None listed
Conditions
Brief summary
A 2011 multicentre randomized control trial, undertaken by Aujesky et al, has supported recent changes to European and American Guidelines, and provides convincing evidence that the outpatient management of low-risk pulmonary embolism (PE), is non-inferior to standard inpatient management. EDPED is a comparative cost analysis (randomised control feasability study) between outpatient and delayed outpatient management of low risk PE diagnosed in the emergency department (ED). This study aims primarily to quantify the savings to the Health Department (cost per patient and cost per institution), and qualify patient satisfaction as a result of early discharge from ED. We hope to identify potential areas where health resources may be better directed in the management of low-risk PE. Secondary outcomes will address safety issues of managing PE in the Outpatient Setting (HITH). Patients who are discharged directly from ED (the intervention group) will be closely monitored for complications of their PE / venous thromboembolism or anticoagulation by HITH until their INRs have been stabilized. They will all receive a Respiratory Outpatient appointment 1 week after discharge from ED. Patients who are admitted to Respiratory Medicine from ED will be discharged to HITH in the conventional way (the control group). EDPED will examine primary and secondary outcomes within 90 days of patient arrival to ED.
Interventions
Intervention arm: outpatient management (early discharge from ED) of low risk pulmonary embolism. Upon diagnosis of a low risk PE and provided they meet the inclusion and exclusion criteria, patients randomized to the intervention arm will be discharged to hospital in the home (HITH) without an admission to or review by the respiratory team. Treatment for PE with enoxaparin (1mg/kg SC twice a day (bd), or 1mg/kg once a day (od) CrCl<30ml/min) and warfarin (5-5-5) is standardized at this hospital
Intervention arm: outpatient management (early discharge from ED) of low risk pulmonary embolism. Upon diagnosis of a low risk PE and provided they meet the inclusion and exclusion criteria, patients randomized to the intervention arm will be discharged to hospital in the home (HITH) without an admission to or review by the respiratory team. Treatment for PE with enoxaparin (1mg/kg SC twice a day (bd), or 1mg/kg once a day (od) CrCl<30ml/min) and warfarin (5-5-5) is standardized at this hospital and HITH and will not be altered for the purposes of this study. Those patients diagnosed with PE after hours (2030-0800) will be admitted to the ED observation ward until referral to HITH can be made the following morning. Discharge analgesia is left to the doctors discression, however a requirement of IM/IV analgesia after discharge from ED is an exclusion criteria to the study. Patients in the early discharge arm will all receive standard HITH treatment / management. All early discharge patients will receive an outpatient respiratory appointment at one week. On discharge from HITH the early discharge group will be asked to complete a patient satisfaction survey.
Sponsors
Discipline of Emergency Medicine UWA
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years or over Diagnosed in ED with a low risk PE Eligible for HITH: needs IM/IV analgesia, violence, intravenous drug use (IVDU), no fixed abode or outside of service area, able to cope at home. Able to give consent
Exclusion criteria
High risk PE: PESI>85, PE despite IVC filter or INR >=2, high clot burden on imaging, proximal DVT spreading to iliac vessels, phlegmasia, syncope. High risk of bleeding: active bleeding, trauma or OP <2/52 ago, CVA <2/52 ago, Plt <75, GI bleed <2/52 ago. History of adverse reactions with anticoagulants: allergies, unstable INR, HIT, bleeding requiring hospitalization after previous anticoagulation. Delayed recruitment > 1 day after diagnosis of PE. Vulnerable groups Additional medical contraindications: (SaO2<90%, ABG pO2<60mmHg (not mandatory), Creat Cl <30ml/min, Trop>=0.04 (not mandatory), Obesity > 150kg, palliative care / life threatening comorbidities, CI to anticoagulation. Admission required for any other medical, toxicological, psychiatric or social grounds (includes failed CCT). Unable to follow-up patient. Previous enrolment in trial. Inelligible for HITH
Outcome results
None listed