Application of the occupational therapy program based on PEO model in elderly patients with mechanical ventilation in ICU: study protocol for a randomized controlled trial

Abstract

Backgrounds

Delirium is a transient state of confusion caused by multiple causes in the intensive care unit (ICU), characterized by impaired consciousness and altered cognitive function. Non-pharmacological measures are effective measures to prevent delirium in the ICU, including occupational therapy, early mobilization, environmental improvement, and correction of hearing and vision. The purpose of this study is to investigate the effectiveness of occupational therapy regimens based on the Person-Environment-Occupation model (PEO) to reduce the incidence of delirium and improve the prognosis of patients with mechanical ventilation in elderly people in ICU.

Methods

This study is a single-center, randomized, controlled trial. We randomized 52 elderly mechanically ventilated patients admitted to the ICU in a 1:1 ratio into conventional delirium care (control group) and occupational therapy (experiment group). Randomization will be conducted using the sequentially numbered, opaque, sealed envelope (SNOSE) technique. The duration of treatment is from patient enrollment to patient discharge or return to baseline functional independence. The primary outcome was the incidence of delirium, which was assessed using Confusion Assessment Method for the ICU (CAM-ICU). Secondary outcome measures were duration of delirium, ability of daily living, length of ICU stay, grip strength, duration of mechanical ventilation, cognitive status, and the Canadian Occupational Performance Measure (COPM) to assess patients’ functional status before and after training.

Discussion

This study will investigate whether occupational therapy based on the PEO model affects the incidence and functional outcomes of delirium in elderly mechanically ventilated patients in the ICU. This study will provide new and important evidence on how to optimize outcomes in elderly patients with mechanical ventilation in the ICU.

Trial registration

ChiCTR2500095640. Registered on January 9, 2025. https://www.chictr.org.cn/showproj.html?proj=257005

Introduction

Background and rationale {6a}

Mechanical ventilation is an effective treatment for patients with respiratory failure in the ICU [1]. However, due to tracheal intubation and limb restraint, patients with mechanical ventilation become a high-risk group for delirium in the ICU [2]. A meta-analysis of 33 studies [3] found that age (> 65 years) and mechanical ventilation were independent risk factors for the development of delirium. Delirium is a transient state of confusion caused by various reasons in the ICU, mainly characterized by disturbance of consciousness and changes in cognitive function [4]. The prevalence of delirium in the ICU has been reported to be about 31.8% [5], up to 80% in mechanically ventilated patients, and even higher in elderly patients [6]. ICU delirium will not only prolong mechanical ventilation time and hospital stay, increase hospitalization costs and mortality, but also lead to long-term cognitive dysfunction and reduce long-term quality of life [7–9]. Once delirium occurs, no specific medication can treat it. Therefore, how to effectively prevent the occurrence of delirium and improve the quality of life of patients is an urgent problem to be solved in clinical practice.

At present, the clinical effect of drugs in preventing delirium has not been proven. Relevant ICU guidelines [10, 11] recommend the application of non-pharmacological measures to prevent the occurrence of delirium, including occupational therapy, early activities, sleep management, psychological intervention, cognitive intervention, etc. Unlike other treatments, occupational therapy is a patient-centered approach that emphasizes active engagement and self-efficacy of patients and their families [12]. In occupational therapy, the patient is not only a passive recipient, but also an active participant. The World Federation of Occupational Therapists defines occupational therapy as a discipline that promotes health and well-being through occupational activities, advocates for a client-centered approach, and states that “assignments” encompass what patients need, want, and are expected to do [13]. From the perspective of occupational performance, occupational therapy covers activities of daily living (ADL) training, vocational training, and recreational activities. From the perspective of occupational skills, occupational therapy includes sensory training, motor function training, cognitive function training, etc. From the perspective of occupational scenarios, occupational therapy involves environmental modification, environmental adaptation training, training in the selection and use of assistive devices, and application of orthoses. In 2009, American scholar Schweichert et al. [14] were the first to apply occupational therapy to ICU mechanically ventilated patients, and the results showed that the experimental group was better than the control group in terms of daily living ability and shortening the duration of delirium. In 2017, Chilean scholar Álvarez et al. [15] applied occupational therapy to elderly patients in the ICU, using games such as cards, dominoes, and visuospatial construction to train patients’ memory, attention, and thinking skills.

However, due to the lack of a clear and actionable occupational therapy plan and the insufficient attention of ICU nursing staff to patient activities, the awareness rate and implementation rate of occupational therapy are generally low. According to statistics, the implementation rate of occupational therapy in ICU patients was only 29.7% ~ 41.0% [16, 17]. Therefore, the application of appropriate occupational therapy theories and scientific and standardized operation plans can provide effective assessment, analysis and decision support for ICU medical staff. The PEO model was proposed in 1994 by Dr. Mary Law et al. in Canada. This model emphasizes the dynamic interaction between the three elements of “people-environment-operation” [18], and its dynamic equilibrium mechanism is especially suitable for ICU patients with drastic changes in the environment. In addition, the PEO model focuses on the evolution of the three elements of people, environment and occupation with life stages, and points out that the three elements change differently at different stages of human development. Therefore, according to the physiological, psychological, disease and social characteristics of elderly patients in ICU, this study innovatively constructed an occupational therapy intervention system for elderly patients with mechanical ventilation in the ICU. Our research will contribute to reducing the incidence of delirium, enhancing patients’ ability to perform daily activities, and improving their cognitive status and clinical outcomes.

Objectives {7}

The primary objective of this study is to assess whether occupational therapy interventions implemented in real-world conditions reduce the incidence of delirium and improve the functional status of elderly mechanically ventilated patients in the ICU.

Trial design {8}

This study is a prospective, single-center, single-blind, parallel-group randomized controlled trial. At present, the trial is being conducted in the Second People’s Hospital of Wuxi. A total of 52 subjects who meet the inclusion criteria will be randomly divided into two groups with 26 participants in each group in a 1:1 ratio. The experimental group will receive occupational therapy based on the PEO model, and the control group will receive routine delirium care. Measurements will be taken before and after the intervention. Figure 1 illustrates the flow of the study in detail.

Fig. 1.

Detailed flow chart of participants. PEO, Person-Environment-Occupation model; ICU, Intensive Care Unit; MBI, Modified Barthel Index; ACE, The John Hopkins Adapted Cognitive Examination; COPM, The Canadian Occupational

Methods: participants, interventions and outcomes

Study setting {9}

This study will be conducted in the comprehensive ICU of a tertiary grade hospital in Wuxi, Jiangsu Province, China.

Eligibility criteria {10}

Inclusion criteria

1. Age ≥ 60 years old.

2. The estimated ICU treatment time and invasive mechanical ventilation time ≥ 48 h.

3. Meet the criteria of baseline functional independence (Modified Barthel Index score 2 weeks before admission ≥ 60 points).

4. Informed consent of subjects and their families was obtained.

Exclusion criteria

1. Diagnosed with dementia, delirium, or acute mental illness at the time of admission.

2. Those who are unable to communicate due to severe hearing impairment, speech impairment and other factors.

3. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) scored > 3.3 [19].

4. Special diseases that restrict activities, such as unstable fractures, spinal cord injuries, active bleeding in the digestive tract, increased intracranial pressure, etc.

5. Have a history of ICU admission.

6. It has been included in other clinical trials.

Dropout criteria

1. Death of the patient.

2. Patients who did not implement the intervention according to the content of the program during the study period.

3. Patients who voluntarily request to withdraw during the study.

Who will take informed consent? {26a}

All patients who meet the criteria will be invited to participate in this study. Two investigators will have face-to-face sessions with these potential participants, and the sessions will be scheduled during daily visitation times. During the sessions, patients and their families will be fully informed about the study’s objectives, significance, procedures, potential risks, benefits, protective measures, and participant rights. At the same time, the participant or their authorized representative will sign a written informed consent form to confirm that informed consent has been obtained.

