Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000002583
Ethics application status
Approved
Date submitted
23/10/2023
Date registered
8/01/2024
Date last updated
8/02/2024
Date data sharing statement initially provided
8/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Early Discharge to Clinic-Based Therapy of Patients Presenting with Heart Failure (EDICT-HF Trial)
Scientific title
Early Discharge to Clinic-Based Therapy of Patients Presenting with Decompensated Heart Failure: A Multi-Centre Randomised Controlled Trial Assessing Impact on Hospital Readmission Rates (EDICT-HF Trial)
Secondary ID [1] 310837 0
none
Universal Trial Number (UTN)
Trial acronym
EDICT-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 331845 0
Condition category
Condition code
Cardiovascular 328590 328590 0 0
Other cardiovascular diseases
Public Health 328954 328954 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves patients presenting to the emergency department or admitted for less than 48 hours with ADHF (acute decompensated heart failure) receiving active management in the out-of-hospital setting. The intervention commences for each participant once they are discharged either directly from the emergency department or within 48 hours of inpatient admission. This will involve a hybrid care model, involving three times weekly reviews in a cardiologist-run clinic alongside daily home reviews by Hospital in the Home (HITH) medical and nursing staff until cleared for discharge from active management. Cardiology clinic reviews will be 30-minute one-on-one face-to-face consults (with a cardiologist/other medical staff plus case discussion with a cardiologist) at Sunshine Hospital. Home reviews will involve 30-minute reviews at least daily, or more frequently as directed by the HITH team, face-to-face at the participant's home. The cardiology clinic reviews will involve implementing appropriate investigation and management according as directed by the treating cardiologist for their ADHF. ADHF management typically involves titrating oral or intravenous diuresis, introducing or titrating medications for heart failure mortality benefit, investigating/addressing the underlying cause of decompensation, correcting iron deficiency anaemia, and monitoring daily weights and haemodynamics. The priority of HITH reviews will be to monitor haemodynamics, daily weights and fluid balance, and titrate/administer required medications. This adherence to the intervention will be assessed by attendance of HITH daily home reviews and attendance at clinic reviews. The overall duration of the intervention involving this hybrid care model is expected to run over two years.
Intervention code [1] 327247 0
Treatment: Other
Comparator / control treatment
Comparator/control group: Usual inpatient ward-based hospital care. Patient treatment will be as directed by the consulting ward cardiologist until deemed suitable for discharge from active management.
Control group
Active

Outcomes
Primary outcome [1] 336391 0
30-day readmission rate
Timepoint [1] 336391 0
30 days from discharge from active outpatient / inpatient care.
Secondary outcome [1] 428137 0
1. Hospitalisation at 30-days
Timepoint [1] 428137 0
30 days from discharge from active inpatient / outpatient-based care.
Secondary outcome [2] 428138 0
2. Composite clinical endpoints (Major adverse cardiac and cerebrovascular event (MACCE))
Timepoint [2] 428138 0
3 months after end of active treatment
Secondary outcome [3] 428139 0
3. Achievement of guideline-directed medical therapy
Timepoint [3] 428139 0
Measured at conclusion of active treatment
Secondary outcome [4] 428140 0
4. Difference in patient global assessment of symptoms
Timepoint [4] 428140 0
Baseline, daily until conclusion of active treatment, 30 days from conclusion of active treatment, 90 days from conclusion of active treatment
Secondary outcome [5] 428141 0
5. Attendance at 3 month outpatient follow up
Timepoint [5] 428141 0
90 days following end of active treatment
Secondary outcome [6] 428142 0
6. Total number of bed stays/clinics attended
Timepoint [6] 428142 0
Calculated at conclusion of active treatment
Secondary outcome [7] 428143 0
7. Proportion of patients free from congestion
Timepoint [7] 428143 0
Baseline, daily until conclusion of active treatment, 30 days from conclusion of active treatment, 90 days from conclusion of active treatment
Secondary outcome [8] 428144 0
8. Change in creatinine
Timepoint [8] 428144 0
Baseline, 2nd daily until conclusion of active treatment, 30 days from conclusion of active treatment, 90 days from conclusion of active treatment
Secondary outcome [9] 428145 0
9. Treatment for electrolyte disturbances
Timepoint [9] 428145 0
Calculated at conclusion of active treatment
Secondary outcome [10] 428146 0
10. Time to transition from intravenous to oral diuretics
Timepoint [10] 428146 0
Calculated at conclusion of active treatment
Secondary outcome [11] 428147 0
Cost-benefit analysis
Timepoint [11] 428147 0
Calculated at conclusion of active treatment
Secondary outcome [12] 429542 0
Cost-utility analysis
Timepoint [12] 429542 0
Calculated at conclusion of active treatment
Secondary outcome [13] 429543 0
Incremental cost effectiveness ratio
Timepoint [13] 429543 0
Calculated at conclusion of active treatment

Eligibility
Key inclusion criteria
• Adult patients (>18 years) presenting to Sunshine Hospital / Footscray Hospital emergency department with ADHF
• Patients admitted to an inpatient ward at Sunshine Hospital / Footscray Hospital with ADHF for <48hrs
• Presentation of ADHF will be determined according to clinical presence of at least 1 relevant symptom and sign:
o Symptoms: Dyspnoea, orthopnoea, oedema
o Signs: Rales, peripheral oedema, ascites, pulmonary vascular congestion on chest radiography
• Raised B-Type Natriuretic Peptide (BNP) (>30 pmol/L)
• Informed consent is able to be received from participant
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Haemodynamic instability: Systolic blood pressure <90mmHg or >180mmHg or Heart Rate >100 bpm or <60bpm
• Raised oxygen requirements: Oxygen saturation < 93% on Room Air or Respiratory rate >24 breaths/min
• Serum creatinine >250 umol/L +/- estimated glomerular filtration rate <30 ml/min/1.73m2
• Elevated Serum C-Reactive Protein (CRP) >50 mg/L
• Intravenous vasodilatory or ionotropic agent requirement (excluding Digoxin)
• Febrile >38 degrees Celsius or clinical suspicion of infection
• Evidence of consolidation on chest radiography
• Inpatient admission >48hrs
• Meeting Fourth Universal Definition of Myocardial Infarction criteria
• Unstable arrhythmia (ventricular or supraventricular arrhythmia associated with haemodynamic instability or symptoms)
• Unsafe home discharge environment
• Social or language barriers limiting capacity to gain informed consent

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design stratified by 1) LVEF >/=40% or <40% and by 2) hospital presentation site
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size estimated were obtained from the Western Health Heart Failure Collaborative Dataset for the 2 clinical sites used in this trial. In the years 2021-2022 there were a total of 466 admissions with Heart failure with 74 having a readmission within 30-days (15.9%, 95% CI 12.7% – 19.5%). Non-inferiority margin of 10% (absolute value) was chosen due to a number of reasons. Firstly, a lack of high quality data on event rates for clinic-based management versus ward-based care makes it difficult to identify an appropriate non-inferiority margin. We also believe that the complexity of management patients with heart failure precludes simplified dichotomous decision making and necessitates some leeway for individual decision making. Additionally, the benefit of an early discharge would likely outweigh the risks associated for participants in the intervention group, particularly given these participants will be closely monitored by medical staff daily and are receiving active management. Furthermore, participants in this study and therefore in the intervention group are considered lower risk ADHF patients given strict exclusion criteria. Accordingly, a higher re-admission rate in the intervention group reflected in this chosen non-inferiority margin would not necessarily significantly impact the health of participants, given their initial admission rate is inherently lowered and re-admission in this cohort does not necessarily correlate with worse outcomes given they are still being actively managed and receiving frequent monitoring and consultant review. Given the above, any tangible health outcomes in the case of a higher re-admission rate within this margin in this group is unlikely to be worse. Finally, following consultation with experienced consultant cardiologists with special interest and expertise in heart failure management, this non-inferiority margin was deemed clinically appropriate.
To declare non-inferiority using absolute 10% non-inferiority margin, two-sided 5% type I error with 80% power (assuming event rate of 16% in both groups), a total of 434 participants are required. Given active follow-up to collect primary outcome and based on trends from existing lost-to-follow-up data from the Western Health Heart Failure Collaborative Dataset, we expect minimal loss-to follow-up (5%) therefore a total of 460 participants will be randomised (230 per arm).

A median of 34(IQR,21-47) patients are admitted with ADHF at Western Health each month, which will support the targeted sample size recruitment within 3 years factoring drop-outs, logistical issues and exclusion of patients unable to consent. Prior demonstration of the safety and efficacy of this concept with a small sample size in October 2021 also indicates a feasible study concept, delivery method, and capacity to be implemented at a larger scale. Cross-departmental collaboration with clinical stakeholders has supported positive uptake of this trial to facilitate its delivery. Adequate staff are available through utilising established participating services, such as RACER clinic, HITH, and the cardiology department, to implement and support the longevity of the trial. Adequate training has already been providing to clinicians, including nurse-practitioners for conducting ADHF-specific reviews, and cardiology advanced trainees for performing PICC insertions.

Overall baseline characteristics will be presented as mean ± SD or median [IQR] and frequency (percentage). All analyses will be performed according to the intention-to-treat principle with additional per protocol analysis given anticipated minimal cross-over of participants to alternate randomisation groups, particularly considering the expected benefit to participants in the intervention group of being actively managed in the comfort of their home without necessitating admission. Accordingly, an intention-to-treat analysis is unlikely to be biased towards demonstrating non-inferiority. Primary analysis will be using generalized linear model with binomial family and identity link to estimate the risk difference between intervention and control. Model will also include adjustment for variable used as strata in randomisation. Results will be presented with two-sided 95% confidence intervals and non-inferiority will be determined if upper limit of the confidence interval does not cross non-inferiority margin of 10%.
Subgroup analysis will be performed by including the subgroup indicator and the interaction between the subgroup and treatment arm in the generalised linear model.
All other binary outcomes will be analysed in the same manner, count outcomes will be analysed using negative binomial regression while linear regression will be used for continuous outcomes. Time to event outcomes will be analysed using Kaplan-Meier curves and Cox regression.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/02/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
460
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25762 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 25763 0
Footscray Hospital - Footscray
Recruitment postcode(s) [1] 41588 0
3021 - St Albans
Recruitment postcode(s) [2] 41589 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 315082 0
Hospital
Name [1] 315082 0
Sunshine Hospital
Country [1] 315082 0
Australia
Primary sponsor type
Individual
Name
Dr Ben Costello
Address
Sunshine Hospital, 176 Furlong Rd St Albans VIC 3021 Australia
Country
Australia
Secondary sponsor category [1] 317105 0
None
Name [1] 317105 0
Address [1] 317105 0
Country [1] 317105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314030 0
Royal Melbourne Hospital HREC
Ethics committee address [1] 314030 0
Ethics committee country [1] 314030 0
Australia
Date submitted for ethics approval [1] 314030 0
28/09/2022
Approval date [1] 314030 0
07/09/2023
Ethics approval number [1] 314030 0
HREC Reference Number: HREC/89710/MH-2022. Royal Melbourne Hospital Site Reference Number: 2022.268

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

Contacts
Principal investigator
Name 130178 0
Dr Mark Ranasinghe
Address 130178 0
Sunshine Hospital, 176 Furlong Rd, St Albans, VIC 3021 Australia
Country 130178 0
Australia
Phone 130178 0
+61 432457457
Fax 130178 0
Email 130178 0
pimalr@gmail.com
Contact person for public queries
Name 130179 0
Ben Costello
Address 130179 0
Sunshine Hospital, 176 Furlong Rd, St Albans, VIC 3021 Australia
Country 130179 0
Australia
Phone 130179 0
+61 421693130
Fax 130179 0
Email 130179 0
Ben.Costello@wh.org.au
Contact person for scientific queries
Name 130180 0
Ben Costello
Address 130180 0
Sunshine Hospital, 176 Furlong Rd, St Albans, VIC 3021 Australia
Country 130180 0
Australia
Phone 130180 0
+61 421693130
Fax 130180 0
Email 130180 0
Ben.Costello@wh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data of primary outcomes only
When will data be available (start and end dates)?
Start date - 8/1/24
End date - 8/1/27
Available to whom?
Other researchers for the purpose of achieving the aims in the approved proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Mark.Ranasinghe@wh.org.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20724Study protocol    386780-(Uploaded-23-10-2023-17-46-52)-Study-related document.docx
20725Informed consent form    386780-(Uploaded-23-10-2023-17-49-11)-Study-related document.pdf
20726Ethical approval    386780-(Uploaded-23-10-2023-17-49-45)-Study-related document.pdf



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.