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

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.