Few portable medical record technologies, paper or electronic have been evaluated in a randomized clinical outcome trial to determine the clinical benefits and the costs. Although there are many studies that have evaluated processes of care, only a minority do so within a randomized design.
The “Portable Health Files (PHF) Improve Quality of Care and Health Outcomes: a Randomized Controlled Trial” (PHF-RCT) (NCT01082978) currently recruiting participants will assess outcomes resulting from the usage of electronic records carried by the patient on a USB memory device versus paper portable health files in a population that uses many medical services. In addition, the study will look how PHFs are used in caring for patients to see if they are acceptable and satisfactory to patients and their healthcare providers either short or long term.
The sponsor of the study is St. George Hospital in Australia with collaborators that include the South Eastern Area Health Service, University of South Wales, and the National Health and Medical Research Council in Australia. Estimated time for the entire study is from 2010 to March 2018 with 750 subjects enrolled.
The first 12 months of the trial constitutes Stage 1 with the subsequent 36 months constituting Stage 2 with the e-PHF or paper PHRF to be used for 4 years total. The subjects will also be followed for an additional 3 years beyond the conclusion of the trial to see if there are any long term effects.
The study will look at Primary outcome measures in terms of the total number of important clinical events such as hospitalizations, serious out of hospital events, and deaths. Secondary outcome measures to be studied include, quality of life, health service utilization, costs, medication errors, duplicative investigations, clinical workflow, subject and health care provider acceptability and satisfactions, health literacy, and information technology and computer expertise.
Several arms of the trial will take place:
• Some Patients will be given a USB memory device containing the Portable Health File (PHF) software. The portable health files will contain core medical data which functions as a subset of a comprehensive medical record. The PHF is updated by the provider at each visit and can also be updated by the patient between visits if necessary
• Some patients will be given a paper portable health file with core medical and other important data to function as a comprehensive medical record and will be updated at each visit and updated by the patient between visits
• Other patients will receive their usual standard of care and not be given a PHF
The subjects for the study must be 60 years or older, live independently, must have visited their medical practitioner in the previous 12 months, have at least two chronic diseases that require prescription oral or drug treatments or surgery, and require at least annual specialist consultation. The subject’s GP must have access to a computer during the consultation visit.
For more information contact the Principal Investigator, Marissa Lassere, Professor, at marissa.lassere@sesiahs.health.nsw.gov.au or +61 (2) 9113 2992. The ClinicalTrials.gov identifier is NCT01082978.
