Title: Remote multicomponent rehabilitation intervention in survivors of critical illness post hospital discharge: a randomised controlled assessor blind clinical and cost effectiveness trial with internal pilot
Funder: Public Health Agency, NI

Abstract: Background. _x000D_ Patients in intensive care need a great deal of special care and support as they are very ill. This often includes some time spent on a breathing machine or oxygen. When patients leave hospital, their muscles are often still weak and their ability to exercise and to do everyday things may still be affected. They also can feel very upset, with flashbacks to what happened, and confused memories of their time in the intensive care unit (ICU). Patients need rehabilitation (support and exercises) when they are home but in most areas in the UK there is no organised rehabilitation offered to patients after discharge home following critical illness._x000D_ _x000D_ Purpose. We need to find out if a rehabilitation programme will help patients following intensive care who are discharged from hospital. This research will test a 6 week remote rehabilitation programme._x000D_ _x000D_ Design and methods. We will include patients (n=428) who have gone home from hospital after critical illness. The 6 week remote rehabilitation programme will be run by a trained healthcare team, who understand critical illness and its after effects. In our previous research studies, patients helped us to identify what should be included in a rehabilitation programme. It will be based on what the patients’ needs are, with additional help from online computer based materials that include information, exercise and strategies to promote recovery. If a person does not have a computer we can provide a Tablet (portable computer like device), or we can provide the information to them by post. A member of the healthcare team will speak to every individual patient by phone on a weekly basis. They will provide guidance about how to manage symptoms. They will also provide information about what happened and what to expect next during recovery._x000D_ _x000D_ In this study we will compare the quality of life, physical strength, and emotional wellbeing of the patients who take part in the rehabilitation programme with the patients who do not. We will also ask patients about their tiredness, views about illness, and anxiety levels. This information will be collected at 6 weeks and at 6 months by researchers not involved in the rehabililation. Additionally, we will be looking at value for money._x000D_ _x000D_ We have a large experienced team of people guiding this study. They include physiotherapists, occupational therapists, dietetics, speech and language therapy, doctors, nurses, pharmacists, health economists, statisticians, former patients, and others who have expertise in the study methods. Together they will ensure that the trial runs smoothly, safely, and finishes on time._x000D_ _x000D_ Proposed benefits and dissemination. We hope that patients will be helped by this rehabilitation programme. If it is successful, then it will provide useful information which will help the development of services for patients after critical illness. At the end of the trial, we will share our findings with other ICUs, clinicians, researchers, and patient groups to help improve patient care.

Lay abstract: Research question What is the clinical and cost effectiveness of a remote multicomponent rehabilitation intervention compared to standard care in survivors of critical illness following discharge home?_x000D_ Background The consequences of critical illness can be substantial and multifactorial, encompassing physical deconditioning, mental health impairments, fatigue, and declines in health-related quality of life._x000D_ Aims and objectives Primary: To investigate, in survivors of critical illness following discharge from Intensive Care Units (ICU), the effects of a six week remote multicomponent rehabilitation intervention compared to standard care on quality of life at eight weeks post randomisation _x000D_ Secondary_x000D_ a) To investigate the effects of a six week remote multicomponent rehabilitation intervention compared to standard care on physical function, illness perception, fatigue, anxiety, and adverse events at eight weeks_x000D_ b) To investigate longer term effects of six week remote multicomponent rehabilitation programme compared to standard care on quality of life, physical function, illness perception, fatigue, and anxiety at six months_x000D_ c) To determine explanatory factors influencing outcomes via process evaluation_x000D_ d) To evaluate the cost-effectiveness of the rehabilitation intervention_x000D_ Methods Design: A pragmatic, randomised controlled, open-label, assessor blind, multi-centre, clinical and cost effectiveness trial with internal pilot_x000D_ Setting: Remote delivery via online video or phone in patients’ homes_x000D_ Population: Adults (n=428) discharged home from hospital following critical illness _x000D_ Inclusion: 1. Adults aged =18 years; 2. ICU admission requiring invasive mechanical ventilation =48hours; 3. Less than 12 weeks post hospital discharge; 4. Willing and able to participate in the programme_x000D_ Exclusion: 1. Declined consent or unable to give consent; 2. Participation in existing structured rehabilitation programme due to ongoing chronic disease_x000D_ Health technologies being assessed_x000D_ Rehabilitation intervention: Remote multi-component, individualised, rehabilitation intervention comprising: 1.Weekly guidance regarding symptom management; 2.Targeted exercise; 3.Support for psychological wellbeing; 4.Information provision and peer support._x000D_ Standard care: no specific formal rehabilitation programme for patients post critical illness. _x000D_ Outcome measures: Assessor blind assessment (baseline, 8 weeks and 6 months), with parallel process evaluation and health economic analysis._x000D_ Primary: Quality of Life – EQ-5D-5L_x000D_ Secondary _x000D_ Physical Function- 30 second sit to stand test_x000D_ Illness Perception - The Brief Illness Perception Questionnaire_x000D_ Fatigue- Functional Assessment of Chronic Illness Therapy– Fatigue_x000D_ Anxiety and Depression - Hospital Anxiety and Depression Scale_x000D_ Healthcare and social care utilisation questionnaire _x000D_ Safety-Adverse Events/Serious Adverse Events_x000D_ Timelines: Total: 36 months. Set-up 6months; 18 months recruitment based on 30 sites recruiting an average of 0.8 patients/site/month, follow-up six months post randomisation, final six months for final analysis and reporting. _x000D_ Anticipated impact and dissemination: This trial provides an opportunity to test a rehabilitation intervention for survivors of critical illness designed for everyone in the UK who could benefit. Dissemination will include publication in high impact factor journals, conference presentations, and circulation via relevant professional, patient and family networks

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: GENERIC HEALTH RELEVANCE