IMPACT-ICU: IMPROVED UPTAKE AND UNDERSTANDING OF RESEARCH IN THE INTENSIVE CARE UNIT

Abstract

Physical rehabilitation (PR) started in the intensive care unit (ICU) may mitigate the physical functional impairments often experienced by survivors. The field of ICU-based PR research is growing; however, trials have had mixed results. While conducting this research, we must consider that deciding whether to participate in clinical research can be stressful for patients and families. This PhD thesis, consisting of four manuscripts, addressed two distinct aims. One explanation for the mixed results in ICU-based trials of PR may be differences across studies in the characteristics of comparator groups. Thus, the first aim was to advance our understanding of comparator groups in this context. The first manuscript (Chapter 2) was a scoping review of the type, content and reporting of comparator groups in 125 ICU-based trials of PR. The second manuscript (Chapter 3) was a secondary analysis of usual care PR received by 30 patients (262 study days) in the comparator group of an ICU-based pilot randomized trial of early in-bed cycling. Together, these manuscripts facilitate the understanding and uptake of current evidence describing comparator groups in ICU-based trials of PR. Traditional research consent forms are long and scientific, particularly for complex interventions and trials, making them challenging to explain and understand in stressful environments such as the ICU. The second aim of this PhD thesis was to support communication for patients, families, and research coordinators during informed consent for a complex ICU-based trial. The first manuscript (Chapter 4) was a protocol for a mixed methods study to co-design and pilot-test a consent infographic. The second manuscript (Chapter 5) reported results of a six-month multi-centre pilot and feasibility study implementing the infographic. Together, these manuscripts provide a foundation for the future evaluation of a consent infographic, which may ease uptake and understanding of trial information during consent discussions.