PHF-RCT
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
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · NHMRC
interventional
382
1 country
1
Study Start
March 2010
Actual (reported)Primary Completion
March 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2010
Actual (reported)March 8, 2010
Actual (reported)March 9, 2010
Actual (reported)March 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
48 months + 36 month extension
Quality of Life
every 12 months for 48 months
health service utilisation and health care costs
every 12 months for 48 months
medication errors, duplicative investigations
every 12 months for 48 months
clinical workflow
every 6 months for 2 years then every 12 months until 48 months
subject and health care provider acceptability and satisfaction with portable health files (PHF)
every 3 months for 12 months then every 6 months 24 months then every 12 months until 48 months
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.
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.
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.
St George Hospital
Kogarah, New South Wales, 2217, Australia
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.
Marissa ND Lassere, MBBS PhD
St George Hospital and Univeristy of NSW
Kent R Johnson, MD
Newcastle University
George Rubin, MD
South East Sydney Area Health Service
Anthony Sara, MBBS MBA
South East Sydney Area Health Service
First Submitted
March 8, 2010
First Posted
March 9, 2010
Study Start
March 2010
Actual (reported)The Role of Framing and Choice Architecture in Patients' Reactions and EHR Error Discovery and Reporting
Patients randomized to this arm of the trial will not be given a Portable Health File. This arm is the concurrent control comparator arm.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Andrew Parle, BSc (Hons) PhD
Consultant
Primary Completion
March 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 1, 2017
Record last verified: 2017-07
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Source: ClinicalTrials.gov.
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