Back to resultsCan Video Clips Improve Patient Comprehension at the Emergency Department?
Primary Purpose
Doctor Patient Communication, Patient Safety, New Technologies in Clinical Medicine
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Videoclips
Sponsored by
About this trial
This is an interventional other trial for Doctor Patient Communication
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
Sites / Locations
- Emergency Department, IRCCS San Matteo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Video group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Patient's satisfaction
This outcome is measured with interview's question n°5 and n°6. Scores will range from 0-12.
Full Information
NCT ID
NCT03734406
First Posted
November 6, 2018
Last Updated
June 5, 2022
Sponsor
IRCCS Policlinico S. Matteo
1. Study Identification
Unique Protocol Identification Number
NCT03734406
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 27, 2021 (Actual)
Study Completion Date
June 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Doctor Patient Communication, Patient Safety, New Technologies in Clinical Medicine, Patient Education and Health Literacy, Safe Hospital Discharge
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Videoclips
Intervention Description
The images contained in the videoclips show the pathophysiological process underlying the two diseases under study, namely deep vein thrombosis and atrial fibrillation.
Primary Outcome Measure Information:
Title
Patient's comprehension of their medical condition and its potential complications
Description
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
Secondary Outcome Measure Information:
Title
Patient's knowledge of the prescribed therapy
Description
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
Title
Patient's satisfaction
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Emergency Department, IRCCS San Matteo University Hospital
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Can Video Clips Improve Patient Comprehension at the Emergency Department?
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