Doctor Patient CommunicationNCT03734406
Can Video Clips Improve Patient Comprehension at the Emergency Department?
A study testing Videoclips in people with Doctor Patient Communication and Patient Safety, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Doctor Patient Communication, Patient Safety, New Technologies in Clinical Medicine
- What is being tested?
- Videoclips
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2018to 5 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Emergency Department, IRCCS San Matteo University Hospital
Pavia, Lombardy, 27100
About this study
Official title: Can Video Clips Improve Patient Comprehension at the Emergency Department? A Multicentric Randomized Controlled Trial.
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).
- Conditions
- Doctor Patient Communication, Patient Safety, New Technologies in Clinical Medicine, Patient Education and Health Literacy, Safe Hospital Discharge
- Being tested
- Videoclips
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoclipsOther
The images contained in the videoclips show the pathophysiological process underlying the two diseases under study, namely deep vein thrombosis and atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Video group | Experimental | 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. Receives: Other: Videoclips |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcome assessed within 48 hours from ED discharge
Secondary outcomes (2)
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).
Measured: Outcome assessed within 48 hours from ED discharge
Patient's satisfaction
This outcome is measured with interview's question n°5 and n°6. Scores will range from 0-12.
Measured: Outcome assessed within 48 hours from ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Dec 2018
- Primary completion27 Dec 2021
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Doctor Patient CommunicationStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santi Di Pietro, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734406
- Sponsor's protocol ID
- 20180068344
- Status last verified
- Jun 2022
- First submitted
- 6 Nov 2018
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Di Pietro S, Ferrari I, Bulgari G, Muiesan ML, Falaschi F, De Silvestri A, Scudeller L, Musella V, Saglio S, Re B, Mattiuzzo E, Cherubini F, Perlini S; Improving Emergency Department Discharge Research Group. Video clips for patient comprehension of atrial fibrillation and deep vein thrombosis in emergency care. A randomised clinical trial. NPJ Digit Med. 2024 Apr 30;7(1):107. doi: 10.1038/s41746-024-01107-7.
PubMed 38688958
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Video Clips Improve Patient Comprehension at the Emergency Department? A Multicentric Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03734406
- Acronym / sponsor ID
- 20180068344
- Conditions
- Doctor Patient Communication, Patient Safety, New Technologies in Clinical Medicine, Patient Education and Health Literacy, Safe Hospital Discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Video group | Experimental | Other: VideoclipsAll 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideoclipsThe images contained in the videoclips show the pathophysiological process underlying the two diseases under study, namely deep vein thrombosis and atrial fibrillation. | Other | Video group |
Primary outcome
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.
2 secondary outcomes
Patient's knowledge of the prescribed therapy
Time frame: Outcome assessed within 48 hours from ED discharge
Patient's satisfaction
Time frame: Outcome assessed within 48 hours from ED discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Derived from this study: PubMed 38688958Di Pietro S, Ferrari I, Bulgari G, Muiesan ML, Falaschi F, De Silvestri A, Scudeller L, Musella V, Saglio S, Re B, Mattiuzzo E, Cherubini F, Perlini S; Improving Emergency Department Discharge Research Group. Video clips for patient comprehension of atrial fibrillation and deep vein thrombosis in emergency care. A randomised clinical trial. NPJ Digit Med. 2024 Apr 30;7(1):107. doi: 10.1038/s41746-024-01107-7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videoclips in people with Doctor Patient Communication and Patient Safety, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's comprehension of their medical condition and its potential complications (time frame: Outcome assessed within 48 hours from ED discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03734406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.