What is the feasibility and acceptability of conducting a randomised controlled trial evaluating a healthcare professional- supported, self-management intervention for fatigue in ICU survivors?

Research question What is the feasibility and acceptability of conducting a randomised controlled trial (RCT) evaluating a healthcare professional (HCP)-supported, self-management intervention for people suffering from fatigue after critical illness?

Background Each year, approximately 110,000 patients survive an intensive care unit (ICU) admission and are discharged from hospital; two-thirds of these experience new mental, physical, and cognitive impairments, and symptoms such as fatigue and weakness, that decrease health-related quality of life (HRQoL).

Fatigue is one of the three most significant problems described by people recovering from critical illness, along with a lack of physical strength and decreased walking distance. Improving recovery from critical illness are research priorities of the James Lind Alliance, NIHR and NICE.

Our completed works include (i) systematic reviews demonstrating a high prevalence of fatigue in ICU survivors, even up to one-year post-discharge; (ii) qualitative research demonstrating a profound impact on all aspects of the patient s life; and (iii) development and early testing of a theory-based, HCP-supported self-management intervention for people suffering from fatigue after critical illness.

Objectives 1.To assess the willingness of ICU survivors to participate in a RCT evaluating a HCP-supported, self-management intervention for fatigue after critical illness 2.

To estimate recruitment and retention rates, and the variability of outcome measures, to inform the design and sample size calculations for a future effectiveness trial 3.

To evaluate the acceptability and fidelity of the intervention by assessing adherence, estimated frequency, and patterns of use 4.

To evaluate the perceptions and experiences of HCPs delivering the support in this intervention Methods Study design: A multicentre, open-label, parallel-group, feasibility RCT with an embedded qualitative evaluation of acceptability of the intervention, across ICUs at 3 UK NHS Trusts. Our planned sample size is 70 participants.

Participants: Adults (>18-years) self-reporting symptoms of fatigue at point of discharge from hospital and had previously required intensive care for minimum of 72 hours during the index admission. Intervention: A theory-based, HCP-supported, self-management intervention along with usual post-ICU care.

This intervention will be given to patients on hospital discharge and will be available for six months. Comparator: Usual post-ICU care Outcomes: The key outcome measures are feasibility and acceptability.

Feasibility outcomes include recruitment and retention rates, and completion rates of fatigue and other HRQoL questionnaires.

Perceived acceptability and engagement of the intervention will be assessed during semi-structured interviews and digital engagement analytics, respectively. Data will be collected at baseline (pre-randomisation), and 3- and 6-months post-randomisation.

Timelines for delivery The study will take place over a period of twenty months - 3-month set-up, 9-month recruitment, 8-month follow-up, analysis, and dissemination) Anticipated Impact and Dissemination The key output of this study will be data indicating potential to recruit to a definitive RCT, and data to support the optimal design of a definitive RCT.

The results will be published in scientific publications, and findings will be presented at national and international conferences. Working with our patient representatives, we will write outputs for a range of audiences in different formats.