Clinical trial NCT03734406: Can Video Clips Improve Patient Comprehension at the Emergency Department?
Official title: Can Video Clips Improve Patient Comprehension at the Emergency Department? A Multicentric Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Doctor Patient Communication
Patient Safety
New Technologies in Clinical Medicine
Patient Education and Health Literacy
Safe Hospital Discharge
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We designed a multicentric, pragmatic, parallel groups trial, with 1:1 randomization, that will involve patients discharged from EDs with a diagnosis of atrial fibrillation (AF) or deep vein thrombosis (DVT).

The study aims to demonstrate the superiority of the intervention in terms of patients' comprehension of their medical condition, assessed with a telephone interview that will be conducted within 48 hours from patients' discharge.
Primary purpose: OTHER

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).


Eligibility criteria: * 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

Primary outcomes:
measure: Patient's comprehension of their medical condition and its potential complications
timeFrame: Outcome assessed within 48 hours from ED discharge
Secondary outcomes:
measure: Patient's knowledge of the prescribed therapy
timeFrame: Outcome assessed within 48 hours from ED discharge
measure: Patient's satisfaction
timeFrame: Outcome assessed within 48 hours from ED discharge
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Emergency Department, IRCCS San Matteo University Hospital
state: Lombardia
Study officials:
References: