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Trial registered on ANZCTR


Registration number
ACTRN12612000067875
Ethics application status
Approved
Date submitted
29/12/2011
Date registered
13/01/2012
Date last updated
19/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Early discharge of patients diagnosed with low risk pulmonary embolism from emergency departments (EDPED): a cost effectiveness study
Scientific title
A prospective randomized case control feasability study between outpatient and delayed outpatient management of patients diagnosed with low risk pulmonary embolism in a tertiary ED.
Secondary ID [1] 262620 0
Nil
Universal Trial Number (UTN)
U1111-1122-9101
Trial acronym
EDPED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low risk pulmonary embolism (primary outcome: cost analysis and satisfaction survey) 268316 0
Venous thromboembolism complications (secondary outcome) 285450 0
Anticoagulation complications (secondary outcome) 285451 0
Condition category
Condition code
Respiratory 268445 268445 0 0
Other respiratory disorders / diseases
Blood 285635 285635 0 0
Clotting disorders
Public Health 285670 285670 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 266967 0
Other interventions
Comparator / control treatment
Control arm (current standard of practice): delayed outpatient management (after admission to a respiratory ward from ED) of low risk pulmonary embolism. Upon diagnosis of a low risk PE and provided they meet the inclusion and exclusion criteria, patients patients randomized to the control arm will be admitted to the respiratory team. Treatment for PE with enoxaparin (1mg/kg SC bd, or 1mg/kg 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. Admission analgesia is left to the doctors discression, however a requirement of IM/IV analgesia after discharge from ED (to the ward) is an exclusion criteria to the study. Patients in the control arm will all receive standard HITH treatment / management once they have been discharged from the respiratory ward. The necessity of an outpatient respiratory appointment will be left to the admitting teams discression. On discharge from HITH the delayed discharge group (control group) will be asked to complete a patient satisfaction survey.
Control group
Active

Outcomes
Primary outcome [1] 269202 0
Cost of health resource utilization from the Health Departments perspective: discharge diagnosis to calculate diagnosis related group (DRG), length of stay (LOS) in ED and as an inpatient including representations and readmissions, readmission ward type, number of visitis to or by GP, number, acuity and length of outpatient visits, number of days requiring outpatient visits, number of visits requiring enoxaparin (LMWH), number of days requiring patient administered LMWH, number of days to reach therapeutic blood thinning as measured by the international normalized ratio (INR).
Timepoint [1] 269202 0
7, 14 and 90 days post diagnosis
Primary outcome [2] 269203 0
Patient satisfaction survey with an 11 point questionnaire. Survey includes questions on patient confidence of medical care, comfort and convenience of treatment, discharge supoport, disease impact, degree of recovery, ability to return to work, ability to perform activities of daily living.
Timepoint [2] 269203 0
On discharge from HITH
Secondary outcome [1] 279109 0
Frequency of all-cause mortality (Safety outcome measure). The ED Research Nurse will contact the patients NOK and / or health care providers to acquire this information. An independent expert safety outcomes panel (3 consultants) has been set up to decide on whether the PE was linked to the cause of death.
Timepoint [1] 279109 0
7, 14 and 90 days post diagnosis
Secondary outcome [2] 279110 0
Frequency of complications of anticoagulation: bleeding requiring admission to ward or ED, blood transfusion or reversal of anticoagulation, failure of anticoagulation (Safety outcome measure). The ED Research Nurse will contact the patients NOK and / or health care providers to acquire this information. An independent expert safety outcomes panel (3 consultants) has been set up to decide on whether the management of the PE was linked to the complications of anticoagulation.
Timepoint [2] 279110 0
7, 14 and 90 days post diagnosis
Secondary outcome [3] 279111 0
Frequency of readmission (ED or as an inpatient) due to PE related complications (chest pain, shortness of breath, pre- / syncope, arrhythmia, or extension of PE). (Safety outcome measure). The ED Research Nurse will contact the patients NOK and / or health care providers to acquire this information. An independent expert safety outcomes panel (3 consultants) has been set up to decide on whether the PE, its management or treatment contributed to the re-admission.
Timepoint [3] 279111 0
7, 14 and 90 days post diagnosis
Secondary outcome [4] 279112 0
Frequency of new venous thromboembolism. The ED Research Nurse will contact the patients NOK and / or health care providers to acquire this information. An independent expert safety outcomes panel (3 consultants) has been set up to decide on whether the appearance of the VTE is old or consistent with extension or de novo formation (failure of treatment).
Timepoint [4] 279112 0
7, 14 and 90 days post diagnosis

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by sealed opaque envelopes into the early or delayed discharge treatment arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The delayed discharge arm is the control arm. The delayed discharge arm is the current standard of practice which has not been changed. The early discharge arm is the intervention arm.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3212 0
Sir Charles Gairdner Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 267430 0
Government body
Name [1] 267430 0
SHRAC Research Translation project 2011
Address [1] 267430 0
Research Development Unit
Department of Health
PO Box 8172
Perth Business Centre
Perth
6849
Western Australia
Country [1] 267430 0
Australia
Primary sponsor type
University
Name
Discipline of Emergency Medicine UWA
Address
Emergency Medicine Academic Unit
R Block
Sir Charles Gairdner Hospital
Nedlands
6011
Western Australia
Country
Australia
Secondary sponsor category [1] 266479 0
Hospital
Name [1] 266479 0
Sir Charles Gairdner Hospital Emergency Department
Address [1] 266479 0
ED Administration
G Block
Sir Charles Gairdner Hospital
Nedlands
6011
Western Australia
Country [1] 266479 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269407 0
HREC Sir Charles Gairdner Group
Ethics committee address [1] 269407 0
HREC
Research Governance Unit
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
6011
Western Australia
Ethics committee country [1] 269407 0
Australia
Date submitted for ethics approval [1] 269407 0
06/12/2011
Approval date [1] 269407 0
20/12/2011
Ethics approval number [1] 269407 0
2011-067

Summary
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.
Trial website
Trial related presentations / publications
Final Report submitted to the State Health Research Advisory Council 30/6/2015. Manuscript is currently being prepared for submission to a medical journal for publication (anticipated Dec 2015)
Public notes

Contacts
Principal investigator
Name 32869 0
Dr Tor Ercleve
Address 32869 0
ED Administration Sir Charles Gairdner Hospital G Block Hospital Avenue Nedlands 6011 Western Australia
Country 32869 0
Australia
Phone 32869 0
+61 8 9287 6747
Fax 32869 0
Email 32869 0
tor.ercleve@health.wa.gov.au
Contact person for public queries
Name 16116 0
Dr Tor Ercleve
Address 16116 0
ED Administration
Sir Charles Gairdner Hospital
G Block
Hospital Avenue
Nedlands
6011
Western Australia
Country 16116 0
Australia
Phone 16116 0
+61 8 9287 6747
Fax 16116 0
Email 16116 0
tor.ercleve@health.wa.gov.au
Contact person for scientific queries
Name 7044 0
Dr Tor Ercleve
Address 7044 0
ED Administration
Sir Charles Gairdner Hospital
G Block
Hospital Avenue
Nedlands
6011
Western Australia
Country 7044 0
Australia
Phone 7044 0
+61 8 9287 6747
Fax 7044 0
Email 7044 0
tor.ercleve@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary