Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): feasibility of a pragmatic randomised controlled trial.

BACKGROUND: ICU survivors often suffer from prolonged physical and mental impairments resulting in the so called "Post-Intensive Care Syndrome" (PICS). The aftercare of former ICU patients affected by PICS in particular has not been addressed sufficiently in Germany so far. The aim of this study was to evaluate the feasibility of a pragmatic randomised trial (RCT) comparing an intensive care unit (ICU) follow-up clinic intervention to usual care. METHODS: This pilot study in a German university hospital evaluated the feasibility of a pragmatic RCT. Patients were assigned in a 1:1 ratio to an ICU follow-up clinic intervention or to usual care. The concept of this follow-up clinic was previously developed in a participatory process with patients, next of kin, health care professionals and researchers. We performed a process evaluation and determined acceptability, fidelity, completeness of measurement instruments and practicality as feasibility outcomes. The RCT's primary outcome (health-related quality of life) was assessed six months after ICU discharge by means of the physical component scale of the Short-Form-12 self-report questionnaire. RESULTS: The pilot study was conducted from June 2020 to May 2021 with 21 and 20 participants in the intervention and control group. Principal findings related to feasibility were 85% consent rate (N = 48), 62% fidelity rate, 34% attrition rate (N = 41) and 77% completeness of outcome measurements. The primary effectiveness outcome (health-related quality of life) could be measured in 93% of participants who completed the study (N = 27). The majority of participants (85%) needed assistance with follow-up questionnaires (practicality). Median length of ICU stay was 13 days and 85% (N = 41) received mechanical ventilation, median Sequential Organ Failure Assessment Score was nine. Six-month follow-up assessment was planned for all study participants and performed for 66% (N = 41) of the participants after 197 days (median). CONCLUSION: The participatory developed intervention of an ICU follow-up clinic and the pragmatic pilot RCT both seem to be feasible. We recommend to start a pragmatic RCT on the effectiveness of the ICU follow-up clinic. TRIAL REGISTRATION: ClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468.

Intensive Care Units Healthcare Professionals' Experiences and Negotiations at the Beginning of the COVID-19 Pandemic in Germany: A Grounded Theory Study.

Faced with the pandemic of the novel coronavirus (SARS-CoV-2), healthcare professionals (HCPs) in intensive care units (ICU) adjusted their organizational, operational, and personal procedures to ensure care for COVID-19 patients. We used grounded theory approach to explore ICU HCPs' perspectives on professional action at the beginning of the COVID-19 pandemic in Germany from March to July 2020. The study aimed to examine implicit principles on negotiating social practice and interaction of ICU HCPs in an exceptional situation, which was characterized by a high level of changes. We conducted theme-guided qualitative telephone/virtual interviews with 39 ICU HCPs from ten German federal states. The data collection followed the principles of theoretical sampling. We adpoted grounded theory approach proposed by Charmaz and discussed using Lüscher's theoretical concept of ambivalence. The analysis revealed five interconnected categories about the ICU HCPs' negotiation of social practice and interaction at the beginning of the COVID-19 pandemic in Germany. In this context, a complex field of ambivalence (key category) emerged between habits and routines of a pre-pandemic normality. Pragmatic restructuring processes were initiated, which quickly resulted in a new normality of a "daily routine of preparation". Dealing with ambivalence offers the potential for change.