Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000554268
Ethics application status
Approved
Date submitted
7/07/2009
Date registered
8/07/2009
Date last updated
22/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving communication between health care professionals to help patients avoid unnecessary hospital visits.
Scientific title
A Single-Blinded Randomised Controlled Trial Comparing the Effect of Care Navigation versus Current Standard Care in Patients Presenting to the Emergency Department with Serious Chronic Illness on the Rate of Re-presentation to the Emergency Department, Re-admission to Hospital and Time Spent in Hospital
Secondary ID [1] 262693 0
ACTRN12609000554268
Universal Trial Number (UTN)
Trial acronym
Care Navigation Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurring presentation of chronically ill patients to the hospital emergency department. 236989 0
Condition category
Condition code
Public Health 237328 237328 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Care Navigation: hospital and community-based care plan development by the Care Navigation nurse, who contacts hospital and community care providers, prior to the discharge of the patient from hospital to discuss the details of the patient's hospital and home care requirements. Participant progress is also followed up after their return home. The study intervention will be given for 24 months from the date of randomisation into the study.
Intervention code [1] 236752 0
Other interventions
Comparator / control treatment
Current Standard Care: participants follows the current patient flow patterns through hospital visits. Care plan advice is given directly to patients, prior to the discharge of the patient from hospital, regarding appropriate community health provider assistance upon discharge from hospital.
Control group
Active

Outcomes
Primary outcome [1] 238147 0
Number of re-presentations to the emergency department
Timepoint [1] 238147 0
24 months after randomisation
Primary outcome [2] 238148 0
Number of re-admissions to the hospital ward
Timepoint [2] 238148 0
24 months after randomisation
Primary outcome [3] 238149 0
Participant quality of life (EQ-5D questionnaire)
Timepoint [3] 238149 0
24 months after randomisation
Secondary outcome [1] 242368 0
Length of hospital stay (days)
Timepoint [1] 242368 0
24 months after randomisation
Secondary outcome [2] 242370 0
Mortality rate
Timepoint [2] 242370 0
24 months after randomisation
Secondary outcome [3] 242371 0
Cause of death
Timepoint [3] 242371 0
24 months after randomisation
Secondary outcome [4] 242372 0
Time to first hospital readmission
Timepoint [4] 242372 0
24 months after randomisation
Secondary outcome [5] 242373 0
Time to first emergency department representation
Timepoint [5] 242373 0
24 months after randomisation
Secondary outcome [6] 244699 0
Quality of life (EQ-5D questionnaire)
Timepoint [6] 244699 0
12 months after randomisation
Secondary outcome [7] 301747 0
Patient satisfaction (PPE-15 questionnaire)
Timepoint [7] 301747 0
12 months after randomisation
Secondary outcome [8] 301748 0
Self-reported medication adherence questionnaire (Morisky et al, 1986)
Timepoint [8] 301748 0
12 months after randomisation
Secondary outcome [9] 301749 0
Self-reported medication adherence questionnaire (Morisky et al, 1986)
Timepoint [9] 301749 0
24 months after randomisation
Secondary outcome [10] 301750 0
Hospital key performance indicator - time from presentation to referral
Timepoint [10] 301750 0
24 months
Secondary outcome [11] 301751 0
Hospital key performance indicator - time from presentation to medical review
Timepoint [11] 301751 0
24 months

Eligibility
Key inclusion criteria
1. Have had three or more admissions to a Sydney West Area Health Service hospital within a calendar year
2. Patients are either a) greater than 69 years old, irrespective of the diagnosis at any of the three admissions, b) greater than 45 years old and of Aboriginal or Torres Strait Islander decent, irrespective of the diagnosis at any of the three admissions, or c) 16 years or older and less than 70 years old, where at least one of the admissions was for a chronic cardiac or respiratory condition (International Classification of Diseases I11.0, I13.0, I13.2, I25.5, I42, I43, I50 & J40-44);
3. Written informed consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients whose clinical conditions (too acutely sick or bewildered) preclude them from giving informed consent.
2. Patients who have received Care Navigation at another hospital.
3. Patients whose language skills prevent them from completing questionnaires (interpreter and translation services will be provided for patients from culturally and linguistically diverse backgrounds).

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)
Patients flagged by the emergency department's admissions database as being eligible for Care Navigation who are capable of providing written, informed consent (at clinician's discretion) will be given information about the study. Those who give consent will have baseline information collected. The trial staff in the emergency department will contact the off-site randomisation officer who will register the patient to the trial. Once registered, the participant will be allocated either the Care Navigation or Current Standard Care intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The trial statistician will generate a randomisation list using a permuted block design. This randomisation list will provide the trial number and intervention for sequentially-registered trial participants. This list will be kept at the NHMRC Clinical Trials Centre, who will provide an IVRS-based randomisation service.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237277 0
Government body
Name [1] 237277 0
NHMRC Project Grant APP1004393 LEEDER
Country [1] 237277 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Menzies Centre for Health Policy
D02 - Victor Coppleson Building
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 236764 0
None
Name [1] 236764 0
Address [1] 236764 0
Country [1] 236764 0
Other collaborator category [1] 748 0
Hospital
Name [1] 748 0
Nepean Hospital - Sydney West Area Health Service
Address [1] 748 0
Derby Street
Kingswood NSW 2747
Country [1] 748 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239376 0
Nepean Blue Mountains Local Health Network Human Research Ethics Committee.
Ethics committee address [1] 239376 0
Ethics committee country [1] 239376 0
Australia
Date submitted for ethics approval [1] 239376 0
01/07/2009
Approval date [1] 239376 0
Ethics approval number [1] 239376 0
HREC/09/NEPEAN/55

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

Contacts
Principal investigator
Name 29738 0
Prof Stephen Leeder
Address 29738 0
Menzies Centre for Health Policy
UNIVERSITY OF SYDNEY NSW 2006
Country 29738 0
Australia
Phone 29738 0
+61293515211
Fax 29738 0
Email 29738 0
[email protected]
Contact person for public queries
Name 12985 0
Natalie Plant - Research Officer - Care Navigation Trial
Address 12985 0
Menzies Centre for Health Policy
University of Sydney NSW 2006
Country 12985 0
Australia
Phone 12985 0
+61 2 9036 7002
Fax 12985 0
+61 2 9351 5204
Email 12985 0
[email protected]
Contact person for scientific queries
Name 3913 0
Natalie Plant - Research Officer - Care Navigation Trial
Address 3913 0
Menzies Centre for Health Policy
University of Sydney NSW 2006
Country 3913 0
Australia
Phone 3913 0
+61 2 9036 7002
Fax 3913 0
+61 2 9351 5204
Email 3913 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
SourceTitleYear of PublicationDOI
EmbaseImplementation and effectiveness of 'care navigation', coordinated management for people with complex chronic illness: rationale and methods of a randomised controlled trial.2013https://dx.doi.org/10.1186/1472-6963-13-164
N.B. These documents automatically identified may not have been verified by the study sponsor.