ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000200785

Ethics application status

Not yet submitted

Date submitted

28/01/2013

Date registered

19/02/2013

Date last updated

1/05/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

Safe and effective early discharge of patients with low-risk coronary artery disease

Scientific title

In patients with low-risk acute coronary syndromes who undergo angioplasty and stenting, or medical therapy after coronary angiography, is early discharge (<72 hours) to ambulatory care as safe as conventional 4-5 day hospital stay with no increase in mortality, adverse events or unexpected readmission to hospital?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1138-9754

Trial acronym

SEED

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Ischaemic heart disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Early hospital discharge to ambulatory care with nursing follow up. Subjects in the this group will be discharged within 72 hours of admission to ambulatory care with daily home visit by the nursing staff for a minimum of 3 days up to a week. Subjects’ blood pressure, heart rate and ECG will be recorded at each visit and further cardiac education will be offered.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Conventional 4-5 day hospital stay with no added nursing intervention

Control group

Active

Outcomes

Primary outcome [1]

All cause mortality and major cardiac adverse events (MACE)

Timepoint [1]

30 day

Primary outcome [2]

Readmission for any of congestive heart failure, unstable angina, arrhythmia, re-infarction, and/or revascularization

Timepoint [2]

30 day

Primary outcome [3]

Non-cardiac complications such as major bleeding, stroke, acute renal impairment and stroke

Timepoint [3]

30 day

Secondary outcome [1]

Health-related quality of life as measured by EQ-5D and Seattle Angina questionnaires

Timepoint [1]

6 weeks and 3 months

Secondary outcome [2]

Patients’ experiences of in-patient care will be evaluated using the Picker Patient Experience Questionnaire

Timepoint [2]

At time of discharge from either ambulatory care or hospital

Secondary outcome [3]

Compliance with medications will be assessed via phone interview using Morisky 8-Item Medication Adherence Questionnaire

Timepoint [3]

6 weeks and 3 months

Secondary outcome [4]

Compliance with smoking cessation
Subjects will be asked about their current smoking status via phone interview.

Timepoint [4]

6 weeks and 3 months

Secondary outcome [5]

Attendance at cardiac rehabilitation session

Timepoint [5]

6 weeks and 3 months

Secondary outcome [6]

Cost-effectiveness
This will be assessed by comparing the total costs in both intervention group (reduced hospital length of stay and cost of ambulatory care) and control group (costs of conventional in-patient stay)

Timepoint [6]

3 months

Secondary outcome [7]

Feasibility of the module of ambulatory care.
The study will be considered feasible if >80% of patients in the intervention group are discharged within 72 hours, and >80% of patients are followed up by ambulatory care nurse for a minimum of 3 days

Timepoint [7]

3 months

Eligibility

Key inclusion criteria

Participants who suffer from heart attacks, over 18 years of age and are willing and able to sign informed consent forms

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Age < 18 years

Pregnant

Non-English speaking background patient without English speaking carer.

Significant medical co-morbidities such as severe COPD, pre-existing heart failure, poorly controlled diabetes, and moderate to severe renal impairment

Lesions that require further revascularization (ie. Staged PCI or CABG)

Other lesions that have >70% intra-luminal stenosis on coronary angiogram and are managed medically

Ejection Fraction <40%

Out of hospital cardiac arrest requiring >3 x DCRs, intubation or inotropic support

Unsuccessful or complicated PCI such as no reflow, temporary pacing and perforation.

Patients who develop non-cardiac complications within 24 hours after PCI: bleeding, stroke, acute renal impairment, vascular sequelae, groin hematoma >5cm diameter, active infection or sepsis

STEMI patients who receive thrombolysis prior to transfer to BHH

Resides >60km radius from Box Hill Hospital

Poor social support and pre-existing significant mobility or memory issue

History of illicit drug use

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)

Concealed allocation using sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation block

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Continuous variables will be summarized by means, standard deviations, medians and ranges. Categorical variables will be summarized by frequencies and percentages.

