Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001273279
Ethics application status
Approved
Date submitted
12/07/2018
Date registered
27/07/2018
Date last updated
10/09/2023
Date data sharing statement initially provided
22/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Risk-guided strategy for reducing readmission for Acute Decompensated Heart Failure
Scientific title
Risk-guided strategy for reducing readmission for Acute Decompensated Heart Failure
Secondary ID [1] 295540 0
Nil known
Universal Trial Number (UTN)
U1111-1217-4134
Trial acronym
Risk-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 308807 0
Condition category
Condition code
Cardiovascular 307739 307739 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enrolled patients will undergo evaluation of risk for hospital readmission or death. Those at high risk ( 33% or more) will be randomized into usual care or our intervention DMP-Plus program. Our risk calculation is based on established algorithm developed with the ETHELRED trial and is based on social, clinical and imaging parameters.

Intervention Plan:
Hospitals standard usual care for outpatient follow up plus:

A Heart Failure nurse who will be working for this study and will be independent from patient’s usual care, will be delivering our DMP-Plus. The HF Nurse will follow the patient for a period of three months, as both an inpatient and outpatient and will 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.
Pre- discharge Lung and Inferior Vena Cava (IVC) assessment (LUICA) will be performed by obtaining images from patients chest from 9 spots, as per study operations manual, with a portable Ultra sound Device.
The HF nurse will follow up the patients once a fortnight at home for one month, for approximate 90minutes, to assess patient’s condition and protocol adherence. The nurse will also detect any problems and will determine if there are any gaps in patients HF education.

The intervention includes:
- A phone call assessment within a week post discharge, to provide post-discharge support and ask patient about his/hers condition. This support will be in addition to any potential scheduled follow ups by the hospital.
-Evaluation of coexisting comorbidities.
- Assessment of psychosocial risk factors including depression, anxiety and social factors. (e.g. Financial changes or relationship changes)

Intensified interaction with patients for three months. This includes assessment of functional capacity, fluid status, cardiac rhythm, cognitive, mood and nutritional status. During home visits assessment of volume/fluid status using our handheld echo (Lung Ultra Sound and IVC congestion), following the same procedures as our initial assessment. If there are changes in volume status, the study personnel will liaise with the care team to guide optimal diuretic treatment. Weight and vital signs records and assessments by the HF nurse. Medication review, including need for titration or change, and possible side effects.
The HF nurse will respond to changes by assessment of the precipitant, drug titration (especially diuretics and fluid restriction), and interaction with the hospital HF care team, patients GP, specialist and ED.
The HF nurse will also try to develop engagement strategy and built appropriate rapport with the patients. Patient’s adherence is critical, therefore engagement strategies need to be developed. Engagement strategies will include phone call support, tele monitoring with a diary that will have reminders or sms reminders and on line HF education.

Online- Heart Failure education
Staying Strong and Healthy with Heart Failure. An educational program that is available online was designed by the Baker heart and Diabetes Institute; University of Tasmania and Menzies Institute (https://www.youtube.com/watch?v=M_7lSKleczQ&t=364s) will be offered to patients to enhance education and HF knowledge. This video emphasizes in HF education main points and it will be offered in conjunction with other information and/or educational materials that will be given by the hospitals. The duration of the video is 8 minutes. A brief questionnaire of five multiple-choice questions will be administered at the end of the video.

A point of care assessment of Hb/Ht will be done using a Nova Stat Strip point of care device that uses plasma volume to assess the levels Hb and Ht. It assesses capillary blood drawn for the prick of the finger. During our follow up period LUICA and PoC Hb/Ht findings will be discussed with clinicians if patients are showing signs of congestion.

Patients that found to be at 32% risk or lower will be followed up at 90 days for primary and secondary outcome measures.
Intervention code [1] 301841 0
Rehabilitation
Intervention code [2] 301842 0
Behaviour
Comparator / control treatment
Usual Care

