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Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial

BACKGROUND: The majority of surgical interventions are performed in day care and patients are discharged after the first critical postoperative period. At home, patients have limited options to contact healthcare providers in the hospital in case of severe pain and nausea. A smartphone application f...

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Autores principales: Thiel, B., Godfried, M. B., van Emst, M. E., Vernooij, L. M., van Vliet, L. M., Rumke, E., van Dongen, R. T. M., Gerrits, W., Koopman, J. S. H. A., Kalkman, C. J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9909143/
https://www.ncbi.nlm.nih.gov/pubmed/36759858
http://dx.doi.org/10.1186/s13063-023-07121-6
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author Thiel, B.
Godfried, M. B.
van Emst, M. E.
Vernooij, L. M.
van Vliet, L. M.
Rumke, E.
van Dongen, R. T. M.
Gerrits, W.
Koopman, J. S. H. A.
Kalkman, C. J.
author_facet Thiel, B.
Godfried, M. B.
van Emst, M. E.
Vernooij, L. M.
van Vliet, L. M.
Rumke, E.
van Dongen, R. T. M.
Gerrits, W.
Koopman, J. S. H. A.
Kalkman, C. J.
author_sort Thiel, B.
collection PubMed
description BACKGROUND: The majority of surgical interventions are performed in day care and patients are discharged after the first critical postoperative period. At home, patients have limited options to contact healthcare providers in the hospital in case of severe pain and nausea. A smartphone application for patients to self-record pain and nausea when at home after day care surgery might improve patient’s recovery. Currently patient experiences with smartphone applications are promising; however, we do not know whether remote monitoring with such an application also improves the patient’s recovery. This study aims to evaluate the experienced quality of recovery after day care surgery between patients provided with the smartphone application for remote monitoring and patients receiving standard care without remote monitoring. METHODS: This non-blinded randomized controlled trial with mixed methods design will include 310 adult patients scheduled for day care surgery. The intervention group receives the smartphone application with text message function for remote monitoring that enables patients to record pain and nausea. An anaesthesia professional trained in empathetic communication, who will contact the patient in case of severe pain or nausea, performs daily monitoring. The control group receives standard care, with post-discharge verbal and paper instructions. The main study endpoint is the difference in perceived quality of recovery, measured with the QoR-15 questionnaire on the 7th day after day care surgery. Secondary endpoints are the overall score on the Quality of Recovery-15 at day 1, 4 and 7-post discharge, the perceived quality of hospital aftercare and experienced psychological effects of remote monitoring during postoperative recovery from day care surgery. DISCUSSION: This study will investigate if facilitating patients and healthcare professionals with a tool for accessible and empathetic communication might lead to an improved quality of the postoperative recovery period. TRIAL REGISTRATION: The ‘Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial’ is approved and registered on 23 February 2022 by Research Ethics Committees United with registration number R21.076/NL78144.100.21. The protocol NL78144.100.21, ‘Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial’, is registered at the ClinicalTrials.gov public website (registration date 16 February 2022; NCT05244772) SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07121-6.
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spelling pubmed-99091432023-02-09 Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial Thiel, B. Godfried, M. B. van Emst, M. E. Vernooij, L. M. van Vliet, L. M. Rumke, E. van Dongen, R. T. M. Gerrits, W. Koopman, J. S. H. A. Kalkman, C. J. Trials Study Protocol BACKGROUND: The majority of surgical interventions are performed in day care and patients are discharged after the first critical postoperative period. At home, patients have limited options to contact healthcare providers in the hospital in case of severe pain and nausea. A smartphone application for patients to self-record pain and nausea when at home after day care surgery might improve patient’s recovery. Currently patient experiences with smartphone applications are promising; however, we do not know whether remote monitoring with such an application also improves the patient’s recovery. This study aims to evaluate the experienced quality of recovery after day care surgery between patients provided with the smartphone application for remote monitoring and patients receiving standard care without remote monitoring. METHODS: This non-blinded randomized controlled trial with mixed methods design will include 310 adult patients scheduled for day care surgery. The intervention group receives the smartphone application with text message function for remote monitoring that enables patients to record pain and nausea. An anaesthesia professional trained in empathetic communication, who will contact the patient in case of severe pain or nausea, performs daily monitoring. The control group receives standard care, with post-discharge verbal and paper instructions. The main study endpoint is the difference in perceived quality of recovery, measured with the QoR-15 questionnaire on the 7th day after day care surgery. Secondary endpoints are the overall score on the Quality of Recovery-15 at day 1, 4 and 7-post discharge, the perceived quality of hospital aftercare and experienced psychological effects of remote monitoring during postoperative recovery from day care surgery. DISCUSSION: This study will investigate if facilitating patients and healthcare professionals with a tool for accessible and empathetic communication might lead to an improved quality of the postoperative recovery period. TRIAL REGISTRATION: The ‘Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial’ is approved and registered on 23 February 2022 by Research Ethics Committees United with registration number R21.076/NL78144.100.21. The protocol NL78144.100.21, ‘Quality of recovery after day care surgery with app-controlled remote monitoring: a randomized controlled trial’, is registered at the ClinicalTrials.gov public website (registration date 16 February 2022; NCT05244772) SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07121-6. BioMed Central 2023-02-09 /pmc/articles/PMC9909143/ /pubmed/36759858 http://dx.doi.org/10.1186/s13063-023-07121-6 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Thiel, B.
Godfried, M. B.
van Emst, M. E.
Vernooij, L. M.
van Vliet, L. M.
Rumke, E.
van Dongen, R. T. M.
Gerrits, W.
Koopman, J. S. H. A.
Kalkman, C. J.
Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial
title Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial
title_full Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial
title_fullStr Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial
title_full_unstemmed Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial
title_short Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial
title_sort quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9909143/
https://www.ncbi.nlm.nih.gov/pubmed/36759858
http://dx.doi.org/10.1186/s13063-023-07121-6
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