Additional consent provisions for collection and use of participant data and biological specimens {26b}

The informed consent form has made clear the purpose of the data and the confidentiality measures. In addition, the trial does not involve the collection of biological specimens.

Interventions

Explanation for the choice of comparators {6b}

In this study, the selection of the control group will be carefully considered to scientifically assess the effectiveness of occupational therapy. The control group will receive routine delirium care, including evidence-guided sedation, early mobilization, psychological care, and environmental adjustments. This comprehensive approach will represent the current ICU standard for delirium prevention. By comparing with this group, the added value of occupational therapy can be accurately measured. Ethically, it will be essential to ensure that the control group receives standard care. This setup will respect the rights of participants and enable fair comparisons, allowing reliable conclusions to be drawn about the efficacy of occupational therapy.

Intervention duration/termination {11a}

The duration of the intervention in this study will be from patient enrollment until the patient is discharged from the hospital or returns to their baseline level of function [20].

Preintervention phase {11a}

Within 24 ~ 48 h of admission to the ICU, the patient will undergo evaluation for occupational therapy initiation criteria. The initiation criteria for occupational therapy are as follows: respiratory rate 5 ~ 30 times/min; saturation of peripheral oxygen (SpO₂) ≥ 88%; oxygen concentration < 60%; positive end-expiratory pressure (PEEP) < 10 cm H₂0; adequate fixation of the artificial airway; haemodynamically stable; heart rate 50 ~ 130 beats/min; systolic blood pressure 90 ~ 180 mmHg; diastolic blood pressure ≤ 110 mmHg; mean arterial pressure 60 ~ 110 mmHg; no adjustment of vasoactive drug doses for at least 2 h; patient’s RASS score of −1 to 1 with stable mood. Muscle strength ≥ grade 2; no specific disorders that restrict activity (e.g., unstable fractures, spinal cord injury, active gastrointestinal bleeding, arrhythmias, myocardial ischemia, increased intracranial pressure).

Criteria for discontinuing or modifying allocated interventions {11b}

Patients with any of the following unstable conditions will have the intervention withheld and will be reassessed the next day. The unstable conditions are as follows: severe human–machine desynchronization; mechanical ventilation mode changed to controlled ventilation mode; development of new arrhythmia, initiation of new anti-arrhythmic drugs, or development of new myocardial infarction; altered mental status (e.g., irritability or agitation); occurrence of adverse events (e.g., falls, accidental extubation); obvious discomfort (e.g., chest tightness, shortness of breath, pain) reported by patients or observed by medical staff; unplanned artificial airway extubation assessed as high risk.

Intervention phase {11a}

This study will assign patients randomized to the intervention group to receive occupational therapy based on the PEO model after sedation interruption, as shown in Table 1 and Online Supplementary Document 1.

Table 1.

Occupational therapy programme

Dimension	Project	Program content	Control group	Experimental group
Improves personal functioning	Early rehabilitation exercises	1. Active and passive joint activities 2. Grip strength training 3. Sitting training 4. Bed-chair transfer and bedside standing 5. Walking training	√	√
	Cognitive training	1. Orientation training 2. Family participatory memory training 3. Attention training 4. Thinking training	×	√
	Psychological interventions	1. Language encouragement 2. Non-verbal communication 3. Touch care 4. Health education	√	√
Optimize the ICU environment	Use of assistive devices	1. Glasses 2. Hearing aid 3. Sleep aids (earplugs, eye masks) 4. Rehabilitation devices (grip devices, walkers, etc.)	×	√
	Optimize the physical environment	1. Light management 2. Noise management 3. Place clocks and signs	√	√
	Optimize the human environment	1. Establish a multidisciplinary team 2. Encourage family visits	×	√
Enhance operational capabilities	Activities of daily living training	1. Grooming training 2. Potty training 3. Put on and take off tops training 4. Put on and take off pants training 5. Eating training 6. Calls training	×	√
	Recreational activities	1. Active recreational activities: playing chess, card games, reading 2. Passive recreational activities: listening to music, watching movies	×	√

