https://orcid.org/0009-0003-8289-844X
Figures
Abstract
Among the deleterious effects caused by hospitalization of elderly patients in intensive care unit (ICU), delirium and impaired performance in occupations are frequent and have long-term negative outcomes. Delirium protocols described in the literature vary in frequency, intensity, and content regarding pertinent interventions. Occupational Therapy (OT) practices are heterogeneous and generally consist of non-personalized interventions. For this reason, the primary outcome of this research is to evaluate the effect of a person-centered OT protocol on the prevention of delirium and the occupational performance of elderly patients admitted to the ICU. This is a randomized clinical trial with blinded assessment of the primary outcome (delirium). A total of 114 patients will be recruited and randomized to the intervention group, where care goals will be defined according to meaningful occupations and personalized cognitive stimulation will be based on patient´s topics of interest, in addition to the institutional standard protocol (ISP); or to the control group, which will receive only the ISP. To our knowledge, this will be the first randomized controlled trial with personalized occupational therapy interventions, as well as care goals, based on patients´ meaningful occupations for the prevention of delirium and improvement of occupational performance in critically ill elderly patients. This clinical trial is duly registered on the ClinicalTrials.gov platform (NCT06479031).
Citation: de Toledo Montesanti L, de Souza Francisco D, Pastore L, Pereira Yamaguti W, Fraga Righetti R, May Moran de Brito C (2025) Person-centered occupational therapy intervention for the prevention of delirium and improvement in occupational performance in elderly patients admitted to an intensive care unit: A randomized controlled single-blinded trial protocol. PLoS ONE 20(3): e0319651. https://doi.org/10.1371/journal.pone.0319651
Editor: Sascha Köpke, University Hospital Cologne: Uniklinik Koln, GERMANY
Received: November 13, 2024; Accepted: January 27, 2025; Published: March 19, 2025
Copyright: © 2025 de Toledo Montesanti et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.
Funding: The author(s) received no specific funding for this work.
Competing interests: The authors have declared that no competing interests exist.
Introduction
Delirium is a reversible neurocognitive disorder with an abrupt onset, and it is a common complication in hospitalized elderly patients. It is estimated that up to 85% of patients admitted to intensive care unit (ICU) experience this condition [1,2]. Evidence shows that ICU patients with delirium have longer hospital stays and higher mortality rates within six months compared to patients without delirium. Additionally, ICU admission for elderly patients can result in functional disability caused by muscle weakness and fatigue, as well as cognitive impairment [3–5]. Therefore, it is necessary to implement interventions to minimize these dysfunctions during the hospitalization period.
Among the efforts of the multidisciplinary team to reduce the risk of delirium and prevent the decline in occupational performance, which includes activities of daily living, instrumental activities of daily living, rest/sleep, work, leisure, and social participation, early mobilization stands out as a highly evidence-supported beneficial intervention in which the occupational therapist plays a key role [6], as they increase the patient’s activity level through engagement in the occupations that the patient needs or desires. In this population, most studies focus on interventions as part of a multidisciplinary program, limiting the measurement of the individualized outcomes directly related to the occupational therapy (OT) intervention [7]. Additionally, studies often utilize standardized interventions, offering a generalized approach without addressing the individual needs of the patients.
OT protocols for delirium prevention described in the literature share interventions based on two solid pillars: cognitive interventions and patient participation in activities of daily living. Sleep management and activities related to the promotion of temporal-spatial orientation are also frequently reported. The total number of sessions ranged from 5 to 10, with a frequency of 1 to 2 times per day, and session duration varied between 20 and 40 minutes [6,8–10]. All interventions were initiated early, and demonstrated safety and feasibility. Only one study cited the practice model (human occupation) that based its intervention on the patient’s meaningful occupation, but it did not present results regarding delirium prevention [10]. Although a clinical trial demonstrated the effect of OT interventions with positive results in the prevention and duration of delirium, as well as improvements in cognition, handgrip strength, and functionality at hospital discharge [8], a recent meta-analysis indicated that OT interventions did not reduce the incidence or duration of delirium in critically ill elderly patients [11]. The authors suggested that the use of interventions based on meaningful occupations could improve these outcomes.
