Portable Health Files Improve Quality of Care and Health Outcomes: a Randomized Controlled Trial (PHF-RCT)

• Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events [ Time Frame: 48 months + 36 month extension ] [ Designated as safety issue: No ]

  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.

  
  

• Quality of Life [ Time Frame: every 12 months for 48 months ] [ Designated as safety issue: No ]
  
• health service utilisation and health care costs [ Time Frame: every 12 months for 48 months ] [ Designated as safety issue: No ]
  
• medication errors, duplicative investigations [ Time Frame: every 12 months for 48 months ] [ Designated as safety issue: No ]
  
• clinical workflow [ Time Frame: every 6 months for 2 years then every 12 months until 48 months ] [ Designated as safety issue: No ]
  
• subject and health care provider acceptability and satisfaction with portable health files (PHF) [ Time Frame: every 3 months for 12 months then every 6 months 24 months then every 12 months until 48 months ] [ Designated as safety issue: Yes ]
  
• guidelines uptake and documentation [ Time Frame: every 6 months for 24 months then every 12 months until 48 months ] [ Designated as safety issue: No ]
  
• health literacy [ Time Frame: every 12 months until 48 months ] [ Designated as safety issue: No ]
  
• information technology and computer expertise [ Time Frame: every 6 months for 24 months then every 12 months until 48 months ] [ Designated as safety issue: No ]
  
• adverse events [ Time Frame: every 3 months for 24 months then every 6 months until 48 months ] [ Designated as safety issue: Yes ]
  

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.