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

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.

Study Overview

• Status: Unknown
• Conditions: Personal Health Records; Chronic Medical Conditions; Electronic Medical Record
• Intervention / Treatment: Device: Electronic (USB) Portable Health File; Device: Paper Portable Health File

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 Type: Interventional
• Enrollment (Anticipated): 382
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.; Other Names: 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
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.	Device: 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.; Other Names: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	SF-36 and EQ-5D	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	every 12 months for 48 months
medication errors, duplicative investigations	Questionnaire, Self-report PROs and CROs	every 12 months for 48 months
clinical workflow	Questionnaire, Self-report PROs and CROs	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	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	every 6 months for 24 months then every 12 months until 48 months
health literacy	Questionnaire, Self-report PROs	every 12 months until 48 months
information technology and computer expertise	Questionnaire, Self-report PROs	every 6 months for 24 months then every 12 months until 48 months
adverse events	Questionnaire, Self-report PROs	every 3 months for 24 months then every 6 months until 48 months

Collaborators and Investigators

• Sponsor: St George Hospital, Australia
• Collaborators: National Health and Medical Research Council, Australia; The University of New South Wales; South Eastern Area Health Service
• Investigators: Study Chair: Marissa ND Lassere, MBBS PhD, St George Hospital and Univeristy of NSW; Principal Investigator: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: March 8, 2010
• First Submitted That Met QC Criteria: March 8, 2010
• First Posted (Estimate): March 9, 2010

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Quality of Life; Randomized controlled trial; Health Care Quality and Safety
• Other Study ID Numbers: PHF-06-124-ML; NHMRC 455467 (Other Grant/Funding Number: NHMRC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No