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Trial registered on ANZCTR


Registration number
ACTRN12623000568617
Ethics application status
Approved
Date submitted
1/05/2023
Date registered
25/05/2023
Date last updated
25/05/2023
Date data sharing statement initially provided
25/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Northern Patient Watch, a comprehensive care program to keep people well in the community
Scientific title
Evaluation of Northern Patient Watch, a comprehensive care program to keep people well in the community
Secondary ID [1] 309557 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
complex care
 329846 0
comprehensive care 329847 0
chronic illness 329848 0
Condition category
Condition code
Public Health 326754 326754 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Northern Patient Watch (NPW) is similar to Monash Watch. Patients who are at risk of multiple admissions to the Northern Hospital are detected by a machine-learning algorithm developed at Northern Health. Those meeting the criteria are invited to participate in the program. Following induction (where the patient's demographic and health details are collected), participants receive regular telephone calls from trained lay persons, known as Telecare Guides (TCGs), for the purposes of self-rated health monitoring. It provides a script for the TCG to ask the enrollee questions regarding their current health and wellbeing. This involves administration of a standardised set of questions which are used to assess the patients current and anticipated near term state as well as any concerns that the TCG identifies from the responses. The frequency and duration of the calls are set by the smart health platform and are more frequent / longer if the patient has more concerns. If concerns are raised regarding the patient’s health or wellbeing, they are referred to a health coach, who is a senior nurse or allied health practitioner. The health coach will get involved personally, and coordinate interventions as required with the aim of stabilising the participants status and averting a presentation to ED or admission to hospital. The Patient Journey Record (PaJR) is used as an IT platform that guides the frequency of calls and helps alert staff to the need for intervention. The responses drive a proprietary rule-based algorithm which detects near-term hospitalisation risk. This algorithm creates an alert for a health coach to attend to if the patient’s health is deteriorating. The patients are part of the program for as long as they and their health coach feel they are deriving benefit from the program; they graduate out of the program if they are no longer benefiting, or when they can manage their own health issues well. Examples of interventions that a health coach would perform are accompanying patient to GP or specialist, arranging mental health review, and educating patients regarding their medications.
Intervention code [1] 325981 0
Treatment: Other
Comparator / control treatment
Propensity matched controls that declined the program. The controls are selected at the time of evaluation, but the period of time these controls presented is concurrent with the roll-out of Northern Patient Watch.
Control group
Active

Outcomes
Primary outcome [1] 334611 0
Primary outcome: difference in acute bed usage between NPW participants versus controls. Acute bed usage = Emergency length of stay + inpatient length of stay.
Timepoint [1] 334611 0
The evaluation will commence after the number of participants has been recruited to achieve statistical power, this is 415 participants. The data will be collected from Victorian Admitted Episodes Dataset (VAED)
Secondary outcome [1] 421406 0
Patient Reported Outcome Measures (PROMS) - Quality of Life measured by Euroqol 5d-5L
Timepoint [1] 421406 0
6 monthly intervals, and on discharge from from the program. People can be discharged if they no longer want to be on the program or they have developed from the program their own capacity to manage their illnesses.
Secondary outcome [2] 421407 0
Patient reported experience measures - Net Promotor Score
Timepoint [2] 421407 0
6 monthly intervals, and on discharge from from the program. People can be discharged if they no longer want to be on the program or they have developed from the program their own capacity to manage their illnesses.
Secondary outcome [3] 421691 0
Patient Reported Experience Measure - Visual Analogue Scale
Timepoint [3] 421691 0
6 monthly intervals, and on discharge from from the program. People can be discharged if they no longer want to be on the program or they have developed from the program their own capacity to manage their illnesses.
Secondary outcome [4] 421692 0
Qualitative experience of participants in the program and staff, measured by qualitative analysis of semi-structured interviews and focus groups of staff members. This will be assessed for themes as a composite secondary outcome.
Timepoint [4] 421692 0
These interviews and focus groups will take place at around the time of evaluation. These interviews and focus groups will take place at around the time of evaluation. The evaluation will commence after the number of participants has been recruited to achieve statistical power, this is 415 participants

Eligibility
Key inclusion criteria
Those presenting to the Emergency Department of Northern Health, or being admitted who have been identified by an algorithm (HURT algorithm, Conilione and Gust, 2023) as being at high risk of 3 or more unplanned admissions to hospital, will be offered participation in Northern Patient watch.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who reside in a residential aged care facility, people unable to consent to participation in the program

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is an evaluation of Northern Patient watch (NPW) which is a newer but established integrated care program which is intended to reduce acute hospital usage in those at high risk. This is the current standard of care. We are seeking to determine whether there is any difference in acute hospital usage between NPW participants and those who declined the program, in a propensity matched fashion, in 1:1 fashion. It had initially been intended to use historical controls in a 1(NPW) to 4 control fashion, however the change in hospital usage with the pandemic necessitated a change in approach.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Propensity score matching (PSM) is an analytical method for studies that is designed to replicate the characteristics of a randomised controlled trial by using probability (or propensity) scores to ensure a balance in the observed baseline characteristics between a group that received treatment and a group that did not. We will utilise nearest neighbour (NN) matching, using the Stata psmatch2 program .

