TELENURSING IN THE IMMEDIATE PREOPERATIVE PERIOD OF ELECTIVE SURGERIES (TIPPES)

July 16, 2025 updated by: Cintia Silva Fassarella, Rio de Janeiro State University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio de Janeiro
      • Vila Isabel, Rio de Janeiro, Brazil, 20551-030
        • State University of Rio de Janeiro
        • Sub-Investigator:
          • Thiago Pinto Proença, Logistics Technologist
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andressa AB Bueno, Nursing student
        • Sub-Investigator:
          • Luize LL Silva, Nursing student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Group
Patients in the intervention group will receive telenursing the day before surgery, with an immediate preoperative anamnesis script to be carried out by the main researcher. The following day, upon admission, before being transferred to the ward, the patient will be sent to the nursing assessment room, where the auxiliary researcher will apply the immediate preoperative anamnesis script in person.
Behavioral: Preoperative telenursing
The role of Nursing in Telenursing includes Nursing Consultation, Interconsultation, Consulting, Monitoring, Health Education and Reception of Spontaneous Demand mediated by Information and Communication Technologies. In this research, the researcher will make a telephone call the day before surgery to patients scheduled in the surgical map in order to guide them on immediate preoperative care.
Other Names:
  • Telemedicine
  • Telehealth
  • eHealth
No Intervention: Control Group
Patients in the control group will not receive telenursing the day before surgery. Only the following day, upon admission, before being transferred to the ward, the patient will be sent to the nursing assessment room, where the auxiliary researcher will apply the immediate preoperative anamnesis script in person.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery cancellation
Time Frame: 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.
The researcher will verify it on the day after the surgery date

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inadequate immediate preoperative preparation
Time Frame: This will be verified at the time of the in-person nursing assessment on the day of surgery.
Patients who fully comply with the instructions received the day before will be considered to have adequate surgical preparation.
This will be verified at the time of the in-person nursing assessment on the day of surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Investigators

  • Principal Investigator: Cintia S Fassarella, Nurse, Postgraduate Program in Nursing at the State University of Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

July 5, 2025

First Submitted That Met QC Criteria

July 5, 2025

First Posted (Actual)

July 16, 2025

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TelenursingBR27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data that support the results of this research are anonymized.

IPD Sharing Time Frame

After publication, no end date

IPD Sharing Access Criteria

A proposal describing the planned analyses will be made available through publication in a data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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