Effectiveness and Costs of a Digital Versus Face-to-face Preoperative Assessment Clinic: a Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Quality of recovery 40 (QOR-40) scale
研究概览
简要总结
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.
详细描述
Study design This is a randomized (1:1), open label, noninferiority trial performed at 2 locations of a Dutch, urban, secondary care hospital.
Aims
- demonstrate the noninferiority of a digital PAC, in terms of postoperative quality of recovery, compared with a face-to-face PAC, and
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •pregnant women
- •patients undergoing a non-standard pre-operative assessment procedure which included breast- and gastrointestinal oncology and cardiac procedures.
研究组 & 干预措施
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.
干预措施: Face-to-face preoperative assessment (Other)
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.
干预措施: Digital preoperative assessment (Other)
结局指标
主要结局
Quality of recovery 40 (QOR-40) scale
时间窗: Measured 48 hours postoperative
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.
次要结局
- Decisional conflict scale (DCS)(Measured at 24 hours preoperative)
- ASA score reliability(During the PAC and just before surgery (1-2 hours))
- Cancelation of PAC appointment or cancelation of surgery(This is measured from moment of randomization to moment of surgery, which is on average 2 months from randomization.)
- Patient satisfaction with the entire screening process(Measured at 24 hours preoperative)
- Postoperative length of stay(until 30 days after surgery)
- 30-day complications and mortality(until 30 days after surgery)
- State-Trait Anxiety Inventory (STAI) form Y1(Measured at 24 hours preoperative)
- Patient satisfaction with the information(Measured at 24 hours preoperative)
- Loan costs(until 30 days after surgery)