Our hypothesis is that a person-centered OT protocol may contribute to the reduction of delirium incidence and the improvement of occupational performance in elderly patients admitted to the ICU. Therefore, the primary objective of this study is to evaluate the effect of this protocol on delirium prevention and the enhancement of occupational performance in critically ill elderly patients. Secondary outcomes will include the characterization of care goals related to occupations, considering their respective areas (self-care, productivity, or leisure), as well as assessing the satisfaction and importance assigned by the patient to these goals. We will also examine the impact of the OT intervention on the cognitive status of participants. Finally, we will assess the safety of the protocol by identifying any possible adverse events associated with the intervention.
Materials and methods
Study design
This is a randomized, controlled, single-blinded clinical trial that was approved by the Ethics Committee of Hospital Sírio-Libanês (approval number 6.768.909). The protocol design was registered in the Clinical Trials database (NCT06479031) and structured according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), as represented in Fig 1. The study will be conducted at Hospital Sírio-Libanês in São Paulo, Brazil. All patients included in the study will sign the Informed Consent Form, whose documentation will be in writing with one copy for the patient, another for the researcher, and a third that will be attached to the medical record.
CAM-ICU: Confusion Assessment Method for the Intensive Care Unit; COPM: Canadian Occupational Performance Measure; MoCA Test: Montreal Cognitive Assessment.
As this is a descriptive protocol study, it does not present results; however, we expect that through a person-centered individualized intervention there will be a lower incidence of delirium, improved occupational performance, and enhanced cognitive status compared to the group that will receive the institutional standard protocol (ISP).
Sample
The sample size calculation was based on the study by Alvarez [8], which reported the occurrence of delirium in 3% of the patients in the intervention group that received OT intervention and 20% of the patients in the control group. Based on these data, for the application of the bilateral statistical test for comparison between two proportions, considering a significance level of 5% (α = 0.05) and a statistical power of 80%, it will be necessary to select 104 patients. However, assuming a follow-up loss rate of around 10% during the study, the total number of patients to be included will be 114, evenly distributed between the groups: 57 in the intervention group (IG) and 57 in the control group (CG).
The inclusion criteria will be: (1) patients aged ≥ 65 years; (2) admitted to the ICU for at least 48 hours; (3) without a diagnosis of severe dementia, psychiatric, additional neurological conditions, or severe communication disorders; (4) not using invasive mechanical ventilation; and (5) with a score ≥ -2 on the Richmond Agitation-Sedation Scale (RASS). Exclusion criteria will be: (1) presence of severe visual impairment that prevents cognitive testing; and (2) patients at risk of mortality within 90 days, assessed through the Acute Physiology and Chronic Health Evaluation (APACHE) II and the Sequential Organ Failure Assessment (SOFA), where APACHE II predicts disease severity and mortality risk based on clinical and physiological data, while SOFA provides an estimate of organ dysfunction and mortality by evaluating the function of multiple organs. The medical records of the patients admitted to the general ICU will be screened by the main investigator, and patients will become eligible based on the inclusion criteria. The screening began on July 22, 2024, and is expected to continue until the target population is reached, with a maximum deadline in December 2025.
Data management plan
The assessment scores will be recorded on a standard evaluation form and subsequently transferred to a computer spreadsheet for analysis, which will tabulate demographic data (age, sex, and education level), as well as pertinent research information (inclusion and exclusion criteria, hospitalar length of stay, and ICU length of stay). The international classification of functioning related to mobility and muscular strength will also be included. Access to these data, whether printed or electronic, will be exclusive to the researchers, who will adhere to strict information security protocols. All collected information will not include participant identification, thereby ensuring their anonymity. It is important to emphasize that, under no circumstances, will there be any transfer or receipt of data between institutions. Furthermore, stored data will be protected by passwords and physical security measures, while data tabulation will be conducted using Microsoft Excel 2003, which will be accessed in secure and controlled settings.
Randomization and blinding
After the screening and inclusion processes, patients will be allocated to the CG or the IG through simple randomization, conducted electronically via the website https://www.randomizer.org/. Access to the randomization results will be restricted to the researcher responsible for the intervention, ensuring that the staff nurse, who is responsible for assessing delirium, remains blinded to this information until the study is comoutpleted. Furthermore, the researcher conducting the intervention will also be unaware of the occurrence of delirium. The aforementioned steps are illustrated in Fig 2.
