AsthmaNCT01815710
Best Strategies for Implementation of Clinical Pathways in Emergency Department Settings
An observational study of Asthma and Diarrhea & Vomiting, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
An Ontario-wide study to identify best strategies to promote uptake of high quality, expert developed Clinical Pathways (CPs) within Emergency Departments. The investigators will work with 16 Community EDs across Ontario to i) tailor an implementation strategy that works for each ED, ii) assist with the implementation… Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Asthma, Diarrhea & Vomiting
- What is being tested?
- Pediatric Asthma Clinical Pathway and Vomiting & Diarrhea Pathway
- How many people
- 6,330 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to 13 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Community hospitals in a variety of local health integration networks across Ontario (very high to low volume).
Who may be able to join
- Selecting from 149 community EDs in Ontario, we will recruit EDs that do not have a CP in place for either Pediatric Asthma or Pediatric V\&D. To minimize contamination between sites, we will request data from Health Force Ontario, an organization that assists with physician coverage at different EDs, to ensure ED physicians are not working at more than one study site. An additional inclusion criterion is commitment to the implementation intervention by an administrative lead on behalf of the hospital. Specific inclusion/exclusion criteria for use with patients have been defined for each CP.
- Medical records departments at each site will be asked to pull relevant charts, using International Statistical Classification of Diseases and Related Health Problems (ICD)-10 codes for all diagnoses related to our index conditions (Asthma and with V\&D) during the defined study periods. In our experience, this approach has worked successfully with community ED studies. Chart auditors will review all records to ensure eligibility criteria are met. All retrieved and eligible patient charts will be audited.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
An Ontario-wide study to identify best strategies to promote uptake of high quality, expert developed Clinical Pathways (CPs) within Emergency Departments.
The investigators will work with 16 Community EDs across Ontario to i) tailor an implementation strategy that works for each ED, ii) assist with the implementation of one pediatric emergency CP (Asthma or Gastroenteritis) at each site, and iii) evaluate the impact on health professionals, patient outcomes and economic costs. The investigators will conduct a 3.5 - year mixed methods health services research project with four study objectives: 1) to design a theory-based and knowledge user-informed intervention strategy to successfully implement two provincial pediatric emergency clinical pathways into practice in community Emergency Departments (EDs); 2) to evaluate the effectiveness of this implementation strategy; 3) to conduct a process evaluation to assess the implementation strategy; and 4) to conduct an economic analysis to evaluate implementation costs and benefits.
Read the detailed description
To meet the first objective, we will use Michie's Theoretical Domains Framework (TDF) to identify and organize CP-relevant behaviours. We will conduct qualitative interviews, guided by the TDF and involving knowledge users from participating sites, to identify barriers and facilitators for change relevant to the proposed CP implementation. Experience from other implementation initiatives will also be used to guide the intervention. An intervention mapping technique will be used to select and organize appropriate strategies to affect behaviour changes. Further input will be sought from knowledge user site partners. The intervention will begin with a site visit to assess readiness for adoption, infrastructure requirements, and ability to implement the pathway.
To meet objective two, we will use a cluster randomized control trial (RCT) design, through measurement of relevant clinical and process outcomes in 16 community EDs in Ontario. Using a balanced incomplete block design, we will study this implementation intervention with two clinical pathways: i) Asthma and ii) Vomiting \& Diarrhea (V\&D). We will recruit and randomize 16 community EDs to receive the intervention for one of the CPs and serve as control for the alternate pathway. Primary clinical outcomes for each CP include the following: i) Asthma: the proportion of asthmatic patients with moderate to severe exacerbation who received steroids within 60 minutes from ED presentation; and ii) V\&D: the proportion of children with mild to moderate dehydration treated with oral rehydration therapy. The primary process outcome measure will be the presence of an appropriately completed CP, as per pre-defined criteria, on the chart for relevant patients. Secondary clinical outcomes include disease-specific treatments, ED length of stay, revisits and hospitalizations. Secondary process outcomes include CP use based on shift-level data relating to the busyness of the ED. A mixed methods evaluation will be used to assess clinical and process outcomes. Data sources include chart audits, administrative databases, environmental scans and knowledge user interviews. Sample size calculations for the primary process outcome yielded the highest number of required charts. A total sample size of 6400 patient charts is required to detect an absolute difference of 12% between control and intervention hospitals using a two-sided test at the 5% level of significance.
To meet objective three, a process log will be used to track progress with site deadline targets, implementation issues, degree of uptake, local adaptations and adherence.
And finally, to meet objective four, comparisons of CP implementation and health care costs will be done for all patients with Asthma or V\&D in the pre and post implementation phases at all sites. Additional costs and outcomes will be synthesized in an incremental cost-effectiveness ratio (ICER) comparing intervention and control sites. Cost-effectiveness analyses (CEAs) will be done to relate ICERs to the primary clinical outcome for each CP.
- Conditions
- Asthma, Diarrhea & Vomiting
- Being tested
- Pediatric Asthma Clinical Pathway, Vomiting & Diarrhea Pathway
- Keywords
- Clinical Pathways, Knowledge translation, Evaluation
- Medical subject headings
- Asthma, Diarrhea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Asthma Clinical PathwayOther
Implementation of a clinical pathway outlining standardized, evidence-based care for pediatric patients with asthma. These clinical pathways use organized, time-sequenced interventions to achieve optimal patient outcomes.
Vomiting & Diarrhea PathwayOther
Implementation of a clinical pathway outlining standardized, evidence-based care for pediatric patients with vomiting and diarrhea. These clinical pathways use organized, time-sequenced interventions to achieve optimal patient outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Vomiting & Diarrhea | Alberta Health Services Acute Childhood Vomiting \& Diarrhea Pathway Receives: Other: Vomiting & Diarrhea Pathway | |
| Pediatric Asthma Clinical Pathway | Pediatric Asthma Clinical Pathway Receives: Other: Pediatric Asthma Clinical Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Received appropriate care based on evidence-based treatments recommended in the CP.
The proportion of pediatric patients with asthma and V\&D who received appropriate care based on evidence-based treatments recommended in the CP.
Measured: 18 months
Secondary outcomes (2)
Asthma - PRAM
Asthma CP intervention will include: 1) documentation of a Pre-school Respiratory Assessment Measure (PRAM) score.
Measured: 18 months
V&D - Gorelick and intravenous therapy.
For the V\&D CP intervention, secondary clinical outcomes will include: 1) documentation of a Gorelick score for dehydration; and 2) the proportion of children treated with intravenous therapy for rehydration.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startJan 2013
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 6,330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, Institute for Clinical Evaluative Sciences
- Responsible party
- Principal investigator, Mona Jabbour, Children's Hospital of Eastern Ontario
- Investigators
- Mona Jabbour, MD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815710
- Sponsor's protocol ID
- DCO150GP
- Status last verified
- Jul 2019
- First submitted
- 19 Mar 2013
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jabbour M, Newton AS, Johnson D, Curran JA. Defining barriers and enablers for clinical pathway implementation in complex clinical settings. Implement Sci. 2018 Nov 12;13(1):139. doi: 10.1186/s13012-018-0832-8.
PubMed 30419942Jabbour M, Curran J, Scott SD, Guttman A, Rotter T, Ducharme FM, Lougheed MD, McNaughton-Filion ML, Newton A, Shafir M, Paprica A, Klassen T, Taljaard M, Grimshaw J, Johnson DW. Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 May 22;8:55. doi: 10.1186/1748-5908-8-55.
PubMed 23692634
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Strategies for Implementation of Clinical Pathways in Emergency Department Settings
- ClinicalTrials.gov ID
- NCT01815710
- Acronym / sponsor ID
- DCO150GP
- Conditions
- Asthma, Diarrhea & Vomiting
- Keywords
- Clinical Pathways, Knowledge translation, Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,330 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, Institute for Clinical Evaluative Sciences
- Study start
- Jan 2013 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Ontario-wide study to identify best strategies to promote uptake of high quality, expert developed Clinical Pathways (CPs) within Emergency Departments.
The investigators will work with 16 Community EDs across Ontario to i) tailor an implementation strategy that works for each ED, ii) assist with the implementation of one pediatric emergency CP (Asthma or Gastroenteritis) at each site, and iii) evaluate the impact on health professionals, patient outcomes and economic costs. The investigators will conduct a 3.5 - year mixed methods health services research project with four study objectives: 1) to design a theory-based and knowledge user-informed intervention strategy to successfully implement two provincial pediatric emergency clinical pathways into practice in community Emergency Departments (EDs); 2) to evaluate the effectiveness of this implementation strategy; 3) to conduct a process evaluation to assess the implementation strategy; and 4) to conduct an economic analysis to evaluate implementation costs and benefits.
Detailed description
To meet the first objective, we will use Michie's Theoretical Domains Framework (TDF) to identify and organize CP-relevant behaviours. We will conduct qualitative interviews, guided by the TDF and involving knowledge users from participating sites, to identify barriers and facilitators for change relevant to the proposed CP implementation. Experience from other implementation initiatives will also be used to guide the intervention. An intervention mapping technique will be used to select and organize appropriate strategies to affect behaviour changes. Further input will be sought from knowledge user site partners. The intervention will begin with a site visit to assess readiness for adoption, infrastructure requirements, and ability to implement the pathway.
To meet objective two, we will use a cluster randomized control trial (RCT) design, through measurement of relevant clinical and process outcomes in 16 community EDs in Ontario. Using a balanced incomplete block design, we will study this implementation intervention with two clinical pathways: i) Asthma and ii) Vomiting \& Diarrhea (V\&D). We will recruit and randomize 16 community EDs to receive the intervention for one of the CPs and serve as control for the alternate pathway. Primary clinical outcomes for each CP include the following: i) Asthma: the proportion of asthmatic patients with moderate to severe exacerbation who received steroids within 60 minutes from ED presentation; and ii) V\&D: the proportion of children with mild to moderate dehydration treated with oral rehydration therapy. The primary process outcome measure will be the presence of an appropriately completed CP, as per pre-defined criteria, on the chart for relevant patients. Secondary clinical outcomes include disease-specific treatments, ED length of stay, revisits and hospitalizations. Secondary process outcomes include CP use based on shift-level data relating to the busyness of the ED. A mixed methods evaluation will be used to assess clinical and process outcomes. Data sources include chart audits, administrative databases, environmental scans and knowledge user interviews. Sample size calculations for the primary process outcome yielded the highest number of required charts. A total sample size of 6400 patient charts is required to detect an absolute difference of 12% between control and intervention hospitals using a two-sided test at the 5% level of significance.
To meet objective three, a process log will be used to track progress with site deadline targets, implementation issues, degree of uptake, local adaptations and adherence.
And finally, to meet objective four, comparisons of CP implementation and health care costs will be done for all patients with Asthma or V\&D in the pre and post implementation phases at all sites. Additional costs and outcomes will be synthesized in an incremental cost-effectiveness ratio (ICER) comparing intervention and control sites. Cost-effectiveness analyses (CEAs) will be done to relate ICERs to the primary clinical outcome for each CP.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vomiting & Diarrhea | – | Other: Vomiting & Diarrhea PathwayAlberta Health Services Acute Childhood Vomiting \& Diarrhea Pathway |
| Pediatric Asthma Clinical Pathway | – | Other: Pediatric Asthma Clinical PathwayPediatric Asthma Clinical Pathway |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Community hospitals in a variety of local health integration networks across Ontario (very high to low volume).
Key inclusion criteria (2 listed)
- Selecting from 149 community EDs in Ontario, we will recruit EDs that do not have a CP in place for either Pediatric Asthma or Pediatric V\&D. To minimize contamination between sites, we will request data from Health Force Ontario, an organization that assists with physician coverage at different EDs, to ensure ED physicians are not working at more than one study site. An additional inclusion criterion is commitment to the implementation intervention by an administrative lead on behalf of the hospital. Specific inclusion/exclusion criteria for use with patients have been defined for each CP.
- Medical records departments at each site will be asked to pull relevant charts, using International Statistical Classification of Diseases and Related Health Problems (ICD)-10 codes for all diagnoses related to our index conditions (Asthma and with V\&D) during the defined study periods. In our experience, this approach has worked successfully with community ED studies. Chart auditors will review all records to ensure eligibility criteria are met. All retrieved and eligible patient charts will be audited.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric Asthma Clinical PathwayImplementation of a clinical pathway outlining standardized, evidence-based care for pediatric patients with asthma. These clinical pathways use organized, time-sequenced interventions to achieve optimal patient outcomes. | Other | Pediatric Asthma Clinical Pathway |
| Vomiting & Diarrhea PathwayImplementation of a clinical pathway outlining standardized, evidence-based care for pediatric patients with vomiting and diarrhea. These clinical pathways use organized, time-sequenced interventions to achieve optimal patient outcomes. | Other | Vomiting & Diarrhea |
Primary outcome
Received appropriate care based on evidence-based treatments recommended in the CP.
Time frame: 18 months
The proportion of pediatric patients with asthma and V\&D who received appropriate care based on evidence-based treatments recommended in the CP.
2 secondary outcomes
Asthma - PRAM
Time frame: 18 months
V&D - Gorelick and intravenous therapy.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Derived from this study: PubMed 30419942Jabbour M, Newton AS, Johnson D, Curran JA. Defining barriers and enablers for clinical pathway implementation in complex clinical settings. Implement Sci. 2018 Nov 12;13(1):139. doi: 10.1186/s13012-018-0832-8.
- Derived from this study: PubMed 23692634Jabbour M, Curran J, Scott SD, Guttman A, Rotter T, Ducharme FM, Lougheed MD, McNaughton-Filion ML, Newton A, Shafir M, Paprica A, Klassen T, Taljaard M, Grimshaw J, Johnson DW. Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 May 22;8:55. doi: 10.1186/1748-5908-8-55.
- Individual participant dataSharing planned: Undecided
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Jabbour, MD principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Diarrhea & Vomiting, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Received appropriate care based on evidence-based treatments recommended in the CP. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01815710, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.