Chronic Medical ConditionsPHF-RCTNCT01082978
Portable Health Files Improve Quality of Care and Health Outcomes: a Randomized Controlled Trial
A study testing Electronic (USB) Portable Health File and Paper Portable Health File in people with Chronic Medical Conditions and Personal Health Records, run by St George Hospital, Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Medical Conditions, Personal Health Records, Electronic Medical Record
- What is being tested?
- Electronic (USB) Portable Health File and Paper Portable Health File
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2010to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be of age 60 or greater
- Patients living independently in the community. Hostel care is acceptable, but patients that are not independent requiring full nursing home care are excluded.
- Subjects must have had six medical practitioner visits in the previous 12 months
- 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.
Who cannot join
- Life expectancy of less than 12 months.
- Inability to carry a paper PHF or e-PHF and having no care-giver willing and able to accomplish same.
- Mentally unable to undertake valid informed consent.
- Patients who are not independent in the community, that cannot mobilise to see a specialist or requiring full nursing home care
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
A common problem faced by patients and clinicians in our health system is continuity of care and 'clinical handovers'. Few medical record technologies, paper or electronic, top down or bottom up, have been evaluated in a randomised clinical outcome trial to determine the clinical benefits and costs of 'shared' medical and health information. Furthermore, although there are many studies that have evaluated processes of care only a minority do so within a randomized design. Given that any difference is, possibly, small to moderate in magnitude, and given confounders, the use of a randomisation is an essential design requirement.
The first 12 months of the trial constitutes Stage 1 whose primary objective is to describe the acceptability and satisfaction of the our Portable Health Files, and other key process measures. The subsequent 36 months constitutes Stage 2 whose primary objective it to compare important clinical outcomes. The assigned treatment (i.e., the e-PHF or p-PHF) will be used for 4 years total.
To take into account a probable lag effect of the interventions, 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 effects.
The trial is un-blinded so there will be a potential for bias in trial conduct and a potential for ascertainment bias in the determination of important clinical outcomes and quality-of-life. To reduce clinical outcome ascertainment bias a blinded Adjudication Committee will make the determination which out-of-hospital events are "serious". The other primary outcomes: mortality and all overnight hospitalizations are objective outcomes and are not subject to ascertainment bias.
Secondary outcomes include quality of life, quality measures uptake, investigations, medication use, medication errors, and adverse drug reactions. Utilities and costs will also be collected for cost-effectiveness analysis. Patient and provider acceptability and satisfaction with the PHFs will be also collected.
All primary analyses will be undertaken masked to randomized arm allocation.
Most secondary analyses including quality of life, quality measures uptake, investigations, medication use, medication errors, and adverse drug reactions, health utilities, health care utilisation and health care costs will also be undertaken masked to randomized arm allocation.
This Adjudication Committee will also monitor trial safety and scientific integrity.
- Being tested
- Electronic (USB) Portable Health File, Paper Portable Health File
- Keywords
- Quality of Life, Health Care Quality and Safety, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic (USB) Portable Health FileDevice
Also called Electronic Personal Health Record, Electronic Patient-Health Provider Shared Medical Record, Electronic Patient-Health Provider Shared Journal, Electronic Patient-carried Shared Medical Record
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.
Paper Portable Health FileDevice
Also called Paper Personal Health Record, Paper Patient-Health Provider Shared Medical Record, Paper Patient-Health Provider Shared Journal, Paper Patient-carried Shared Medical Record
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.
| Study group | Role | What they receive |
|---|---|---|
| Electronic (USB) Portable Health File | Experimental | 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. Receives: Device: Electronic (USB) Portable Health File |
| Paper Portable Health File | Experimental | 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. Receives: Device: Paper Portable Health File |
| Usual standard of care | No intervention | Patients randomized to this arm of the trial will not be given a Portable Health File. This arm is the concurrent control comparator arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 months + 36 month extension
Secondary outcomes (9)
Quality of Life
SF-36 and EQ-5D
Measured: every 12 months for 48 months
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
Measured: every 12 months for 48 months
medication errors, duplicative investigations
Questionnaire, Self-report PROs and CROs
Measured: every 12 months for 48 months
clinical workflow
Questionnaire, Self-report PROs and CROs
Measured: 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)
Questionnaire, Self-report PROs and CROs
Measured: every 3 months for 12 months then every 6 months 24 months then every 12 months until 48 months
guidelines uptake and documentation
Questionnaire, Self-report PROs and CROs
Measured: every 6 months for 24 months then every 12 months until 48 months
health literacy
Questionnaire, Self-report PROs
Measured: every 12 months until 48 months
information technology and computer expertise
Questionnaire, Self-report PROs
Measured: every 6 months for 24 months then every 12 months until 48 months
adverse events
Questionnaire, Self-report PROs
Measured: every 3 months for 24 months then every 6 months until 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George Hospital, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- South Eastern Area Health Service, The University of New South Wales, National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Marissa Lassere, St George Hospital, Australia
- Investigators
- Marissa ND Lassere, MBBS PhD, Study chair, St George Hospital and Univeristy of NSWKent R Johnson, MD, Principal investigator, Newcastle UniversityGeorge Rubin, MD, Principal investigator, South East Sydney Area Health ServiceAnthony Sara, MBBS MBA, Principal investigator, South East Sydney Area Health ServiceAndrew Parle, BSc (Hons) PhD, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082978
- Sponsor's protocol ID
- PHF-06-124-ML
- Other IDs
- NHMRC 455467
- Acronym
- PHF-RCT
- Status last verified
- Jul 2017
- First submitted
- 8 Mar 2010
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
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.