Outcome assessments
Assessments will be conducted in both groups on the first and seventh days, where the following tools will be applied: The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) will be used to assess the incidence of delirium. This tool is easy to apply and is considered the most widely used in intensive care units, demonstrating high reliability and validity for the diagnosis of delirium [12,13]. In Brazil, this tool has been translated and validated according to Diagnostic and Statistical Manual of Mental Disorders IV criteria, demonstrated a sensitivity of 72.5% and a specificity of 96.2% for delirium diagnosis [14]. This instrument evaluates four criteria: (1) Acute onset or fluctuating course: acute change in mental status compared to the previous state or fluctuation in mental status over the last 24 hours; (2) Inattention: a brief attention test in which the patient is asked to signal upon hearing the letter “A” among other letters read aloud by the examiner; (3) Altered level of consciousness measured by the RASS; and (4) Disorganized thinking, assessed through questions that observe incoherent speech, lack of logic, or difficulty maintaining a line of reasoning during interaction (for example, “Can you use a hammer to cut wood?”). The incidence of delirium will be assessed from baseline to final assessment in both groups. The evaluation will be conducted every 24 hours (once a day), in the afternoon, by a blinded staff nurse.
Aligned with the scope of the protocol, which encourages the patient to become the protagonist of their own care, the Canadian Occupational Performance Measure (COPM) will be utilized to assess performance, satisfaction, and the importance of occupations in the areas of self-care, productivity, and leisure, as well as the significance of these occupations in the patient’s life [15,16]. This tool consists of a person-centered OT assessment in which, through a therapist-mediated interview, the patient selects the occupations they wish, need, or expect to perform. The COPM was translated and validated into Brazilian Portuguese and demonstrated high intra-rater and inter-rater reliability, both for identifying the occupations deemed important and for the performance scores [17]. No cultural adaptation was necessary, as the instrument does not pose closed and directed questions for specific tasks, thereby respecting the cultural perspective of the interviewee [18]. For scoring, the importance of the occupation, performance, and satisfaction will be considered, which will be evaluated by the patient on a scale from 1 to 10, with higher values reflecting greater importance, better performance, and higher satisfaction [19]. In the IG, between 1 and 3 care goals will be established, agreed upon by the therapist and the patient, taking into consideration the feasibility and safety for execution in the ICU context. These goals will be part of the person-centered intervention. Leisure activities and/or productivity-related themes, such as work, even if not defined as care goals, will be utilized to develop personalized cognitive activities for the patient. In the CG, the COPM will be used exclusively to measure changes in occupational performance and satisfaction.
Cognitive screening will be conducted using the Montreal Cognitive Assessment (MoCA), which evaluates eight cognitive domains: executive function, visuospatial ability, memory, attention, concentration, working memory, language, and orientation. This tool has been translated and validated into Brazilian Portuguese and demonstrates high internal consistency, as well as high sensitivity and specificity (81% and 77%, respectively) [20,21]. The score ranges from 0 to 30, with higher values indicating better cognitive performance [22]. The use of the MoCA test has been authorized by its author, and the researchers responsible for administering it will be trained through the mandatory training available on the platform https://mocacognition.com.
Adverse events
To assess the safety of the intervention, potential adverse events will be monitored in the IG during each session and recorded in the electronic medical record and on the data sheet. For the adverse event, the definition provided by the World Health Organization [23] will be used, which is described as “an incident occurring during the provided care that results in harm to the patient, causing injury, suffering, disability, or death”. These will include: falls, syncope, angina, hypotension (mean arterial pressure < 65 mmHg), hypertension (mean arterial pressure > 120 mmHg), oxygen saturation < 88% despite supplemental oxygen, displacement of the nasoenteric tube, and loss of venous access.
Interventions
Institutional standard protocol
The patients in the CG will be subjected to the ISP of Hospital Sírio-Libanês, which consists of: (1) using minimal sedation to maintain RASS scores between 0 and -1. Intense sedation and the concurrent use of neuromuscular blockers are discouraged and used only in specific contexts, such as severe acute respiratory distress syndrome and intracranial hypertension; (2) early rehabilitation protocol for critically ill patients [24], conducted by the physiotherapy team, twice a day, according to an individualized treatment plan based on muscle strength (Medical Research Council) and/or functional status (Surgical Intensive Care Unit Optimal Mobilization Score). Additionally, the institution uses a “mobility clock” - a visual tool based on the ICU Mobility Scale to engage family, staff, and patients in mobilization efforts [25]; (3) prevention of mechanical restraint use, which is applied only when clearly indicated for patient and staff safety or to control psychomotor agitation after non-restrictive approaches have been exhausted. In such cases, the need for this measure is reassessed every two hours; (4) education for caregivers on strategies for delirium prevention, such as use of glasses, dental appliances, and/or hearing aids, sleep hygiene, and orientation regarding time and space. These guidelines are also available on the institutional website (https://hospitalsiriolibanes.org.br/materiais-informativos); (5) adjustment of routines (e.g., timing of medications and capillary blood glucose monitoring to avoid waking the patient during the night) and mimicking pre-admission habits (e.g., maintaining bath schedules); and (6) allowing a family member or caregiver to be present 24 hours a day, and visits authorized at least twice a day.
