Early occupational therapy in mechanically ventilated patients improves functional status: Study protocol

Abstract

Background:

Experts suggest implementing measures that include analgesia, sedation, delirium prevention and early mobilization (ASDM) in patients undergoing mechanical ventilation (MV) to reduce complications. However, there is limited evidence of occupational therapy in these patients. The aim of the research is to compare functional independence in patients undergoing MV of an intensive and early occupational therapy protocol versus to standard ASDM strategy.

Method/Design:

A prospective, multicenter, randomized clinical trial, with parallel groups (control and intervention groups). Participants will be hospitalized patients, over 18 years of age, admitted to the intensive care unit (ICU) and with the need of invasive MV. The intervention group will receive two daily 30-minute sessions of occupational therapy for 10 days. This study will research the effect of occupational therapy on functional independence, motor and cognitive status, evaluating at days 28 and 90.

Discussion:

This work contributes to the theoretical and practical work of occupational therapists who work in the ICU. The implementation of protocols of occupational therapy in mechanically ventilated patients can contribute to the independence and functionality of patients.

Conclusion:

Our research aims to contribute to the generation of systematized, organized, and feasible protocols that can be implemented in ICU.

Trial Registration:

ClinicalTrials.gov NCT04819529

Keywords

Occupational therapy mechanical ventilated early rehabilitation intensive care unit

Introduction

Intensive care unit (ICU) beds have increased globally (Gálvez et al., 2013; Halpern et al., 2006) which have been associated with a 35% decrease in mortality between 1988 and 2012 (Zimmerman et al., 2013). This in turn has progressively improved the survival of patients admitted to ICUs (Kaukonen et al., 2014). However, these patients may present motor, cognitive, emotional, and independence level complications at hospital discharge and in their long-term follow-up (Schweickert et al., 2009). The concept “Post-ICU Syndrome” has been proposed to systematically analyze the health domains that can be affected after ICU stay (Needham et al., 2012).

Activity daily living (ADL) deficiencies may be more frequent in patients on mechanical ventilation (MV) at 48 hours because 86% and 69% of patients had limitations in physical function at 3 and 12 months, respectively (Desai et al., 2011). It has also been observed greater dependence on self-care activities, transfers (Azevedo et al., 2016), and slow gait (da Silva and Santos, 2019) at discharge. The implementation and evaluation of these activities are directly related to independence or functional impairment. In the case of critically ill patients, functional impairment has a negative impact on patients, caregivers, and the health system. For example, an association between loss of functionality at hospital discharge and long-term outcomes, including mortality, quality of life reduction, greater risk of hospitalization, and an increase in health system costs (Herridge et al., 2016; Roche et al., 1999; Sacanella et al., 2011) have been found.

Therefore, there is a significant need of analyzing and implementing strategies that minimize this impairment. Although the evidence is not entirely conclusive, guidelines suggest the need to implement protocols with bundles of measures that include analgesia, sedation, prevention and treatment of delirium, and early mobilization (ASDM) in patients under MV (Devlin et al., 2018; Marra et al., 2017). These guidelines and bundles are implemented by a critical care team, which seek in a coordinated manner, to favor the organization of care delivery, optimizing patients; recovery and survival (Barnes-Daly et al., 2017; Marra et al., 2017). In the case of occupational therapy (OT), it is a health profession centered on the patient that promotes health and well-being through occupation, aiming at promoting that people participate in ADL. Interventions are focused on the person, occupation, environment, or a combination of these elements (World Federation of Occupational Therapists, n.d.). The available evidence shows that OT interventions improve the functional independence of non-ventilated elderly people admitted to critical care units (Álvarez et al., 2017) and people who have suffered stroke (Fletcher-Smith et al., 2013; Legg et al., 2017). Despite the advances in early rehabilitation, the role of occupational therapists in mechanically ventilated patients in the ICU still requires studies to guide us about the functions and actions to be implemented by occupational therapists (Costigan et al., 2019).

We will conduct a multicenter randomized clinical trial (RCT) focusing on patients who require MV and testing an early and intensive OT protocol associated with a standard analgesia, sedation, delirium prevention, and early mobilization (ASDM) strategy (intervention group) is compared to the standard ASDM strategy (control group). The outcome is to determine the efficacy of the protocol on functional independence, measured with the Functional Independence Measure (FIM) score at day 28 from the initiation of MV. Secondary aims will be to compare the intervention and control groups in (i) delirium-free days in ICU stay, (ii) cognitive and motor status at day 28 and day 90 from the start of MV; and (iii) quality of life at day 90.

Method

Participants, interventions, and outcomes

Study design

A multicenter prospective RCT with parallel groups using a 1:1 ratio in three Chilean hospitals. SPIRIT methodological recommendations for the planning of the RCT are used (Hoffmann et al., 2014). The reporting of this RCT will follow the CONSORT guideline (Boutron et al., 2017) and the TIDieR checklist (Hoffmann et al., 2014). This project was registered at ClinicalTrials.gov (ID NCT04819529).

