Evaluation of the Utility of Preanestes@s, a Web Based Application for Preoperative Assessment

NCT04787783 | Recruiting

• 1 other identifier: Preanestes@s. Phase2
• Study Type: interventional
• Target: 2,254
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective two-arm study, the investigators will evaluate the incidence of suboptimal preoperative assessments when the participants are evaluated through a web based application (Preanestes@s) versus the traditional outpatient interview.

Conditions

Mobile Applications; Internet-Based Intervention; Ambulatory Surgical Procedures; Preoperative Period

Keywords

Electronic Health Records; Patient Health Questionnaire; Health Impact Assessment

Outcome Measures

Primary Outcomes (1)

• Suboptimal preoperative assessments (SOPA).

  Dichotomous (present/absent) composite variable comprising all possible causes of a predefined suboptimal result. Presence of any of the following: 1. Lack of relevant information in the preoperative assessment that conducts to: * Inadequate conciliation of chronic medication * Inadequate preoperative fasting * Inadequate register of clinical or functional conditions that may cause delayed intervention the day of surgery (presence of uncontrolled chronic diseases, presence of impaired functional status undetected in the preoperative assessment, etc) 2. Lack of complementary tests indicated according to preoperative protocol 3. Presence of not indicated complementary tests according to preoperative protocol 4. Lack of properly filled informed consent 5. Cancellation of the intervention due to inadequate preoperative preparation (attributable to mismanagement of preoperative information-and analyzed by an expert´s committee )

  From the day of intervention up to 7 days after intervention

Study Arms (2)

Web based assessment

EXPERIMENTAL

Participants will be leaded through preoperative period on a web based application. Participants will be addressed to either virtual or traditional face to face outpatient consultation on the basis of the information registered in the web based preoperative questionnaire that the application incorporates. 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.

Other: Web based preoperative assessment

Traditional face to face assessment

NO INTERVENTION

Participants will be leaded through preoperative period following traditional institutional standards of care. 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.

Interventions

Web based preoperative assessment OTHER

Preoperative assessment conducted through a web based application

Also known as: Preanestes@s

Web based assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants undergoing day surgery in our institution: Hospital Duques del Infantado, from Hospital Universitario Virgen del Rocío
• surgical specialities included: ENT, general surgery, orthopedics

You may not qualify if:

• Urgent procedures, patients without the ability to understand informed consent.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Related Publications (8)

• 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: 29708905 BACKGROUND

• Pajuelo-Gallego A. Consejería de Salud, Junta de Andalucía. Bloque Quirúrgico: proceso de soporte. 2004. https://www.juntadeandalucia.es/organismos/saludyfamilias/areas/calidad-investigacion-conocimiento/gestion-conocimiento/paginas/pai-bloque-quirurgico.html

  BACKGROUND

• 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: 25146773 BACKGROUND

• 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: 22784647 BACKGROUND

• 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: 27798453 BACKGROUND

• National Guideline Centre (UK). Preoperative Tests (Update): Routine Preoperative Tests for Elective Surgery. London: National Institute for Health and Care Excellence (NICE); 2016 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK355755/

  PMID: 27077168 BACKGROUND

• 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: 27185698 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: 12468478 BACKGROUND

Study Officials

• Manuel de la Matta, MD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel de la Matta, MD

CONTACT

0034 647493362; mdlmatta@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: April 12, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)