The aim of this study is to assess the utility of two interventional videos, showed to patients discharged from the ED with a diagnosis of atrial fibrillation or deep vein thrombosis. We have focused our attention on these two medical conditions because they share some important features: they are frequently seen in EDs; their main complication (stroke and pulmonary embolism) can cause significant morbidity and mortality; both conditions and their related complications are probably not very intuitive to comprehend for the general population. In fact, the understanding of these conditions implies the knowledge of a number of pathological processes, with which most people are unfamiliar. The primary hypothesis is that patients enrolled in the study group will show a higher degree of comprehension of their medical condition and its related complications, as compared to the control group. Secondly, we will also analyze any possible effect of the videos on the knowledge of the therapy prescribed, return instructions and patients' satisfaction with the quality of communication in the ED. Eventually, we will examine the association of some factors with the outcomes (age, sex, level of education, atrial fibrillation vs. deep vein thrombosis group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
144
The images contained in the videoclips show the pathophysiological process underlying the two diseases under study, namely deep vein thrombosis and atrial fibrillation.
Emergency Department, IRCCS San Matteo University Hospital
Pavia, Lombardy, Italy
Patient's comprehension of their medical condition and its potential complications
The main outcome corresponds to interview's questions n°1-3-4. Patients' answers will receive a score on a 4-points Likert scale (from zero to three) from low to high knowledge. Scores from the two independent reviewers will be averaged and then added to obtain an overall score. The score for the main outcomes will therefore range 0-18 for the main outcome. To the best of our knowledge, no currently available validated questionnaires would serve for the purpose of our study, i.e. for the simultaneous measurement of different domains of comprehension across two different medical conditions. Hence, we have developed the ad-hoc interview and its related interpretation scheme using face and content validity. Construct validation would require an amount of time and resources equivalent to that of the trial itself, pushing it beyond practical feasibility.
Time frame: Outcome assessed within 48 hours from ED discharge
Patient's knowledge of the prescribed therapy
This outcome is measured with interview's question n°2. Scores will range from 0-6 (low to high comprehension).
Time frame: Outcome assessed within 48 hours from ED discharge
Patient's satisfaction
This outcome is measured with interview's question n°5 and n°6. Scores will range from 0-12.
Time frame: Outcome assessed within 48 hours from ED discharge
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