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

Surgery Clinical Trial

Official title:

Effectiveness and Costs of a Digital Versus Face-to-face Preoperative Assessment Clinic: a Non-inferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05535205
• Other study ID #: 21-010
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 5, 2022

Study information

• Verified date: September 2022
• Source: Diakonessenhuis, Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: September 5, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Digital preoperative assessment
a digital preoperative assessment for patient requiring surgery
• Face-to-face preoperative assessment
a face-to-face preoperative assessment for patient requiring surgery

Locations

Country	Name	City	State
Netherlands	Diakonessenhuis	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Diakonessenhuis, Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

Blanco Vargas D, Faura Messa A, Izquierdo Tugas E, Santa-Olalla Bergua M, Noguera Sopeña MM, Mañoso 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: — View 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. — View 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):e — View 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. — View 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 — View 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 Aug 5;82:110941. doi: 10.1016/j.jclinane.2022.110941. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	State-Trait Anxiety Inventory (STAI) form Y1	A psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety. The range of possible scores of the STAI varies from a minimum score of 20 (minimum anxiety) to a maximum score of 80 (maximum anxiety)	Measured at 24 hours preoperative
Secondary	Decisional conflict scale (DCS)	The decisional conflict scale (DCS) measures personal perceptions of: uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.; Scores range from 0, no decisional conflict, to 100, extremely high decisional conflict.	Measured at 24 hours preoperative
Secondary	Patient satisfaction with the information	On a NR-scale from 1-10. 1 is least satisfied, 10 is most satisfied.	Measured at 24 hours preoperative
Secondary	Patient satisfaction with the entire screening process	On a NR-scale from 1-10. 1 is least satisfied, 10 is most satisfied.	Measured at 24 hours preoperative
Secondary	ASA score reliability	Reliability of the ASA score administered by the physician during the PAC and the ASA score administered by the physician just before surgery. Reliability is presented as quadratic weighted kappa values: 0 is low agreement, 1 is perfect agreement.	During the PAC and just before surgery (1-2 hours)
Secondary	Postoperative length of stay	in days	until 30 days after surgery
Secondary	30-day complications and mortality	Complications due to surgery or anesthesia are registered, as well as 30-day mortality	until 30 days after surgery
Secondary	Cancelation of PAC appointment or cancelation of surgery	Number of PAC appointment cancellations and cancelled surgeries. Each cancelled appointment of surgery is registered in the medical record an retrospectively assessed.	This is measured from moment of randomization to moment of surgery, which is on average 2 months from randomization.
Secondary	Loan costs	Difference in loan costs of nurses and physicians	until 30 days after surgery