NCT04259268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

January 2, 2020

Last Update Submit

May 25, 2021

Conditions

Keywords

Patient Health QuestionnaireElectronic Health Records

Outcome Measures

Primary Outcomes (1)

  • Change in ASA grade classification

    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

    60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)

Secondary Outcomes (5)

  • Change in the register of any allergies

    60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)

  • Change in the register of antiplatelet or blood thinners

    60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)

  • Change in the register of cardiovascular diseases

    60 days before intervention (web-based questionnaire) and 30 days before intervention (virtual and outpatient assessment)

  • Register of the ASA grade in the informed consent form

    The day of intervention

  • Register of personal name and surname in the informed consent form

    The day of intervention

Study Arms (3)

Web based questionnaire

Information registered by patient in the web based questionnaire

Other: Quality of preoperative information register

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 registerOther: Suitability of information contained in the informed consent

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 registerOther: Suitability of information contained in the informed consent

Interventions

Register of principal (grade ASA classification) and secondary variables (allergies, antiplatelet or blood thinners prescriptions, cardiovascular diseases, present medication)

Outpatient assessmentVirtual assessmentWeb based questionnaire

Register of information regarding specific individual risks and personal data (patient and doctor identification and signature)

Outpatient assessmentVirtual assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Related Publications (15)

  • De Hert S, Staender S, Fritsch G, Hinkelbein J, Afshari A, Bettelli G, Bock M, Chew MS, Coburn M, De Robertis E, Drinhaus H, Feldheiser A, Geldner G, Lahner D, Macas A, Neuhaus C, Rauch S, Santos-Ampuero MA, Solca M, Tanha N, Traskaite V, Wagner G, Wappler F. Pre-operative evaluation of adults undergoing elective noncardiac surgery: Updated guideline from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2018 Jun;35(6):407-465. doi: 10.1097/EJA.0000000000000817.

    PMID: 29708905BACKGROUND
  • Katz RI, Dexter F, Rosenfeld K, Wolfe L, Redmond V, Agarwal D, Salik I, Goldsteen K, Goodman M, Glass PS. Survey study of anesthesiologists' and surgeons' ordering of unnecessary preoperative laboratory tests. Anesth Analg. 2011 Jan;112(1):207-12. doi: 10.1213/ANE.0b013e31820034f0. Epub 2010 Nov 16.

    PMID: 21081771BACKGROUND
  • Zaballos M, Lopez-Alvarez S, Argente P, Lopez A; Grupo de Trabajo de Pruebas Preoperatorias. Preoperative tests recommendations in adult patients for ambulatory surgery. Rev Esp Anestesiol Reanim. 2015 Jan;62(1):29-41. doi: 10.1016/j.redar.2014.07.007. Epub 2014 Aug 18. English, Spanish.

    PMID: 25146773BACKGROUND
  • Arias A, Benitez S, Canosa D, Borbolla D, Staccia G, Plazzotta F, Casais M, Michelangelo H, Luna D, Bernaldo de Quiros FG. Computerization of a preanesthetic evaluation and user satisfaction evaluation. Stud Health Technol Inform. 2010;160(Pt 2):1197-201.

    PMID: 20841873BACKGROUND
  • Applegate RL 2nd, Gildea B, Patchin R, Rook JL, Wolford B, Nyirady J, Dawes TA, Faltys J, Ramsingh DS, Stier G. Telemedicine pre-anesthesia evaluation: a randomized pilot trial. Telemed J E Health. 2013 Mar;19(3):211-6. doi: 10.1089/tmj.2012.0132. Epub 2013 Feb 5.

    PMID: 23384334BACKGROUND
  • Blanco Vargas D, Faura Messa A, Izquierdo Tugas E, Santa-Olalla Bergua M, Noguera Sopena MM, Manoso Noriego M. [Online versus non-standard face to face preoperative assessment: cost effectiveness]. Rev Esp Anestesiol Reanim. 2012 Aug-Sep;59(7):350-6. doi: 10.1016/j.redar.2012.05.039. Epub 2012 Jul 10. Spanish.

    PMID: 22784647BACKGROUND
  • de la Matta Martin M, Forastero Rodriguez A, Lopez Romero JL. [Evaluation of a new computerized recording system for preoperative assessment data]. Rev Esp Anestesiol Reanim. 2011 Oct;58(8):485-92. doi: 10.1016/s0034-9356(11)70123-2. Spanish.

    PMID: 22141216BACKGROUND
  • Ludbrook G, Seglenieks R, Osborn S, Grant C. A call centre and extended checklist for pre-screening elective surgical patients - a pilot study. BMC Anesthesiol. 2015 May 19;15:77. doi: 10.1186/s12871-015-0057-1.

    PMID: 25985775BACKGROUND
  • Law TT, Suen DT, Tam YF, Cho SY, Chung HP, Kwong A, Yuen WK. Telephone pre-anaesthesia assessment for ambulatory breast surgery. Hong Kong Med J. 2009 Jun;15(3):179-82.

    PMID: 19494372BACKGROUND
  • Lozada MJ, Nguyen JT, Abouleish A, Prough D, Przkora R. Patient preference for the pre-anesthesia evaluation: Telephone versus in-office assessment. J Clin Anesth. 2016 Jun;31:145-8. doi: 10.1016/j.jclinane.2015.12.040. Epub 2016 Apr 15.

    PMID: 27185698BACKGROUND
  • Goodhart IM, Andrzejowski JC, Jones GL, Berthoud M, Dennis A, Mills GH, Radley SC. Patient-completed, preoperative web-based anaesthetic assessment questionnaire (electronic Personal Assessment Questionnaire PreOperative): Development and validation. Eur J Anaesthesiol. 2017 Apr;34(4):221-228. doi: 10.1097/EJA.0000000000000545.

    PMID: 27798453BACKGROUND
  • Sankar A, Johnson SR, Beattie WS, Tait G, Wijeysundera DN. Reliability of the American Society of Anesthesiologists physical status scale in clinical practice. Br J Anaesth. 2014 Sep;113(3):424-32. doi: 10.1093/bja/aeu100. Epub 2014 Apr 11.

    PMID: 24727705BACKGROUND
  • 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

    BACKGROUND
  • Kinley H, Czoski-Murray C, George S, McCabe C, Primrose J, Reilly C, Wood R, Nicolson P, Healy C, Read S, Norman J, Janke E, Alhameed H, Fernandes N, Thomas E. Effectiveness of appropriately trained nurses in preoperative assessment: randomised controlled equivalence/non-inferiority trial. BMJ. 2002 Dec 7;325(7376):1323. doi: 10.1136/bmj.325.7376.1323.

    PMID: 12468478BACKGROUND
  • de la Matta M, Alonso-Gonzalez M, Moreno-Conde J, Salas-Fernandez S, Lopez-Romero JL; Preanestesas study investigators. Development and patient acceptance of Preanestes@s, a web-based application and electronic questionnaire for preoperative assessment. A prospective cohort study. Rev Esp Anestesiol Reanim (Engl Ed). 2022 Aug-Sep;69(7):383-392. doi: 10.1016/j.redare.2022.01.002. Epub 2022 Jul 20.

Study Officials

  • Manuel de la Matta, MD

    Hospitales Universitarios Virgen del Rocío

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2020

First Posted

February 6, 2020

Study Start

February 7, 2020

Primary Completion

March 31, 2021

Study Completion

May 25, 2021

Last Updated

May 26, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations