Trial Review

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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
20/04/2022
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 ;PATHFINDER study follow up forms (including assessment, medication titration plan, HF helpline, problem solving guide) 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; patients be referred to cardiac rehabilitation program (an existing program in care system, involving a health care team, a personalised education and exercise program, the program runs 30-50 minute per session, two to three times per week and for 6-10 weeks depending on patients' health condition) ; 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; HF helpline, 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 , facilitated cardiac rehabilitation program, and PATHFINDER study follow up forms; HF NP will triage and facilitate medication titration support. GPs will receive the PAHTFINDER study follow up form when patients visit GPs. If the GP needs support, they will contact HF helpline (HF NP )in the first instance, who will either provide advice or escalate to a cardiologist as described at b). (NP helpline has been created specifically for GPs for this study. The aim of NP helpline is to help GPs to manage patients' HF symptoms and patients' heart failure medication if GPs are not confident with HF medication titration or if they have any questions with HF care. NP helpline can be accessed during the study period, Monday to Friday, from 8 am to 4 pm)
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
Proportion of participants receiving 5 out of 5 guideline-recommended treatments if indicated amongst eligible participants 6 months following index change. (assessed by patient report, medical records, pharmacy medication list )
Timepoint [1] 324214 0
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
baseline-following and 6 months post-enrolment
Secondary outcome [2] 385555 0
PROMIS Physical Function Short Form 4a---physical function
Timepoint [2] 385555 0
6 month post-enrolment
Secondary outcome [3] 385556 0
Patient Health Questionnaire (PHQ-2)--depression screening
Timepoint [3] 385556 0
baseline- following enrolment and 6 months post-enrolment
Secondary outcome [4] 385557 0
Self-care of Heart Failure Index
Timepoint [4] 385557 0
6 months post-enrolment
Secondary outcome [5] 385558 0
Medication Compliance Questionnaire
Timepoint [5] 385558 0
baseline following-enrolment and 6 month post-enrolment
Secondary outcome [6] 385559 0
Numbers of re-admission to hospital by medical records confirmed by participant report.
Timepoint [6] 385559 0
6 month post-enrolment
Secondary outcome [7] 385560 0
All-cause mortality by medical records confirmed by participant report.
Timepoint [7] 385560 0
6 month post-enrolment
Secondary outcome [8] 387051 0
Length of stay for those readmitted to hospital by medical records, hospital records.
Timepoint [8] 387051 0
6 month post-enrolment
Secondary outcome [9] 408919 0
function capacity by six minute walk test distance
Timepoint [9] 408919 0
baseline following-enrolment and 6 months-post enrolment
Secondary outcome [10] 408920 0
proportion of patients receiving ACE inhibitor/ARB/ARNI unless drug was not tolerated or otherwise inappropriate at 6 month post-discharge (assessed by patient report, medical record review and pharmacy medication list)
Timepoint [10] 408920 0
6 months post-enrolment
Secondary outcome [11] 408921 0
proportion of patients receiving beta-blocker unless drug was not tolerated or otherwise inappropriate at 6 month post-discharge (assessed by patient report, medical record review and pharmacy medication list)
Timepoint [11] 408921 0
6 months post-enrolment
Secondary outcome [12] 408922 0
proportion of patients receiving MRA unless drug was not tolerated or otherwise inappropriate at 6 month post-discharge (assessed by patient report, medical record review and pharmacy medication list)
Timepoint [12] 408922 0
6 months post-enrolment
Secondary outcome [13] 408923 0
Proportion of patients receiving anticoagulation for eligible patients with atrial fibrillation at 6 month post-discharge (assessed by patient report, medical record review and pharmacy medication list)
Timepoint [13] 408923 0
6 months post enrolment
Secondary outcome [14] 408924 0
Proportion of patients referral to an exercise training program or cardiac rehabilitation program (assessed by patient report, medical record review, referral records )
Timepoint [14] 408924 0
6 months post enrolment
Secondary outcome [15] 408925 0
Proportion of patients reaching 50% of target dose of ACEI/ARB/ARNI (assessed by general practitioners' follow-up form at 1 week, 4 week, 3 months, and or patient report, pharmacy medication list )
Timepoint [15] 408925 0
1 week, 4 weeks, 3 months, 6 months post enrolment
Secondary outcome [16] 408926 0
proportion of patients reaching 50% of the target dose of beta-blocker (assessed by general practitioners' follow-up form at 1 week, 4 week, 3 months, and or patient report, pharmacy medication list )
Timepoint [16] 408926 0
1 week, 4 weeks, 3 months, 6 months post enrolment
Secondary outcome [17] 408927 0
proportion of patients reaching 50% of the target dose of MRA (assessed by patient report, medical record review and pharmacy medication list)
Timepoint [17] 408927 0
1 week, 4 weeks, 3 months, 6 months post enrolment
Secondary outcome [18] 408928 0
Proportion of patients attending >= 16 sessions of exercise training program or cardiac rehabilitation program (by patient report, allied health medical records)
Timepoint [18] 408928 0
6 months post enrolment
Secondary outcome [19] 408929 0
Proportion of patients prescribed of ACEI/ARB/ARNI at the target dose or maximum tolerated dose (assessed by patient report, medical record review and pharmacy medication list)
Timepoint [19] 408929 0
6 month post-enrolment
Secondary outcome [20] 408930 0
Proportion of patients prescribed of beta-blocker at the target dose or maximum tolerated dose (assessed by patient report, medical record review and pharmacy medication list)
Timepoint [20] 408930 0
6 months post-enrolment
Secondary outcome [21] 408931 0
Proportion of patients prescribed of MRA at the target dose or maximum tolerated dose (assessed by patient report, medical record review and pharmacy medication list)
Timepoint [21] 408931 0
6 months post-enrolment

Eligibility
Key inclusion criteria
Men and women over the age of 18 years with a diagnosis of heart failure with reduced ejection fraction, with left ventricular ejection fraction less than 50%, life expectancy expected more than 6 months, 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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients attending the Advanced Heart Failure Service (FSH), patients who need palliative care, nursing homes/assisted living residents; impaired cognitive function; patients with end-stage renal failure (eGFR <15ml./min per 1.73 m2)

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
Recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
28/01/2021
Date of last participant enrolment
Anticipated
1/09/2023
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
200
Accrual to date
6
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
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 outcomes for heart failure with reduce ejection fraction 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 cardiac rehabilitation program or exercise training program 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) . Primary outcome includes proportion of patients adhering to guideline-recommended treatment at 6 months post-enrolment. Secondary outcomes include proportion of patients receiving the guideline-recommended treatment independently at 6 months post-enrolment; exercise training program or cardiac rehabilitation program adherence by 6 month post-enrolment, 6 minute walk test distance, patient-reported outcome includes Kansas City Cardiomyopathy Questionnaire-short version (KCQ12), Patient Health Questionnaire (PHQ-2),Medication Compliance Questionnaire at baseline following enrolment and 6 month post-enrolment, ;PROMIS Physical Function Short Form 4a, Self-care of Heart Failure Index at 6 months post-enrolment.
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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8304Ethical approval    379506-(Uploaded-01-07-2020-11-30-49)-Study-related document.pdf
8305Ethical approval    379506-(Uploaded-01-07-2020-11-31-10)-Study-related document.pdf
8373Informed consent form    379506-(Uploaded-01-07-2020-11-20-59)-Study-related document.doc
8374Study protocol    379506-(Uploaded-01-07-2020-11-21-42)-Study-related document.docx
15827Informed consent form    379506-(Uploaded-02-02-2021-20-55-40)-Study-related document.pdf
15828Ethical approval    379506-(Uploaded-02-02-2021-20-57-01)-Study-related document.pdf
15829Ethical approval    379506-(Uploaded-02-02-2021-20-57-29)-Study-related document.pdf
15830Ethical approval    379506-(Uploaded-19-04-2022-17-33-09)-Study-related document.pdf
15831Study protocol    379506-(Uploaded-19-04-2022-17-36-28)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseP rimary care A dherence T o H eart F ailure guidelines in D iagnosis, e valuation and R outine management (PATHFINDER): A randomised controlled trial protocol.2023https://dx.doi.org/10.1136/bmjopen-2022-063656
N.B. These documents automatically identified may not have been verified by the study sponsor.