Piloting an ICU follow-up clinic — qualitative process evaluation alongside a feasibility study

BACKGROUND: Previous studies have not demonstrated sufficient effects of intensive care unit (ICU) follow-up clinics on health-related quality of life. This may also be influenced by the design and implementation of these studies. Feasibility and context of such studies have yet to be sufficiently researched. It is therefore crucial to investigate these contextual factors. This study aimed to explore the experiences of patients, relatives, and healthcare professionals with both the randomised controlled trial (RCT) and the ICU follow-up clinic, to assess the feasibility and acceptability of the intervention and the study design from the perspectives of those involved. METHODS: This qualitative research was embedded in the process evaluation of a pilot RCT on an ICU follow-up clinic. We conducted 18 semi-structured interviews with former ICU patients, relatives and the clinical study team who participated in the PINA study and used field notes from the clinical study team. Data analysis was carried out using qualitative content analysis. RESULTS: The pilot RCT was well received by potential patients and their relatives, and the motivation to participate was high, as was the motivation of the clinical study team. The main benefits of the ICU follow-up clinic intervention named by participants were being taken seriously and receiving referrals that they would not typically get from a general practitioner. The offer of home visits for patients with long travel distances to the ICU follow-up clinic was highly appreciated. CONCLUSIONS: It was feasible to integrate the perspectives of patients, relatives, and healthcare professionals within a pilot RCT on an ICU follow-up clinic. Across all stakeholder groups, the ICU follow-up clinic and the RCT trial design were considered acceptable and valuable, suggesting that such follow-up care meets patient needs and that a large-scale study appears feasible. TRIAL REGISTRATION: ClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468 .