Trial reportBMC anesthesiology2023
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.
Trial report in BMC anesthesiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04186468 (Piloting an ICU Follow-up Clinic to Improve Health Related Quality of Life After a Prolonged Intensive Care Stay), which is not on this map. Cited by 8 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Piloting an ICU Follow-up Clinic to Improve Health Related Quality of Life After a Prolonged Intensive Care Stay
Who cites it
8 citing papers in PubMed, 13 citations in OpenAlex.
- Piloting an ICU follow-up clinic - qualitative process evaluation alongside a feasibility study.Pilot and feasibility studies · 2026Article
- Surviving Sepsis Campaign: international guidelines for management of sepsis and septic shock 2026.Intensive care medicine · 2026Article
- Post-Intensive Care Syndrome: From Diagnosis To Treatment.Deutsches Arzteblatt international · 2026Review
- Post-intensive care syndrome: a state-of-the-art review.Singapore medical journal · 2026Review
- Interventions for adult survivors discharged from the intensive care unit: a scoping review.BMJ open · 2025Article
- The implementation and evaluation of a family-led novel intervention for delirium prevention and management in adult critically ill patients: A mixed-methods pilot study.Nursing in critical care · 2025Article
- ICU follow-up services and their impact on post-intensive care syndrome: a scoping review protocol.BMJ open · 2024Article
- Post intensive care syndrome: A review of clinical symptoms, evaluation, intervention.Heliyon · 2024Review
Corrections and comments
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Authors and funding
11 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundICU 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.
methodsThis 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.
resultsThe 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).
conclusionThe 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 registrationClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468.
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