Construction and empirical of ICU patient follow-up model based on symptom management theory: a quasi-randomized controlled trial study protocol

Abstract

AbstractIntroductionWith the gradual improvement of medical treatment and nursing, more and more patients are successfully transferred out of the ICU. However, intensive care unit (ICU) survivors often experience long-term physical, cognitive, and psychological problems, and their family members also experience physical and psychological dysfunction, summarized as post-intensive care syndrome (PICS), affecting their health-related quality of life. Post-ICU follow-up can improve post-ICU syndrome in patients and their families, but the optimal mode of post-ICU follow-up remains uncertain. The purpose of this study was to build a follow-up model of ICU patients based on symptom management theory.Methods and analysisThis study is a quasi-randomized controlled trial that will be conducted in multiple ICUs at one hospital in China, with patients enrolled from January 2024 to December 2024 and followed for 6 months. We expect to enroll 180 ICU patients. The primary outcome measure was the incidence of post-ICU syndrome (PICS) after ICU transfer, and the secondary outcome measure was the incidence of PCS-F, health economics evaluation, and patient/family satisfaction.Ethics and disseminationThe protocol was approved by the research ethics committee of the Affiliated Hospital of Guizhou Medical University (2023 ethical review No. 061). The results will be published in peer-reviewed journals and presented at national and international scientific conferences to publicize the research to healthcare professionals, health service authorities and the public.Strengths and limitations of this studyThe strength of this study is that this project adopts systematic and scientific research methods, and the ICU post-follow-up model built on the basis of symptom management theory aims to provide patients with the required, predictable and whole-course ICU post-follow-up service, which is helpful to meet the needs of patients under the realistic situation of limited medical resources, and is conducive to improving the utilization efficiency of medical resources. It is of great significance to optimize medical service system.In the process of clinical implementation of randomized controlled trials, there are many resistance and force majeure factors, and ICU patients are especially special, and they are still in a weak state after being transferred out of ICU, and the implementation of randomized controlled trials is very difficult. Based on this, this study adopts experimental research.This study was only conducted in one hospital in Guizhou, China, which may have some limitations and should be expanded in the future.The nature of the intervention does not allow blinding of study personnel and eligible patients at ICUs.