Clinical trial NCT04560023: Effectiveness of Multimedia Exposure in Patients Transferred to Hospital Suffering From Acute Myocardial Infarction
Official title: Effectiveness of Multimedia Content Exposure in Improving the Experience and Reported Patient Outcomes in Patients Suffering From Acute Mycardial Infarction During the Transfer to Hospital: a Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myocardial Infarction, Acute
Anxiety State
Emergencies
Keywords: ambulances
video
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: Junta de Andalucia
First posted: 2020-09-23
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomisation in blocks will be considered. Software will contain and allocation sequence, in each block, 50% of patients will be allocated in control group (standard practice) and the other 50% will be allocated in the experimental group (multimedia exposure).
Primary purpose: SCREENING

Brief summary: Randomised clinical trial, single-center, blinded assessment, controlled with standard practice with two-group parallel design.

Eligible patients are those assisted and transferred suffering from ST-Elevation myocardial infarction in an Advanced Life Support ambulance from an public Emergency Medical Service in the Cadiz area (Spain).

Experimental group will watch an ad hoc design multimedia content in a tablet (video with sound and subtitles) during the transfer and control group will be assisted as standard procedures.

Main outcome variables will be conformed by patient reported outcomes (anxiety State, pain and comfort) and patient experience (transfer experience).

Detailed description: Due to intrinsic characteristics of ambulance transport raises stress or anxiety in patients. Moreover, other outcomes such as pain and some specific vital signs are affected. In the last years, empowerment patient strategies have been launched in several clinical settings but none in the ER field.

Main objective Comparative assessment of the effectiveness of multimedia exposure vs standard clinical procedures to improve the experience and patient reported outcomes in patients suffering from ST-Elevation myocardial infarction transferred to hospital in an Advanced Life Support ambulance for a percutaneous coronary intervention (PCI).

Methods Randomised clinical trial, single-center, blinded assessment, controlled with usual practice with two-group parallel design.

Eligible patients are those assisted and transferred suffering from STEMI in an Advance Life Support (ALS) ambulance from public Emergency Medical System in the Cadiz region.

Experimental group will watch multimedia content on a tablet (movie or image with sound) ad hoc designed, control group will be assisted as usual procedures.

Main outcomes will be conformed by informed patient results (anxiety State, pain and comfort) and patient experience (transfer experience).

Eligibility criteria: Inclusion Criteria:

* All genders patients.
* Assisted by ALS ambulance.
* Diagnosed with STEMI, "Killip I".
* Transferred by an ambulance to the hospital to receive a percutaneous coronary intervention.
* Informed consent must be signed.
* Conscious and oriented patients.

Exclusion Criteria:

* Sedation and/or assisted ventilation.
* Blinded or visual defects.
* Deafness.
* Severe mental disorders or behavior disorders.

Primary outcomes:
measure: Anxiety state
timeFrame: Minute 0.
measure: Anxiety state change
timeFrame: Minute 10.
measure: Experience measure of the ambulance service
timeFrame: 1 measure: one week after the patient has been discharge from hospital. Qualitative interview tool.
measure: Comfort
timeFrame: Minute 0.
measure: Comfort change
timeFrame: Minute 10.
Secondary outcomes:
measure: Pain assessment
timeFrame: Minute 0.
measure: Pain assessment change
timeFrame: Minute 10.
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Universidad de Cádiz
Study officials:
affiliation: Universidad Cádiz
name: Olga Paloma, PhD
role: PRINCIPAL_INVESTIGATOR
References: