Effectiveness and Costs of a Digital Versus Face-to-face Preoperative Assessment Clinic: a Non-inferiority Trial
Effectiveness and Costs of a Digital Versus Face-to-face Preoperative Assessment Clinic: a Non-inferiority Trial
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.
Study design This is a randomized (1:1), open label, noninferiority trial performed at 2 locations of a Dutch, urban, secondary care hospital.
Aims
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):
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.
Inclusion Criteria:
Exclusion Criteria: