Acute AsthmaNCT01079000
Emergency Department (ED)-Directed Interventions to Improve Asthma Outcomes
A study testing Opinion Leader letter and Involvement of a care manager in people with Acute Asthma, run by University of Alberta at 2 sites in Canada.
Trial summary
The purpose of this study is to determine if evidence-based guidance on follow-up care and self-management provided to PCPs and patients, respectively, reduces relapses within 90 days for acute asthma (primary outcome). Read more about this study
- Who is it for?
- Ages 17 to 55 years
- Conditions the study is for
- Acute Asthma
- What is being tested?
- Opinion Leader letter and Involvement of a care manager
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 367 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2012to Mar 2016
- Phase
- Interventional
- 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 17 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 17-55 years old;
- Patients treated and discharged from one of the four study sites with acute asthma (not simply for a prescription refill) during the study period;
- Patients must have had a previous physician-diagnosis of asthma and an exacerbation diagnosed by the ED physician (e.g., past asthma history, recorded response to β-agonists in the ED, and increased asthma symptoms). In the event of a new diagnosis, the patient is still eligible for the study if the treating physician feels that the history is compatible with a diagnosis of asthma;
- Patients must have evidence of airflow obstruction on presentation at the ED, defined as an FEV1 or PEF <80% of predicted;
- Patients must not have a history of more than 20 pack-years of smoking;
- All patients should have a PCP (FP, nurse practitioner or internist) with whom to follow-up or attempts will be made to find one for them.
Who cannot join
- These criteria ensure the exclusion of suspected COPD patients and patients who require different treatments:
- Patients with asthma who are primarily cared for by a Respirologist/Pulmonologist;
- Patients not seen by an emergency physician in the ED (e.g., direct referrals);
- Physician diagnosis of acute COPD (e.g., failure of FEV1 or PEF to respond to ED treatment and a FEV1/FVC ratio ≤ 70%);
- Radiologically confirmed pneumonia during the 10 days preceding trial entry;
- Patients with an active history of bronchiectasis, cystic fibrosis, or lung cancer;
Show all 11Show fewer
- Clinically confirmed congestive heart failure at ED presentation;
- Patients not able/unwilling to perform spirometry assessment;
- Inability to provide informed consent or comply with the study protocol due to cognitive impairment, language barrier, or no contact details;
- Patient has previously participated in the study;
- Patients who in the opinion of the investigator are unsuitable for enrolment.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta
University of Alberta
Edmonton, Alberta, T6G2B7
About this study
Official title: Emergency Department (ED)-Directed Interventions to Improve Outcomes After Asthma Exacerbations
The purpose of this study is to determine if evidence-based guidance on follow-up care and self-management provided to PCPs and patients, respectively, reduces relapses within 90 days for acute asthma (primary outcome). Secondary outcomes will include follow-up visits with the primary care provider, patients' quality of life and cost-effectiveness indicators.
Read the detailed description
This prospective, randomized, open label study will include asthmatics 17-55 years of age with no evidence of chronic obstructive pulmonary disease. Patients will be eligible if they visit one of four Emergency Departments (EDs) in Edmonton or Calgary and receive treatment for acute asthma resulting in discharge home. All patients should have a primary care provider (PCP: Family Physician, Internist or Nurse Practitioner) with whom to follow-up or one will be found for them. At discharge patients will be randomized into three groups: A: Usual care; PCPs will receive a faxed copy of the ED chart and patients will receive a discharge plan and a paper-based educational pamphlet (treatment in the ED and at discharge will be left to ED physicians' discretion); B: Usual care + personalized fax to the patients' PCP including a copy of the ED chart and a opinion-leader (OL) letter encouraging follow-up within two weeks and providing management suggestions; or C: Usual care + personalized fax to the patients' PCP including the OL letter as described above + involvement of a case manager who will encourage patients' to pursue follow-up, provide management review and offer brief education within the next week. Outcomes will be ascertained blinded to treatment allocation through telephone follow-up at 30 and 90 days. A sample of 366 patients (122 per group) is required based on the proportion with relapse at 90 days (40%) and a chi-square test of association and post-hoc tests (groups A vs. B, groups B vs. C). This sample will allow for the detection of an moderate effect size of at least 0.171, and a difference between groups A and B of 50% (i.e., 40% vs. 20%) and between groups B and C of 75% (i.e., 20% vs. 5%) using two-sided z-tests, 80% power, α=0.025. Intention to treat analyses will be conducted. Relapse rates by group and associated 95% confidence intervals (CI) will be calculated. Proportions among groups will be compared using chi-square tests and if statistically significant, separate proportion tests will compare pairs of groups adjusting for multiple testing. A multivariable logistic regression model will adjust effect estimates for potential baseline imbalances and site-specific differences in effectiveness.
