ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Cardiovascular

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]

Rehabilitation

Intervention code [2]

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]

All-cause mortality (HF and non-HF) will be determined by hospital records and/or telephone follow up.

Timepoint [1]

30 days post discharge

Primary outcome [2]

Hospital readmission will be determined by hospital medical records and/or telphone follow up.

Timepoint [2]

30 days post discharge.

Primary outcome [3]

Quality of life with Kansas City Cardiomyopathy Questionnaire (KCCQ).

Timepoint [3]

30 and 90 days post discharge

Secondary outcome [1]

Self-care will be measured with European Heart Failure Self-Care Behaviour Scale (EHFScB scale)

Timepoint [1]

30 and 90 days follow up

Secondary outcome [2]

All cause mortality post discharge.

Timepoint [2]

90 days

Secondary outcome [3]

Assessement of coexisting comorbidities from hospital medical records,

Timepoint [3]

30and 90 days post discharge

Secondary outcome [4]

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]

30 and 90 days post discharge

Secondary outcome [5]

Score of "Knowledge of Heart Failure Questionnaire"

Timepoint [5]

30 and 90 days post discharge

Secondary outcome [6]

HF knowledge with:
European Heart Failure Self-care Behavior Scale (EHFScBS)
Dutch Heart Failure Knowledge Scale (15 item scale).

Timepoint [6]

30 and 90 days

Secondary outcome [7]

Activity with Duke Activity Status Index (DASI)

Timepoint [7]

30 and 90 days

Secondary outcome [8]

Mood with Generalised Anxiety Disorder (GAD)-7

Timepoint [8]

30 and 90 days

Secondary outcome [9]

Cognitive function with Montreal Cognitive Assessment (MOCA)

Timepoint [9]

30 and 90 days

Secondary outcome [10]

All cause hospital readmission.
Investigator follow up with patients via interview. Study specific questionnaires are being used.

Timepoint [10]

90 days

Secondary outcome [11]

Lung Ultra Sound guided fluid treatment delivered by trained Nurses.
Investigator designed study specific questionnaire.

Timepoint [11]

30 and 90 days

Secondary outcome [12]

Characteristics and readmission rates of HF patients who failed participation.
Readmission rates will be determined by review of medical records.

Timepoint [12]

Characteristics and mortality rates of HF patients who failed participation.
Readmission rates will be determined by review of medical records.

Secondary outcome [13]

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]

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?

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]

The Alfred - Prahran

Recruitment hospital [2]

Western Hospital - Footscray - Footscray

Recruitment hospital [3]

Sunshine Hospital - St Albans

Recruitment hospital [4]

Royal Hobart Hospital - Hobart

Recruitment hospital [5]

Nepean Hospital - Kingswood

Recruitment postcode(s) [1]

3004 - Prahran

Recruitment postcode(s) [2]

3011 - Footscray

Recruitment postcode(s) [3]

3021 - St Albans

Recruitment postcode(s) [4]

7000 - Hobart

Recruitment postcode(s) [5]

2747 - Kingswood

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Baker Institute for Heart and Diabetes

Address [1]

75 Commercial ROad Melbourne, Vic 3004

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee [EC00315]

Ethics committee address [1]

55 Commercial Rd, Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/03/2018

Approval date [1]

04/07/2018

Ethics approval number [1]

HREC-18-Alfred-61 (Local Reference 149-18)

Ethics committee name [2]

Western Health SSA

Ethics committee address [2]

Level 3, Western Centre for Health, Research & Education (CHRE) Sunshine Hospital, Furlong Rd, St Albans, VIC 3021

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

09/07/2018

Approval date [2]

19/12/2018

Ethics approval number [2]

40036

Ethics committee name [3]

Tasmania Health and Medical HREC

Ethics committee address [3]

301 Sandy Bay Road Sandy Bay TAS 7005Building 1, Map Ref AC06

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

06/09/2019

Approval date [3]

22/11/2019

Ethics approval number [3]

18399

Summary

Brief summary

Heart Failure (HF), often accompanied by comorbidities, is characterised by high rates of death and hospital readmissions. Hospital readmissions consume beds and resources. There has been a lot of effort in the USA (less to date in Australia) to reduce them. This seems to vary from >30% at one month in Victoria and Tasmania, to 20% in South Australia. (CSANZ 2017). The disease management program (DMP) is one of the variables most associated with readmissions following index admission for HF. DMPs are expensive making their availability difficult, hence if applied uniformly to all patients, they may prove wasteful in low-risk, and insufficient, in high-risk patients.
Data from the TasHELP study have shown that such readmissions can be predicted (JAMA Cardiol 2016;1:362-4) and possibly prevented, opening the possibility of risk-based targeting of DMP.
This proposed PhD project, that will follow a prospective randomised controlled trial, will apply TAS-HELP risk algorithm focusing on intensities of HF DMPs to investigate its effectiveness in reducing 30-day readmission following HF diagnosis and lowering costs. 
Consecutive patients admitted for HF from July 2019 will be screened for eligibility and asked to participate following their informed consent. Enrolled patients will undergo evaluation of readmission risk and those 50% or more risk will be randomnised to usual care or intervention arm. 
The Victorian hospitals participating will include The Alfred Hospital and Western Health Footscray and Sunshine Hospitals.  The impact of comorbidities on readmission will also be evaluated. A secondary outcome of this RCT will focus on quality of life (QoL) measures and fluid status.
Patients in the control arm will receive hospital's usual care while those in the intervention arm will receive hospital care plus the following: 
DMP intensity adjusted for risk, based on five steps:
 i) adequate pre-discharge review of fluid status, ii) continuity of transitional care to the community, iii) a nurse-based home DMP lead by independent HF- Nurse, iv) surveillance and v) home-based pre-crisis management. In addition, the intervention group will be offered our HF app. This app is designed to deliver education for HF patients. It also measures QoL, HF Knowledge and self-care behaviors. Throughout the duration of the program which is 52 days, the patient records daily weight and is being given tasks and goals to achieve. The HF app is designed based on Heart Foundation guidelines.

This proposed RCT will provide the strongest possible evidence for a home based nursing follow up base on risk for hospital readmission. The novelty of this study is the intervention delivered by an independent health practitioner, ensuring external validity and the application of both an avatar style patient education program, as well as the addition of a portable echo assessment in patient’s home.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Thomas Marwick

Address

Baker Institute for Heart and Diabetes,
75 Commercial Road Melbourne, Vic, 3004

Country

Australia

Phone

+61 3 8532 1550

Fax

tom.marwick@baker.edu.au

Contact person for public queries

Name

George Zisis

Address

Baker Institute for Heart and Diabetes,
75 Commercial Road Melbourne, Victoria, 3004

Country

Australia

Phone

+61 3 8532 1550

Fax

george.zisis@baker.edu.au

Contact person for scientific queries

Name

George Zisis

Address

Baker Institute for Heart and Diabetes,
75 Commercial Road Melbourne, Victoria, 3004

Country

Australia

Phone

+61 3 8532 1550

Fax

george.zisis@baker.edu.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?

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

Source	Title	Year of Publication	DOI
Embase	Rationale and design of a risk-guided strategy for reducing readmissions for acute decompensated heart failure: the Risk-HF study.	2020	https://dx.doi.org/10.1002/ehf2.12897

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically