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Trial registered on ANZCTR


Registration number
ACTRN12619000055101
Ethics application status
Approved
Date submitted
19/11/2018
Date registered
15/01/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
15/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot ranDomisEd trial of nurSe-led patIent follow-up using a diGital platform to reduce re-admissioNs after an acute presentation with Heart Failure. (DESIGN-HF)
Scientific title
A pilot ranDomisEd trial of nurSe-led patIent follow-up using a diGital platform to reduce re-admissioNs after an acute presentation with Heart Failure. (DESIGN-HF)
Secondary ID [1] 296378 0
Nil known
Universal Trial Number (UTN)
U1111-1222-6594
Trial acronym
DESIGN-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 310121 0
Public health 310629 0
Condition category
Condition code
Cardiovascular 308872 308872 0 0
Other cardiovascular diseases
Public Health 309349 309349 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DESIGN-HF is a randomised study to measure the usefulness of the Personify Care clinical pathway/ surveillance platform to both the patient and heart failure (HF) care team, and assess its potential impact on HF hospital readmission. Potential participants will be assessed for their ability to use a website on a digital system (eg. mobile phone, tablet, or computer) and regularity of access to such a device and internet/wifi. This will determine if participants are eligible to take part in the study.

The assessments conducted by Heart failure nurses (HFN) have been translated into a digital platform, PersonifyHF. After gaining informed consent, participants randomised to the intervention arm will receive a text message prompting them to register on the PersonifyHF platform. During the follow-up period participants are prompted via text messages to log in and complete assessments usually performed over the phone by a HFN. During the online assessments participants will be prompted to answer additional questions depending on answers given. This includes the additional questions the HFN asks as part of ascertaining overall status of their heart failure patient, and rephrases certain formal assessment questions in the same manner the HFN does while speaking with the patient when conducting such assessments over the phone. If certain answers to particular questions are given the participant will be prompted to take action which include calling an ambulance in the case of a life threatening emergency or to contact the HFN within a given time frame (e.g. within 2 hours). Depending on answers given in the assessment the database will flag the HFN to contact the participant within a certain time frame. The HFN will also be flagged to contact the participant if the online assessment has not been completed within 4 working days of scheduled. When the database flags a participants response the HFN will receive a text message informing them of the timeframe required to respond. The frequency of assessments are the same as standard telephone follow-up. The standard care model for HF post-discharge follow-up is based on the Australian Heart Foundation Heart Failure Clinical Guidelines. A more detailed description of the follow-up timeframes are given below.

Recruited participants will be randomised 1:1 to the intervention and the standard care control:

Control: Standard evidence-based transition of care nursing model; specifically:
• Standard home visit 1-week post-discharge
• Follow-up phone calls by nurse at 2, 4, and 6 weeks post-discharge
• Follow-up phone calls by nurse at 3 and 6 months post-discharge
• Nurse-initiated additional clinical care as directed by patient response, eg. investigative testing, medication adjustment, clinical appointments.

Intervention: Protocolised contact and clinical care guided by nurse surveillance of patient-entered data using the Personify Care platform synergistically with the standard evidence-based transition of care nursing model; specifically:
• Standard home visit 1-week post-discharge
• Nurse surveillance of patient-entered data at 2, 4, and 6 weeks post-discharge
• Nurse surveillance of patient-entered data at 3 and 6 months post-discharge
• Nurse-initiated additional clinical care as directed by patient response, eg. investigative testing, medication adjustment, clinical appointments.

Both groups:
• Except for the digital platform evaluation which will be provided to the intervention group at the 6 month visit, all assessments throughout the project are as per standard HF care but via different methods for initial communication.
• All participants will receive a standard, evidence-based transition of care home visit at 1 week post-discharge, regardless of study randomisation.
Intervention code [1] 312714 0
Other interventions
Comparator / control treatment
Standard evidence-based transition of care nursing model; specifically:
• Standard home visit 1-week post-discharge
• Follow-up phone calls by nurse at 2, 4, and 6 weeks post-discharge
• Follow-up phone calls by nurse at 3 and 6 months post-discharge
• Nurse-initiated additional clinical care as directed by patient response, eg. investigative testing, medication adjustment, clinical appointments.
Control group
Active

Outcomes
Primary outcome [1] 307842 0
The primary endpoint of this study will be defined as re-admission to hospital for heart failure, evidenced by breathlessness and clinical signs of volume overload (elevated JVP, crepitations in lung fields, or SOA) together with an elevated NT-proBNP, or via admission to hospital with ICD-10AM code of I50.X in any of the top 5 diagnosis positions. This outcome will be sourced from hospital records and databases.
Timepoint [1] 307842 0
12 Months post hospital discharge
Primary outcome [2] 307843 0
Evaluation of cost-effectiveness: HF specialist nursing care utilisation will be measured and compared between standard care and intervention arms over the length of the follow-up. Utilisation of nursing care will be assessed by logging the time needed by the HF nurse on each participant including; face to face, telephone, and online review of patient entered data. The HF nurse will keep a log of all time spent engaged in nursing care for each participant.
Timepoint [2] 307843 0
12 Months post hospital discharge
Secondary outcome [1] 353107 0
Death: All cause mortality and cardiovascular mortality
Timepoint [1] 353107 0
12 Months post hospital discharge
Secondary outcome [2] 353108 0
Days free from hospital admission: From a patient-focused perspective, this outcome will measure the total number of days spent admitted/not admitted to an acute care/rehabilitation facility as a proportion of their follow-up duration. This outcome will be assessed from hospital records and data linkage to medical records.
Timepoint [2] 353108 0
12 Months post hospital discharge
Secondary outcome [3] 353109 0
Myocardial infarction: chest pain/discomfort associated with a rise and fall in serum troponin, or a new myocardial wall motion defect on echocardiography and consistent with the Universal Definition. This outcome will be assessed from hospital records and data linkage to medical records.
Timepoint [3] 353109 0
12 Months post hospital discharge
Secondary outcome [4] 355106 0
Total resource utilisation over the length of follow-up will be obtained from hospital and centrally-collected SA Health data to provide estimates of in- and out-of-hospital costs.
Timepoint [4] 355106 0
12 months post hospital discharge
Secondary outcome [5] 355107 0
Stroke: New onset neurological defect consistent with a single contiguous vascular territory, with supportive cerebral imaging. This outcome will be assessed from hospital records and data linkage to medical records.
Timepoint [5] 355107 0
12 months post hospital discharge
Secondary outcome [6] 355108 0
Cardiovascular Hospitalisation including; coronary revascularization (PCI or CABG); cerebrovascular accidents with supportive cerebral imaging; atrial or ventricular cardiac arrhythmias; CCF without myocardial infarction; peripheral vascular revascularization; unstable angina, reoperation for surgical bleeding; surgical wound infection; pericardial effusion; and valvular dysfunction as documented by a hospital discharge summary or diagnosis-related group report.
Timepoint [6] 355108 0
12 months post hospital discharge

Eligibility
Key inclusion criteria
1. Primary diagnosis of heart failure (HFREF or HFPEF) for whom transition of care nursing support is planned.
2. Documented ability to interact with an electronic platform and confirmed regular access to device and internet/wifi.
3. Aged >18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability or unwillingness to provide informed consent.
2. Dementia or significant cognitive impairment of any cause (eg including delirium, hypoxia) as per judgement of clinical care provider(s).
3. Life-expectancy of <12 months, as determined by treating specialist.
4. Inability to understand English or sufficient visual impairment such as would be unable to understand instructions within the platform, unless sufficient reliable access to help is available eg next of kin.

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)
Allotment will be revealed by study staff (3 contacts- primary, secondary, and tertiary) to the study coordinator at the time of participant enrolment. Allocation will involve contacting the holder of the allocation schedule located at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation. An online randomisation generator will split the 100 participants into two groups via blocks of four, and double checked via review and data filtering of the resultant excel output
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
This study is a pilot study and is not powered to address clinical outcomes. Nevertheless, the planned enrollment of 100 patients (50 per arm) will provide >90% power to detect a halving of HF specialist nurse time per patient, assuming a baseline of 3 hours (SD± 1.5hours), while providing an estimate of clinical safety (greater re-admission rates). These event rates will be used to inform the design of a definitive study.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
28/01/2019
Actual
16/04/2019
Date of last participant enrolment
Anticipated
16/04/2020
Actual
25/07/2019
Date of last data collection
Anticipated
16/04/2021
Actual
25/07/2019
Sample size
Target
100
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12213 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 24392 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 300981 0
Commercial sector/Industry
Name [1] 300981 0
Personify Care
Country [1] 300981 0
Australia
Funding source category [2] 300983 0
Government body
Name [2] 300983 0
Australian Government Department of Industry, Innovation and Science
Country [2] 300983 0
Australia
Primary sponsor type
University
Name
Flinders University of South Australia
Address
Sturt Road, Bedford Park, South Australia 5042
Country
Australia
Secondary sponsor category [1] 300565 0
Hospital
Name [1] 300565 0
Flinders Medical Centre
Address [1] 300565 0
1 Flinders Drive, Bedford Park, South Australia 5042
Country [1] 300565 0
Australia
Secondary sponsor category [2] 300567 0
Government body
Name [2] 300567 0
SA Health
Address [2] 300567 0
Citi Centre Building, 11 Hindmarsh Square, Adelaide South Australia 5000
Country [2] 300567 0
Australia
Other collaborator category [1] 280399 0
Commercial sector/Industry
Name [1] 280399 0
Personify Care
Address [1] 280399 0
Ground Floor, 10 Pulteney Street, Adelaide, South Australia, 5000
Country [1] 280399 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301743 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 301743 0
Ethics committee country [1] 301743 0
Australia
Date submitted for ethics approval [1] 301743 0
14/12/2018
Approval date [1] 301743 0
07/01/2019
Ethics approval number [1] 301743 0
HREC/19/SAC/1

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

Contacts
Principal investigator
Name 87962 0
Prof Derek Chew
Address 87962 0
Flinders Medical Centre, 1 Flinders Drive, Bedford Park 5042 South Australia
Country 87962 0
Australia
Phone 87962 0
+61 884042001
Fax 87962 0
Email 87962 0
derek.chew@flinders.edu.au
Contact person for public queries
Name 87963 0
Erin Morton
Address 87963 0
Flinders Medical Centre- Cardiology
Level 6, Rm 6R347
1 Flinders Drive Bedford Park SA 5042
Country 87963 0
Australia
Phone 87963 0
+61 8 82045836
Fax 87963 0
Email 87963 0
erin.morton@flinders.edu.au
Contact person for scientific queries
Name 87964 0
Erin Morton
Address 87964 0
Flinders Medical Centre- Cardiology
Level 6, Rm 6R347
1 Flinders Drive Bedford Park SA 5042
Country 87964 0
Australia
Phone 87964 0
+61 8 82045836
Fax 87964 0
Email 87964 0
erin.morton@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.