- Conditions
- Acute Asthma
- Being tested
- Opinion Leader letter, Involvement of a care manager, Usual care
- Keywords
- asthma, exacerbation, emergency department, relapse
- Medical subject headings
- Asthma, Emergencies, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opinion Leader letterBehavioural
The patients' PCP will be notified by fax about the ED visit and management. The Opinion Leader letter will contain a summary of the current asthma guidelines for ambulatory care (including: asthma education, long-term recommendations, smoking cessation, and action plan) signed by a local opinion leader. A review of the patient's management within a week of the ED visit will be recommended. The patient will also receive information regarding their acute exacerbation and will be told to review the current management of their disease with their PCP.
Involvement of a care managerBehavioural
The involvement of a care manager will encourage patients' to pursue follow-up, provide management review and offer brief education via telephone within a week of being discharged
Usual careBehavioural
Usual care provided to asthma patients when discharged from the ED
| Study group | Role | What they receive |
|---|---|---|
| Control - usual care (UC) | Active comparator | Usual care after an ED visit for asthma will include the provision of discharge instructions/plan, and action plan, and verbal instructions for follow-up with their PCP, and a faxed copy of the ED chart to the patient's PCP. Receives: Behavioral: Usual care |
| Opinion leader (OL) guidance to patients' PCPs | Experimental | In addition to UC, OL guidance will be provided to the patients' PCP. A letter signed by an influential, respected, and local clinical leader (Respirologist) will encourage follow-up within two weeks and provide management suggestions. Receives: Behavioral: Opinion Leader letter; Behavioral: Usual care |
| Care manager education to patients | Experimental | In addition to UC and OL guidance provided to the patients' PCP, care manager self-management education will be provided to patients. A care manager will encourage patients' to pursue follow-up, provide management review and offer brief education via telephone within a week of being discharged. Receives: Behavioral: Opinion Leader letter; Behavioral: Involvement of a care manager; Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapses within 90 days after discharge
Any unscheduled medical visit to a walk-in clinic, family doctor's office or an emergency department resulting from the patient's perceived need for further asthma treatment within 90 days after discharge.
Measured: 90 days
Secondary outcomes (3)
Time to relapse
Time from Emergency Department (ED) discharge to first asthma relapse.
Measured: 90 days
Primary care provider follow-up
A patient having a face-to-face meeting with their PCP within 30 days after discharge. Telephone interactions with the office will be classified as "no PCP follow-up".
Measured: 30 days
Health related quality of life (HRQoL)
A disease specific, validated instrument for asthma patients (AQLQ) will be used. We will also employ the EQ-5D.
Measured: Baseline, 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startJun 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AsthmaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian H Rowe, MD, MSc, Principal investigator, University of AlbertaCristina Villa-Roel, MD, MSc, Principal investigator, University of AlbertaEddy Lang, MD, Principal investigator, University of CalgaryMohit Bhutani, MD, Principal investigator, University of AlbertaBjug Borgundvaag, MD, Principal investigator, University of TorontoRichard Leigh, MD, Principal investigator, University of CalgarySumit Majumdar, MD, MSc, Principal investigator, University of AlbertaChristopher McCabe, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079000
- Sponsor's protocol ID
- CIHR operating grant # 201109
- Other IDs
- CIHR Grant
- Status last verified
- Nov 2016
- First submitted
- 1 Mar 2010
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department (ED)-Directed Interventions to Improve Outcomes After Asthma Exacerbations
- ClinicalTrials.gov ID
- NCT01079000
- Acronym / sponsor ID
- CIHR operating grant # 201109
- Conditions
- Acute Asthma
- Keywords
- asthma, exacerbation, emergency department, relapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Mar 2010 (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.
The purpose of this study is to determine if evidence-based guidance on follow-up care and self-management provided to PCPs and patients, respectively, reduces relapses within 90 days for acute asthma (primary outcome). Secondary outcomes will include follow-up visits with the primary care provider, patients' quality of life and cost-effectiveness indicators.
