Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000659707
Ethics application status
Approved
Date submitted
12/04/2022
Date registered
5/05/2022
Date last updated
5/09/2023
Date data sharing statement initially provided
5/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Community Health Navigator (CHN) (Community Health Worker) assisted transition of care from hospital to community.
Scientific title
The impact of Community Health Navigator (CHN) (Community Health Worker) assisted transition of care from hospital to community.
Secondary ID [1] 306979 0
Nil known
Universal Trial Number (UTN)
U1111-1276-3305
Trial acronym
Community Health Navigators Extending Care in the Community (CHECC) study
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
chronic respiratory disease 325944 0
diabetes 326092 0
chronic neurological cancer conditions 326093 0
chronic renal disease 326094 0
chronic musculoskeletal conditions 326095 0
Condition category
Condition code
Respiratory 323255 323255 0 0
Chronic obstructive pulmonary disease
Metabolic and Endocrine 323349 323349 0 0
Diabetes
Cancer 323350 323350 0 0
Any cancer
Renal and Urogenital 323351 323351 0 0
Kidney disease
Musculoskeletal 323405 323405 0 0
Other muscular and skeletal disorders
Public Health 323406 323406 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be implemented under the SLHD Aged Health, Chronic Care and Rehabilitation (AHCCR) service by Community Health Navigators (CHNs). CHNs are frontline public health workers who are trusted members of and /or have an unusually close understanding of the community served. This trusting relationship enables them to serve as a liaison /link between health/social services and the community to facilitate access to services and improve the quality and cultural competence of service delivery.
Community Health Navigators (CHN) will follow up patients at risk of readmission on discharge from four Sydney hospitals. The CHNs will provide a minimum of two home visits for each patient (first visit, within the first 72 hours of participant discharge from the hospital and a second visit within two to four weeks from the first visit).
The first visit will be of 30 min duration during which the CHNs will :
a. build patient understanding of their condition and confidence in self-management.
b. identify problems in the living environment that might impact on the patient’s health and wellbeing, including social isolation.
c. check medicines with the discharge summary, assessing if they are safely stored and asking about side effects of medicines (to alert GP or other clinical staff).
d. monitor self-management.

Following the first visit, an action plan will be developed by the CHNs in consultation with the social worker/coordinator attached to the SLHD Aged Health, Chronic Care and service. The action plan will be based on the hospital discharge summary and if relevant, the GPs management plan. Components of the plan will include problems and strategies to address:
• Activities of daily living,
• Access to food
• Housing
• Changes to medication, access to medications
• Follow visits to GPs, specialist services, allied health services
• Language and cultural issues
• Social support/isolation

At the follow up visit the CHN will be of 30 minutes duration
a. review actions and monitor progress from the first visit.
b support provided for self- management using translated web- or printed- resource. Translated resource materials appropriate to the individual patients needs will be provided from NSW Health multicultural resource unit, Central and Eastern Primary Health Network, Diabetes Australia, National Heart Foundation, Stroke Foundation, Lung Foundation, Kidney Foundation, Cancer Council.
c. communicate by phone or e-mail with the patient’s GP, pharmacist, allied health provider, community health services, aged and/or home care services and other health and/or social care providers.

There will be an additional two to four contacts as required up to 60 days in
accordance with the action plan to address identified issues at the first home visit.

CHNs will record a contact checklist at each visit or contact. This will be reviewed to assess and monitor adherence to the intervention.
Intervention code [1] 323324 0
Prevention
Intervention code [2] 323438 0
Lifestyle
Comparator / control treatment
Control group will receive usual discharge care which includes a discharge letter which describes medication and follow up.
Control group
Active

Outcomes
Primary outcome [1] 331027 0
The primary outcome is hospital readmissions. and this will be assessed by data linkage.
Timepoint [1] 331027 0
During 60 days post discharge
Secondary outcome [1] 408540 0
Change in patient reported medication adherence (measured by the Adherence to Refills Medication Scale (ARMS)).
Timepoint [1] 408540 0
Baseline and 3 months post discharge
Secondary outcome [2] 408657 0
Change in patient reported quality of life measured by the EQ5D-5L questionnaire,
Timepoint [2] 408657 0
Baseline and 6 months post discharge
Secondary outcome [3] 408658 0
Change in patient reported Health Literacy (measured by 3 domains of the HLQ: Domain 4: Social support for health; Domain 7: Navigating the health system and Domain 9: Understanding health information well enough to know what to do.
Timepoint [3] 408658 0
Baseline and 3 months post discharge
Secondary outcome [4] 408659 0
Change in patient reported assessment of chronic illness (measured by the Patient Assessment of Chronic Illness (PACIC short form adapted)
Timepoint [4] 408659 0
Baseline and 6 months post discharge
Secondary outcome [5] 408660 0
Change in Hospital-use as determined by inpatient and Emergency Department (ED) data-linkage
Timepoint [5] 408660 0
6 months prior to admission and 6 months after admission
Secondary outcome [6] 408983 0
Change in use of health services using individually linked Medicare Benefits Schedule items,
Timepoint [6] 408983 0
6 months prior to admission and 6 months after admission
Secondary outcome [7] 409079 0
Change in pharmaceutical Benefits Scheme (PBS) items.
Timepoint [7] 409079 0
6 months prior to admission and 6 months after admission
Secondary outcome [8] 415191 0
Patient experience of hospital discharge measured through a subset of questions based on the NSW Bureau of Health Information (BHI) patient surveys.
Timepoint [8] 415191 0
Baseline and 3 months post discharge

