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
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 randomized 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, relatives, health 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
Principal findings related to feasibility were 85% consent rate (N = 48), 34% attrition rate (N = 41) and 77% completeness of outcome measurements. 41 participants (15 women, median age 60 years) were included of whom 66% completed the study (12/21 in the intervention group, 15/20 in the control group). Median length of ICU stay was 13 days and 85% (N = 41) received mechanical ventilation, median Sequential Organ Failure Assessment Score was nine. 62% of the intervention group (N = 21) fully completed all components of the intervention (fidelity). Six-month follow-up assessment was planned for all study participants and performed after 197 days (median). The primary effectiveness outcome (health-related quality of life) could be measured in 93% of participants who completed the study (N = 27).
Conclusion
The participatory developed intervention of an ICU follow-up clinic and the pilot RCT both seem to be feasible. We recommend to start the 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
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