Detailed description
This prospective, randomized, open label study will include asthmatics 17-55 years of age with no evidence of chronic obstructive pulmonary disease. Patients will be eligible if they visit one of four Emergency Departments (EDs) in Edmonton or Calgary and receive treatment for acute asthma resulting in discharge home. All patients should have a primary care provider (PCP: Family Physician, Internist or Nurse Practitioner) with whom to follow-up or one will be found for them. At discharge patients will be randomized into three groups: A: Usual care; PCPs will receive a faxed copy of the ED chart and patients will receive a discharge plan and a paper-based educational pamphlet (treatment in the ED and at discharge will be left to ED physicians' discretion); B: Usual care + personalized fax to the patients' PCP including a copy of the ED chart and a opinion-leader (OL) letter encouraging follow-up within two weeks and providing management suggestions; or C: Usual care + personalized fax to the patients' PCP including the OL letter as described above + involvement of a case manager who will encourage patients' to pursue follow-up, provide management review and offer brief education within the next week. Outcomes will be ascertained blinded to treatment allocation through telephone follow-up at 30 and 90 days. A sample of 366 patients (122 per group) is required based on the proportion with relapse at 90 days (40%) and a chi-square test of association and post-hoc tests (groups A vs. B, groups B vs. C). This sample will allow for the detection of an moderate effect size of at least 0.171, and a difference between groups A and B of 50% (i.e., 40% vs. 20%) and between groups B and C of 75% (i.e., 20% vs. 5%) using two-sided z-tests, 80% power, α=0.025. Intention to treat analyses will be conducted. Relapse rates by group and associated 95% confidence intervals (CI) will be calculated. Proportions among groups will be compared using chi-square tests and if statistically significant, separate proportion tests will compare pairs of groups adjusting for multiple testing. A multivariable logistic regression model will adjust effect estimates for potential baseline imbalances and site-specific differences in effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control - usual care (UC) | Active comparator | Behavioral: Usual careUsual care after an ED visit for asthma will include the provision of discharge instructions/plan, and action plan, and verbal instructions for follow-up with their PCP, and a faxed copy of the ED chart to the patient's PCP. |
| Opinion leader (OL) guidance to patients' PCPs | Experimental | Behavioral: Opinion Leader letter, Behavioral: Usual careIn addition to UC, OL guidance will be provided to the patients' PCP. A letter signed by an influential, respected, and local clinical leader (Respirologist) will encourage follow-up within two weeks and provide management suggestions. |
| Care manager education to patients | Experimental | Behavioral: Opinion Leader letter, Behavioral: Involvement of a care manager, Behavioral: Usual careIn addition to UC and OL guidance provided to the patients' PCP, care manager self-management education will be provided to patients. A care manager will encourage patients' to pursue follow-up, provide management review and offer brief education via telephone within a week of being discharged. |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 17-55 years old;
- Patients treated and discharged from one of the four study sites with acute asthma (not simply for a prescription refill) during the study period;
- Patients must have had a previous physician-diagnosis of asthma and an exacerbation diagnosed by the ED physician (e.g., past asthma history, recorded response to β-agonists in the ED, and increased asthma symptoms). In the event of a new diagnosis, the patient is still eligible for the study if the treating physician feels that the history is compatible with a diagnosis of asthma;
- Patients must have evidence of airflow obstruction on presentation at the ED, defined as an FEV1 or PEF <80% of predicted;
- Patients must not have a history of more than 20 pack-years of smoking;
Key exclusion criteria (11 listed)
- These criteria ensure the exclusion of suspected COPD patients and patients who require different treatments:
- Patients with asthma who are primarily cared for by a Respirologist/Pulmonologist;
- Patients not seen by an emergency physician in the ED (e.g., direct referrals);
- Physician diagnosis of acute COPD (e.g., failure of FEV1 or PEF to respond to ED treatment and a FEV1/FVC ratio ≤ 70%);
- Radiologically confirmed pneumonia during the 10 days preceding trial entry;
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 |
|---|---|---|
| Opinion Leader letterThe patients' PCP will be notified by fax about the ED visit and management. The Opinion Leader letter will contain a summary of the current asthma guidelines for ambulatory care (including: asthma education, long-term recommendations, smoking cessation, and action plan) signed by a local opinion leader. A review of the patient's management within a week of the ED visit will be recommended. The patient will also receive information regarding their acute exacerbation and will be told to review the current management of their disease with their PCP. | Behavioural | Care manager education to patients, Opinion leader (OL) guidance to patients' PCPs |
| Involvement of a care managerThe involvement of a care manager will encourage patients' to pursue follow-up, provide management review and offer brief education via telephone within a week of being discharged | Behavioural | Care manager education to patients |
| Usual careUsual care provided to asthma patients when discharged from the ED | Behavioural | Care manager education to patients, Control - usual care (UC), Opinion leader (OL) guidance to patients' PCPs |
Primary outcome
Relapses within 90 days after discharge
Time frame: 90 days
Any unscheduled medical visit to a walk-in clinic, family doctor's office or an emergency department resulting from the patient's perceived need for further asthma treatment within 90 days after discharge.
3 secondary outcomes
Time to relapse
Time frame: 90 days
Primary care provider follow-up
Time frame: 30 days
Health related quality of life (HRQoL)
Time frame: Baseline, 30 and 90 days
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 21 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Brian H Rowe, MD, MSc principal investigator
University of Alberta
Cristina Villa-Roel, MD, MSc principal investigator
University of Alberta
Eddy Lang, MD principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opinion Leader letter and Involvement of a care manager in people with Acute Asthma, run by University of Alberta at 2 sites 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 6 inclusion and 11 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Relapses within 90 days after discharge (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2016.