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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
NHMRC 455467
Secondary ID [2] 0 0
PHF-06-124-ML
Universal Trial Number (UTN)
Trial acronym
PHF-RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Medical Conditions 0 0
Personal Health Records 0 0
Electronic Medical Record 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events - 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.
Timepoint [1] 0 0
48 months + 36 month extension
Secondary outcome [1] 0 0
Quality of Life - SF-36 and EQ-5D
Timepoint [1] 0 0
every 12 months for 48 months
Secondary outcome [2] 0 0
health service utilisation and health care costs - Emergency Department encounters, General Practitioner and Specialist Encounters via record linkage, and their estimated costs by MBS and other costs data
Timepoint [2] 0 0
every 12 months for 48 months
Secondary outcome [3] 0 0
medication errors, duplicative investigations - Questionnaire, Self-report PROs and CROs
Timepoint [3] 0 0
every 12 months for 48 months
Secondary outcome [4] 0 0
clinical workflow - Questionnaire, Self-report PROs and CROs
Timepoint [4] 0 0
every 6 months for 2 years then every 12 months until 48 months
Secondary outcome [5] 0 0
subject and health care provider acceptability and satisfaction with portable health files (PHF) - Questionnaire, Self-report PROs and CROs
Timepoint [5] 0 0
every 3 months for 12 months then every 6 months 24 months then every 12 months until 48 months
Secondary outcome [6] 0 0
guidelines uptake and documentation - Questionnaire, Self-report PROs and CROs
Timepoint [6] 0 0
every 6 months for 24 months then every 12 months until 48 months
Secondary outcome [7] 0 0
health literacy - Questionnaire, Self-report PROs
Timepoint [7] 0 0
every 12 months until 48 months
Secondary outcome [8] 0 0
information technology and computer expertise - Questionnaire, Self-report PROs
Timepoint [8] 0 0
every 6 months for 24 months then every 12 months until 48 months
Secondary outcome [9] 0 0
adverse events - Questionnaire, Self-report PROs
Timepoint [9] 0 0
every 3 months for 24 months then every 6 months until 48 months

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.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
2217 - Kogarah

Funding & Sponsors
Primary sponsor type
Other
Name
St George Hospital, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
South Eastern Area Health Service
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of New South Wales
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National Health and Medical Research Council, Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01082978
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marissa ND Lassere, MBBS PhD
Address 0 0
St George Hospital and Univeristy of NSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01082978