Effectiveness and Costs of a Digital Versus Face-to-face Preoperative Assessment Clinic

NCT05535205 | Completed

• 1 other identifier: 21-010
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

A digital preoperative assessment clinic provides a solution for the increasing demand and declining performance on waiting times for surgery, while conducting assessments to a high standard. However, it remains unclear if a digital preoperative assessment is as effective as a face-to-face clinic in terms of patient health outcomes and experience compared. This study aimed to compare quality or recovery and overall patient experience in patients undergoing a digital preoperative assessment versus regular face-to-face consultations.

Conditions

Surgery

Keywords

Preoperative assessment clinic; Preoperative anesthetic screening; Patients requiring surgery; Surgical patients

Outcome Measures

Primary Outcomes (1)

• Quality of recovery 40 (QOR-40) scale

  The QoR-40 is a validated composite endpoint that can be used to evaluate anesthetic or surgical procedure. The questionnaire consists of 40 questions on a 5-point Likert scale that provides a global score and sub scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. The highest achievable score, indicating maximum quality of recovery, is 200. The lowest score, indicating worst quality of recovery, is 40. The questions are related to the quality of recovery over the past 24 hours.

  Measured 48 hours postoperative

Secondary Outcomes (9)

• State-Trait Anxiety Inventory (STAI) form Y1

  Measured at 24 hours preoperative

• Decisional conflict scale (DCS)

  Measured at 24 hours preoperative

• Patient satisfaction with the information

  Measured at 24 hours preoperative

• Patient satisfaction with the entire screening process

  Measured at 24 hours preoperative

• ASA score reliability

  During the PAC and just before surgery (1-2 hours)

Study Arms (2)

Face-to-face preoperative assessment group

ACTIVE COMPARATOR

The face-to-face screening consist of two 20-minute consecutive consultations with a nurse and subsequently an anesthesiologist or PA. The nurse obtains basic patient health information, provides information on the upcoming hospital admission, and gives advice in lifestyle procedures around the surgery. The physician assesses the patient's health status based on co-morbidities, medication use, previous surgery, and lifestyle habits to predict preoperative risks and determine the optimal anesthetic technique. Additional diagnostics, such as blood tests or electrocardiogram, can be ordered and optional anesthetic techniques will subsequently be presented and discussed with the patient, after which informed consent will be obtained.

Other: Face-to-face preoperative assessment

Digital preoperative assessment group

ACTIVE COMPARATOR

Patients in the digital preoperative assessment group are asked to complete an electronic screening questionnaire through the digital patient portal of the hospital. The questionnaire was designed by the anesthetic department physicians and consisted of 50 health related questions. Through the same digital patient portal, patients have access to animated instructional videos that provides information on anesthetic techniques, preoperative lifestyle advises and procedures around the upcoming surgery. The videos can be reviewed at any desired moment in time. A telephone appointment is scheduled solemnly to decide on the anesthesia technique and obtain informed consent since this process was technically not available in the electronic portal. Physicians were thoroughly instructed not to provide more information or answer questions. Patients are instructed to complete the electronic screening questionnaire and assess the animated videos before the scheduled appointment with the physician.

Other: Digital preoperative assessment

Interventions

Digital preoperative assessment OTHER

a digital preoperative assessment for patient requiring surgery

Digital preoperative assessment group

Face-to-face preoperative assessment OTHER

a face-to-face preoperative assessment for patient requiring surgery

Face-to-face preoperative assessment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients to the PAC department with a request of undergoing surgery
• and older
• ASA classification I to IV
• general surgery (vascular, traumatic, gastrointestinal, oncological), gynecology, otolaryngology, neurosurgery, plastic surgery, orthopedics, and ophthalmology.
• fluent in Dutch
• the availability of an online personal computer at home
• and able to give informed consent.

You may not qualify if:

• pregnant women
• patients undergoing a non-standard pre-operative assessment procedure which included breast- and gastrointestinal oncology and cardiac procedures.

Sponsors & Collaborators

• Diakonessenhuis, Utrecht: lead

Study Sites (1)

Diakonessenhuis

Utrecht, 3582 KE, Netherlands

Location

Related Publications (7)

• van den Blink A, Janssen LMJ, Hermanides J, Loer SA, Straat FK, Jessurun EN, Schwarte LA, Schober P. Evaluation of electronic screening in the preoperative process. J Clin Anesth. 2022 Nov;82:110941. doi: 10.1016/j.jclinane.2022.110941. Epub 2022 Aug 5.

  PMID: 35939972 BACKGROUND

• Milne-Ives M, Leyden J, Maramba I, Chatterjee A, Meinert E. The Potential Impacts of a Digital Preoperative Assessment Service on Appointments, Travel-Related Carbon Dioxide Emissions, and User Experience: Case Study. JMIR Perioper Med. 2022 Feb 16;5(1):e28612. doi: 10.2196/28612.

  PMID: 35171104 RESULT

• 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 RESULT

• Howell M, Hood AJ, Jayne DG. Use of a patient completed iPad questionnaire to improve pre-operative assessment. J Clin Monit Comput. 2017 Feb;31(1):221-225. doi: 10.1007/s10877-015-9818-0. Epub 2015 Dec 29.

  PMID: 26715416 RESULT

• Taylor SK, Andrzejowski JC, Wiles MD, Bland S, Jones GL, Radley SC. A prospective observational study of the impact of an electronic questionnaire (ePAQ-PO) on the duration of nurse-led pre-operative assessment and patient satisfaction. PLoS One. 2018 Oct 19;13(10):e0205439. doi: 10.1371/journal.pone.0205439. eCollection 2018.

  PMID: 30339687 RESULT

• Osman T, Lew E, Lum EP, van Galen L, Dabas R, Sng BL, Car J. PreAnaesThesia computerized health (PATCH) assessment: development and validation. BMC Anesthesiol. 2020 Nov 14;20(1):286. doi: 10.1186/s12871-020-01202-8.

  PMID: 33189131 RESULT

• van Hoorn BT, Tromp DJ, van Rees RCM, van Rossenberg LX, Cazemier HK, van Heijl M, Tromp Meesters RC. Effectiveness of a digital vs face-to-face preoperative assessment: A randomized, noninferiority clinical trial. J Clin Anesth. 2023 Nov;90:111192. doi: 10.1016/j.jclinane.2023.111192. Epub 2023 Jul 18.

  PMID: 37467628 DERIVED

Study Officials

• Reinier Tromp Meesters, Msc

  Diakonessenhuis, Utrecht

  STUDY CHAIR

• Mark van Heijl, PhD

  Diakonessenhuis, Utrecht

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 10, 2022
• Study Start: March 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 5, 2022
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)