Person-Centered OT Intervention
The patients in the IG will receive, in addition to the ISP, a person-centered OT intervention. This protocol will be implemented over seven sessions, with the first and last days dedicated to assessment and reassessment, respectively. The remaining five sessions will occur once daily, lasting 40 minutes each. The intervention will address three aspects, described below and also represented in Fig 3.
- 1. Participation and Engagement in Occupations: The care goals related to occupations will be selected based on their importance to the patient, as measured by the COPM, focusing on those that are considered challenging to perform satisfactorily. These occupations may include self-care (e.g., brushing teeth, shaving, eating, dressing), productivity (e.g., work-related tasks), or leisure (e.g., recreational activities, socialization, using a computer, smartphone, or reading a magazine). To promote and facilitate occupational performance, adaptations and resources may be used (e.g., adjustable-height tables, pen or utensil grips, high-edged plates, or cushions to improve pressure distribution and tolerance while seated).
- 2. Cognitive Stimulation: Activities will be individualized and personalized for each patient, considering their autobiographical themes and the performance areas identified by the COPM. Based on the MoCA test results, the occupational therapist will create activities that may vary in content and format, including but not limited to word searches, logic puzzles, anagrams, spot-the-difference games, crosswords, and association games. These activities will be designed to train memory, attention, abstraction, language, executive functions, calculation, and orientation. Challenges and games will be tailored to each patient’s needs and abilities.
- 3. Environmental Enrichment: Installation of a large calendar and clock, both easily visible, will be positioned within the patient’s visual field. An alternative option could be an adapted wristwatch. The caregiver will be instructed to verbally inform the patient of the exact time and current date twice daily. During these instructions, the caregiver will provide a pen and ask the patient to mark the date on the calendar (Fig 4).
The sessions will be interrupted, or outcome assessments will not be conducted in the following situations: deterioration of clinical status or the presence of a barrier that prevents the continuation of the intervention, such as in cases where it is not possible to manage the patient’s confusion, agitation, or aggressiveness, or when it is not feasible to complete the full 40 minutes of the session; uncontrolled arrhythmias; heart rate greater than 140 bpm or less than 50 bpm with clinical repercussions; oxygen saturation measured by pulse oximetry < 88%; fever ≥ 37.9 degrees Celsius; and refusal.
Outcomes
The primary outcomes will include the incidence of delirium and occupational performance, while the secondary outcomes will encompass the characterization and categorization of the occupations defined by the patients, considering the domains (self-care, productivity, or leisure), as well as their importance and satisfaction. Additionally, we will assess the effect of the occupational therapy intervention on cognitive status, as well as the occurrence of adverse events related to the intervention.
Statistical analysis
The data will be analyzed using the Statistical Package for the Social Sciences (SPSS) version 28.0.1 (SPSS® Inc.; Chicago, IL, USA) [26]. Data normality will be assessed using the Kolmogorov-Smirnov test, with continuous variables expressed as mean and standard deviation or median and interquartile range 25-75%, depending on data distribution. Categorical data will be presented as absolute and relative frequencies. Comparisons between groups will be performed using the Student’s t-test for parametric data or the Mann-Whitney U test for non-parametric data. Odds Ratios will be calculated to evaluate the association between exposure or non-exposure to the intervention and the primary outcome of the study. Effect sizes will be reported along with 95% confidence intervals. The effect size of the intervention will be calculated for the variables of delirium and occupational performance. Correlations between variables will be assessed using Pearson (parametric data) or Spearman (non-parametric data) tests, will be categorized as: low (0.26 to 0.49); moderate (0.50 to 0.69); high (0.70 to 0.89); and very high (0.90 to 1.00) [27]. Missing data will be handled using an intention-to-treat approach with multiple imputation for missing completely at random (MCAR) and missing at random (MAR) data. For data identified as not missing at random (NMAR), alternative methods will be explored.
Dissemination of results
The authors commit to disseminating the results of this study through publication in peer-reviewed journals and presentation at relevant conferences in the fields of rehabilitation, occupational therapy, intensive care, and gerontology. Any changes to the study, including outcomes, design, sample size, and interventions, will be reported to the institution’s Ethics Committee and updated in the Clinical Trials registry.
Discussion
There are several multidisciplinary and multi-component programs integrated into the care of hospitalized older adults that focus on the prevention of delirium and functional decline. Examples include the Delirium Reduction Program developed by the Clinical Innovation Center at the University of California, San Francisco [28], and the AGS CoCare®: Hospital Elder Life Program (HELP). The latter is pioneering the development of a program that addresses six risk factors for delirium: cognitive impairment, sleep deprivation, immobility, as well as visual and auditory impairments, and dehydration. Interventions are carried out by volunteers trained by the interdisciplinary team [29,30].
Although these programs have demonstrated positive results regarding their effectiveness, their implementation has predominantly occurred in developed countries, whose sociocultural, economic, and structural realities differ substantially from the Brazilian context. OT is part of this set of measures, applied in synergy with other care strategies, making it difficult to measure its individual impact. Therefore, our study becomes especially relevant as it seeks to evaluate the effect of an OT intervention, in isolation, contributing to a more detailed and precise understanding of its role in delirium prevention and the improvement of occupational performance in elderly patients admitted to ICU. In the literature, only one clinical trial has studied the effect of an OT intervention in this context [8], including cognitive stimulation through standardized exercise booklets in its program. In our study, all cognitive approaches will be personalized based on the autobiographical themes of the interviewee. The COPM will be used to gather this information, focusing on outcomes that are important to the individual, thus reinforcing the active role of the person in their care.
In parallel, the MoCA will evaluate cognitive aspects. The use of both instruments allows for a more comprehensive view of the OT process in delirium prevention and occupational performance, with targeted interventions. To the best of our knowledge, this is the first randomized controlled clinical trial to evaluate the effect of OT on delirium prevention and the improvement of occupational performance through individualized and personalized interventions.
The main limitation of this study is that the occupational therapist who will conduct the intervention will not be blinded to the results of the COPM assessment and the cognitive assessment. It is understood that the active participation of the therapist in the evaluation and in setting care goals related to occupations is essential for the therapeutic process. Delegating this assessment to a researcher not involved in the therapy could compromise the accuracy in identifying the patient’s needs and priorities, potentially impacting the intervention outcomes. However, the assessment using the CAM-ICU, considered the gold standard in identifying delirium [12], will be conducted by a staff nurse who will be blinded to the allocation. Another limitation is that the adherence rate to the use of the calendar will not be measured, nor will the barriers to the implementation of OT. Furthermore, the inclusion criteria defined for this research will recruit patients with more favorable functional profiles, as it excludes individuals diagnosed with dementia, severe visual impairments, and those with high scores on the APACHE and SOFA severity scales. These aspects may impact adherence to the proposed interventions, as patients with this profile may perceive them as irrelevant, which may compromise the generalization of the results obtained. A Brazilian study that evaluated the feasibility of implementing the HELP program categorized the reasons for the non-completion of interventions, including factors related to patients and caregivers, interventions perceived as unnecessary or unimportant, and factors related to the hospital context. Among the findings, it was noted that the relatively preserved pre-existing functionality led caregivers and patients to decline some recommendations [31]. Another study that evaluated OT interventions using the RASS revealed the feasibility of delivering OT interventions regardless of the patients’ level of consciousness and sedation [9].
We believe that a significant differentiating factor of this study is the use of a person-centered approach that aims to guide best practices in OT, recognizing the importance of occupation in the individual’s life and promoting their active participation as the protagonist of their care, in line with the guidelines for OT practice in activating and engaging individuals in acute care [32]. Although the patient experience is not measured in this study, our hypothesis is that the continuous use of meaningful occupations and personalized cognitive activities, based on autobiographical themes, may enrich the journey of hospitalized patients, as well as engage them in enjoyable activities with cognitive grounding that could contribute to the maintenance and/or improvement of occupational performance and the prevention of delirium — concepts fundamental to OT practice in acute settings, improving health outcomes.
Supporting information
S1 File. Standard protocol items: Recommendations for interventional trials (SPIRIT).
https://doi.org/10.1371/journal.pone.0319651.s001
(PDF)
S1 SPIRIT Checklist.
Recommended items to address in a clinical trial protocol and related documents.
https://doi.org/10.1371/journal.pone.0319651.s002
(DOCX)
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