Doctor Patient Communication, New Technologies in Clinical Medicine, Patient Education and Health Literacy, Patient Safety, Safe Hospital Discharge
Conditions
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).
Interventions
OTHERVideoclips
The images contained in the videoclips show the pathophysiological process underlying the two diseases under study, namely deep vein thrombosis and atrial fibrillation.
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's comprehension of their medical condition and its potential complications | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient's knowledge of the prescribed therapy | 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). |
| Patient's satisfaction | 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. |
Countries
Italy
Outcome results
None listed