The average length of stay (LOS) of HLCC patients in the twelve-month period following their trigger admission for eligibility to participate in NPW is 3.7 days. The average number of admissions a year is 2.2, and from this we calculated that the mean annual bed day usage by eligible participants is 8.133 bed days, with a standard deviation of 11.76 days. Given that a reduction in bed day usage per year of 25% was achieved (as per the Monash Watch case, reference 1), a sample size of 415 participants in each of the enrollee and control groups (830 in total; 1 enrollee; 1 PSM controls) would have 80% power to detect this change, with the probability of type 1 error being 0.05

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2020
Date of last participant enrolment
Anticipated
29/09/2023
Actual
Date of last data collection
Anticipated
27/10/2023
Actual
Sample size
Target
415
Accrual to date
360
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24627 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 40238 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 313748 0
Hospital
Name [1] 313748 0
Northern Hospital
Country [1] 313748 0
Australia
Primary sponsor type
Hospital
Name
Northern Health
Address
185 Cooper St Epping Victoria 3076
Country
Australia
Secondary sponsor category [1] 315569 0
None
Name [1] 315569 0
Address [1] 315569 0
Country [1] 315569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312919 0
Northern Health Human Research Ethics Committee
Ethics committee address [1] 312919 0
185 Cooper St Epping Vic 3076
Ethics committee country [1] 312919 0
Australia
Date submitted for ethics approval [1] 312919 0
04/01/2021
Approval date [1] 312919 0
04/02/2021
Ethics approval number [1] 312919 0
HREC/69129/NH-2021-246618

Summary
Brief summary
Introduction:
People in higher income countries are living longer, with higher burden of chronic disease, disability and psychosocial distress. People affected by this are more likely to present to hospital, where they may receive inefficient and fragmented care. Northern Patient Watch (NPW)was implemented with the aim of better meeting the needs of these patients. This program utilizes trained lay telecare guides, who monitor the patient and health coaches who aid the patient with self-management of their conditions, guided by a rules-based algorithm called the Patient Journey Record. This evaluation will determine whether NPW is effective in reducing acute hospital usage, its effects on participant quality of life, and the quality of the participant’s experience.
Methods and Analysis:
Emergency department and hospital length of stay will be determined for NPW participants, and compared with these metrics in propensity-matched patients who were eligible for but declined the program. Participant reported outcomes will be measured using EQol-5D-5L, and their experience of the program will be measured using a visual analogue scale and net promoter score. NPW participants and Northern Health staff will be offered the opportunity to participate in interviews and focus groups, to obtain qualitative data regarding the program.
Ethics and Dissemination:
Patient Watch, and the accompanying collection of hospital usage and patient reported outcome and experience measures, is established as standard care, hence audit-level ethics approval has been obtained. Low-risk ethics approval was obtained for patient/staff interviews and focus groups - see public note below.
Trial website
n/a
Trial related presentations / publications
Public notes
1. Northern patient watch was implemented as standard care offered at Northern Health to those at high risk of hospital admissions. The first patient was enrolled on 1/7/2020. Given it was standard care and based on a model at Monash watch, ethics approval was not needed. However, given it is a comprehensive care program, it was desirable that the program was evaluated, and ethics approval was sought for a mixed-methods evaluation subsequent to enrolment of participants. Ethics approval for analysis/dissemination of routinely collected/quantitative data as well as qualitative interviews (non-routine data) was sought in a single application as per Northern Health processes.

2. From Monash Watch (upon which Northern Patient Watch was Based)
Martin C, Hinkley N, Stockman K, Campbell D. Capitated Telehealth Coaching Hospital Readmission Service in Australia: Pragmatic Controlled Evaluation. Journal of medical Internet research. 2020;22(12):e18046

Contacts
Principal investigator
Name 126334 0
Dr Cilla Haywood
Address 126334 0
Northern Health, 185 Cooper Street Epping, Victoria, 3076
Country 126334 0
Australia
Phone 126334 0
+61 3 84058397
Fax 126334 0
Email 126334 0
[email protected]
Contact person for public queries
Name 126335 0
Cilla Haywood
Address 126335 0
Northern Health, 185 Cooper St Epping, Victoria 3076
Country 126335 0
Australia
Phone 126335 0
+61 3 84058397
Fax 126335 0
Email 126335 0
[email protected]
Contact person for scientific queries
Name 126336 0
Cilla Haywood
Address 126336 0
Northern Health, 185 Cooper St Epping, Victoria, 3076
Country 126336 0
Australia
Phone 126336 0
+61 3 84058397
Fax 126336 0
Email 126336 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19024Study protocol    385819-(Uploaded-01-05-2023-14-12-05)-Study-related document.docx



Results publications and other study-related documents

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