Mobilisation in the EveNing to TreAt deLirium (MENTAL): protocol for a mixed-methods feasibility randomised controlled trial

David McWilliams; Elizabeth King; Peter Nydahl; Julie Lorraine Darbyshire; L Gallie; Dalia Barghouthy; C Bassford; Owen Gustafson

doi:10.1136/bmjopen-2022-066143

Mobilisation in the EveNing to TreAt deLirium (MENTAL): protocol for a mixed-methods feasibility randomised controlled trial

BMJ Open. 2023 Feb 3;13(2):e066143. doi: 10.1136/bmjopen-2022-066143.

Authors

David McWilliams^{1

2}, Elizabeth King³, Peter Nydahl⁴, Julie Lorraine Darbyshire⁵, L Gallie⁶, Dalia Barghouthy⁷, C Bassford⁷, Owen Gustafson⁸

Affiliations

¹ Centre for Care Excellence, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK david.mcwilliams@uhcw.nhs.uk.
² Centre for Care Excellence, Coventry University, Coventry, UK.
³ Adult Intensive Care Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
⁴ Nursing Research, Universitatsklinikum Schleswig-Holstein, Kiel, Germany.
⁵ Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UK.
⁶ Patient Representative, Plymouth, UK.
⁷ Critical Care, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
⁸ Oxford Allied Health Professions Research & Innovation Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.

Abstract

Introduction: Delirium is common in critically ill patients and is associated with longer hospital stays, increased mortality and higher healthcare costs. A number of risk factors have been identified for the development of delirium in intensive care, two of which are sleep disturbance and immobilisation. Non-pharmacological interventions for the management of intensive care unit (ICU) delirium have been advocated, including sleep protocols and early mobilisation. However, there is a little published evidence evaluating the feasibility and acceptability of evening mobilisation.

Methods and analysis: Mobilisation in the EveNing to TreAt deLirium (MENTAL) is a two-centre, mixed-methods feasibility randomised controlled trial (RCT). Sixty patients will be recruited from ICUs at two acute NHS trusts and randomised on a 1:1 basis to receive additional evening mobilisation, delivered between 19:00 and 21:00, or standard care. The underpinning hypothesis is that the physical exertion associated with evening mobilisation will promote better sleep, subsequently having the potential to reduce delirium incidence. The primary objective is to assess the feasibility and acceptability of a future, multicentre RCT. The primary outcome measures, which will determine feasibility, are recruitment and retention rates, and intervention fidelity. Acceptability of the intervention will be evaluated through semi-structured interviews of participants and staff. Secondary outcome measures include collecting baseline, clinical and outcome data to inform the power calculations of a future definitive trial.

Ethics and dissemination: Ethical approval has been obtained through the Wales Research and Ethics Committee 6 (22/WA/0106). Participants are required to provide written informed consent. We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media.

Trial registration number: NCT05401461.

Keywords: Delirium & cognitive disorders; INTENSIVE & CRITICAL CARE; REHABILITATION MEDICINE; SLEEP MEDICINE.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Critical Care / methods
Delirium* / etiology
Delirium* / therapy
Feasibility Studies
Humans
Intensive Care Units
Physical Therapy Modalities
Randomized Controlled Trials as Topic

Associated data

ClinicalTrials.gov/NCT05401461