Portable Health Files Improve Quality of Care and Health Outcomes: a Randomized Controlled Trial

NCT01082978 | Unknown DMC

• 2 other identifiers: PHF-06-124-MLNHMRC 455467
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Medical Conditions; Personal Health Records; Electronic Medical Record

Keywords

Quality of Life; Health Care Quality and Safety; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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

Study Arms (3)

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.

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.

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.

Interventions

Electronic (USB) Portable Health File DEVICE

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.

Also known as: Electronic Personal Health Record, Electronic Patient-Health Provider Shared Medical Record, Electronic Patient-Health Provider Shared Journal, Electronic Patient-carried Shared Medical Record, Electronic Patient-carried Continuity of Care Record

Electronic (USB) Portable Health File

Paper Portable Health File DEVICE

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.

Also known as: Paper Personal Health Record, Paper Patient-Health Provider Shared Medical Record, Paper Patient-Health Provider Shared Journal, Paper Patient-carried Shared Medical Record, Paper Patient-carried Continuity of Care Record

Paper Portable Health File

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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.
• \. Subjects must be able to understand the purpose of the trial and undergo full and valid informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• St George Hospital, Australia: lead
• South Eastern Area Health Service: collaborator
• The University of New South Wales: collaborator
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Related Publications (1)

• 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.

  PMID: 26040644 DERIVED

Study Officials

• Marissa ND Lassere, MBBS PhD

  St George Hospital and Univeristy of NSW

  STUDY CHAIR

• Kent R Johnson, MD

  Newcastle University

  PRINCIPAL INVESTIGATOR

• George Rubin, MD

  South East Sydney Area Health Service

  PRINCIPAL INVESTIGATOR

• Anthony Sara, MBBS MBA

  South East Sydney Area Health Service

  PRINCIPAL INVESTIGATOR

• Andrew Parle, BSc (Hons) PhD

  Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Primary outcomes, death and overnight hospitalisations, are obtained through record linkage and are masked outcomes. Outcome assessor, however, is not masked to patient-reported outcomes. Chief Investigator and statistical analyses are masked to randomisation/intervention group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Specialist

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

AU (1)