Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001157561
Ethics application status
Approved
Date submitted
17/08/2015
Date registered
29/10/2015
Date last updated
1/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Care coordination through Emergency Department, Residential Aged Care and Primary Health Collaboration.
Scientific title
Care coordination through Emergency Department, Residential Aged Care and Primary Health Collaboration: effect on Hospital and ED admission, Length of stay, cost effectiveness, service delivery and patient satisfaction.
Secondary ID [1] 287263 0
Nil
Universal Trial Number (UTN)
U1111-1173-1375
Trial acronym
The CEDRiC Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic disease 295886 0
Acute illness 305299 0
Condition category
Condition code
Public Health 296137 296137 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 1. Health Intervention Projects for Seniors (HIPS) - Residential Aged Care Facility (RACF) and primary health sector mediated interventions including provision of a Nurse Practitioner Candidate (NPC) within the RACFs to support an enhanced model of Primary Health Care encompassing general practitioners (GP); development of advanced care plans for residents; better coordination of GP care in the RACF; a training program for RACF staff; and development of a sustainable model of care through endorsed NP medicare billing.
ARM 2. Geriatric Emergency Department Intervention (GEDI) - Hospital ED mediated interventions (Clinical Nurse Consultant (CNC) and Clinical Nurses (CN) with further education/experience in gerontology and community health) providing a dedicated single point of contact within the ED for RACF and primary health professionals; rapid and comprehensive assessment of RACF residents on presentation; streamlined patient flow in ED; clear and timely intersectoral communication; focused discharge planning and health professional education and training
a) How each intervention component is practically administered – Arm 1: The NPC supports the model of primary healthcare via:
* Clinically reviewing RACF elders upon referral by the RACF nurse or as requested by the elder themselves.
* liaising with GPs to order medications and tests
* facilitates development of advanced care plans for elders in coordination with GP
* provides one-on-one education to RACF staff in the review and care of specific elders at the bedside. The amount, type and length of training is determined by the NPC of the clinical service based on assessment of the situation and by the needs of the clinician. There is no formal education program in place
Arm 2 - GEDI nurses will screen all people presenting to the ED who are 70 years of age and over or those who appear extremely frail. These nurses will provide frontload assessment, liaise with family, GP, other support services to collect all relevant information, discuss disposition planning with medical team and provide age appropriate interventions in the ED. Health professional education and training in ED is facilitated via GEDI nurses and Gerontology physician providing education sessions attended by ED staff on each shift changeover for up to 1 hour. One-on-one education with primary care staff in ED while reviewing patients presenting to ED will be provided. This will be a decision for the clinical service GEDI team and determined by the needs of the clinician by the GEDI CN or CNC
b) The intervention will be evaluated for 12 months
c) Strategies to monitor adherence – ongoing regular meetings both internal with research team, external with the CEDRiC team and expert advisory committee, time and motion studies of both the NPC and GEDI nurses.
Intervention code [1] 292565 0
Treatment: Other
Intervention code [2] 292663 0
Prevention
Comparator / control treatment
ED data collected at participating hospital for the 12 months prior to commencement of the interventions.
Control group
Historical

Outcomes
Primary outcome [1] 295812 0
ED re-presentation within 72hours and 28 days
Timepoint [1] 295812 0
Outcome assessed via hospital records for ED re-presentations 72 hours and 28 days post discharge
Primary outcome [2] 295813 0
Avoided transfer to hospital - elder remained at the RACF for illness duration under care directions of NPC
Timepoint [2] 295813 0
Outcome assessed via RACF records demonstrating they remained at the RACF measured at any point during the 12 month intervention.
Secondary outcome [1] 316585 0
Cost effectiveness of dual model of care
Timepoint [1] 316585 0
Outcome assessed via cost effectiveness analysis for duration of the project
Secondary outcome [2] 317153 0
ED length of stay from >=70 years cohort seen by GEDI
Timepoint [2] 317153 0
From of admission to ED until time of discharge to ward, home or RACF. Outcome assessed via hospital records for duration of project
Secondary outcome [3] 317154 0
Hospital admissions from >=70 years cohort seen by GEDI
Timepoint [3] 317154 0
From time of admission to ED until time of discharge to ward, home or RACF. Outcome assessed via hospital records for duration of project

Eligibility
Key inclusion criteria
Arm 1: People aged 70 years or older who present to participating hospital ED.
Arm 2: RACF residents
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Arm 1: People younger than 70 years who present to participating hospital ED.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
11/10/2016
Actual
30/09/2016
Date of last data collection
Anticipated
30/11/2016
Actual
30/09/2016
Sample size
Target
1200
Accrual to date
Final
2496
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4380 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 10601 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 291843 0
Government body
Name [1] 291843 0
Department of Social Services
Country [1] 291843 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast
Address
90 Sippy Downs Drive, Sippy Downs QLD 4556, Australia
Country
Australia
Secondary sponsor category [1] 290511 0
None
Name [1] 290511 0
Address [1] 290511 0
Country [1] 290511 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293343 0
Metro North Hospital and Health Service
Ethics committee address [1] 293343 0
Ethics committee country [1] 293343 0
Australia
Date submitted for ethics approval [1] 293343 0
Approval date [1] 293343 0
23/10/2014
Ethics approval number [1] 293343 0
HREC/14/QPCH/220
Ethics committee name [2] 293577 0
Sunshine Coast Hospital and Health Service
Ethics committee address [2] 293577 0
Ethics committee country [2] 293577 0
Australia
Date submitted for ethics approval [2] 293577 0
01/07/2015
Approval date [2] 293577 0
10/09/2015
Ethics approval number [2] 293577 0
HREC/14/QRCH/220 SSA/15/QNB/40
Ethics committee name [3] 293578 0
University of the Sunshine Coast
Ethics committee address [3] 293578 0
Ethics committee country [3] 293578 0
Australia
Date submitted for ethics approval [3] 293578 0
Approval date [3] 293578 0
02/08/2015
Ethics approval number [3] 293578 0
A/15/718

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59474 0
Prof Marianne Wallis
Address 59474 0
University of the Sunshine Coast
School of Nursing, Midwifery and Paramedicine
Locked Bag 4
MAROOCHYDORE DC QLD 4558
Country 59474 0
Australia
Phone 59474 0
61 7 5456 5032
Fax 59474 0
Email 59474 0
[email protected]
Contact person for public queries
Name 59475 0
Alison Craswell
Address 59475 0
University of the Sunshine Coast
School of Nursing, Midwifery and Paramedicine
Locked Bag 4
MAROOCHYDORE DC QLD 4558
Country 59475 0
Australia
Phone 59475 0
61 7 5456 3453
Fax 59475 0
Email 59475 0
[email protected]
Contact person for scientific queries
Name 59476 0
Marianne Wallis
Address 59476 0
University of the Sunshine Coast
School of Nursing, Midwifery and Paramedicine
Locked Bag 4
MAROOCHYDORE DC QLD 4558
Country 59476 0
Australia
Phone 59476 0
61 7 5456 5032
Fax 59476 0
Email 59476 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Ageing populations are placing increasing pressure... [More Details]
Study results articleYes Wallis, M., Marsden, E., Taylor, A., Craswell, A.,... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA structure, process and outcome evaluation of the Geriatric Emergency Department Intervention model of care: a study protocol.2017https://dx.doi.org/10.1186/s12877-017-0462-z
EmbaseThe Geriatric Emergency Department Intervention model of care: a pragmatic trial.2018https://dx.doi.org/10.1186/s12877-018-0992-z
N.B. These documents automatically identified may not have been verified by the study sponsor.