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Completed

NCT Number: NCT03734406

Can Video Clips Improve Patient Comprehension at the Emergency Department?

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).

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Key information

Conditions

Doctor Patient Communication New Technologies in Clinical Medicine Patient Education and Health Literacy Patient Safety Safe Hospital Discharge

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department, IRCCS San Matteo University Hospital

Pavia, Lombardy, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Age >18
  • Being diagnosed with one of the two medical condition under study: patients with first-time diagnosis of deep vein thrombosis; patients with first-time diagnosis of atrial fibrillation; patients with second episode in life of atrial fibrillation who have never been prescribed take-home medications for its cure or prevention of recurrence (anticoagulants, antiarrhythmic drugs including beta-blockers)
  • Being discharged home directly from the Emergency Department/Emergency Unit
  • Capacity of the patient to understand the explanations and instructions provided by the doctor (this includes excellent command of the Italian language)
  • Having provided a valid phone number
  • Having signed the informed consent

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

  • Previous diagnosis of deep vein thrombosis
  • Two or more previous episodes of atrial fibrillation; or one previous episode of atrial fibrillation for which the patient has been prescribed one of the following take-home medications: anticoagulants, antiarrhythmic drugs including beta-blockers.
  • Being hospitalized

Treatment and study plan

Videoclips

Other

The images contained in the videoclips show the pathophysiological process underlying the two diseases under study, namely deep vein thrombosis and atrial fibrillation.

Primary outcomes

  1. 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

  1. Patient's knowledge of the prescribed therapy

    Time frame: Outcome assessed within 48 hours from ED discharge

    This outcome is measured with interview's question n°2. Scores will range from 0-6 (low to high comprehension).

  2. Patient's satisfaction

    Time frame: Outcome assessed within 48 hours from ED discharge

    This outcome is measured with interview's question n°5 and n°6. Scores will range from 0-12.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Nov 8, 2018
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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