Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001303437
Ethics application status
Approved
Date submitted
27/08/2016
Date registered
16/09/2016
Date last updated
26/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multicentre Tasmanian Study of a Multidisciplinary Intervention to Reduce Readmission and Death of Patients admitted with Heart Failure
Scientific title
Multicentre Tasmanian Study of a Multidisciplinary Intervention to Reduce Readmission and Death of Patients admitted with Heart Failure
Secondary ID [1] 289172 0
None
Universal Trial Number (UTN)
Trial acronym
ETHELRED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 298706 0
Condition category
Condition code
Cardiovascular 298759 298759 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This approach will involve the following deviations from standard practice:
1. Pre-discharge
- 1a. Discussion and assessment of palliative care needs. This will be performed by the physician or nurse on the care team, prompted by study co-ordinator;
- 1b. Echocardiography (including pulmonary imaging) and/or BNP to ensure that the patient is as close as possible to euvolaemic before discharge. This will be performed by the physician or sonographer, prompted by study co-ordinator;
- 1c. Assessment of risk based on clinical, cognitive and psychosocial factors. Clinical data will include patient history, medications, physical measurements, blood tests, and findings on echocardiography. Nonclinical data included age, sex, language background, marital status, living alone or with others, education, socioeconomic status, remoteness index (differentiating residence in a metropolitan, rural, or remote area of Australia), medical insurance, and any home health care services provided. Questionnaires used for data collection included the Montreal Cognitive Assessment (MoCA), Patient Health Questionnaire (PHQ-9), and Generalized Anxiety Disorder (GAD-7). This was obtained by the study co-ordinator and communicated to the heart failure nurse.
2. Transition care - A heart failure nurse who will follow the patient as both an inpatient and outpatient and act as a ’transition coach‘ to visit the patient in the hospital prior to discharge and ensure appropriate medication reconciliation, follow-up plans, and education.
3. Follow-up –The heart failure nurse will provide at least two calls (telephone and home visit) within the first 30 days to provide post-discharge support. Surveillance over the next year will involve calls and/or home visits, monthly over the 1st 3 months, with frequency determined by the risk and status of the patient thereafter. Telemonitoring of weight and vital signs if needed. Assistance will be provided to maximize the likelihood of up-titration of medications.
4. The heart failure nurse will be the first contact for changes in patient status and liaise with the cardiologists or Emergency Department (ED) if review rather than admission is needed;
5. Action plan - Provision of clear instructions to patients and caretakers regarding personalized actions to take when weight or symptoms change.
Intervention code [1] 294695 0
Prevention
Intervention code [2] 295788 0
Treatment: Other
Comparator / control treatment
Usual care
- Standard clinical evaluation pre-discharge;
- Usual arrangements for transitional care, including discharge prescriptions, discharge summary and home nursing as required;
- GP review for surveillance
- Standard education, including pamphlets from National Heart Foundation
Control group
Active

Outcomes
Primary outcome [1] 298235 0
All-cause readmission (HF and non-HF) or death at 30 days, assessed by data linkage to patient records
Timepoint [1] 298235 0
30 days post discharge
Primary outcome [2] 298236 0
All cause readmission (HF and non-HF) and death at 90 days, assessed by data linkage to patient records
Timepoint [2] 298236 0
90 days post discharge
Secondary outcome [1] 323622 0
All cause readmission (HF and non-HF) and death at 12 months, assessed by data linkage to patient records
Timepoint [1] 323622 0
12 months post randomisation
Secondary outcome [2] 323623 0
General health status (EQ5D)
Timepoint [2] 323623 0
90 days post discharge
Secondary outcome [3] 323624 0
General health status (EQ5D)
Timepoint [3] 323624 0
12 months post discharge
Secondary outcome [4] 327636 0
Duke activity status index (DASI)
Timepoint [4] 327636 0
90 days post discharge
Secondary outcome [5] 327637 0
Duke activity status index (DASI)
Timepoint [5] 327637 0
12 months post discharge
Secondary outcome [6] 327638 0
Heart failure disease-specific quality of life (Kansas City HF questionnaire)
Timepoint [6] 327638 0
90 days post discharge
Secondary outcome [7] 327639 0
Heart failure disease-specific quality of life (Kansas City HF questionnaire)
Timepoint [7] 327639 0
12 months post discharge
Secondary outcome [8] 327749 0
Days alive and out of hospital, assessed by data linkage to patient records
Timepoint [8] 327749 0
90 days post discharge
Secondary outcome [9] 327750 0
Days alive and out of hospital, assessed by data linkage to patient records
Timepoint [9] 327750 0
12 months post discharge

Eligibility
Key inclusion criteria
Admission to hospital with heart failure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to provide written informed consent to participate in this study
- Participating in another clinical research trial where randomized treatment would be unacceptable
- Moderate or worse primary mitral or aortic valve disease
- Any HF admission within the last 6 months
- Concomitant unstable angina, acute myocardial infarction
- Device malfunction, endocarditis
- Patients with LVAD
- Potentially reversible LV dysfunction – post-partum, alcoholic cardiomyopathy, hyperthyroidism
- Concomitant terminal non-cardiac illnesses that could influence 12 month prognosis (e.g. advanced malignancy),
- Inability to acquire interpretable images (identified from baseline echo)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer. Allocation concealment to decision-makers regarding readmission.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation by random numbers generated by computer. Randomisation by computer access to central administration site before discharge to intervention vs usual care.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
n=412 based on assumption of a 90 day readmission rate of 40% and 33%; 206 subjects/group will have 80% power to show a difference in outcome at p=0.05
Analysis will be based upon intention to treat. The readmission and death rates in each arm will be compared using a chi square test. Survival analysis will be used to compare admissions and other events over 12 months. The effect size of the guided-DMP arm will be investigated using a logistic, linear and Cox models for readmissions, QOL and survival, respectively.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/03/2014
Date of last participant enrolment
Anticipated
30/09/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
412
Accrual to date
410
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 5778 0
Royal Hobart Hospital - Hobart
Recruitment hospital [2] 5779 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 13227 0
7000 - Hobart
Recruitment postcode(s) [2] 13228 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 293559 0
Government body
Name [1] 293559 0
NHMRC
Country [1] 293559 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Avenue, Hobart TAS 7005
Country
Australia
Secondary sponsor category [1] 292377 0
None
Name [1] 292377 0
Address [1] 292377 0
Country [1] 292377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294996 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 294996 0
Ethics committee country [1] 294996 0
Australia
Date submitted for ethics approval [1] 294996 0
15/09/2013
Approval date [1] 294996 0
09/10/2013
Ethics approval number [1] 294996 0
H0013550

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65730 0
Prof Thomas H Marwick
Address 65730 0
Baker-IDI Heart and Diabetes Institute,
75 Commercial Road,
Melbourne Vic 3004
Country 65730 0
Australia
Phone 65730 0
+61 3 8532 1550
Fax 65730 0
+61 3 8532 1160
Email 65730 0
[email protected]
Contact person for public queries
Name 65731 0
Thomas H Marwick
Address 65731 0
Baker-IDI Heart and Diabetes Institute,
75 Commercial Road,
Melbourne Vic 3004
Country 65731 0
Australia
Phone 65731 0
+61 3 8532 1550
Fax 65731 0
+61 3 8532 1160
Email 65731 0
[email protected]
Contact person for scientific queries
Name 65732 0
Thomas H Marwick
Address 65732 0
Baker-IDI Heart and Diabetes Institute,
75 Commercial Road,
Melbourne Vic 3004
Country 65732 0
Australia
Phone 65732 0
+61 3 8532 1550
Fax 65732 0
+61 3 8532 1160
Email 65732 0
[email protected]

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Patients admitted with heart failure were randomiz... [More Details]
Study results articleYes Huynh QL, Whitmore K, Negishi K, et al. Influence ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInfluence of Risk on Reduction of Readmission and Death by Disease Management Programs in Heart Failure.2019https://dx.doi.org/10.1016/j.cardfail.2019.01.015
N.B. These documents automatically identified may not have been verified by the study sponsor.