Clinical trial NCT05535205: Effectiveness and Costs of a Digital Versus Face-to-face Preoperative Assessment Clinic
Official title: Effectiveness and Costs of a Digital Versus Face-to-face Preoperative Assessment Clinic: a Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Preoperative assessment clinic
Preoperative anesthetic screening
Patients requiring surgery
Surgical patients
Lead sponsor: Diakonessenhuis, Utrecht
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed description: Study design This is a randomized (1:1), open label, noninferiority trial performed at 2 locations of a Dutch, urban, secondary care hospital.

Aims

1. demonstrate the noninferiority of a digital PAC, in terms of postoperative quality of recovery, compared with a face-to-face PAC, and
2. demonstrate if there is a difference in preoperative anxiety, decisional conflict, patient satisfaction, morbidity, mortality, American Society of Anesthesiologists score (ASA) reliability, and costs.

Study population Participants aged 18 and older admitted to the PAC department with a request of undergoing surgery were evaluated for study enrollment. The trial inclusion criteria are age 18 and older, ASA classification I to IV, fluent in Dutch, the availability of an online personal computer at home, and able to give informed consent. Exclusion criteria are pregnant women, and patients undergoing a non-standard pre-operative assessment procedure which included breast- and gastrointestinal oncology and cardiac procedures.

Outcomes Primary: Quality of recovery 40 (QOR-40) scale assessed at 48 hours postoperative.

Secondary outcomes (Measured 1 day prior to surgery):

* State-Trait Anxiety Inventory (STAI) form Y1 (also at baseline)
* Decisional conflict scale (DCS)
* Patient satisfaction with information (NR 1-10)
* Patient satisfaction with the screening process (NR 1-10) Measured during the study
* ASA reliability
* Postoperative length of stay
* 30-day complications
* 30-day mortality
* preoperative anesthetic assessment and surgery cancelation
* loan costs

Sample size This sample size calculation will be based on noninferiority tests for the continuous primary outcome quality of recovery score (QoR-40) measured at 48 hours after surgery. The noninferiority margin is set at -6 points, which is based on a study by Myles et al. who found a minimal clinical important difference (MCID) of 6.3 for the QOR-40 questionnaire, which was subsequently rounded down. Based on this study, the expected QoR-40 score was177 with a standard deviation of 16 on postoperative day 2 for the control group (face-to-face consultations). A total of 224 patients, 112 in each group, would yield a power of 80%, using a one-sided 97,5% confidence interval (CI), to establish whether a digital PAC is noninferior compared to a face-to-face PAC. With an estimated dropout rate of 25%, a total of 299 patients (150 patients per group) need to be enrolled.

Analysis Data will be analyzed as per-protocol. A linear mixed effects model will be conducted with study group and QOR-baseline as fixed effects and treating specialism as random effect. The primary outcome of QoR-40 will be presented as the mean difference between study groups (digital screening - face-to-face screening) with the upper and lower bound of the 95% CI and will be labelled non-inferior when the non-inferiority margin of -6 lies outside the lower bound of the 95% CI. CIs will be calculated using linear regression analysis.

Eligibility criteria: Inclusion Criteria:

* patients to the PAC department with a request of undergoing surgery
* 18 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Quality of recovery 40 (QOR-40) scale
timeFrame: Measured 48 hours postoperative
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI) form Y1
timeFrame: Measured at 24 hours preoperative
measure: Decisional conflict scale (DCS)
timeFrame: Measured at 24 hours preoperative
measure: Patient satisfaction with the information
timeFrame: Measured at 24 hours preoperative
measure: Patient satisfaction with the entire screening process
timeFrame: Measured at 24 hours preoperative
measure: ASA score reliability
timeFrame: During the PAC and just before surgery (1-2 hours)
measure: Postoperative length of stay
timeFrame: until 30 days after surgery
measure: 30-day complications and mortality
timeFrame: until 30 days after surgery
measure: Cancelation of PAC appointment or cancelation of surgery
timeFrame: This is measured from moment of randomization to moment of surgery, which is on average 2 months from randomization.
measure: Loan costs
timeFrame: until 30 days after surgery
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
affiliation: Diakonessenhuis, Utrecht
name: Reinier Tromp Meesters, Msc
role: STUDY_CHAIR
affiliation: Diakonessenhuis, Utrecht
name: Mark van Heijl, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.