Background Intensive care unit (ICU) survivors often suffer from cognitive, physical and mental impairments, known as post-intensive care syndrome (PICS). ICU follow-up clinics may improve aftercare of these patients. There is a lack of evidence whether or which concept of an ICU follow-up clinic is effective. Within the PINA study, a concept for an ICU follow-up clinic was developed and will be tested in a pilot randomised controlled trial (RCT), primarily to evaluate the feasibility and additionally the potential efficacy. Methods/design Design: Pilot RCT with intervention and control (usual care) arms plus mixed-methods process evaluation. Participants: 100 ICU patients (50 per arm) of three ICUs in a university hospital (Regensburg, Germany), ≥ 18 years with an ICU stay of > 5 days, a sequential organ failure assessment (SOFA) score > 5 during the ICU stay and a life expectancy of more than 6 months. Intervention: The intervention will contain three components: information, consultation and networking. Information will be available in form of an intensive care guide for patients and next of kin at the ICU and phone support during follow-up. For consultation, patients will visit the ICU follow-up clinic at least once during the first 6 months after discharge from ICU. During these visits, patients will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The networking part (e.g. special referral letter from the ICU follow-up clinic) aims to provide a network of outpatient care providers for former ICU patients. Feasibility Outcomes: Qualitative and quantitative evaluation will be used to explore reasons for non-participation and the intervention´s acceptability to patients and caregivers. Efficacy Outcomes: Health-related quality of life (HRQOL) will be assessed as primary outcome by the physical component score (PCS) of the Short-Form 12 Questionnaire (SF-12). Secondary outcomes encompass further patient-reported outcomes. All outcomes are assessed at 6 months after discharge from ICU. Discussion The PINA study will determine feasibility and potential efficacy of a complex intervention in a pilot RCT to enhance follow-up care of ICU survivors. The pilot study is an important step for further studies in the field of ICU aftercare and especially for the implementation of a pragmatic multi-centre RCT. Trial registration ClinicalTrials.gov, NCT04186468. Submitted 2 December 2019

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.

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Healthcare professionals (HCPs) are facing remarkable challenges in their daily work since the outbreak of the COVID-19 pandemic. Being well prepared is crucial for dealing with such a pandemic. The aim of our study was to explore HCPs’ subjective perspectives on their professional action and coping strategies in critical care during the preparation and coping phase after the outbreak of the COVID-19 pandemic in Germany.Together with HCPs working in critical care, we collaboratively designed an interview study based on an ethnomethodological approach. We performed semi-structured qualitative interviews via telephone or video call and analysed the data based on grounded theory.Our research interest was focused on HCPs (qualified nurses, physicians, medical students) working in critical care during the first wave of the COVID-19 pandemic in Germany between April and July 2020.Our sample consisted of 39 HCPs (19 nurses, 17 physicians, three medical students, 18/39 female) from ten German federal states. All participants were involved in the acute care of COVID-19 infected patients in hospitals and had a mean professional experience of 14.8±10.1 years, 15 participants held a management position (e.g. senior physician or head nurse). We recruited participants via personal contacts and snowballing.Initial and focused coding resulted in seven categories: Creating structural measures, handling operational changes, dealing with personal protective equipment, building up knowledge and skills, managing information, perceiving peer support and experiencing emotions.Professional action and subjectively perceived preparedness (professional and emotional) interacted with each other. Their interrelation was not static, but rather dynamic and ambiguous according to the situation. The findings of our study can be beneficial in developing guidelines, policy interventions or personnel and work practice strategies.