strategyclinical 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 OHAs now Ontario Lung Associations OLAs 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
Detailed Description:
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 5000 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 Josephs 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
Hospitalcommunity size and location urbanrural geographic setting
Level of care communityacademic -tertiaryquaternary 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 patients 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 Queens University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board REB Appendix F Ethics is also being sought at all participating sites The Queens 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 eg 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
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 5000 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 Josephs 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
Hospitalcommunity size and location urbanrural geographic setting
Level of care communityacademic -tertiaryquaternary 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 patients 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 Queens University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board REB Appendix F Ethics is also being sought at all participating sites The Queens 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ORS 2003-342 | OTHER_GRANT | Government of Ontario | None |