Mobilisation in the EveNing to prevent and TreAt deLirium (MENTAL): a mixed-methods, randomised controlled feasibility trial.

Background: Delirium is common in critically ill patients and associated with longer hospital stays, increased morbidity and higher healthcare costs. Non-pharmacological interventions have been advocated for delirium management, however there is little evidence evaluating feasibility and acceptability of physical interventions administered in the evening. The aim of this study was to conduct a feasibility trial of evening mobilisation to prevent and treat delirium in patients admitted to intensive care. Methods: In this mixed-methods, randomised controlled feasibility trial we recruited participants from intensive care units at two university hospitals in the United Kingdom. Eligible participants who were able to respond to verbal stimulus (Richmond agitation and sedation scale ≥3) and expected to stay in intensive care for at least 24 h were randomly assigned (1:1) to receive usual care or usual care plus evening mobilisation. The evening mobilisation was delivered between 19:00 and 21:00, for up to seven consecutive evenings or ICU discharge, whichever was sooner. All outcome assessments were completed by a team member blinded to randomisation and group allocation. Primary objective was to assess feasibility and acceptability of evening mobilisation. Primary feasibility outcomes were recruitment, consent and retention rates, and intervention fidelity. Intervention acceptability was evaluated through semi-structured interviews of participants and staff. Secondary outcomes included prevalence in incidence and duration of delirium, measured using the Confusion Assessment Method for ICU. This trial is registered at ClinicalTrials.gov, NCT05401461. Findings: Between July 16th, 2022, and October 31st, 2022, 58 eligible patients (29 usual care; 29 usual care plus evening mobilisation) were enrolled. We demonstrated the feasibility and acceptability of both the trial design and evening mobilisation intervention. Consent and retention rates over three months were 88% (58/66) and 90% (52/58) respectively, with qualitative analysis demonstrating good acceptability reported by both participants and staff. Secondary outcomes for the evening intervention group compared with the control group were: delirium incidence 5/26 (19%; 95% CI: 6-39%) vs 8/28 (29%; 95% CI: 13-49%) and mean delirium duration 2 days (SD 0.7) vs 4.25 days (SD 2.0). Interpretation: Results of this trial will inform the development of a definitive full-scale randomised controlled trial investigating the effects of evening mobilisation to treat delirium and improve health-related outcomes. Funding: None.

Intensive Care Unit Structure Variation and Implications for Early Mobilization Practices. An International Survey.

RATIONALE: Early mobilization (EM) improves outcomes for mechanically ventilated patients. Variation in structure and organizational characteristics may affect implementation of EM practices. OBJECTIVES: We queried intensive care unit (ICU) environment and standardized ICU practices to evaluate organizational characteristics that enable EM practice. METHODS: We recruited 151 ICUs in France, 150 in Germany, 150 in the United Kingdom, and 500 in the United States by telephone. Survey domains included respondent characteristics, hospital and ICU characteristics, and ICU practices and protocols. MEASUREMENTS AND MAIN RESULTS: We surveyed 1,484 ICU leaders and received a 64% response rate (951 ICUs). Eighty-eight percent of respondents were in nursing leadership roles; the remainder were physiotherapists. Surveyed ICUs were predominantly mixed medical-surgical units (67%), and 27% were medical ICUs. ICU staffing models differed significantly (P < 0.001 each) by country for high-intensity staffing, nurse/patient ratios, and dedicated physiotherapists. ICU practices differed by country, with EM practices present in 40% of French ICUs, 59% of German ICUs, 52% of U.K. ICUs, and 45% of U.S. ICUs. Formal written EM protocols were present in 24%, 30%, 20%, and 30%, respectively, of those countries' ICUs. In multivariate analysis, EM practice was associated with multidisciplinary rounds (odds ratio [OR], 1.77; P = 0.001), setting daily goals for patients (OR, 1.62; P = 0.02), presence of a dedicated physiotherapist (OR, 2.48; P < 0.001), and the ICU's being located in Germany (reference, United States; OR, 2.84; P < 0.001). EM practice was also associated with higher nurse staffing levels (1:1 nurse/patient ratio as a reference; 1:2 nurse/patient ratio OR, 0.59; P = 0.05; 1:3 nurse/patient ratio OR, 0.33; P = 0.005; 1:4 or less nurse/patient ratio OR, 0.37; P = 0.005). Those responding rarely cited ambulation of mechanically ventilated patients, use of a bedside cycle, or neuromuscular electrical stimulation as part of their EM practice. Physical therapy initiation, barriers to EM practice, and EM equipment were highly variable among respondents. CONCLUSIONS: International ICU structure and practice is quite heterogeneous, and several factors (multidisciplinary rounds, setting daily goals for patients, presence of a dedicated physiotherapist, country, and nurse/patient staffing ratio) are significantly associated with the practice of EM. Practice and barriers may be far different based upon staffing structure. To achieve successful implementation, whether through trials or quality improvement, ICU staffing and practice patterns must be taken into account.