ICU Intensive Care Unit

P (Person): improves personal functioning {11a}

(1) Early rehabilitation exercise: Based on the “ICU Early Rehabilitation Pocket Book” of this hospital, the ICU specialist and the responsible ICU nurse will conduct condition assessment and activity safety screening. According to the patient’s consciousness and limb muscle strength score, early rehabilitation exercises will be implemented, as shown in Table 2. (2) Cognitive intervention: Including orientation training, family-participatory memory training, attention training, and thinking ability training. (3) Psychological intervention: Including appropriate non-verbal communication, appropriate touch care, and adequate health education.

Table 2.

Early rehabilitation exercise treatment program

Condition	Item
−1 ≤ RASS score ≤ 1 point, upper limb muscle strength is grade 2, and oxygenation index is 100 ~ 200 mmHg	Patients will receive grip strength training, active or assisted joint movement, active or assisted in-bed sitting training, and assisted in-bed pedal cycling. These exercises will be conducted twice daily, 10–20 min per session.
−1 ≤ RASS score ≤ 1 point, upper limb muscle strength ≥ grade 3, and oxygenation index > 200 mmHg	Patients will receive seated exercises, bedside sitting, and active in-bed pedal biking. These will be conducted twice daily, 10–20 min per session.
Conscious, upper and lower limb muscle strength ≥ grade 3 and oxygenation index > 200 mmHg	Patients will undergo bed-to-chair transfer training with the assistance of assistive devices and medical staff. This will be conducted twice daily, with training duration based on patient tolerance.
Conscious, upper and lower limb muscle strength ≥ grade 4 and oxygenation index > 200 mmHg	Patients will receive bedside standing training and walking practice with the assistance of walkers and medical staff. This will be conducted twice daily, with training duration based on patient tolerance.

RASS Richmond Agitation-Sedation Scale

E (Environment): optimize the ICU environment {11a}

(1) Use of assistive devices: Based on patients’ needs, ICU medical staff will provide sleep aids such as earplugs and eye masks, as well as rehabilitation devices including grip strength trainers, limb rehabilitation training instruments, and walking aids. If a patient has visual or hearing impairment, investigators will inform the patient’s family members to prepare daily-use glasses or hearing aids. (2) Optimization of the humanistic environment: A multidisciplinary team will be established, including but not limited to intensive care physicians, psychiatrists, intensive care nurses, and rehabilitation therapists. Physicians will be responsible for disease assessment, diagnosis, consultation, and medical order issuance. Nurses will be responsible for patient and family education, environmental management, orientation training, memory training, and recreational activities. Rehabilitation therapists will be responsible for rehabilitation exercises, occupational performance assessment, occupational ability training, attention training, and thinking ability training. In addition, family members will be encouraged to visit and participate in occupational therapy. (3) Optimization of the physical environment: Curtains will be opened during the day to provide natural light or incandescent lighting. When patients are asleep (12:30–13:30, 22:00–6:00), lights will be turned off or dimmed, and the alarm volume of ventilators and monitors will be reduced to 35 dB to minimize unnecessary nursing or medical interventions.

O (Occupation): enhance operational capabilities {11a}

(1) Daily living activities training: Patients will receive training in activities of daily living, including grooming, toileting, donning and doffing tops, donning and doffing pants, eating, and telephone use training. (2) Leisure and entertainment activities: Patients will participate in leisure and entertainment activities tailored to their preferences and needs, including playing chess, card games, reading, listening to music, watching movies, etc.

Control: usual care {11a}

The control group will be given a conventional analgesic sedation strategy, early activity strategy and humanistic care. (1) Analgesia: Routine analgesia will be performed on the patient according to the doctor’s instructions, and the intensive care pain observation tool (CPOT) will be maintained at less than 3 points. (2) Sedation: The degree of sedation will be assessed using the Richmond Agitation-Sedation Score (RASS). A goal-oriented sedation strategy will be implemented; unless there is a clinical indication for deep sedation, shallow sedation will be used, and the RASS score will be maintained at −2 ~ 1 points. (3) Early activity strategy: According to the routine care of early activity of patients with mechanical ventilation in the ICU of our hospital, passive extremities, active activities, sitting training, bed and chair transfer and standing training will be given twice a day for 10 ~ 20 min each time. (4) Psychological nursing: according to the patient’s condition and treatment, appropriate health education will be given; positive encouragement and reassurance will be provided to the patient, and appropriate touch care will be administered. (5) Environmental care: nursing and medical operations at night will be reduced; indoor lighting will conform to the circadian rhythm of the human body; patient rooms will be equipped with environmental signage and 24-h electronic clocks.

Strategies to improve adherence to interventions {11c}

In order to improve participants’ adherence to the intervention, appropriate recreational activities and occupational therapy modalities will be chosen based on the patient’s condition, interests, and abilities. For example, activities that are familiar or interesting to the patient will be selected, such as listening to music or reading newspapers. In addition, systematic occupational therapy training will be provided to the medical staff participating in the study, so that they will be able to master professional treatment skills and communication skills, implement interventions accurately and standardly, and answer the questions of patients and their families.

Relevant concomitant care permitted or prohibited during the trial {11d}

During the intervention period, participants will refrain from engaging in other research projects to avoid interfering with the trial results.

Provisions for post-trial care {30}

If the participant suffers trial-related damages, corresponding treatment and compensation will be provided in accordance with relevant national regulations.

Quality control

During the activity training, the patient’s condition will be dynamically monitored, and the starting and suspending standards of occupational therapy will be strictly enforced. After the procedure, the tubing will be properly placed, the patient’s vital signs are assessed, and the patient’s response will be recorded. If there is an adverse event during the patient’s activity training, the emergency plan will be activated immediately and the symptoms will be treated. After the vital signs are stable, the investigator will evaluate the patient’s physical condition again and select the appropriate training method.

Outcome {12}

Primary outcome: delirium

The primary outcome will be the occurrence of delirium assessed using the CAM-ICU scale [21, 22]. The scale contains 4 items: (1) acute alterations or recurrent fluctuations in mental status; (2) attention deficit; (3) disordered thinking; (4) Altered clarity of consciousness. Delirium is diagnosed when the CAM-ICU assessment is positive = (1) + (2) and at least 1 of (3) and (4) is positive.

Secondary outcomes 1: duration of delirium

Duration of delirium will be defined as the duration from the onset of delirium to the absence of delirium.

Secondary outcomes 2: ability to live in daily living

The Modified Barthel Index (MBI) will be used to measure the ability to participate in activities of daily living [23, 24]. The scale mainly evaluates 11 items, including eating, bathing, personal hygiene, dressing, stool control, urine control, toileting, bed and chair transfer, walking, wheelchair operation, and going up and down stairs. Wheelchair operation can only be assessed if it is unable to walk. The scale has a total score of 100 points, with higher scores indicating greater independence and less dependence.

Secondary outcomes 3: cognitive function

The John Hopkins Adapted Cognitive Examination (ACE) will be used to measure cognitive function [25]. This scale is the first tool capable of testing the overall cognitive function of ICU patients without verbal expression. The Chinese version of ACE includes five aspects: orientation, language ability, imitation ability, attention and calculation ability, and memory. The scale has a total score of 100 points, with higher scores indicating better cognitive function.