Eligibility
Key inclusion criteria
Inclusion criteria
Patients will be identified via the Patient Flow Portal (PFP) contained within the Sydney Local Health District (SLHD).
1. Aged 40 years and over
2. Living within Sydney Local Health District boundaries
3. Admitted for a chronic condition or under the aged care service as recorded under reason for admission in the patient flow portal based (coded using ICD10)
4. Speaks English or any of the top five languages (Arabic, Cantonese, Mandarin, Greek or Italian)
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1. Selected for follow-up by any other chronic care program offered by the SLHD
2. Planned discharge to hostel, Residential Aged Care Facilities (RACF), rehabilitation facilities, transferred to another SLHD facility or transferred to another hospital or may be too unwell to participate in the study
3. Admitted primarily for COVID-19 diagnosis
4. Receiving community palliative care services
5. Receiving 7-day post discharge follow up from Mental Health services
6. Mild to moderate cognitive impairment (based on Rowland Universal Dementia Assessment Scale (RUDAS) score, able to give verbal assent and has a carer/informant as their primary carer available for an interview. People diagnosed with severe cognitive impairment unable to give verbal assent will be excluded
7. Patient or their primary carer does not have a landline or a mobile phone contact number available

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation module will be prepared externally and uploaded to REDCap. The Research Officer will run the randomisation module at the point that patients are consented to the project and complete their baseline assessment. Patients will not be blinded to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants will be performed by a randomisation module within REDCap. Intervention and control lists of random numbers will be generated for each of the hospital stratum (Royal Prince Alfred, Canterbury, Balmain, Concord). Allocation of intervention or control will be sequentially allocated from the lists based on the date of entry of the participant into the study by an independent researcher.
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
We aim to recruit (n=460) patients and for 390 to remain in the study at the six-month follow-up (based on 3% mortality and 12% loss to follow up). Power calculation based on the primary outcome measure of readmission rate: Assuming a readmission rate of 20% within 60 days (based on pilot and published data) a sample size of 392 or 196 in each group would be required to detect a 50% reduction in readmissions to 10% with 95% confidence intervals and 80% power. Survival analysis of time to readmission would require a similar sample size of 200 in each group.
We will compare the primary and secondary outcomes between intervention and control groups, using multivariate regression techniques that adjust for age, sex and those independent variables that are significantly different between the two groups, and using multiple imputation for missing values. Sensitivity analyses will assess unmeasured variation. We will also conduct time to event analysis to examine the relationship between seeing a CHW following discharge from the index hospitalisation and reduced re-hospitalisation in the subsequent 60 days and six months. This will be undertaken by first calculating propensity weights to account for differences in characteristics between those who were allocated to the CHW intervention and those in the control group, and then, using Cox proportional hazards regression modelling. Outcomes will be censored at first re-hospitalisation, death or 60 days/six months following index hospitalisation, whichever occurred first.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/11/2022
Actual
8/12/2022
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
460
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22191 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 22192 0
Canterbury Hospital - Campsie
Recruitment hospital [3] 22193 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 22194 0
Balmain Hospital - Balmain
Recruitment postcode(s) [1] 37348 0
2041 - Balmain
Recruitment postcode(s) [2] 37345 0
2050 - Camperdown
Recruitment postcode(s) [3] 37347 0
2139 - Concord
Recruitment postcode(s) [4] 37352 0
2193 - Canterbury

