An interventional study of Videoclips in Doctor Patient Communication, Patient Safety and New Technologies in Clinical Medicine, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-08.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Other
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).
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's enrollment of 144 is close to the median of 145 across 931 interventional studies indexed under Emergencies.
Browse Emergencies studies →Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.
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In case of patients lacking capacity, and in all cases of patients who will be judged by the recruiting doctor as incapable to safely receive the discharge instructions, the caregiver will be enrolled to the study with identical modalities.
In the context of a pragmatic trial, we did not set exclusion criteria in terms of education level and comorbidities of the enrolled patients.
Exclusion criteria:
All subjects enrolled in the study group will be showed during the discharge process the video related to patient's condition (DVT vs AF), using it as a graphic support to doctor's verbal explanation of the diagnosed pathology and its possible complications. For the purposes of the study we have selected two 3D videoclips, available on various internet sites and not covered by any copyright restrictions; these have been modified and shortened to make them suitable to use in our study setting. The images contained show the pathophysiological process underlying the two diseases under study, namely deep vein thrombosis and atrial fibrillation. The SIs will show the videos to patients on the institutional computer or, alternatively, on their personal smartphone / tablet. The videos were purposely left without audio content.
Other: Videoclips
Patients of the control group will receive discharge explanations without the aid of any video. The communication strategy in these cases won't be standardized, in order to leave the treating doctors free to express themselves in the way they are used to in their clinical practice, which is based solely on doctor's verbal and non-verbal communication skills.
The images contained in the videoclips show the pathophysiological process underlying the two diseases under study, namely deep vein thrombosis and atrial fibrillation.
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Policlinico San Matteo di Pavia