Secondary outcome 4: occupational performance and satisfaction

The Canadian Occupational Performance Measure (COPM) will be used to evaluate patients’ satisfaction with their own occupational performance and activities of daily living [26].

Secondary outcomes 5: grip strength

Grip strength will be measured using a handgrip dynamometer (Anta, China). Three measurements will be taken for each grip strength assessment, and the average of the three measurements (unit: kilograms) will be used to represent grip strength.

Participant timeline {13}

For an estimated study period of 1 year, all ICU patients will be admitted to this study equally. Every elderly mechanically ventilated patient admitted to the ICU is screened during daily morning rounds. The inclusion of study subjects must be decided by discussion between two or more members of the study group (at least one doctor). If the patient meets the study criteria, the investigator will speak face-to-face with the patient or family to obtain their informed consent. Figure 2 summarises the enrolment, intervention, and assessment timeline.

Fig. 2.

Participant timeline. Schedule of enrolment, interventions, and assessments

Sample size calculation {14, 15}

This study is a randomized controlled trial design. The experimental group is the occupational therapy group, and the control group is the conventional delirium care group. The incidence of delirium will be the primary outcome measure to be observed. According to the literature review [27], P1 was 0.107 in the experimental group and 0.510 in the control group. The two-sided α = 0.05, the power of 1-β is 0.9, and the ratio of sample size between the experimental group and the control group is 1:1. According to Chow et al. [28], calculated using R language, each group will require a sample size of 23 cases. Considering the 10% loss to follow-up and rejection of follow-up, at least 26 cases will be finally required for both the experimental group and the control group, with a total sample size of 52 cases.

Assignment of interventions: allocation

Sequence generation {16a}

The researchers will use Excel software to generate random sequences of 1 ~ 52 and will randomly divide them into the experimental group and the control group according to the ratio of 1:1.

Concealment mechanism and implementation {16b, 16c}

To avoid selective bias, researchers who will not be involved in the clinical trial will place 52 randomized serial numbers and intervention methods into 52 sealed, opaque envelopes. Members of the study group will screen the patients and open the envelopes according to the random serial numbers so that the grouping status will be known.

Assignment of interventions: blinding

Who will be blinded {17a}

Due to the nature of the intervention, blinding of patients and investigators will not be possible. Therefore, this study will be single-blind, with evaluators blinded. The evaluators will be intensive care nurses from other departments. None of them will be involved in the development or implementation of the intervention plan before the study begins, and they will be unaware of the study hypothesis and grouping. In addition, all evaluators will receive systematic theoretical and operational training to ensure the accuracy and reliability of the evaluation.

Procedure for unblinding if needed {17b}

This study will use evaluator blinding and will not require unblinding of investigators or participants. In the event of a serious adverse event, which will require unblinding, the Data Monitoring Committee (DMC) will follow pre-established written procedures to ensure data integrity and bias control.

Data management and monitoring

Plans for assessment and collection of outcomes {18a}

According to the reviewed literature and the study content, the investigators will design a general information questionnaire for patients. The first part will be a demographic questionnaire, including gender, age, education level, marital status, religious belief, BMI index, etc. The second part will be a disease-related information questionnaire, including the main diagnosis upon ICU admission, previous underlying diseases, surgical history, sedative drugs and doses, and the Acute Physiology and Chronic Health Evaluation (APACHE II). The investigators will be responsible for collecting general data. ICU stay time, mechanical ventilation time, and sedative medication doses will be extracted from the electronic data collection and management system of Wuxi Second People’s Hospital.

Plans to promote participant retention and complete follow-up {18b}

In order to improve participant retention, we will develop an individualized intervention plan based on each patient’s condition to ensure safety and efficacy. In addition, we will establish regular communication, incentives, and psychological support to encourage participants to continue to participate in the study.

