Trial from ANZCTR


Trial ID ACTRN12609000554268
Trial Status: Registered
Date Submitted: 7/07/2009
Date Registered: 8/07/2009
Prospectively registered

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Public title Improving communication between health care professionals to help patients avoid unnecessary hospital visits.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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
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Secondary ID [1] 262693 0
ACTRN12609000554268
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UTN
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Trial acronym Care Navigation Trial
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Health condition(s) or problem(s) studied:
Recurring presentation of chronically ill patients to the hospital emergency department. 236989 0
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Condition category: Condition code:
Public Health Health service research
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237328 237328 0 0

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Descriptions 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.
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Intervention Code:
Other interventions 236752 0
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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.
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Control group Active
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Primary Outcome: Number of re-presentations to the emergency department 238147 0
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Timepoint: 24 months after randomisation 238147 0
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Primary Outcome: Number of re-admissions to the hospital ward 238148 0
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Timepoint: 24 months after randomisation 238148 0
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Primary Outcome: Participant quality of life (EQ-5D questionnaire) 238149 0
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Timepoint: 24 months after randomisation 238149 0
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Secondary Outcome: Length of hospital stay (days) 242368 0
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Timepoint: 24 months after randomisation 242368 0
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Secondary Outcome: Mortality rate 242370 0
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Timepoint: 24 months after randomisation 242370 0
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Secondary Outcome: Cause of death 242371 0
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Timepoint: 24 months after randomisation 242371 0
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Secondary Outcome: Time to first hospital readmission 242372 0
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Timepoint: 24 months after randomisation 242372 0
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Secondary Outcome: Time to first emergency department representation 242373 0
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Timepoint: 24 months after randomisation 242373 0
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Secondary Outcome: Quality of life (EQ-5D questionnaire) 244699 0
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Timepoint: 12 months after randomisation 244699 0
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Secondary Outcome: Patient satisfaction (PPE-15 questionnaire) 301747 0
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Timepoint: 12 months after randomisation 301747 0
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Secondary Outcome: Self-reported medication adherence questionnaire (Morisky et al, 1986)
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Timepoint: 12 months after randomisation 301748 0
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Secondary Outcome: Self-reported medication adherence questionnaire (Morisky et al, 1986) 301749 0
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Timepoint: 24 months after randomisation 301749 0
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Secondary Outcome: Hospital key performance indicator - time from presentation to referral 301750 0
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Timepoint: 24 months 301750 0
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Secondary Outcome: Hospital key performance indicator - time from presentation to medical review 301751 0
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Timepoint: 24 months 301751 0
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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.
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Minimum age 16 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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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).
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 17/05/2010
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 500
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Recruitment status Closed: follow-up complete
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Government body 237277 0
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Name: NHMRC Project Grant APP1004393 LEEDER 237277 0
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Address: Level 1
16 Marcus Clarke Street
Canberra ACT 2601
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Country: Australia 237277 0
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Primary Sponsor University
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Name: The University of Sydney
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Address: Menzies Centre for Health Policy
D02 - Victor Coppleson Building
University of Sydney NSW 2006
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Country: Australia
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Secondary Sponsor: None 236764 0
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Name: 236764 0
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Other Collaborator: Hospital 748 0
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Name: Nepean Hospital - Sydney West Area Health Service 748 0
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Address: Derby Street
Kingswood NSW 2747
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Country: Australia 748 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Nepean Blue Mountains Local Health Network Human Research Ethics Committee. 239376 0
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Address: Nepean Hospital
Cnr Somerset & Derby Sts
Kingswood NSW 2747
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Country: Australia 239376 0
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Approval Date: 239376 0
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Submitted Date: 01/07/2009 239376 0
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HREC: HREC/09/NEPEAN/55 239376 0
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Brief summary This trial hopes to improve the quality of life of patients whose age, heart or respiratory condition means that they regularly attend the emergency department. It aims to reduce the number of times patients come to hospital by improving the patient's home-based care plan. To do this, hospital staff will contact the patient's GP and other community-based health providers to discuss the best care plan. The outcomes of these patients will be compared to patients who do not receive this extra care planning.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
Title: Prof
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Name: Stephen Leeder
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Address: Menzies Centre for Health Policy UNIVERSITY OF SYDNEY NSW 2006
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Country: Australia
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Tel: +61293515211
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Email: Stephen.Leeder@sydney.edu.au
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Contact person for public queries
Title: Ms
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Name: Natalie Plant - Research Officer - Care Navigation Trial
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Address: Menzies Centre for Health Policy University of Sydney NSW 2006
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Country: Australia
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Tel: +61 2 9036 7002
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Fax: +61 2 9351 5204
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Email: carenavigation@health.usyd.edu.au
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Contact person for scientific queries
Title: Ms
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Name: Natalie Plant - Research Officer - Care Navigation Trial
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Address: Menzies Centre for Health Policy University of Sydney NSW 2006
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Country: Australia
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Tel: +61 2 9036 7002
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Fax: +61 2 9351 5204
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Email: carenavigation@health.usyd.edu.au
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Contact person responsible for updating information
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Name: Natalie Plant: Research Officer - Care Navigation Trial
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Address: Menzies Centre for Health Policy University of Sydney NSW 2006
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Country: Australia
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Tel: +61 2 9036 7002
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Fax: +61 2 9351 7204
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Email: carenavigation@health.usyd.edu.au
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Addition Cancer fields
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