跳至主要内容
临床试验/NCT06602310
NCT06602310终止不适用

Evaluation of the Utility of the Preanestes@s2.0, a Web Based Application for Preoperative Assessment. Comparison of the Rate of Suboptimal Web Based Telematic Assessments Versus the Outpatient Visit.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla4 个研究点 分布在 1 个国家目标入组 2,254 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2,254
试验地点
4
主要终点
Suboptimal preoperative assessments (SOPA).

研究概览

简要总结

The use of web based self-assessment questionnaires as a complementary tool for conducting preoperative assessment (POA) is gaining increasing acceptance. Preanestes@s2.0 is a web based application fully developed by the investigators team which potentially allows for remote non-telephonic POA. It has already been evaluated as a feasible tool in terms of patient acceptance and quality of the information recorded. In this prospective two-arm study, the investigators will evaluate the incidence of suboptimal POA when the participants are evaluated through Preanestes@s2.0 versus the traditional outpatient face to face visit. The investigators will consider as suboptimal any POA that potentially may generate an inadequate preparation of the patient which may affect the expected results. A total 1.127 participants will be evaluated through Preanestes@s2.0 (intervention arm) and compared to a cohort of 1.127 patients evaluated by traditional face-to-face interview (non-intervention arm). The comparison will be made by means of a propensity score matching study. Patients included in both arms of the study will be recruited throughout the same period of time.

详细描述

Preoperative evaluation models that integrate the use of electronic health records and telephone or electronic questionnaires are evolving aiming to optimize the preoperative assessment process. In 2018, the investigators developed Preanestes@s, a web based application conceived to allow for remote preoperative assessment and guide patients through the preoperative period. The application includes a patient interface which offers general and individualized information on the preoperative process, with the possibility of generating a dynamic interaction between patients and medical staff. Patient interface incorporates a smart web based preoperative questionnaire (PreQuest), which once fully completed automatically classifies patients as per their American ASA grade (from the American Society of Anesthesia Physical Status Classification), and suggests the convenience of a face-to-face visit (f-visit) versus a virtual non-face-to-face non-telephonic visit (v-visit) according to the assigned ASA grade (patients with ASA grade≥3 are systematically recommended for f-visit) and the presence of predefined comorbidities or physical conditions not necessarily related to a specific ASA grade (i.e., current or persistent cough or dyspnea). Both virtual and f-visit are performed by an anesthesiologist. Preanestes@s also determines the preoperative tests that should be conducted according to the patient's condition and offers individualized health advice and recommendations on treatment, with the option of electronically signing an experimental model of electronic informed consent.

In its original version, Preanestes@s has been evaluated both in terms of user acceptance and usability, as well as in terms of the quality of information recording, this last by means of a paired study which compared the information recorded through PreQuest with that recorded by the anesthesiologist when performing the v-visit and the f-visit. The results have been favorable to the model, both in terms of user acceptance and of the quality of the information recording.

On april 2021 the investigators launched a prospective study to evaluate the feasibility and utility of the model, this estimated by comparing the rate of suboptimal preoperative studies carried out using the application versus the traditional outpatient f-visit (Evaluation of the Utility of Preanestes@s, a Web Based Application for Preoperative Assessment; NCT04787783). Unfortunately, the study recruitment rate has been lower than expected, partly due to the difficulties derived from the limited collaboration of the surgeons, the actors initially proposed to lead the recruiting process (recruitment should preferably take place at the time of the surgical indication at the surgeon´s office). Once the investigators detected the difficulties in recruiting by surgeons, they considered filling this shortage through the figure of a recruiting agent, but the investigators were forced to discontinue this task due to lack of funding, what finally led them to seek alternatives to improve the effectiveness and efficiency of the model. From that moment on, the investigators began to work with the objective of achieving automatic patient recruitment. This is how the Preanestes@s2.0 version came about.

Preanestes@s2.0 incorporates a new automatic recruitment interface, so that information that previously had to be entered by the surgeon or, in its defect, by a recruiting agent, is now filled in automatically. Similarly, the new patient management interface has also been improved in automatism and simplified, so that the information that previously had to be managed by the administrative staff is now managed automatically.

On the other hand, the f-visit has been replaced by a telephone visit (t-visit), so that the options available in the model would be the v-visit (non face-to-face non-telephone) and the t-visit (non face-to-face but telephone), regardless of the fact that the anesthesiologist evaluating each case may request a f-visit on demand for specific cases.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants undergoing day scheduled surgery in our institutions: Hospitales Universitarios Virgen del Rocío y Virgen Macarena.
  • Surgical specialities included: Urology, General Surgery, Orthopedics, Ear, nose, and throat surgery.

排除标准

  • Urgent procedures, oncologic procedures, patients without the ability to understand informed consent.

结局指标

主要结局

Suboptimal preoperative assessments (SOPA).

时间窗: From the day of intervention up to 7 days after intervention

Dichotomous (present/absent) composite variable comprising any of the following: 1. Lack of relevant information in the preoperative assessment that conducts to: - Inadequate conciliation of chronic medication - Inadequate preoperative fasting - Inadequate register of clinical or functional conditions that may cause delayed intervention the day of surgery (presence of uncontrolled chronic diseases, presence of impaired functional status undetected in the preoperative assessment, etcetera. 2. Lack of complementary tests indicated according to preoperative protocol 3. Presence of not indicated complementary tests according to preoperative protocol 4. Lack of properly filled informed consent 5. Cancellation of the intervention due to inadequate preoperative preparation (attributable to mismanagement of preoperative information)

次要结局

未报告次要终点

研究者

研究点 (4)

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