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Trial registered on ANZCTR


Registration number
ACTRN12620001069943
Ethics application status
Approved
Date submitted
1/07/2020
Date registered
19/10/2020
Date last updated
19/10/2020
Date data sharing statement initially provided
19/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An Intervention to improve Primary Care Adherence To Heart Failure guidelines IN Diagnosis, Evaluation & Routine management (PATHFINDER) pilot program
Scientific title
An Intervention to improve Primary Care Adherence To Heart Failure guidelines IN Diagnosis, Evaluation & Routine management (PATHFINDER) pilot program
Secondary ID [1] 301671 0
Nil Known
Universal Trial Number (UTN)
U1111-1253-9661
Trial acronym
PATHFINDER (Primary Care Adherence To Heart Failure guidelines IN Diagnosis, Evaluation & Routine management )
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure
317975 0
Condition category
Condition code
Cardiovascular 316009 316009 0 0
Other cardiovascular diseases
Public Health 316432 316432 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) Physical or informational materials used: There are two distinct components to the PATHFINDER intervention, i.e. the information/resources provided to the patients and the medication titration plan etc. for GPs. Heart failure (HF) education materials will be given to patients to support self-management ; heart failure medication titration plans will be provided to patients’ GPs to support titrating medication to target dose.
b) each of the procedures, activities, and/or processes used: HF education to patients upon discharge; medication titration support for GP post-discharge with cardiologist support through the Advanced Heart Failure and Cardiac Transplant Service (FSH); The type of support for GPs will be medication titration plan at discharge; unlimited phone calls or video-conferencing for case management. The NP will review the case initially and provide recommendations that are within their scope of practice. For more complex cases and those that are outside their scope of practice they will escalate the case to a cardiologist who will review and provide recommendations.
c) who will deliver the intervention: the study HF nurse practitioner (NP) will deliver the heart failure education after enrolment and medication titration plan upon discharge; HF NP will triage and facilitate medication titration support. GPs will receive the medication titration plan after the patient gets discharge. If the GP needs support, they will contact the HF NP in the first instance, who will either provide advice or escalate to a cardiologist as described at b).
d) the mode of delivery: face-to-face of heart failure education; via telephone or video conference to support medication titration
e) the number of times the intervention will be delivered and over what period of time: HF education 1 session *1 hour; GP/NP interactions will be ad hoc (as needed).
f) the location/setting where the intervention occurs: FSH
g) any strategies used to assess or monitor adherence or fidelity to the intervention: audit and feedback from patients/GPs
Intervention code [1] 317899 0
Treatment: Other
Intervention code [2] 318311 0
Behaviour
Comparator / control treatment
The Usual Care (Control) Group will receive standard inpatient and outpatient care, without additional heart failure management support being provided to either the patient or the GP.
These are based on current heart failure guideline, that is , "National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand: Guidelines for the Prevention, Detection, and Management of Heart Failure in Australia 2018"
Control group
Active

Outcomes
Primary outcome [1] 324214 0
6 minutes walk test will be used to test functional capacity
Timepoint [1] 324214 0
baseline-following enrolment, 8 weeks post-enrolment (primary timepoint) and 6 months post-enrolment
Secondary outcome [1] 384087 0
Kansas City Cardiomyopathy Questionnaire-short version (KCQ12) ---patient-reported symptoms, function and quality of life for patients with heart failure
Timepoint [1] 384087 0
8 weeks post-enrolment and 6 months post-enrolment
Secondary outcome [2] 385555 0
PROMIS Physical Function Short Form 4a---physical function
Timepoint [2] 385555 0
8 weeks post-enrolment and 6 months post-enrolment
Secondary outcome [3] 385556 0
Patient Health Questionnaire (PHQ-2)--depression screening
Timepoint [3] 385556 0
8 weeks post-enrolment and 6 months post-enrolment
Secondary outcome [4] 385557 0
Self-care of Heart Failure Index
Timepoint [4] 385557 0
8 weeks post-enrolment and 6 months post-enrolment
Secondary outcome [5] 385558 0
Medication Compliance Questionnaire
Timepoint [5] 385558 0
8 weeks post-enrolment and 6 months post-enrolment
Secondary outcome [6] 385559 0
Numbers of re-admission to hospital by medical records confirmed by participant report.
Timepoint [6] 385559 0
8 weeks post-enrolment and 6 months post-enrolment
Secondary outcome [7] 385560 0
All-cause mortality by medical records confirmed by participant report.
Timepoint [7] 385560 0
8 weeks post-enrolment and 6 months post-enrolment
Secondary outcome [8] 387051 0
Length of stay for those readmitted to hospital by medical records, hospital records.
Timepoint [8] 387051 0
8 weeks post-enrolment and 6 months post-enrolment

Eligibility
Key inclusion criteria
men and women over the age of 18 years with a diagnosis of CHF, able to identify provide contact details of a primary care general practitioner, willing to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients attending the Advanced Heart Failure Service (FSH), patients who need CHF palliative care, nursing homes/assisted living residents.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16995 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 16996 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 30660 0
6000 - Perth
Recruitment postcode(s) [2] 30659 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 305309 0
University
Name [1] 305309 0
Curtin University
Address [1] 305309 0
Kent St, Bentley WA 6102
Country [1] 305309 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 306493 0
None
Name [1] 306493 0
Address [1] 306493 0
Country [1] 306493 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305648 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 305648 0
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH WA 6150
Ethics committee country [1] 305648 0
Australia
Date submitted for ethics approval [1] 305648 0
Approval date [1] 305648 0
13/05/2020
Ethics approval number [1] 305648 0
RGS0000003531
Ethics committee name [2] 306262 0
the Curtin University Human Research Ethics Committee
Ethics committee address [2] 306262 0
GPO Box U1987
Perth Western Australia 6845
Ethics committee country [2] 306262 0
Australia
Date submitted for ethics approval [2] 306262 0
Approval date [2] 306262 0
15/06/2020
Ethics approval number [2] 306262 0
HRE2020-0322

Summary
Brief summary
The project's aim is to conduct a pilot randomised controlled trial to determine the efficacy of PATHFINDER on patient-reported outcomes for CHF over a 6-month period.
Two hundred patients with CHF will be randomised to receive the PATHFINDER Heart Health Plan or control (usual care). For the PATHFINDER group, the project’s Nurse Practitioner (NP) will help facilitate the transition from tertiary to primary care including a Heart Health Plan, and be a point of contact for GPs needing support for medication titration. Referrals for multidisciplinary management will be facilitated by the NP, with input from other Allied Health Professionals. Complex issues will be triaged for cardiologist support through the Advanced Heart Failure and Cardiac Transplant Service (FSH). Patient-reported outcomes include 6 minute walk test distance(primary outcome), Kansas City Cardiomyopathy Questionnaire-short version (KCQ12), PROMIS Physical Function Short Form 4a, Patient Health Questionnaire (PHQ-2),Self-care of Heart Failure Index, Medication Compliance Questionnaire (secondary outcome) will be measured at 8-week and 6 -month follow-up.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101082 0
A/Prof Andrew Maiorana
Address 101082 0
Andrew Maiorana, School of Physiotherapy and Exercise Science, Curtin University,
Kent St, Bentley WA 6102
Country 101082 0
Australia
Phone 101082 0
+61 8 9266 9225
Fax 101082 0
+61 8 9266 3699
Email 101082 0
A.Maiorana@curtin.edu.au
Contact person for public queries
Name 101083 0
Ms Zoe Dai
Address 101083 0
Fiona Stanley Hospital,
11 Robin Warren Dr, Murdoch, WA 6150
Country 101083 0
Australia
Phone 101083 0
+61 8 6152 0871
Fax 101083 0
Email 101083 0
liying.dai@postgrad.curtin.edu.au
Contact person for scientific queries
Name 101084 0
A/Prof Andrew Maiorana
Address 101084 0
Andrew Maiorana, School of Physiotherapy and Exercise Science, Curtin University,
Kent St, Bentley WA 6102
Country 101084 0
Australia
Phone 101084 0
+61 8 9266 9225
Fax 101084 0
+61 8 9266 3699
Email 101084 0
A.Maiorana@curtin.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
For patient confidentiality concerns and the access
possibilities of the data source, the clinical data collected will not be shared with
the public. However, non-clinical data, such as PATHFINDER educational materials, will
be shared with the public and other researchers.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 8304 0
Ethical approval
Citation [1] 8304 0
Link [1] 8304 0
Email [1] 8304 0
Other [1] 8304 0
Type [2] 8305 0
Ethical approval
Citation [2] 8305 0
Link [2] 8305 0
Email [2] 8305 0
Other [2] 8305 0
Type [3] 8373 0
Informed consent form
Citation [3] 8373 0
Link [3] 8373 0
Email [3] 8373 0
Other [3] 8373 0
Type [4] 8374 0
Study protocol
Citation [4] 8374 0
Link [4] 8374 0
Email [4] 8374 0
Other [4] 8374 0
Summary results
No Results