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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]

n/a

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

complex care

comprehensive care

chronic illness

Condition category

Condition code

Public Health

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]

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]

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]

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]

Patient Reported Outcome Measures (PROMS) - Quality of Life measured by Euroqol 5d-5L

Timepoint [1]

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]

Patient reported experience measures - Net Promotor Score

Timepoint [2]

Secondary outcome [3]

Patient Reported Experience Measure - Visual Analogue Scale

Timepoint [3]

Secondary outcome [4]

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]

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?

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]

The Northern Hospital - Epping

Recruitment postcode(s) [1]

3076 - Epping

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Northern Hospital

Address [1]

185 Cooper St Epping Victoria 3076

Country [1]

Australia

Primary sponsor type

Hospital

Name

Northern Health

Address

185 Cooper St Epping Victoria 3076

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Health Human Research Ethics Committee

Ethics committee address [1]

185 Cooper St Epping Vic 3076

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/01/2021

Approval date [1]

04/02/2021

Ethics approval number [1]

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

Dr Cilla Haywood

Address

Northern Health, 185 Cooper Street Epping, Victoria, 3076

Country

Australia

Phone

+61 3 84058397

Fax

[email protected]

Contact person for public queries

Name

Cilla Haywood

Address

Northern Health, 185 Cooper St Epping, Victoria 3076

Country

Australia

Phone

+61 3 84058397

Fax

[email protected]

Contact person for scientific queries

Name

Cilla Haywood

Address

Northern Health, 185 Cooper St Epping, Victoria, 3076

Country

Australia

Phone

+61 3 84058397

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

patient privacy

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19024	Study protocol					385819-(Uploaded-01-05-2023-14-12-05)-Study-related document.docx

Results publications and other study-related documents

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No additional documents have been identified.

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