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Clinical Trials/NCT03734406
NCT03734406
Completed
N/A

Can Video Clips Improve Patient Comprehension at the Emergency Department? A Multicentric Randomized Controlled Trial.

Fondazione IRCCS Policlinico San Matteo di Pavia1 site in 1 country144 target enrollmentDecember 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Doctor Patient Communication
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Enrollment
144
Locations
1
Primary Endpoint
Patient's comprehension of their medical condition and its potential complications
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
June 5, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Responsible Party
Principal Investigator
Principal Investigator

Santi Di Pietro

Clinical Research Coordinator

Fondazione IRCCS Policlinico San Matteo di Pavia

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Patient's comprehension of their medical condition and its potential complications

Time Frame: Outcome assessed within 48 hours from ED discharge

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.

Secondary Outcomes

  • Patient's knowledge of the prescribed therapy(Outcome assessed within 48 hours from ED discharge)
  • Patient's satisfaction(Outcome assessed within 48 hours from ED discharge)

Study Sites (1)

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