Preanestes@s Phase 2. Evaluation of the Utility of a Web Based Application for Preoperative Care: Comparison of the Rate of Suboptimal Web-Based Assessments Versus the Outpatient Visit
试验速览
- 阶段
- 不适用
- 入组人数
- 2,254
- 试验地点
- 1
- 主要终点
- Suboptimal preoperative assessments (SOPA).
研究概览
简要总结
In this prospective two-arm study, the investigators will evaluate the incidence of suboptimal preoperative assessments when the participants are evaluated through a web based application (Preanestes@s) versus the traditional outpatient interview.
详细描述
Preanestes@s is a web based application conceived to lead patients through the preoperative period. The application includes a patient interface which offers general and individualized information on the perioperative process, with the possibility of generating a dynamic interaction between patients and medical staff. Patient interface incorporates a web based preoperative questionnaire that once fully completed automatically indicates which preoperative tests are necessary and addresses patients to a virtual (non face to face) consultation or to traditional outpatient assessment. Both virtual and outpatient assessment are performed by an anesthesiologist. The web based questionnaire automatically assigns patients an ASA (from the American Society of Anesthesia Physical Status Classification) grade; this being a determining variable, although not the only one, when directing patients to the virtual or face-to-face consultation.The questionnaire therefore serves both for collection of clinical information and as a patient classification tool as well.
Virtual assessment is performed by evaluating both the filled web based questionnaire together with patient´s electronic records. Face to face assessment is performed in the traditional way by means of a clinical interview together with the consultation of patient's previous electronic records.
The virtual assessment is reserved for participants without significant comorbidity, which would correspond to patients classified as grade ASA 1-2; this means without diseases or with diseases that do not significantly compromise the integrity of the patient: well-controlled hypertension, active smoking without major lung disease, non-morbid obesity, etc. Patients with significant comorbidity (grade ASA ≥ 3), are referred to a face-to-face consultation.
This study has been approved by the local Ethics Committee -Comité de Ética e Investigación de Huelva-and signed by its Secretary María Dolores Santos Rubio, date 18.12.2019, and corresponds to the Phase 2 of the study "Evaluation of the utility and quality of the clinical information obtained through Preanestes@s, a web based application for preoperative assessment. Comparison of the virtual preanesthetic visit and the outpatient face-to-face visit.". Phase 2 is independent of Phase 1, entitled "Evaluation of the Quality of Preoperative Information Obtained Through Preanestes@s, a Web Based Application: Paired Comparison of a Web Based Questionnaire, a Virtual Non Face to Face Assessment and Outpatient Visit", registered in Clinical Trials with number of reference NCT04259268. Primary completion of Phase 1 have been concluded with date February 19, 2021, and preliminary analysis of data is currently being conducted by investigators.
In this study, the objective of the investigators is to assess whether the use of a web based application for the preoperative assessment allows an adequate completion of the preoperative process when compared to traditional face to face outpatient interview. The quality of the information recorded by this web based application has been previously tested by the investigators showing promising results in terms of security and accuracy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants undergoing day surgery in our institution: Hospital Duques del Infantado, from Hospital Universitario Virgen del Rocío
- •surgical specialities included: ENT, general surgery, orthopedics
排除标准
- •Urgent procedures, patients without the ability to understand informed consent.
研究组 & 干预措施
Web based assessment
Participants will be leaded through preoperative period on a web based application. Participants will be addressed to either virtual or traditional face to face outpatient consultation on the basis of the information registered in the web based preoperative questionnaire that the application incorporates. Virtual assessment will be the performed by evaluating both the filled web based questionnaire together with participants´ electronic records. Face to face assessment will be performed in the traditional way by means of an interview with the participant together with the consultation of participant´s previous electronic records.
干预措施: Web based preoperative assessment (Other)
Traditional face to face assessment
Participants will be leaded through preoperative period following traditional institutional standards of care.
Face to face assessment will be performed in the traditional way by means of an interview with the participant together with the consultation of participant´s previous electronic records.
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 all possible causes of a predefined suboptimal result. Presence of 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, etc) 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-and analyzed by an expert´s committee )
次要结局
未报告次要终点
