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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-09-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Face-to-face preoperative assessment group

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.

Group Type ACTIVE_COMPARATOR

Face-to-face preoperative assessment

Intervention Type OTHER

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

Digital preoperative assessment group

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.

Group Type ACTIVE_COMPARATOR

Digital preoperative assessment

Intervention Type OTHER

a digital preoperative assessment for patient requiring surgery

Interventions

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Digital preoperative assessment

a digital preoperative assessment for patient requiring surgery

Intervention Type OTHER

Face-to-face preoperative assessment

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes