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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01082978
Registration number
NCT01082978
Ethics application status
Date submitted
8/03/2010
Date registered
9/03/2010
Date last updated
1/08/2017
Titles & IDs
Public title
Portable Health Files Improve Quality of Care and Health Outcomes: a Randomized Controlled Trial
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Scientific title
A Randomized Controlled Trial of Portable Electronic(USB)and Paper Medical Records as an Adjunct to Usual Care (Portable Health File RCT): an Evaluation of Short Term Quality Measures and Long-term Clinical Outcomes
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Secondary ID [1]
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NHMRC 455467
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Secondary ID [2]
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PHF-06-124-ML
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Universal Trial Number (UTN)
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Trial acronym
PHF-RCT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Medical Conditions
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Personal Health Records
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Electronic Medical Record
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Electronic (USB) Portable Health File
Treatment: Devices - Paper Portable Health File
Experimental: Electronic (USB) Portable Health File - Patients randomized to this arm of the trial will be given a USB memory device that contains the Portable Health File (PHF) software. The portable health files contained core medical data which functions as a subset of a comprehensive medical record. The portable health file is updated by the health care provider at each visit and could also be updated by patient between visits if necessary.
Experimental: Paper Portable Health File - Patients randomized to this arm of the trial will be given the paper Portable Health File. The paper Portable Health File contains core medical and other important data which functions as a subset of a more comprehensive medical record. This paper-based portable health file is updated by health care providers at each visit. The PHF can also be updated by patient between visits.
No intervention: Usual standard of care - Patients randomized to this arm of the trial will not be given a Portable Health File. This arm is the concurrent control comparator arm.
Treatment: Devices: Electronic (USB) Portable Health File
Patients randomized to this arm of the trial will be given a USB memory device that contains the Portable Health File (PHF) software. The portable health files contained core medical data which functions as a subset of a comprehensive medical record. The portable health file is updated by the health care provider at each visit and could also be updated by patient between visits if necessary.
Treatment: Devices: Paper Portable Health File
Patients randomized to this arm of the trial will be given the paper Portable Health File. The paper Portable Health File contains core medical and other important data which functions as a subset of a more comprehensive medical record. This paper-based portable health file is updated by health care providers at each visit. The PHF can also be updated by patient between visits.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events
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Assessment method [1]
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The primary outcome is the total number of important clinical events (all hospitalisations except same-day hospitalisations, all serious out-of-hospital events and deaths).
See above: The assigned treatment (i.e., the e-PHF or p-PHF) will be used for 4 years total. Patients will also be followed for an additional 3 years beyond the conclusion of the randomised trial to see if there are any longer-term lag effects.
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Timepoint [1]
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48 months + 36 month extension
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Secondary outcome [1]
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Quality of Life
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Assessment method [1]
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SF-36 and EQ-5D
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Timepoint [1]
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every 12 months for 48 months
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Secondary outcome [2]
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health service utilisation and health care costs
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Assessment method [2]
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Emergency Department encounters, General Practitioner and Specialist Encounters via record linkage, and their estimated costs by MBS and other costs data
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Timepoint [2]
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every 12 months for 48 months
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Secondary outcome [3]
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medication errors, duplicative investigations
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Assessment method [3]
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Questionnaire, Self-report PROs and CROs
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Timepoint [3]
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every 12 months for 48 months
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Secondary outcome [4]
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clinical workflow
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Assessment method [4]
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Questionnaire, Self-report PROs and CROs
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Timepoint [4]
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every 6 months for 2 years then every 12 months until 48 months
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Secondary outcome [5]
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subject and health care provider acceptability and satisfaction with portable health files (PHF)
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Assessment method [5]
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Questionnaire, Self-report PROs and CROs
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Timepoint [5]
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every 3 months for 12 months then every 6 months 24 months then every 12 months until 48 months
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Secondary outcome [6]
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guidelines uptake and documentation
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Assessment method [6]
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Questionnaire, Self-report PROs and CROs
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Timepoint [6]
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every 6 months for 24 months then every 12 months until 48 months
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Secondary outcome [7]
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health literacy
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Assessment method [7]
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Questionnaire, Self-report PROs
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Timepoint [7]
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every 12 months until 48 months
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Secondary outcome [8]
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information technology and computer expertise
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Assessment method [8]
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Questionnaire, Self-report PROs
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Timepoint [8]
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every 6 months for 24 months then every 12 months until 48 months
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Secondary outcome [9]
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adverse events
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Assessment method [9]
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Questionnaire, Self-report PROs
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Timepoint [9]
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every 3 months for 24 months then every 6 months until 48 months
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Eligibility
Key inclusion criteria
1. Subjects must be of age 60 or greater
2. Patients living independently in the community. Hostel care is acceptable, but patients that are not independent requiring full nursing home care are excluded.
3. Subjects must have had six medical practitioner visits in the previous 12 months
4. Subjects must have at least two of the following confirmed chronic diseases that require prescription oral or parenteral drug treatment or surgery and requiring at least annual specialist consultation: cardiovascular, respiratory, endocrine, renal, neurologic, gastrointestinal, hepatic, genitourinary, haematologic. infective, rheumatic, inflammatory, immunologic or neoplastic disease.
6. Subject's GP must have access to a computer during the consultation visit. 7. Subjects must have at least two medical specialists at least one of whom has access to a computer during the consultation visit.
8. Subjects must be able to understand the purpose of the trial and undergo full and valid informed consent.
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Life expectancy of less than 12 months.
2. Inability to carry a paper PHF or e-PHF and having no care-giver willing and able to accomplish same.
3. Mentally unable to undertake valid informed consent.
4. Patients who are not independent in the community, that cannot mobilise to see a specialist or requiring full nursing home care
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2020
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Actual
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Sample size
Target
382
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St George Hospital - Kogarah
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Funding & Sponsors
Primary sponsor type
Other
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Name
St George Hospital, Australia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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South Eastern Area Health Service
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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The University of New South Wales
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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National Health and Medical Research Council, Australia
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Address [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
The PHF trial will assess the acceptability and long term outcomes resulting from the usage of electronic (carried by the patient on a USB memory device) and paper portable health files in a population with high intensity use of medical services. The rationale is that use of the portable health files provides a conduit of direct communication among health care providers of a patient's important health care information and this leads to better care and patient outcomes. Primary hypothesis: Addition of a patient-held portable health file (PHF) to usual care improves patient outcome and quality-of-life compared to usual care alone. Secondary hypothesis: Addition of patient-held portable health file (PHF) to usual care is acceptable and satisfactory to patients and their health care providers.
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Trial website
https://clinicaltrials.gov/study/NCT01082978
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Trial related presentations / publications
Lassere MN, Baker S, Parle A, Sara A, Johnson KR. Improving quality of care and long-term health outcomes through continuity of care with the use of an electronic or paper patient-held portable health file (COMMUNICATE): study protocol for a randomized controlled trial. Trials. 2015 Jun 4;16:253. doi: 10.1186/s13063-015-0760-8.
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Public notes
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Contacts
Principal investigator
Name
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Marissa ND Lassere, MBBS PhD
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Address
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St George Hospital and Univeristy of NSW
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01082978
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