Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000496910
Ethics application status
Approved
Date submitted
5/07/2010
Date registered
11/05/2011
Date last updated
31/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Very High Intensity Users of Middlemore Hospital Emergency Department
Scientific title
A randomised controlled trial of intergrated care compared to usual care on hospital admissions, costs and patient outcomes in very high intensity users of Middlemore Hospital Emergency Department
Secondary ID [1] 252155 0
Nil
Universal Trial Number (UTN)
U1111-1115-9452
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
frequent attendance at a hospital emergency department 257694 0
long term conditions 257695 0
Condition category
Condition code
Public Health 257869 257869 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A systematic assessment of health and social service needs followed by multidisciplinary case review followed by coordinated care and advocacy. The intervention involves undertaking an enhanced risk assessment on admission into the emergency department followed by a case conference with dedicated clinicians. A care plan is then determined in conjunction with a dedicated clinical team, pharmacists, cultural support, and social workers and at discharge, a locality coordinator will be assigned to visit the patient in their home until their health stabilises and their access to social support services is realised. The service will not exceed 6 months.
Intervention code [1] 256753 0
Treatment: Other
Comparator / control treatment
Usual care or current best practice. The control involves undertaking a basic risk assessment on admission into the emergency department. No case conference is undertaken. A care plan is then determined in conjunction with a dedicated clinical team, pharmacists, cultural support, and social workers. No locality coordinator is assigned to visit the patient in their home on discharge, but home visits may be aranged for these patients on a case by case basis.
Control group
Active

Outcomes
Primary outcome [1] 258727 0
Hospital Emergency Department attendance from hospital records
Timepoint [1] 258727 0
6 months and 1 year from when all participants have completed the intervention of comparator
Primary outcome [2] 258728 0
Hospital admissions from hospital records
Timepoint [2] 258728 0
6 months and 1 year from when all participants have completed the intervention of comparator
Primary outcome [3] 258729 0
Costs and resource use. A tool has been designed that will ensure the health care teams capture how much time is spent with each patient, and on what activity
Timepoint [3] 258729 0
6 months and 1 year from when all participants have completed the intervention of comparator
Secondary outcome [1] 264768 0
Resolution of presenting problem/s through hospital records and qualitative interviews
Timepoint [1] 264768 0
6 months to 1 year from when all participants have completed the intervention of comparator
Secondary outcome [2] 264769 0
Satisfaction of patients and health professionals through qualitative interviews
Timepoint [2] 264769 0
6 months to 1 year from when all participants have completed the intervention of comparator
Secondary outcome [3] 264770 0
Patient safety through hospital records and serious adverse event reporting
Timepoint [3] 264770 0
6 months from baseline

Eligibility
Key inclusion criteria
Presented to Emergency Department 5 or more times in the last year; able to give written consent
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under regular care from renal, haematology services; assigned to surgical, orthopaedic, obstetric, gynaecology services; principal problem mental health

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)
Patients will be invited to participate in a trial of a new way of organising their health care, after which a baseline assessment will be conducted then they will be randomly assigned as below. Allocation will be centralised by a computer generated randomisation sequence
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be approached by a research nurse and once their consent has been obtained, the nurse will allocate them to either control or intervention as pre-determined by the computer generated randomisation sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 2743 0
New Zealand
State/province [1] 2743 0
Auckland

Funding & Sponsors
Funding source category [1] 257245 0
Government body
Name [1] 257245 0
Health Research Council of New Zealand
Country [1] 257245 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor Timothy Kenealy
Address
South Auckland Clinical School, University of Auckland, Middlemore Hospital, Private Bag 93311, Otahuhu, Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 256488 0
Government body
Name [1] 256488 0
Counties Manukau District Health Board
Address [1] 256488 0
Private Bag 94052
South Auckland Mail Centre
Manukau 2240
Country [1] 256488 0
New Zealand
Secondary sponsor category [2] 256489 0
Commercial sector/Industry
Name [2] 256489 0
ProCare Health (PHO) Ltd
Address [2] 256489 0
PO Box 105 346, Auckland 1140
Country [2] 256489 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259265 0
Northern X Regional Ethics Committee
Ethics committee address [1] 259265 0
3rd Floor, Unisys Building, 650 Great South Road, Penrose, 1061
Ethics committee country [1] 259265 0
New Zealand
Date submitted for ethics approval [1] 259265 0
10/08/2010
Approval date [1] 259265 0
03/12/2010
Ethics approval number [1] 259265 0
NTX/10/EXP/244

Summary
Brief summary
This project aims to further improve care for patients who frequently attend Middlemore Hospital Emergency Department (ED). About 850 adults attend ED five or more times each year for ‘medical‘ (rather than surgical and other) services. We call these people Very High Intensity Users (VHIU). These people might have unmet needs. Counties Manukau DHB has established a new pathway for VHIU clients whereby, upon discharge from ED or a medical ward, health and social care is coodinated by a community-bsed case manager. The DHB wishes to ascertain whether the programme reduces re-admissions to hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31363 0
Address 31363 0
Country 31363 0
Phone 31363 0
Fax 31363 0
Email 31363 0
Contact person for public queries
Name 14610 0
Associate Professor Timothy Kenealy
Address 14610 0
South Auckland Clinical School of the University of Auckland, Middlemore Hospital, Private Bag 93311, Otahuhu, Auckland 1640
Country 14610 0
New Zealand
Phone 14610 0
+ 64 9 2760044 ext 8415
Fax 14610 0
Email 14610 0
[email protected]
Contact person for scientific queries
Name 5538 0
Associate Professor Timothy Kenealy
Address 5538 0
South Auckland Clinical School of the University of Auckland, Middlemore Hospital, Private Bag 93311, Otahuhu, Auckland 1640
Country 5538 0
New Zealand
Phone 5538 0
+ 64 9 2760044 ext 8415
Fax 5538 0
Email 5538 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.