PubMed 26040644
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01082978
- Acronym / sponsor ID
- PHF-RCT / PHF-06-124-ML
- Keywords
- Quality of Life, Health Care Quality and Safety, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- St George Hospital, AustraliaUniversity, hospital or other
- Collaborators
- South Eastern Area Health Service, The University of New South Wales, National Health and Medical Research Council, Australia
- Study start
- Mar 2010 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A common problem faced by patients and clinicians in our health system is continuity of care and 'clinical handovers'. Few medical record technologies, paper or electronic, top down or bottom up, have been evaluated in a randomised clinical outcome trial to determine the clinical benefits and costs of 'shared' medical and health information. Furthermore, although there are many studies that have evaluated processes of care only a minority do so within a randomized design. Given that any difference is, possibly, small to moderate in magnitude, and given confounders, the use of a randomisation is an essential design requirement.
The first 12 months of the trial constitutes Stage 1 whose primary objective is to describe the acceptability and satisfaction of the our Portable Health Files, and other key process measures. The subsequent 36 months constitutes Stage 2 whose primary objective it to compare important clinical outcomes. The assigned treatment (i.e., the e-PHF or p-PHF) will be used for 4 years total.
To take into account a probable lag effect of the interventions, 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 effects.
The trial is un-blinded so there will be a potential for bias in trial conduct and a potential for ascertainment bias in the determination of important clinical outcomes and quality-of-life. To reduce clinical outcome ascertainment bias a blinded Adjudication Committee will make the determination which out-of-hospital events are "serious". The other primary outcomes: mortality and all overnight hospitalizations are objective outcomes and are not subject to ascertainment bias.
Secondary outcomes include quality of life, quality measures uptake, investigations, medication use, medication errors, and adverse drug reactions. Utilities and costs will also be collected for cost-effectiveness analysis. Patient and provider acceptability and satisfaction with the PHFs will be also collected.
All primary analyses will be undertaken masked to randomized arm allocation.
Most secondary analyses including quality of life, quality measures uptake, investigations, medication use, medication errors, and adverse drug reactions, health utilities, health care utilisation and health care costs will also be undertaken masked to randomized arm allocation.
This Adjudication Committee will also monitor trial safety and scientific integrity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electronic (USB) Portable Health File | Experimental | Device: Electronic (USB) Portable Health FilePatients 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. |
| Paper Portable Health File | Experimental | Device: Paper Portable Health FilePatients 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. |
| Usual standard of care | No intervention | –Patients randomized to this arm of the trial will not be given a Portable Health File. This arm is the concurrent control comparator arm. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be of age 60 or greater
- Patients living independently in the community. Hostel care is acceptable, but patients that are not independent requiring full nursing home care are excluded.
- Subjects must have had six medical practitioner visits in the previous 12 months
- 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.
Key exclusion criteria (4 listed)
- Life expectancy of less than 12 months.
- Inability to carry a paper PHF or e-PHF and having no care-giver willing and able to accomplish same.
- Mentally unable to undertake valid informed consent.
- Patients who are not independent in the community, that cannot mobilise to see a specialist or requiring full nursing home care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic (USB) Portable Health FileAlso: Electronic Personal Health Record, Electronic Patient-Health Provider Shared Medical Record, Electronic Patient-Health Provider Shared Journal, Electronic Patient-carried Shared Medical RecordPatients 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. | Device | Electronic (USB) Portable Health File |
| Paper Portable Health FileAlso: Paper Personal Health Record, Paper Patient-Health Provider Shared Medical Record, Paper Patient-Health Provider Shared Journal, Paper Patient-carried Shared Medical RecordPatients 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. | Device | Paper Portable Health File |
Primary outcome
Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events
Time frame: 48 months + 36 month extension
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.
9 secondary outcomes
Quality of Life
Time frame: every 12 months for 48 months
health service utilisation and health care costs
Time frame: every 12 months for 48 months
medication errors, duplicative investigations
Time frame: every 12 months for 48 months
clinical workflow
Time frame: 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)
Time frame: every 3 months for 12 months then every 6 months 24 months then every 12 months until 48 months
guidelines uptake and documentation
Time frame: every 6 months for 24 months then every 12 months until 48 months
health literacy
Time frame: every 12 months until 48 months
information technology and computer expertise
Time frame: every 6 months for 24 months then every 12 months until 48 months
adverse events
Time frame: every 3 months for 24 months then every 6 months until 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Derived from this study: PubMed 26040644Lassere 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marissa ND Lassere, MBBS PhD study chair
St George Hospital and Univeristy of NSW
Kent R Johnson, MD principal investigator
Newcastle University
George Rubin, MD principal investigator
South East Sydney Area Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic (USB) Portable Health File and Paper Portable Health File in people with Chronic Medical Conditions and Personal Health Records, run by St George Hospital, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events (time frame: 48 months + 36 month extension). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01082978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.