Emergency Department (ED)-Directed Interventions to Improve Outcomes After Asthma Exacerbations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 367
- 试验地点
- 2
- 主要终点
- Relapses within 90 days after discharge
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •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.
研究组 & 干预措施
Control - usual care (UC)
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.
干预措施: Usual care (Behavioral)
Opinion leader (OL) guidance to patients' PCPs
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.
干预措施: Opinion Leader letter (Behavioral)
Opinion leader (OL) guidance to patients' PCPs
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.
干预措施: Usual care (Behavioral)
Care manager education to patients
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.
干预措施: Opinion Leader letter (Behavioral)
Care manager education to patients
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.
干预措施: Involvement of a care manager (Behavioral)
Care manager education to patients
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.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Relapses within 90 days after discharge
时间窗: 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.
次要结局
- Time to relapse(90 days)
- Primary care provider follow-up(30 days)
- Health related quality of life (HRQoL)(Baseline, 30 and 90 days)