Emergency Department (ED)-Directed Interventions to Improve Asthma Outcomes

Acute Asthma Clinical Trial

Official title:

Emergency Department (ED)-Directed Interventions to Improve Outcomes After Asthma Exacerbations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079000
• Other study ID #: CIHR operating grant # 201109
• Secondary ID: CIHR Grant
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: November 17, 2016
• Start date: June 2012
• Est. completion date: March 2016

Study information

• Verified date: November 2016
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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). Secondary outcomes will include follow-up visits with the primary care provider, patients' quality of life and cost-effectiveness indicators.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Age 17-55 years old;

2. Patients treated and discharged from one of the four study sites with acute asthma (not simply for a prescription refill) during the study period;

3. 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 ß-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;

4. Patients must have evidence of airflow obstruction on presentation at the ED, defined as an FEV1 or PEF <80% of predicted;

5. Patients must not have a history of more than 20 pack-years of smoking;

6. 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.

Exclusion criteria:

These criteria ensure the exclusion of suspected COPD patients and patients who require different treatments:

1. Patients with asthma who are primarily cared for by a Respirologist/Pulmonologist;

2. Patients not seen by an emergency physician in the ED (e.g., direct referrals);

3. Physician diagnosis of acute COPD (e.g., failure of FEV1 or PEF to respond to ED treatment and a FEV1/FVC ratio = 70%);

4. Radiologically confirmed pneumonia during the 10 days preceding trial entry;

5. Patients with an active history of bronchiectasis, cystic fibrosis, or lung cancer;

6. Clinically confirmed congestive heart failure at ED presentation;

7. Patients not able/unwilling to perform spirometry assessment;

8. Inability to provide informed consent or comply with the study protocol due to cognitive impairment, language barrier, or no contact details;

9. Patient has previously participated in the study;

10. Patients who in the opinion of the investigator are unsuitable for enrolment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Asthma
• Asthma
• Emergencies

Intervention

Behavioral:
• Opinion Leader letter
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 manager
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 care
Usual care provided to asthma patients when discharged from the ED

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days	Yes
Secondary	Time to relapse	Time from Emergency Department (ED) discharge to first asthma relapse.	90 days	Yes
Secondary	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".	30 days	No
Secondary	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.	Baseline, 30 and 90 days	Yes