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Evaluation of the Quality of Preoperative Information Obtained Through Preanestes@s, a Web Based Application (Preanestes@s)

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ClinicalTrials.gov Identifier: NCT04259268
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary:
In this prospective and paired study, the investigators evaluate whether the preoperative information recorded through a web based questionnaire together with a virtual non face to face patient assessment based on the information recorded by the questionnaire and the electronic records of patients is of a comparable quality to that obtained with the traditional outpatient interview.

Condition or disease Intervention/treatment
Mobile Applications Internet-Based Intervention Preoperative Period Other: Quality of preoperative information register Other: Suitability of information contained in the informed consent

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Study Type : Observational
Estimated Enrollment : 318 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Quality of Preoperative Information Obtained Through Preanestes@s, a Web Based Application: Paired Comparison of a Web Based Questionnaire, a Virtual Non Face to Face Assessment and Outpatient Visit
Actual Study Start Date : February 7, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : September 30, 2021

Group/Cohort Intervention/treatment
Web based questionnaire
Information registered by patient in the web based questionnaire
Other: Quality of preoperative information register
Register of principal (grade ASA classification) and secondary variables (allergies, antiplatelet or blood thinners prescriptions, cardiovascular diseases, present medication)

Outpatient assessment
Information registered by the anesthesiologist and based on the web based questionnaire, the electronic records of patient and the "face to face" interview
Other: Quality of preoperative information register
Register of principal (grade ASA classification) and secondary variables (allergies, antiplatelet or blood thinners prescriptions, cardiovascular diseases, present medication)

Other: Suitability of information contained in the informed consent
Register of information regarding specific individual risks and personal data (patient and doctor identification and signature)

Virtual assessment
Information registered by the anesthesiologist and based on the web based questionnaire and the electronic records of patient
Other: Quality of preoperative information register
Register of principal (grade ASA classification) and secondary variables (allergies, antiplatelet or blood thinners prescriptions, cardiovascular diseases, present medication)

Other: Suitability of information contained in the informed consent
Register of information regarding specific individual risks and personal data (patient and doctor identification and signature)




Primary Outcome Measures :
  1. Change in ASA grade classification [ Time Frame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment) ]
    Comparison of the ASA grade assigned automatically when patients fill the web based questionnaire versus that assigned by the anesthesiologist following the virtual or outpatient assessment


Secondary Outcome Measures :
  1. Change in the register of any allergies [ Time Frame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment) ]
    Comparison of the presence of any allergies registered by patient in the web based questionnaire those included in patient´s electronic records or registered by the anesthesiologist following the virtual or outpatient assessment

  2. Change in the register of antiplatelet or blood thinners [ Time Frame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment) ]
    Comparison in the register of antiplatelet or blood thinners either by patient through the web based questionnaire versus those registered in patient´s electronic records or by the anesthesiologist following the virtual or outpatient assessment

  3. Change in the register of cardiovascular diseases [ Time Frame: 60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment) ]
    Comparison in the register of cardiovascular diseases registered either by patient through the web based questionnaire or by the anesthesiologist following the virtual or outpatient assessment

  4. Register of the ASA grade in the informed consent form [ Time Frame: The day of intervention ]
    Comparison in the register of the ASA grade either in the paper based informed consent versus the electronic informed consent

  5. Register of personal name and surname in the informed consent form [ Time Frame: The day of intervention ]
    Comparison in the register of the names and surnames of both patient and anesthesiologist either in the paper based informed consent versus the electronic informed consent



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients submitted to programmed interventions under anesthetic care in Hospital Universitario Virgen del Rocío
Criteria

Inclusion Criteria:

  • Adult patients submitted to programmed interventions under anesthetic care in Hospital Universitario Virgen del Rocío

Exclusion Criteria:

  • Patients unable to fully understand the informed consent
  • Urgent or emergent surgery
  • Patients submitted to cataract surgery, as far as this procedure is attended by specific clinical pathway

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04259268


Contacts
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Contact: Manuel de la Matta, MD 00 34 647493362 mdlmatta@hotmail.com

Locations
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Spain
Hospital Universitario Virgen del Rocío Recruiting
Seville, Spain, 41013
Contact: Manuel de la Matta, MD    00 34 647493362    mdlmatta@hotmail.com   
Sub-Investigator: Juan Sánchez Peña         
Sub-Investigator: Magdalena Arance García, MD         
Sub-Investigator: Marta García Santigosa         
Sub-Investigator: Enar Amalia Buisán Fernández         
Sub-Investigator: Juan Luis López Romero         
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Principal Investigator: Manuel de la Matta, MD Hospitales Universitarios Virgen del Rocío
Publications:
ASA House of Delegates/Executive Committee. ASA Satandards and Guidelines. ASA Physical Status Classification System.2014. https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system

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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT04259268    
Other Study ID Numbers: PIN-0224-2018
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
Patient Health Questionnaire
Electronic Health Records