Chronic Medical Conditions Clinical 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
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.
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.
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