In order to assess comparability of treatment groups, subject demographics and other baseline characteristics will be tabulated separately by treatment group.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/03/2013

Actual

Date of last participant enrolment

Anticipated

28/02/2014

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Box Hill Hospital - Box Hill

Recruitment postcode(s) [1]

3128 - Box Hill

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Cardiology Department Eastern Health

Address [1]

Box Hill Hospital
Nelson Road, Box Hill 3128
Victoria

Country [1]

Australia

Primary sponsor type

Hospital

Name

Cardiology Department Eastern Health

Address

Box Hill Hospital
Nelson Road, Box Hill 3128
Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Eastern Health Research and Ethics Committee

Ethics committee address [1]

5 Arnold Street, Box Hill 3128
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/02/2013

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Traditionally patients presenting to hospital with a heart attack are hospitalized for at least 5-7 days to monitor for complications such as increasing shortness of breath, recurrence of chest pain and fast irregular heart rate and also to increase their medications and receive a basic understanding of future management of their chest pain.
A randomized trial in Canada showed that early discharge from hospital for low risk heart attack patients was feasible and safe when combined with close nursing follow up at home.

We propose to randomize low risk heart attack patients to early discharge (<72 hours) with hospital-in-the-home (HITH) nurses and doctors compared with conventional 4-5 day stay in hospital. 

The aims of this study are
1.	To prove that an early discharge strategy is safe and acceptable to patients with no increase in deaths, adverse events or unexpected readmission to hospital 

2.	To evaluate the patients’ experience and quality of life in both groups using questionnaires.

3.	To examine the cost effectiveness of early discharge from hospital to HITH versus conventional 4-5 day hospital stay.

Patients presenting to Box Hill Hospital with a heart attack and have undergone coronary angiogram and are treated with either medical therapy such as medications or angioplasty and stent will be screened using validated tools to assess for low risk. They will then be randomized to either early discharge with HITH (intervention group) or conventional 4-5 day hospital stay (control group).

About 300 hundred patients will be recruited for the trial.

The intervention group will be discharged from hospital before 72 hours and followed up daily by HITH nurse for at least 3 days. In the first week they will be reviewed by the HITH consultant doctor at the Maroondah clinic.

The control group will be discharged home according to standard care at day 4 or 5.

The main outcomes to be measured are: all-cause death, readmission or re-presentation to hospital due to chest pain, recurrent heart attacks or heart failure, as well as procedural and non-cardiac complications related to the index event at 30 days. The information will be gathered via phone interviews and medical records.

Health-related quality of life and patients’ experiences of in-patient care will be evaluated using validated questionnaires. A telephone call to all patients at 6 weeks and 3 months will remind them about completing the questionnaires, and include a brief interview regarding re-presentation to the hospital, readmission, compliance with medications, attendance at cardiac rehabilitation and smoking cessation. All information collected will remain confidential and be de-identified for research purposes.  

The cost-effectiveness (reduced length of stay) of the early discharge strategy will also be analysed.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Gishel New

Address

Cardiology Department
Box Hill Hospital
Nelson Road, Box Hill 3128
Victoria

Country

Australia

Phone

+61 3 9895 4833

Fax

+61 3 9895 4834

Gishel.new@easternhealth.org.au

Contact person for public queries

Name

Louise Roberts

Address

Eastern Health
5 Arnold Street, Box Hill 3128
Victoria

Country

Australia

Phone

+61 3 9095 2441

Fax

+61 3 9899 6810

Louise.roberts@easternhealth.org.au

Contact person for scientific queries

Name

Gishel New

Address

Cardiology Department
Box Hill Hospital
Nelson Road, Box Hill 3128
Victoria

Country

Australia

Phone

+61 3 9895 4833

Fax

+61 3 9895 4834

Gishel.new@easternhealth.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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