Outpatient-based physical rehabilitation for survivors of prolonged critical illness: A randomized controlled trial.

INTRODUCTION: The physical and psychological impact of critical illness is well documented. Recovery may take many months and is often incomplete. The optimal way of addressing these important sequelae following hospital discharge remains unclear. METHODS: Single center, randomized controlled trial in patients invasively ventilated for ≥5 days. The treatment group (TG) underwent a 7-week, outpatient-based exercise and education program, with the control group (CG) receiving no intervention during the study period. Primary outcome measures were changes in functional capacity assessed using the cardiopulmonary exercise testing parameters, peak VO2, and anaerobic threshold (AT). Secondary outcome measures were changes in and health-related quality of life assessed using the Short Form 36 version 2 questionnaire. Assessors remained blinded to group allocation. RESULTS: Sixty-three patients completed the study (target n = 90). Improvements in both peak VO2 and AT were seen in both TG and CG but no significant difference between groups was evident. AT improved by 11.7% in CG (baseline 10.3 ml O2 kg(-1) min(-1), follow-up 11.5 ml O2 kg(-1) min(-1)), and by 14.6% in TG (baseline 10.3 ml O2 kg(-1) min(-1), follow-up 11.8 ml O2 kg(-1) min(-1); ANCOVA p = 0.74). Peak VO2 improved by 14.0% in CG (baseline 13.6 ml O2 kg(-1) min(-1), follow-up 15.5 ml O2 kg(-1) min(-1)), and by 18.8% in TG (baseline 13.8 ml O2 kg(-1) min(-1), follow-up 16.4 ml O2 kg(-1) min(-1); ANCOVA p = 0.68). Significant improvements were seen in both groups for physical component summary scores (PCS) (TG 39.6 versus 31.0; CG 36.1 versus 32.6) and mental component summary scores (MCS) (TG 48.6 versus 38.4; CG 41.3 versus 37.0). The degree of improvement was significantly higher in the treatment group in comparison to control subjects (PCS p = 0.048; MCS p = 0.017). This improvement was most marked in the subgroup ventilated for >14 days. CONCLUSIONS: A 7-week, outpatient-based exercise and education program resulted in improved health-related quality of life scores but not improved exercise capacity.

An Environmental Scan for Early Mobilization Practices in U.S. ICUs.

OBJECTIVE: Early mobilization improves patient outcomes. However, diffusion of this intervention into standard ICU practice is unknown. Dissemination and implementation efforts may be guided by an environmental scan to detail readiness for early mobilization, current practice, and barriers to early mobilization. DESIGN: A telephone survey. SETTING: U.S. ICUs. SUBJECTS: Five hundred randomly selected U.S. ICUs stratified by regional hospital density and hospital size. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We surveyed 687 ICUs for a 73% response rate (500 ICUs); 99% of respondents were nursing leadership. Fifty-one percent of hospitals reported an academic affiliation. Surveyed ICUs were most often mixed medical/surgical (58%) or medical (22%) with a median of 16 beds (12-24). Thirty-four percent reported presence of a dedicated physical and/or occupational therapy team for the ICU. Overall, 45% of ICUs reported early mobilization practice; two thirds of ICUs with early mobilization practice reported using a written early mobilization protocol. In ICUs with early mobilization practice, 52% began the intervention at admission and 74% enacted early mobilization for both ventilated and nonventilated patients. Early mobilization was provided a median of 6 days per week, twice daily. Factors independently associated with early mobilization protocols include dedicated physical/occupational therapy (odds ratio, 3.34; 95% CI, 2.13-5.22; p<0.01), American Hospital Association region 2 (odds ratio, 3.33; 95% CI, 1.04-10.64; p=0.04), written sedation protocol (odds ratio, 2.36; 95% CI, 1.25-4.45; p<0.01), daily multidisciplinary rounds (odds ratio, 2.31; 95% CI, 1.29-4.15; p<0.01), and written daily goals for patients (odds ratio, 2.17; 95% CI, 1.02-4.64; p=0.04). Commonly cited barriers included equipment, staffing, patient and caregiver safety, and competing priorities. In ICUs without early mobilization adoption, 78% have considered implementation but cite barriers including competing priorities and need for further planning. CONCLUSIONS: Diffusion regarding benefits of early mobilization has occurred, but adoption into practice is lagging. Mandates for multidisciplinary rounds and formal sedation protocols may be necessary strategies to increase the likelihood of successful early mobilization implementation. Methods to accurately assess and compare institutional performance via practice audit are needed.