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临床试验/NCT07068152
NCT07068152尚未招募不适用

COST-EFFECTIVENESS ANALYSIS OF "PIGGYBACK" TELENURSING IN THE IMMEDIATE PREOPERATIVE PERIOD OF ELECTIVE SURGERIES: RANDOMIZED CLINICAL TRIAL PROTOCOL

Rio de Janeiro State University2 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
352
试验地点
2
主要终点
Surgery cancellation

研究概览

简要总结

Introduction: Telenursing encompasses Nursing Consultation, Interconsultation, Consulting, Monitoring, Health Education and Reception of Spontaneous Demand mediated by Information and Communication Technology. Objective: To perform a cost-effectiveness analysis of telenursing in the immediate preoperative period of adult patients undergoing elective surgeries in a university hospital of the SUS. Materials and method: Cost-effectiveness analysis nested in a clinical trial or empirical economic analysis of the piggyback evaluation type. Divided into 2 phases: a) Experimental research - randomized clinical trial to be carried out in a university hospital located in Rio de Janeiro and part of the SUS, with two parallel groups - intervention and control - with 1:1 allocation. The inclusion criteria will be adult patients, of both sexes, in the immediate preoperative period who are admitted on the day of elective surgery from their home. Patients who are hospitalized, patients in ophthalmology and obstetrics specialties, and those who will undergo examinations in the surgical center will be excluded. The sample size calculation was performed with a 95% confidence level and a sample loss of 5%, totaling 352 patients. The sampling will be random. Randomization and allocation concealment will be performed by the independent researcher. Patients in the GI will receive telenursing on the day before surgery with an anamnesis script for telenursing by the main researcher. On the day of surgery, all patients on the surgical map who came from their residence will be directed to the nursing assessment room where the auxiliary researcher will apply the in-person anamnesis script. The data will be processed by two independent researchers in an electronic spreadsheet and will be analyzed using descriptive and inferential statistics. The research will respect all legal and ethical frameworks necessary for its implementation; b) Prospective analysis of complete economic evaluation - in the piggyback evaluation modality - of the cost-effectiveness type. The effectiveness of telenursing will be verified by the outcome of surgical cancellation. A decision tree model will be used with a view to analyzing the SUS user at the local level (microcosting). The time horizon will be two days. The cost-effectiveness threshold will be 1 GDP per capita and the data analysis will include deterministic and probabilistic sensitivity. Expected results: It is expected to prove that telenursing can be a safe and efficient method for guiding patients before surgery, generating greater patient satisfaction, increasing access to information about health care for users through remote communication with nurses, reducing the waiting list by reducing surgical cancellations and possible incorporation of telenursing as a consolidated practice in the university hospital studied.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

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

入选标准

  • Patient recruitment will be conducted using the hospital's general surgical center surgical map. The participating population will consist of:
  • All patients 18 years of age or older, of both sexes, in the immediate preoperative period;
  • Admitted on the day of elective surgery;
  • Coming from their home.

排除标准

  • Inpatients;
  • Ophthalmology, obstetrics, and pediatrics specialties;
  • Exams performed in the surgical center, such as endoscopy, colonoscopy, video hysteroscopy, and others.

结局指标

主要结局

Surgery cancellation

时间窗: The researcher will verify it on the day after the surgery date

The main outcome of this research is the surgery cancellation, which will be verified in the hospital's electronic system with its respective reason. This is a binary outcome.

次要结局

  • Inadequate immediate preoperative preparation(This will be verified at the time of the in-person nursing assessment on the day of surgery.)

研究者

发起方
Rio de Janeiro State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cintia Silva Fassarella

Advisor

Rio de Janeiro State University

研究点 (2)

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