The control group for this study will be the usual care patients and it will consist the routine care of either the HARP or Healthlink programs. Control patients will be only followed up at 30 and 90- days via telephone calls and then they will be discharged from the study. In the event that a patient form the controls arm requires hospital admission they will be followed up in hospital and reasons for hospital readmission will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 306724 0
All-cause mortality (HF and non-HF) will be determined by hospital records and/or telephone follow up.
Timepoint [1] 306724 0
30 days post discharge
Primary outcome [2] 306832 0
Hospital readmission will be determined by hospital medical records and/or telphone follow up.
Timepoint [2] 306832 0
30 days post discharge.
Primary outcome [3] 306833 0
Quality of life with Kansas City Cardiomyopathy Questionnaire (KCCQ).
Timepoint [3] 306833 0
30 and 90 days post discharge
Secondary outcome [1] 349357 0
Self-care will be measured with European Heart Failure Self-Care Behaviour Scale (EHFScB scale)
Timepoint [1] 349357 0
30 and 90 days follow up
Secondary outcome [2] 349842 0
All cause mortality post discharge.
Timepoint [2] 349842 0
90 days
Secondary outcome [3] 349843 0
Assessement of coexisting comorbidities from hospital medical records,
Timepoint [3] 349843 0
30and 90 days post discharge
Secondary outcome [4] 349844 0
Assessment of clinical and laboratory markers related to hospital readmission will be obtained from medical records.
Biomarkers collected at baseline will be compared with those at hospital readmission for deterioration.
Biomarker to be recorded:

HB, HT, Lymphocytes,
ALK, ALT, GGT,
Urea, Uric Acid, LDH, Cholesterol, Triglycerides, Cr, eGFR, Glucose, Calcium, Potassium, Sodium, Mag, Albumin, CK, BNP,
NT-proBNP.
Timepoint [4] 349844 0
30 and 90 days post discharge
Secondary outcome [5] 349845 0
Score of "Knowledge of Heart Failure Questionnaire"
Timepoint [5] 349845 0
30 and 90 days post discharge
Secondary outcome [6] 349949 0
HF knowledge with:
European Heart Failure Self-care Behavior Scale (EHFScBS)
Dutch Heart Failure Knowledge Scale (15 item scale).
Timepoint [6] 349949 0
30 and 90 days
Secondary outcome [7] 349950 0
Activity with Duke Activity Status Index (DASI)
Timepoint [7] 349950 0
30 and 90 days
Secondary outcome [8] 349951 0
Mood with Generalised Anxiety Disorder (GAD)-7
Timepoint [8] 349951 0
30 and 90 days
Secondary outcome [9] 349952 0
Cognitive function with Montreal Cognitive Assessment (MOCA)
Timepoint [9] 349952 0
30 and 90 days
Secondary outcome [10] 380705 0
All cause hospital readmission.
Investigator follow up with patients via interview. Study specific questionnaires are being used.
Timepoint [10] 380705 0
90 days
Secondary outcome [11] 380706 0
Lung Ultra Sound guided fluid treatment delivered by trained Nurses.
Investigator designed study specific questionnaire.
Timepoint [11] 380706 0
30 and 90 days
Secondary outcome [12] 426552 0
Characteristics and readmission rates of HF patients who failed participation.
Readmission rates will be determined by review of medical records.
Timepoint [12] 426552 0
Characteristics and mortality rates of HF patients who failed participation.
Readmission rates will be determined by review of medical records.
Secondary outcome [13] 426553 0
Efficacy of a point of care device that measures Hemoglobin (Hb) and Hematocrit (Ht). A point of Care assessment (POCA) of Hb and Ht will be measured at discharge and at follow up home visits; the result will be used to determine associations with congestion evidence and LUICA.
Timepoint [13] 426553 0
discharge 14 days post-discharge 30 days post-discharge.

Eligibility
Key inclusion criteria
1. 18 years of age or older
2. Emergency Department admission with a primary diagnosis of Acute Decompensated Heart Failure confirmed by the treating physicians, in accordance with the HF guidelines.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to provide written informed consent to participate in this study
2. Patients that need palliative care. Discussion with the physician and assessment of palliative care needs.
3. Participating in another clinical research trial where randomisation to study arms would be unacceptable
4. Patients who live in an aged care facility (eg. Nursing Home)
5. Moderate to severe primary mitral or aortic valve disease
6. Concomitant unstable angina, acute myocardial infarction
7. Cardiac device malfunction
8. Endocarditis
9. Patients with Left Ventricular Assistant Device (LVAD)
10. Patients with asymptomatic Left Ventricular (LV) dysfunction
11. Potentially reversible LV dysfunction, such as post-partum, alcoholic cardiomyopathy, hyperthyroidism.
12. Abuse of alcohol or drugs
13. Concomitant terminal non-cardiac illnesses that could influence 12 month prognosis (e.g. advanced malignancy)
14. Inability to acquire interpretable images (identified from baseline echo)
Risk-guided strategy for reducing readmission for Acute Decompensated Heart Failure,
15. In the investigators opinion any other condition that may affect the safety procedures of the study. (patient and personnel)