Data management {19}

To avoid measurement deviation, the assessment will be performed by a trained and qualified critical care nurse. Delirium data will be assessed and recorded using the CAM-ICU twice daily, at 8:00 a.m. and 16:00. The MBI and grip strength will be assessed before the intervention, 1 week after enrollment, at ICU discharge, and at hospital discharge. The ACE and COPM will be assessed prior to the intervention and at ICU discharge. The data collection form will be checked daily to ensure the completeness and accuracy of data collection. All data will be entered using double-entry to ensure the accuracy of data entry.

Confidentiality {27}

The privacy of all participants will be protected in accordance with the law. Participants’ medical records will become this study’s data, but participants’ names will not appear in this data or the results of the data analysis. All participants will have a unique identification number to ensure anonymity. If the study results are published in a journal, participants’ names and identification information will not be included.

Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}

Not applicable. This study does not involve the collection and evaluation of biological specimens.

Statistical methods

Statistical methods for primary and secondary outcomes {20a}

SPSS 26.0 software will be used for statistical analysis, with the test level set at 0.05; P < 0.05 will be considered statistically significant. Continuous data with a normal or approximately normal distribution will be expressed as mean ± standard deviation, and the independent samples t-test will be used for intergroup comparisons. Non-normally distributed continuous data will be expressed as M (P25, P75) and compared using the two independent samples rank sum test. Count data will be expressed as counts (percentages) and compared using the chi-square test. The rank sum test will be used for ordinal data. The generalized estimating equation (GEE) will not be constrained by data distribution conditions, will effectively handle data correlations, and will be used to evaluate differences in preliminary efficacy signals between groups and explore the interaction effect of time and group [29].

Interim analyses {21b}

Not applicable. This study will perform data analysis after the end of the intervention for all participants.

Methods for additional analyses (e.g. subgroup analyses) {20b}

Not applicable. Other analysis methods such as subgroup analysis will not be used in this study.

Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}

This study will strictly follow the principles of intention-to-treat analysis (ITT) to comprehensively evaluate the impact of dropout on the study results [30]. All participants randomized to the groups, regardless of whether they complete the trial or have missing data, will be included in the final analysis, and missing values will be scientifically processed using multiple imputation.

Plans to give access to the full protocol, participant level-data and statistical code {31c}

The full protocol, participant-level data, and statistical codes will be available by contacting the corresponding authors.

Oversight and monitoring

Composition of the coordinating centre and trial steering committee {5d}

The data monitoring of this trial will be done by the Data Coordination Center (DCC), investigators, and the sponsor. The DCC will be responsible for the day-to-day management and quality control of the data, investigators will be responsible for collecting and recording data at the trial site, and the sponsor will be responsible for overseeing the progress of the entire trial. Data monitoring will be conducted on a monthly basis, including participant recruitment, the occurrence of adverse events, data quality indicators, and trial effectiveness.

Composition of the data monitoring committee, its role and reporting structure {21a}

The DMC of this study will be composed of ICU clinical medical experts and nursing experts. Safety monitoring, effectiveness evaluation, data quality review, and program compliance supervision will be conducted every 2 weeks.

Adverse event reporting and harms {22}

The interventions of this study, focusing on occupational therapy for critically ill ICU patients, are anticipated to pose minimal risks. Nevertheless, patients may encounter adverse events such as falls during mobilization, muscle strains, or temporary hemodynamic instability, which might not always be directly attributable to the early mobility protocol. All adverse events, regardless of whether they are actively sought or spontaneously reported, will be meticulously documented from patient enrollment through study conclusion. Reports will include comprehensive information on causality assessment, onset and resolution timings, severity grading, management strategies, and their relevance to the study. Serious adverse events will be promptly reported to the ethics committee within 24 h of discovery, with researchers providing immediate appropriate care.

Frequency and plans for auditing trial conduct {23}

The Ethics Committee will audit the study on an annual basis. The audit will cover protocol implementation compliance, adverse event statistics and processing, informed consent updates, and data security measures.

Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}

If the plan needs to be revised, the amendment will be submitted to the Medical Ethics Committee of Wuxi Second People’s Hospital for approval. Once approved, we will update the trial registry in the Chinese Clinical Trials Registry. At the same time, we will inform the participants who are participating in the trial of the changes in the trial and obtain informed consent.

Ethics and dissemination {31a}

This study was approved by the Medical Ethics Committee of Wuxi No. 2 People’s Hospital on November 26, 2024, with the approval document number: (2024) Ethics Review No. Y-320. It was successfully registered in the Chinese Clinical Trial Registry on January 9, 2025, with the registration number: ChiCTR2500095640. The research results of this study will be compiled into an academic paper and submitted to a high-quality peer-reviewed journal. At the same time, the research team will actively participate in domestic and international academic conferences, share research findings through oral presentations, poster exchanges, and other formats, and promote academic progress.

Discussion

This study developed an occupational therapy program for elderly patients with mechanical ventilation in the ICU based on the PEO model, which includes four aspects: occupational therapy preparation, personal function enhancement, ICU environment optimization, and occupational ability strengthening. The program is both scientific and feasible. To ensure the quality of the research, the research team—consisting of two researchers who have received systematic evidence-based training—independently conducted literature search, screening, and quality evaluation, strictly following evidence-based research norms. This laid a reliable foundation for constructing a scientific and standardized occupational therapy program for elderly ICU patients on mechanical ventilation. Subsequently, the research team conducted two rounds of expert consultation on the program’s initial draft using the Delphi method, ensuring its feasibility, scientificity, and rigor when implemented in China. This step is the most crucial for constructing the occupational therapy program for elderly ICU patients on mechanical ventilation. Moreover, with the PEO model as its framework, this study focuses on the evolutionary laws of the “person-environment-occupation” interaction across different life stages. It fully considers the physiological, psychological, disease-related, and social characteristics of elderly ICU patients, and innovatively constructed an occupational therapy intervention system for elderly patients with mechanical ventilation in the ICU. Considering the research subjects’ disease characteristics and physiological decline, the program strengthened rehabilitation exercises and cognitive function training in the “person” element, as well as daily living activities in the “occupation” element. Given that the research subjects are retired individuals, vocational training in the “occupation” element was removed, further enhancing the program’s clinical feasibility.

Trial status

Patient enrollment begins on March 18, 2025, and will conclude on December 1, 2025.

Abbreviations

ICU

Intensive Care Unit

PEO

Person-Environment-Occupation model

SNOSE

Sequentially Numbered, Opaque, Sealed Envelope

CAM-ICU

Confusion Assessment Method for the ICU

COPM

Canadian Occupational Performance Measure

IQCODE

Informant Questionnaire on Cognitive Decline in the Elderly

SpO₂

Saturation of Peripheral Oxygen

PEEP

Positive end-expiratory Pressure

MBI

Modified Barthel Index

ACE

Adapted Cognitive Examination

ITT

Intention-to-treat analysis

Author contributors {31b}

JT, PY and LL have made significant contributions in ideation and experimental design. JT, CD and TZ will be responsible for the implementation of the trial. HB and LL are responsible for the supervision of the implementation of the trial. JT devised a statistical analysis scheme. JT and PY drafted the manuscript, and PY and LL reviewed the manuscript. All authors agree to be responsible for all aspects of the work, read and approve the final manuscript.

Funding {4}

This work was supported by the Wuxi Municipal Health Committee (HB2023037), Wuxi Nursing Society (Z202302), and Journal of Chinese Medical Association (CMAPH-NRD2022028).

Data availability {29}

The full protocol, participant-level data, and statistical codes are available by contacting the corresponding authors.

Declarations

Ethics approval and consent to participate {24}

This study was approved by the Medical Ethics Committee of Wuxi NO.2 People’s Hospital on November 26, 2024 [(2024) Ethics Review No. (Y-320)].

Consent for publication {32}

Not applicable.

Competing interests {28}

The authors declare that they have no competing interests.