Telemedicine for Postoperative Follow-up After Oncological Surgeries
NCT ID: NCT06282354
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2024-03-01
2025-02-15
Brief Summary
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Detailed Description
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The patient will be invited to participate in the study at the preoperative evaluation. If it agrees to participate, it will sign the agreement informed consent, and will be randomized in the Redcap® software to one of the study arms (post-operative consultations in person or telemedicine). Patient follow-up in the study will be carried out with the first post-surgery visit between 10 - 20 days after discharge, according to the type of consultation for which the patient was randomized pre-surgery. The main outcome assessed will be the degree of patient satisfaction assessed by using a Likert scale. For patients randomized to the telemedicine arm, the global perception of satisfaction in all aspects of the teleconsultation will be quantified through a Patient Satisfaction Assessment questionnaire served via telemedicine. It will also be evaluated the perception of security defined as security of personal information (Laws General Data Protection - LGPD) . For patients randomized to the in-person postoperative consultations arm, it will be applied an adapted questionnaire, based on QAS-Tele, in order to verify the degree of patient satisfaction in relation to their type of consultation and their interest in carrying out telemedicine consultations in the future.
Questionnaires will be administered to patients 5 to 10 days after the first post-operative return to evaluate the issues mentioned by members of the research team via telephone contact. In addition to this information, patients coming to the institution's emergency room will be quantified within a period of up to 30 days after surgery.
The secondary outcomes will be the number of unattended arrivals programmed at the institution, presence of postoperative complications graded according to the Clavien-Dindo classification, appointment's duration, number of exams requested by the attending physicians, total cost involved per service (expenses with travel, mobile internet data package, necessary structure to telemedicine services) and environmental impact generated with both types of services. Patients will have their demographic data and clinical conditions recorded in appropriate database using RedCap software (Sex, Age, index of body mass, classification of the American Society of Anesthesiologists, Charlson classification, Clavien-Dindo classification). The descriptive analysis will be made by reporting the quantitative variables through the mean, standard deviation, median and quartile, and statistical analysis performed using the Wilcoxon-Mann-Whitney.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Face-to-face appointment
Patients allocated in face-to-face appointment after urooncologic surgical procedures
Type of post-operative appointment
remote post-operative appointment for small or medium urooncology procedures
Telemedicine appointment
Patients allocated in telemedicine appointment after urooncologic surgical procedures
Type of post-operative appointment
remote post-operative appointment for small or medium urooncology procedures
Interventions
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Type of post-operative appointment
remote post-operative appointment for small or medium urooncology procedures
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Instituto do Cancer do Estado de São Paulo
OTHER
Responsible Party
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Central Contacts
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References
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Heymann DL, Shindo N; WHO Scientific and Technical Advisory Group for Infectious Hazards. COVID-19: what is next for public health? Lancet. 2020 Feb 22;395(10224):542-545. doi: 10.1016/S0140-6736(20)30374-3. Epub 2020 Feb 13. No abstract available.
Lerner AM, Folkers GK, Fauci AS. Preventing the Spread of SARS-CoV-2 With Masks and Other "Low-tech" Interventions. JAMA. 2020 Nov 17;324(19):1935-1936. doi: 10.1001/jama.2020.21946. No abstract available.
Walker J, Fleece ME, Griffin RL, Leal SM, Alsip JA, Stigler WS, Nafziger SD, Marrazzo JM, Lee RA. Decreasing High-risk Exposures for Healthcare Workers Through Universal Masking and Universal Severe Acute Respiratory Syndrome Coronavirus 2 Testing on Entry to a Tertiary Care Facility. Clin Infect Dis. 2021 Nov 2;73(9):e3113-e3115. doi: 10.1093/cid/ciaa1358.
Loeb AE, Rao SS, Ficke JR, Morris CD, Riley LH 3rd, Levin AS. Departmental Experience and Lessons Learned With Accelerated Introduction of Telemedicine During the COVID-19 Crisis. J Am Acad Orthop Surg. 2020 Jun 1;28(11):e469-e476. doi: 10.5435/JAAOS-D-20-00380.
Ohannessian R, Duong TA, Odone A. Global Telemedicine Implementation and Integration Within Health Systems to Fight the COVID-19 Pandemic: A Call to Action. JMIR Public Health Surveill. 2020 Apr 2;6(2):e18810. doi: 10.2196/18810.
Committee on Improving the Quality of Cancer Care: Addressing the Challenges of an Aging Population; Board on Health Care Services; Institute of Medicine; Levit L, Balogh E, Nass S, Ganz PA, editors. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. Washington (DC): National Academies Press (US); 2013 Dec 27. Available from http://www.ncbi.nlm.nih.gov/books/NBK202148/
Kummerow Broman K, Roumie CL, Stewart MK, Castellanos JA, Tarpley JL, Dittus RS, Pierce RA. Implementation of a Telephone Postoperative Clinic in an Integrated Health System. J Am Coll Surg. 2016 Oct;223(4):644-51. doi: 10.1016/j.jamcollsurg.2016.07.010. Epub 2016 Aug 18.
Nikolian VC, Williams AM, Jacobs BN, Kemp MT, Wilson JK, Mulholland MW, Alam HB. Pilot Study to Evaluate the Safety, Feasibility, and Financial Implications of a Postoperative Telemedicine Program. Ann Surg. 2018 Oct;268(4):700-707. doi: 10.1097/SLA.0000000000002931.
Moreira TC, Constant HM, Faria AG, Matzenbacher AMF, Balardin GU, Matturro L, Silva MS, Umpierre RN, Rodrigues AS, Cabral FC, Pagano CGM. Tradução, adaptação transcultural e validação de questionário de satisfação em telemedicina. Rev Bras Med Fam Comunidade. 2022;17(44):2837.
Other Identifiers
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NP4035/2023
Identifier Type: -
Identifier Source: org_study_id
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