Continuous monitoring of patients in and after the acute admission ward to improve clinical pathways: study protocol for a randomized controlled trial (Optimal-AAW)

Trials

Study Protocol

Carine J. M. Doggen¹  Niels Kant²  Sjoerd H. Garssen³  Mark V. Koning⁴  Gert-Jan Mauritz⁵  Frank H. Bosch⁶  Carlijn A. Vernooij⁷ 

[1] Clinical Research Center, Rijnstate Hospital, Arnhem, The Netherlands;Department of Health Technology and Services Research, Technical Medical Center, University of Twente, Enschede, The Netherlands;Clinical Research Center, Rijnstate Hospital, Arnhem, The Netherlands;Department of Health Technology and Services Research, Technical Medical Center, University of Twente, Enschede, The Netherlands;Department of Anesthesiology, Rijnstate Hospital, Arnhem, The Netherlands;Clinical Research Center, Rijnstate Hospital, Arnhem, The Netherlands;Department of Patient Care and Monitoring, Philips Research, Eindhoven, The Netherlands;Department of Health Technology and Services Research, Technical Medical Center, University of Twente, Enschede, The Netherlands;Department of Anesthesiology, Rijnstate Hospital, Arnhem, The Netherlands;Department of Emergency Medicine, Rijnstate Hospital, Arnhem, The Netherlands;Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands;Department of Internal Medicine, Radboudumc, Nijmegen, The Netherlands;Department of Patient Care and Monitoring, Philips Research, Eindhoven, The Netherlands;

关键词: Wearable electronic device;    Acute admission ward;    Length of stay;    Patient discharge;    Clinical trial protocol;    Monitoring, physiologic;    Clinical deterioration;    Clinical decision rules;   

DOI  :  10.1186/s13063-023-07416-8

 received in 2023-02-09, accepted in 2023-05-26,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundBecause of high demand on hospital beds, hospitals seek to reduce patients’ length of stay (LOS) while preserving the quality of care. In addition to usual intermittent vital sign monitoring, continuous monitoring might help to assess the patient’s risk of deterioration, in order to improve the discharge process and reduce LOS. The primary aim of this monocenter randomized controlled trial is to assess the effect of continuous monitoring in an acute admission ward (AAW) on the percentage of patients who are discharged safely.MethodsA total of 800 patients admitted to the AAW, for whom it is equivocal whether they can be discharged directly after their AAW stay, will be randomized to either receive usual care without (control group) or with additional continuous monitoring of heart rate, respiratory rate, posture, and activity, using a wearable sensor (sensor group). Continuous monitoring data are provided to healthcare professionals and used in the discharge decision. The wearable sensor keeps collecting data for 14 days. After 14 days, all patients fill in a questionnaire to assess healthcare use after discharge and, if applicable, their experience with the wearable sensor. The primary outcome is the difference in the percentage of patients who are safely discharged home directly from the AAW between the control and sensor group. Secondary outcomes include hospital LOS, AAW LOS, intensive care unit (ICU) admissions, Rapid Response Team calls, and unplanned readmissions within 30 days. Furthermore, facilitators and barriers for implementing continuous monitoring in the AAW and at home will be investigated.DiscussionClinical effects of continuous monitoring have already been investigated in specific patient populations for multiple purposes, e.g., in reducing the number of ICU admissions. However, to our knowledge, this is the first Randomized Controlled Trial to investigate effects of continuous monitoring in a broad patient population in the AAW.Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT05181111. Registered on 6 January 2022. Start of recruitment: 7 December 2021.

【 授权许可】

CC BY   
© The Author(s) 2023

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