Clinical trial NCT01082978: Portable Health Files Improve Quality of Care and Health Outcomes: a Randomized Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Medical Conditions
Personal Health Records
Electronic Medical Record
Keywords: Quality of Life
Health Care Quality and Safety
Randomized controlled trial
Lead sponsor: St George Hospital, Australia
Sponsor class: OTHER
Collaborators: name: South Eastern Area Health Service
name: The University of New South Wales
name: National Health and Medical Research Council, Australia
First posted: 2010-03-09
Enrollment: 382
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events
timeFrame: 48 months + 36 month extension
Secondary outcomes:
measure: Quality of Life
timeFrame: every 12 months for 48 months
measure: health service utilisation and health care costs
timeFrame: every 12 months for 48 months
measure: medication errors, duplicative investigations
timeFrame: every 12 months for 48 months
measure: clinical workflow
timeFrame: every 6 months for 2 years then every 12 months until 48 months
measure: subject and health care provider acceptability and satisfaction with portable health files (PHF)
timeFrame: every 3 months for 12 months then every 6 months 24 months then every 12 months until 48 months
measure: guidelines uptake and documentation
timeFrame: every 6 months for 24 months then every 12 months until 48 months
measure: health literacy
timeFrame: every 12 months until 48 months
measure: information technology and computer expertise
timeFrame: every 6 months for 24 months then every 12 months until 48 months
measure: adverse events
timeFrame: every 3 months for 24 months then every 6 months until 48 months
Other outcomes:
Locations:
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
Study officials:
affiliation: St George Hospital and Univeristy of NSW
name: Marissa ND Lassere, MBBS PhD
role: STUDY_CHAIR
affiliation: Newcastle University
name: Kent R Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South East Sydney Area Health Service
name: George Rubin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South East Sydney Area Health Service
name: Anthony Sara, MBBS MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultant
name: Andrew Parle, BSc (Hons) PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.