Evaluation of the Quality of Preoperative Information Obtained Through Preanestes@s, a Web Based Application
NCT ID: NCT04259268
Last Updated: 2021-05-26
Study Results
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Basic Information
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COMPLETED
318 participants
OBSERVATIONAL
2020-02-07
2021-05-25
Brief Summary
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Detailed Description
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Virtual assessment will be the performed by evaluating both the filled web based questionnaire together with participants´ electronic records. Face to face assessment will be performed in the traditional way by means of an interview with the participant together with the consultation of participant´s previous electronic records.
The virtual assessment will be reserved for participants without significant comorbidity, which would correspond to patients classified as grade ASA 1-2; this means participants without diseases or with diseases that do not significantly compromise the integrity of the participant: well-controlled hypertension, active smoking without major lung disease, non-morbid obesity, etcetera. Participants with significant comorbidity (grade ASA ≥ 3), will always be referred to a face-to-face consultation.
This study has been approved by the local Ethics Committee -Comité de Ética e Investigación de Huelva-and signed by its Secretary María Dolores Santos Rubio, date 18.12.2019.
The investigators´objective is to evaluate whether the information recorded through the web based questionnaire and the virtual assessment is of a comparable quality to that obtained with the gold standard, the traditional face to face outpatient interview.To answer this question, the investigators have designed a prospective paired stud. After obtaining the correspondent informed consent, the investigators will ask participants to fill the web based questionnaire. In participants submitted to virtual assessment after completing the questionnaire, an investigator will perform the virtual preoperative evaluation; these participants will also be submitted to traditional outpatient evaluation in order to compare both types of evaluation. In participants submitted to outpatient assessment, the investigators will compare traditional face to face visit with the questionnaire information.
The investigators will study the degree of concordance in the recording of preoperative variables between different methods (web based questionnaire, virtual assessment and outpatient assessment). The variables to be analysed are described in the Outcomes Measure section.
The investigators will also compare the suitability of information recorded in the anesthetic paper based informed consent (pIC) versus the electronic informed consent (eIC) included in the application. The investigators hypothesis is that Preanestes@s web based questionnaire together with the virtual assessment allows a collection of preoperative information at least as reliable as the classic face to face interview format.
Statistical analysis: the investigators will analyze the agreement between observers (Interrater reliability) for the qualitative variables selected, making comparisons between the different methods of recording information for each variable included in the analysis (study of paired samples). The investigators will use the Fleiss Kappa coefficient to study the concordance in the measurement of the categorical variables.
For the estimation of the sample size, the investigators will group the categories ASA grade 1-2 versus ASA grade 3 and 4, since in the model proposed , the ASA grade ≥ 3 leads patients to a face-to-face outpatient visit. The investigators assume, therefore, the ASA grade as a dichotomous variable (ASA ≥ 3 present or absent). With these considerations, and based on the Table of Concordance of the work of Sankar et al and their results (Kappa index 0.68 (95% CI 0.67-0.69)), the investigators estimate a sample size of 318 patients for a Kappa index of 0.68 with a precision level of 0.08 and an 95% CI. The investigators will recruit, in principle, a total of 382 participants, assuming a potential loss of 20% of the patients initially included.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Web based questionnaire
Information registered by patient in the web based questionnaire
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
Quality of preoperative information register
Register of principal (grade ASA classification) and secondary variables (allergies, antiplatelet or blood thinners prescriptions, cardiovascular diseases, present medication)
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
Quality of preoperative information register
Register of principal (grade ASA classification) and secondary variables (allergies, antiplatelet or blood thinners prescriptions, cardiovascular diseases, present medication)
Suitability of information contained in the informed consent
Register of information regarding specific individual risks and personal data (patient and doctor identification and signature)
Interventions
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Quality of preoperative information register
Register of principal (grade ASA classification) and secondary variables (allergies, antiplatelet or blood thinners prescriptions, cardiovascular diseases, present medication)
Suitability of information contained in the informed consent
Register of information regarding specific individual risks and personal data (patient and doctor identification and signature)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Urgent or emergent surgery
* Patients submitted to cataract surgery, as far as this procedure is attended by specific clinical pathway
18 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Manuel de la Matta, MD
Role: PRINCIPAL_INVESTIGATOR
Hospitales Universitarios Virgen del Rocío
Locations
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Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
Other Identifiers
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PIN-0224-2018
Identifier Type: -
Identifier Source: org_study_id
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