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)
Allocation is concealled. An allocation schedule has been deployed and will run through external app/program. (RedCap)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block (per site), Stratified by HF type (HrEF or HFpEF), randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analyses will be performed using standard software (STATA 15, Statacorp, College Station, TX). Analysis will be based upon intention to treat. Time-to-event analyses (Cox proportional hazards to model mortality or competing risk regressions to model readmission) will be used to investigate study outcomes. The 30-day readmission rates in each arm will be compared using a chi square test, and QoL using the KCCQ will be compared with a t-test and Mann-Whitney test. Survival analysis will be used to compare admissions and other events over 30 days. The effect-size of the guided-DMP arm will be investigated using Cox models for readmissions and survival, respectively. Quality of life measures over time will be analyzed using the Generalized Estimating Equations (GEE) approach.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/03/2019
Actual
13/08/2019
Date of last participant enrolment
Anticipated
Actual
23/11/2021
Date of last data collection
Anticipated
Actual
30/04/2022
Sample size
Target
404
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
Recruitment hospital [1] 11434 0
The Alfred - Prahran
Recruitment hospital [2] 11435 0
Western Hospital - Footscray - Footscray
Recruitment hospital [3] 11436 0
Sunshine Hospital - St Albans
Recruitment hospital [4] 14723 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 25505 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 23442 0
3004 - Prahran
Recruitment postcode(s) [2] 23443 0
3011 - Footscray
Recruitment postcode(s) [3] 23444 0
3021 - St Albans
Recruitment postcode(s) [4] 27765 0
7000 - Hobart
Recruitment postcode(s) [5] 41317 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 300117 0
Charities/Societies/Foundations
Name [1] 300117 0
Baker Institute for Heart and Diabetes
Country [1] 300117 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Baker Institute for Heart and Diabetes
Address
75 Commercial ROad Melbourne, Vic 3004
Country
Australia
Secondary sponsor category [1] 299517 0
None
Name [1] 299517 0
Address [1] 299517 0
Country [1] 299517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300957 0
Alfred Hospital Ethics Committee [EC00315]
Ethics committee address [1] 300957 0
Ethics committee country [1] 300957 0
Australia
Date submitted for ethics approval [1] 300957 0
19/03/2018
Approval date [1] 300957 0
04/07/2018
Ethics approval number [1] 300957 0
HREC-18-Alfred-61 (Local Reference 149-18)
Ethics committee name [2] 304255 0
Western Health SSA
Ethics committee address [2] 304255 0
Ethics committee country [2] 304255 0
Australia
Date submitted for ethics approval [2] 304255 0
09/07/2018
Approval date [2] 304255 0
19/12/2018
Ethics approval number [2] 304255 0
40036
Ethics committee name [3] 313786 0
Tasmania Health and Medical HREC
Ethics committee address [3] 313786 0
Ethics committee country [3] 313786 0
Australia
Date submitted for ethics approval [3] 313786 0
06/09/2019
Approval date [3] 313786 0
22/11/2019
Ethics approval number [3] 313786 0
18399

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

Contacts
Principal investigator
Name 85410 0
Prof Thomas Marwick
Address 85410 0
Baker Institute for Heart and Diabetes,
75 Commercial Road Melbourne, Vic, 3004
Country 85410 0
Australia
Phone 85410 0
+61 3 8532 1550
Fax 85410 0
Email 85410 0
[email protected]
Contact person for public queries
Name 85411 0
George Zisis
Address 85411 0
Baker Institute for Heart and Diabetes,
75 Commercial Road Melbourne, Victoria, 3004
Country 85411 0
Australia
Phone 85411 0
+61 3 8532 1550
Fax 85411 0
Email 85411 0
[email protected]
Contact person for scientific queries
Name 85412 0
George Zisis
Address 85412 0
Baker Institute for Heart and Diabetes,
75 Commercial Road Melbourne, Victoria, 3004
Country 85412 0
Australia
Phone 85412 0
+61 3 8532 1550
Fax 85412 0
Email 85412 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified/Raw data , study questionnaires, demographics, clinical data.
When will data be available (start and end dates)?
after the end of the project (march 2019 to march 2022) and after first publication, if any.
Available to whom?
Questionnaires copyrights authors and anyone who may ask for the data will be considered by case to case basis and to the discretion of the Chief investigator, the principal investigator (PhD student for this project).
Available for what types of analyses?
Related to the approved study protocol
How or where can data be obtained?
send encrypted email or grant temporary access to Baker secured server (study folder and requested file only)


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
SourceTitleYear of PublicationDOI
EmbaseRationale and design of a risk-guided strategy for reducing readmissions for acute decompensated heart failure: the Risk-HF study.2020https://dx.doi.org/10.1002/ehf2.12897
N.B. These documents automatically identified may not have been verified by the study sponsor.