NCT07068152

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Aug 2025Feb 2027

First Submitted

Initial submission to the registry

July 5, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 5, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

Elective Surgical Procedurestelenursingpatient safetyPreoperative CareHospitals

Outcome Measures

Primary Outcomes (1)

  • Surgery cancellation

    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 Outcomes (1)

  • Inadequate immediate preoperative preparation

    This will be verified at the time of the in-person nursing assessment on the day of surgery.

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

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.

Interventions

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.

Also known as: Telehealth, eHealth, Telemedicine
Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of Rio de Janeiro

Vila Isabel, Rio de Janeiro, 20551-030, Brazil

Location

Related Publications (14)

  • Turunen E, Miettinen M, Setala L, Vehvilainen-Julkunen K. Elective Surgery Cancellations During the Time Between Scheduling and Operation. J Perianesth Nurs. 2019 Feb;34(1):97-107. doi: 10.1016/j.jopan.2017.09.014. Epub 2018 Apr 17.

    PMID: 29678317BACKGROUND
  • McVey C. Telenursing: A Concept Analysis. Comput Inform Nurs. 2023 May 1;41(5):275-280. doi: 10.1097/CIN.0000000000000973.

    PMID: 36223609BACKGROUND
  • Silva, L. de L. T., Souza, F. C. D. de, Coelho, K. R., & Araújo, S. S. Rate and causes of cancellation of elective surgeries in a hospital of Minas Gerais, Brazilian Journal of Development, 2021, 7, 77998-78011

    BACKGROUND
  • Silva Junior JM, Chaves RCF, Correa TD, Assuncao MSC, Katayama HT, Bosso FE, Amendola CP, Serpa Neto A, Malbouisson LMS, Oliveira NE, Veiga VC, Rojas SSO, Postalli NF, Alvarisa TK, Lucena BMN, Oliveira RAG, Sanches LC, Silva UVAE, Nassar Junior AP. Epidemiology and outcome of high-surgical-risk patients admitted to an intensive care unit in Brazil. Rev Bras Ter Intensiva. 2020 Mar;32(1):17-27. doi: 10.5935/0103-507x.20200005. Epub 2020 May 8.

    PMID: 32401988BACKGROUND
  • Burguez Romero, L., Alves Ferreira, R., Bernardo Bueno, A. A., Duarte Pereira Silva Pinheiro, L., Silvestre Dos Santos Azevedo, A. P., Giron Camerini, F., De Mendonça Henrique, D., & Silva Fassarella, C., OUTPATIENT PREOPERATIVE TELECONSULTATION: NA INTEGRATIVE REVIEW, Revista Enfermagem Atual In Derme, 2023, 97, e023159

    BACKGROUND
  • Santos ML, Novaes CO, Iglesias AC. [Epidemiological profile of patients seen in the pre-anesthetic assessment clinic of a university hospital]. Rev Bras Anestesiol. 2017 Sep-Oct;67(5):457-467. doi: 10.1016/j.bjan.2016.06.002. Epub 2016 Aug 27. Portuguese.

    PMID: 27576163BACKGROUND
  • Rocco M, Oliveira BL, Rizzardi DAA, Rodrigues G, Oliveira G, Guerreiro MG, Cruz VS, Naufel-Junior CR. Impact of the COVID-19 Pandemic on Elective and Emergency Surgical Procedures in a University Hospital. Rev Col Bras Cir. 2022 Aug 22;49:e20223324. doi: 10.1590/0100-6991e-20223324-en. eCollection 2022.

    PMID: 36000684BACKGROUND
  • Pinheiro, Silvania Lopes; Vasconcelos, Raissa Ottes; Oliveira, João Lucas Campos de; Matos, Fabiana Gonçalves de Oliveira Azevedo; Tonini, Nelsi Salete; Alves, Débora Cristina Ignácio, Surgical cancellation rate: quality indicator at a public university hospital, REME rev. min. enferm, 2017, 21, e-1014.

    BACKGROUND
  • Pinheiro LDPS, Fassarella CS, Camerini FG, Henrique D de M, Ribeiro OMPL, Romero LB, Cancellation of outpatient surgery: an integrative review, Rev. enferm. UERJ, 2022, 30, 30:e66477

    BACKGROUND
  • Moura MSS, Carvalho SB, Braz ZR, Leal LB, Santos AMRD, Gouveia MTO, Avelino FVSD, Silva ARVD. Use of technologies by nurses to promote breastfeeding: a scoping review. Rev Esc Enferm USP. 2024 Feb 2;57:e20220466. doi: 10.1590/1980-220X-REEUSP-2022-0466en. eCollection 2024.

    PMID: 38407608BACKGROUND
  • Lisboa LA, Mejia OAV, Arita ET, Guerreiro GP, Silveira LMVD, Brandao CMA, Dias RR, Dallan LRP, Miana L, Caneo LF, Jatene MB, Dallan LAO, Jatene FB. Impact of the First Wave of the COVID-19 Pandemic on Cardiovascular Surgery in Brazil: Analysis of a Tertiary Reference Center. Arq Bras Cardiol. 2022 Mar;118(3):663-666. doi: 10.36660/abc.20210235. No abstract available. English, Portuguese.

    PMID: 35319617BACKGROUND
  • Islam, M. and Hossain, T. (2024) Exploring the Effects of Digital Transformation on Employees' Performance Management Systems of the Telecommunication Industry in Bangladesh. Journal of Human Resource and Sustainability Studies, 12, 289-314. doi: 10.4236/jhrss.2024.122016.

    BACKGROUND
  • Chua M, Lau XK, Ignacio J. Facilitators and barriers to implementation of telemedicine in nursing homes: A qualitative systematic review and meta-aggregation. Worldviews Evid Based Nurs. 2024 Jun;21(3):318-329. doi: 10.1111/wvn.12711. Epub 2024 Feb 10.

    PMID: 38340069BACKGROUND
  • Bhanvadia RR, Carpinito GP, Kavoussi M, Lotan Y, Margulis V, Bagrodia A, Roehrborn CG, Gahan JC, Cadeddu J, Woldu S. Safety and Feasibility of Telehealth Only Preoperative Evaluation Before Minimally Invasive Robotic Urologic Surgery. J Endourol. 2022 Aug;36(8):1070-1076. doi: 10.1089/end.2021.0819. Epub 2022 Jul 5.

    PMID: 35596562BACKGROUND

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Cintia S Fassarella, Nurse

    Postgraduate Program in Nursing at the State University of Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andressa AB Bueno, Nursing student

CONTACT

Cintia S Fassarella, Nurse

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Target of 176 patients for each arm of the research
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Advisor

Study Record Dates

First Submitted

July 5, 2025

First Posted

July 16, 2025

Study Start

August 1, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After publication, no end date
Access Criteria
A proposal describing the planned analyses will be made available through publication in a data repository.

Locations