Funding & Sponsors
Funding source category [1] 311176 0
Government body
Name [1] 311176 0
National Health and Medical Research Council
Country [1] 311176 0
Australia
Funding source category [2] 311237 0
Government body
Name [2] 311237 0
Central Eastern Sydney Primary Health Network
Country [2] 311237 0
Australia
Funding source category [3] 311238 0
Government body
Name [3] 311238 0
Sydney Local Health District
Country [3] 311238 0
Australia
Funding source category [4] 311239 0
Government body
Name [4] 311239 0
Agency for Clinical Innovatoion
Country [4] 311239 0
Australia
Funding source category [5] 311240 0
Charities/Societies/Foundations
Name [5] 311240 0
Health Consumers New South Wales
Country [5] 311240 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Centre for Primary Health Care and Equity
UNSW Sydney
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 312598 0
None
Name [1] 312598 0
Address [1] 312598 0
Country [1] 312598 0
Other collaborator category [1] 282255 0
Government body
Name [1] 282255 0
Sydney Local Health District (SLHD)
Address [1] 282255 0
Post Office Box M30
Missenden Road NSW 2050
Country [1] 282255 0
Australia
Other collaborator category [2] 282256 0
Government body
Name [2] 282256 0
Agency for Clinical Innovation (ACI)
Address [2] 282256 0
1 Reserve Rd, St Leonards NSW 2065
Country [2] 282256 0
Australia
Other collaborator category [3] 282257 0
Government body
Name [3] 282257 0
Central and Eastern Sydney Primary Health Network
Address [3] 282257 0
Tower A, Level 5, 201 Coward Street, Mascot NSW 2020
Country [3] 282257 0
Australia
Other collaborator category [4] 282258 0
Charities/Societies/Foundations
Name [4] 282258 0
Health Consumer NSW
Address [4] 282258 0
Suite 3/Level 8/280 Pitt St, Sydney NSW 2000
Country [4] 282258 0
Australia
Other collaborator category [5] 282259 0
University
Name [5] 282259 0
University of Otago
Address [5] 282259 0
362 Leith Street, Dunedin North, Dunedin 9016, New Zealand
Country [5] 282259 0
New Zealand
Other collaborator category [6] 282260 0
University
Name [6] 282260 0
University of Ottawa
Address [6] 282260 0
75 Laurier Ave. E, Ottawa, ON K1N 6N5, Canada
Country [6] 282260 0
Canada
Other collaborator category [7] 282261 0
University
Name [7] 282261 0
Flinders university
Address [7] 282261 0
Sturt Rd, Bedford Park SA 5042
Country [7] 282261 0
Australia
Other collaborator category [8] 282262 0
University
Name [8] 282262 0
Maastricht University
Address [8] 282262 0
Minderbroedersberg 4-6, 6211 LK Maastricht, Netherlands
Country [8] 282262 0
Netherlands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310707 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310707 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 310707 0
Australia
Date submitted for ethics approval [1] 310707 0
23/11/2021
Approval date [1] 310707 0
21/01/2022
Ethics approval number [1] 310707 0
X21-0438 & 2021/ETH12171

Summary
Brief summary
This study will assess the implementation and impact of a Community Health Navigator (CHN) delivered model of care that will specifically support the transition of care from hospital to the community for patients who have a chronic health condition, including cancer.

Who is it for?
You may be eligible for this study if you are aged 40 or older, you have been admitted to any of the Royal Prince Alfred, Concord, Balmain, and Canterbury hospitals for a chronic condition (including cancer), or you have been admitted under the aged care service.

Study details
Participants who choose to enroll in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants in the first group will be given access to the Community Health Navigator program which will involve at least two home visits by Community Health Navigators to assess problems, provide non-clinical support and assist in navigation to other services as required. The second group will receive usual care and will not be included in the CHN program at this time.

It is hoped this research will demonstrate that the CHN program is practical to deliver to patients with chronic health conditions (including cancer), and that the CHN program has a positive impact upon the care provided to these patients which may result in fewer hospital admissions.
Trial website
https://cphce.unsw.edu.au/research/community-health-workers-extending-care-community-checc
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118586 0
Prof Mark Harris
Address 118586 0
Centre for Primary Health Care and Equity
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 118586 0
Australia
Phone 118586 0
+61 2 9385 8384
Fax 118586 0
Email 118586 0
m.f.harris@unsw.edu.au
Contact person for public queries
Name 118587 0
Prof Mark Harris
Address 118587 0
Centre for Primary Health Care and Equity
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 118587 0
Australia
Phone 118587 0
+61 2 9385 8384
Fax 118587 0
Email 118587 0
m.f.harris@unsw.edu.au
Contact person for scientific queries
Name 118588 0
Prof Mark Harris
Address 118588 0
Centre for Primary Health Care and Equity
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 118588 0
Australia
Phone 118588 0
+61 2 9385 8384
Fax 118588 0
Email 118588 0
m.f.harris@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
For verification of published results: immediately following publication
For new analysis 12 months after the trial has concluded
Data will be available 5 years post conclusion of the trial
Available to whom?
Researchers employed by universities or government health organisations who have obtained ethical consent from Sydney Local Health District Ethics Review Committee (RPAH Zone)
Available for what types of analyses?
Research that aligns with the primary and secondary objectives of the trial and may benefit people living with chronic conditions and/ or in aged care services and is approved by Sydney Local Health District Ethics Review Committee (RPAH Zone)
How or where can data be obtained?
Initial enquiries can be made to the Principal Investigator Professor Mark Harris (Email m.f.harris@unsw.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15761Study protocol  m.f.harris@unsw.edu.au 383882-(Uploaded-29-04-2022-16-31-57)-Study-related document.doc
15762Informed consent form  m.f.harris@unsw.edu.au 383882-(Uploaded-29-04-2022-16-36-39)-Study-related document.docx
15763Ethical approval  m.f.harris@unsw.edu.au 383882-(Uploaded-29-04-2022-16-38-46)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCommunity health navigator-assisted transition of care from hospital to community: protocol for a randomised controlled trial.2024https://dx.doi.org/10.1136/bmjopen-2023-077877
N.B. These documents automatically identified may not have been verified by the study sponsor.