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临床试验/NCT03737396
NCT03737396已完成不适用

Development and Validation of Pre-Anaesthesia CompuTerized Health Assessment (PATCH)

KK Women's and Children's Hospital2 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2018年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
402
试验地点
2
主要终点
Concordance of responses

研究概览

简要总结

Pre-anaesthesia assessment is an important component of preoperative care of surgical patients. With the increasing prevalence of same-day-admission and ambulatory surgery, patients no longer undergo preanaesthesia assessment as an inpatient in traditional "premed rounds". Currently, a nurse-administered paper-based health screening questionnaire is used at the Preadmission Service to identify patients who require outpatient evaluation by anaesthetists prior to elective surgery. In this study, the investigators aim to re-design and convert the current paper-based, nurse-administered health screening questionnaire into a reliable patient self-administered digital tool- Pre-Anaesthesia CompuTerized Health-assessment (PATCH). The electronic questionnaires will be validated by comparison of responses from digital self-administration against that obtained from a nurse interview structured to the same format. The investigators hypothesize that the responses obtained using PATCH will have at least 95% agreement with responses obtained in a nurse-led structured interview. Finally, the use of PATCH would be compared with standard nurse-led paper-based interview in a non-blinded, randomised controlled trial with regard to time taken for nurse processing of the patient at the clinic.

详细描述

Pre-anaesthesia assessment is an important component of preoperative care of surgical patients. Early engagement of medically-complex patients is critical to allow ample time for risk evaluation, discussion of anaesthetic plan and medical optimization. Timely and optimal preparation of patients before elective surgery could reduce morbidity and mortality, and day-of-surgery case cancellations. Due to the implementation of same-day-admission and ambulatory surgeries, medically complex patients would require preanaesthesia evaluation at an appropriate time interval prior to their elective surgery, in an outpatient facility. Currently, a nurse-administered, paper-based health screening questionnaire is used at the Preadmission Service to determine the need for outpatient specialized assessment by an anaesthetist prior to elective surgery. This process is labour-intensive and time-consuming for both patients and nurses.

The need for efficient and cost-saving processes are driving healthcare practice. Computer-assisted history-taking systems have been shown to assist clinicians in the accurate eliciting of information from patients. Increasing evidence supports the use of such systems to triage patients and determine the timing of specialist-led anaesthetic review. Low-risk patients could be evaluated by an anaesthetist on the day of surgery while high-risk patients could be channeled into appropriate pathways for evaluation and optimisation prior to day of elective surgery.

This study is planned to be conducted in several phases:

In the first phase, the investigators aim to re-design and convert the current paper-based, nurse-administered health screening questionnaire into a reliable patient self-administered digitized tool - Pre-Anaesthesia CompuTerized Health-assessment (PATCH). The feasibility of introducing a digital pre-anaesthesia health assessment screening tool will first be assessed by conducting two discrete anonymized surveys on healthcare providers and elective surgical patients to explore their needs, attitudes and acceptability towards having a digitized tool. Next, a new paper-based preanaesthesia health screening questionnaire will be designed after extensive literature review of published, validated preanaesthesia screening questionnaires and a focus group evaluation by clinicians of the anaesthesia department.

Using the draft self-administered paper questionnaire, a pilot study of about 100 patients would be conducted after obtaining written informed consent. Feedback would be sought through a short structured interview that focuses on patient's perception of language, relevance of content and ease of completion. Patients would then be processed, as per standard of care, through a nurse-led interview using the paper-based tool. Validity of each assessment question is determined by percentage agreement method. Percentage agreement of 95% or higher is considered as good criterion validity. Analysis would also include measurement of identical, contradictory and non-contradictory response rates.

研究设计

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

盲法说明

In the validation phase of the study, patients, nurses and investigators are aware of participating patients' allocation in the cross over validation study. However, nurses would be blinded to the electronic responses of patients. In the randomized phase of the study, patient, nurses and investigators will be aware of group allocation and no blinding is involved.

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Listed for elective surgery requiring preanaesthesia health assessment at the Preadmission Service
  • English-literate
  • Able to use an iPad / tablet device
  • Of any nationality

排除标准

  • Patients who are severely ill or listed for emergency operations
  • Visually impaired
  • Not English-literate
  • Unable or refuses to use an iPad / tablet device

结局指标

主要结局

Concordance of responses

时间窗: 1 year

% concordance between responses obtained from self-administration vs nurse administration of the questionnaires

Duration of nurse assessment at Preadmission Service

时间窗: 1 year

Duration of nurse assessment will be compared between digital and standard care patients

次要结局

  • Patient's perception and experience in using self-administered digital preanaesthesia health assessment tool(1 year)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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