Effectiveness of Multimedia Exposure in Patients Transferred to Hospital Suffering From Acute Myocardial Infarction

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Myocardial Infarction, Acute, Anxiety State, Emergencies

Intervention / Treatment
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* Other: Exposition to multimedia content


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposition to multimedia content<br>Ad hoc design multimedia content in a tablet (video with sound and subtitles). | Other: Exposition to multimedia content<br>* Video and images watched on a tablet. Patient could decide which information want to watch.<br>|
| No Intervention: Standard procedures<br>Standard procedures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety state | Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18. | Minute 0. | 
| Anxiety state change | Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18. | Minute 10. | 
| Experience measure of the ambulance service | Tool Ambulance Patient Reported Experience Measure (APREMS) | 1 measure: one week after the patient has been discharge from hospital. Qualitative interview tool. | 
| Comfort | Kolcaba General Comfort Questionnaire scale. More punctuation means better outcomes. Range 0-10. | Minute 0. | 
| Comfort change | Kolcaba General Comfort Questionnaire scale. More punctuation means better outcomes. Range 0-10. | Minute 10. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment | Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10. | Minute 0. | 
| Pain assessment change | Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10. | Minute 10. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ambulances, video