Study setting

The research will develop in three hospital centers in Chile. These are Hospital Clínico de la Universidad de Chile (HCUCH), Hospital Santiago Oriente Dr. Luis Tisné (HSOLT), and Hospital Base de Valdivia (HBV). Two correspond to public institutions and one to a private institution. Patients hospitalized in ICU wards will be recruited. These units serve people over 18 years old who require admission for more complex acute pathologies that require life support, such as invasive MV and hemodynamic stabilization.

All centers have intensivists, nurses, nursing technicians, physical therapists, pharmaceutical chemists, occupational therapists, and speech therapists. The three ICUs will implement the protocol for analgesia, sedation, delirium, and mobility (ASDM).

Eligibility criteria

Patients older than 18 years, who have been undergoing MV and have been hospitalized in the ICUs of (i) Hospital Clínico Universidad de Chile, (ii) Hospital Santiago Oriente Luis Tisne, (iii) HBV. Eligibility criteria are as follows:

Inclusion criteria

Age equal to or greater than 18 years.

Need for hospitalization in the ICU.

At least 12 hours of invasive MV.

Informed consent signed by a legal representative and/or patient.

Exclusion criteria

Cognitive impairment prior to admission evaluated with Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly Scores >3.32 were excluded.

Functional impairment prior evaluated with Pfeffer Functional Activities Questionnaire defined as > 6 points.

Severe communication disorder and cultural limitation of language (language different from Spanish).

Patient at the end-of-life care.

Neurocritical patients (moderate to severe traumatic brain injury/stroke of some kind/among others)

Spinal injury or unstable fractures that limit mobilization.

Interventions

Patients will be randomized to one of the following groups: (i) Control Group: standard ASDM or (ii) Intervention Group: early and intensive OT plus ASDM. The full description of the protocol of the control and experimental group is described in the Supplemental Material 1.

Control group – Standard ASDM

On a general level, patients will be subjected to a non-pharmacological intervention based on the 2018 PADIS guidelines (Devlin et al., 2018), which consider the areas of analgesia, sedation, delirium, and mobility. This protocol is the gold standard for critical patients, which contributes to the reduction of sequelae and post-ICU syndrome.

For this, a team of physicians, nurses, and physiotherapists will be trained to understand and facilitate the ASDM protocol that each one must implement. Table 1 describes delivery method, schedule, dose, and other information.

Table 1.

Description of the implemented measures of the ASDM intervention.

Areas	Procedure	Materials	Responsible party	Delivery method	Frequency	Registration
Analgesia	CPOT Evaluation Registration and use of medicine in doses.	Medical chart	Team of nurses Physician	Direct evaluation Revision of clinical data	Every 6 hours (0-6-12-18) Daily and according to evaluation results	On paper or intranet registration system. It will be monitored by an evaluating team
Sedation	SAS Evaluation Registration and use of medicine in doses.	Registration sheet Medical chart	Team of nurses Physician	Direct evaluation Revision of clinical data	Every 6 hours (0-6-12-18) Daily and according to the results of the evaluations
Delirium	CAM-ICU Evaluation Registration and use of neuroleptics in doses Implementation of non-pharmacological measures: - Use of glasses and / or hearing aids, as required - Regulation of physical restraint - Use of updated clock and calendar	Registration sheet Medical chart Pamphlet with information for the family, Clock, calendar.	Team of nurses Physician Team of nurses Physiotherapist.	Direct evaluation Revision of clinical data Direct contact with the patient	Every 12 hours (8–20) Daily, according to the results of the evaluations Daily
Early mobilization	Passive mobilization (which includes maintenance of ranges of motion, elongation, changes in position) Active mobilization (maintenance of ranges of motion performed by patients, changes in position in bed, exercises in bed, inspiratory muscle training / breathing exercises, balance exercises in bedside sitting, bipedal exercises, transfer to a chair, walking in place, assisted walking and independent)^5,36	Footstool Armchair Patient’s sneakers	Physiotherapist.	Direct contact with the patient which will be graduated as per the physical and medical conditions of the patient	Twice a day

CPOT: critical-care pain observation tool; SAS: Sedation-Agitation Scale; CAM-ICU: confusion assessment method for the intensive care unit.

Intervention group – early and intensive OT plus standard ASDM

These sessions will be implemented by occupational therapists previously trained to work with ICU patients. They will carry out two 30-minute sessions every day for 10 days; thus, each patient will receive 20 sessions; if the patient continues hospitalized and needs more OT sessions, it will be indicated by their treating doctor.

The interventions will be organized based on (i) level of sedation, (ii) presence or absence of delirium (according to Confusion Assessment Method for the Intensive Care Unit/CAM-ICU ±), (iii) movement with or without gravity (cut-off point three points in elbow flexion movement with medical research council—MRC), in areas of intervention recognized in other hospital units (Álvarez et al., 2017), but which have not been tested and adapted in MV patients in the ICU:

(a) Polysensory stimulation: Intense external stimulation with the objective of increasing the patient’s level of alertness (MINSAL, 2013). It will be implemented in the patient evaluated with SAS 2 (See Figure 1 and Table 2).

(b) Cognitive stimulation: Exercises with the objective of activating mental functions, which include alertness, visual perception, memory, calculus, problem solving, praxis and language, among others (Inouye et al., 1999). These tasks will preferably be implemented in the afternoon sessions, with patients in SAS 3, 4, and 5. In SAS 1, 2, 6, and 7, only aspects of environmental orientation will be considered (See Figure 1 and Table 2).

(c) Stimulation of motor function: Exercises to keep the patient’s upper extremities active and functional (Taekema et al., 2010). These tasks will preferably be implemented in the afternoon sessions, with patients in SAS 3, 4, and 5. It also has a subarea of positioning that corresponds to the use of devices and adaptations to prevent edema and bedsores on vulnerable body areas (Clavet et al., 2008). This will be implemented in all sessions (See Figure 1 and Table 2).

(d) Basic ADL: Group of activities that promotes independent living that initially include hygiene, personal grooming, and eating (Álvarez et al., 2017). This will preferably be implemented in the morning sessions, with SAS 3, 4, and 5 patients (See Figure 1 and Table 2).

(e) Education: daily visits by trained family members (Martinez et al., 2012). Three education sessions will be held so that family members support the intervention process. Moreover, occupational therapists will give information about the intervention process to the healthcare team (See Figure 1 and Table 2).

Figure 1.

Scheme of occupational therapy activities according to the level of sedation.

Table 2.

Occupational therapy intervention overview.

	SAS* 1/2	SAS 3	SAS 4	SAS 5	SAS 6/7
Polysensory stimulation	- Auditive, tactile, proprioceptive, vestibular, olfactory, visual	Suspended	Suspended	Suspended	Suspended
Cognitive stimulation	Environmental management orientation	- Orientation - Ideomotor apraxia - Attention	- Orientation - Attention - Memory - Executive functions - Language	- Orientation - Ideomotor apraxia - Attention	Environmental management orientation
Stimulation of motor function	- Use of devices and adaptations to prevent edema and bedsores - Passive mobilization of upper limbs	- Use of devices and adaptations to prevent edema and bedsores - Sit in bed - Passive mobilization of upper limbs -Reach and power grip	- Sit in bed, on the edge of the bed or chair - Active mobilization - Reach, power grip and precision grip - Strength is considered	-Sit in bed - Active mobilizations of upper limbs - Reach and power grip	Suspended
Training in ADL	Suspended	- Preparatory in basic ADL, emphasis on self-care and change of positions -Sitting in bed	- Training in AVD, sitting on the edge of the bed or in the armchair, feeding, modified bathing, transfers or changing of room can be performed	- Training in ADL -Sitting in bed	Suspended
Education	- Education aspects of rehabilitation: - Evaluation of historical aspects of the patient - Environmental modification	- Education aspects of rehabilitation: -Evaluation of historical aspects of the patient - Environmental modification	- Rehabilitation actions, such as orientation, newspaper reading, games such as puzzles, dominoes, etc. - ADL support	- Education Rehabilitation aspects: - Evaluation of historical aspects of the patient - Environmental modification	-Education aspects of rehabilitation: -Environmental modification

OT: occupational therapy; ADL: activity daily living.

The actions organized according to the level of sedation can be seen in the description and in Figure 1. In the case of the adaptations or modifications of the activities for the presence of delirium and movements without gravity, the details of the proposed adjustment at each level are developed in detail in Supplemental Material 1.

The selection of these areas contributes to functional independence. Patients with MV present sedation, requiring starting their process with polysensory stimulation to maintain alertness and therefore remain connected to the environment. On the other hand, cognitive and motor stimulation, highly affected in hospital processes, are necessary to carry out more complex activities, such as activities of daily living. In this way, these actions are intertwined to achieve functional independence.

The interventions will be noted in the patient’s clinical chart and on the project notebook, in order to keep a record of the process and verify the implementation and adherence of the planned measures. Moreover, adverse effects (pain, fatigue, homeostatic changes), suspension of the session (causes, time) will be recorded. These will be only registered on the occupational therapists.

Outcomes

Primary outcome

Functional independence at day 28 from the initiation of MV, the outcome at day 28 is highly used in studies of ICU patients (Li Bassi et al., 2021; Moreno et al., 2008; O’Brien et al., 2006). This will be done through the use of the FIM.

Secondary outcome

Delirium-free days with daily CAM-ICU (confusion assessment method for the intensive care unit).

Coma-free days with daily SAS (Sedation-Agitation Scale; Robinson et al., 2013).

Delirium-coma free days. SAS and CAM-ICU instruments will be applied once a day by the evaluator. Each day without coma or delirium is a delirium-coma free day.

Hazard ratio for delirium in the intervention versus control groups. A composite analysis that considers delirium-coma free days to day 15. Hazard Ratio <1 interpreted as a lower daily hazard of delirium – implying a shorter mean duration of delirium among days at risk for delirium.

Functional independence at day 90 from the initiation of MV with FIM.

Cognitive status with the Montreal cognitive assessment (MoCA) test at day 28 and 90 from the initiation of MV.

Motor status using Jamar dynamometer at day 28 from the beginning of VM.

Quality of life of patients will be assessed using the EQ-5D-5L (EuroQol 5 dimensions 5 levels), which will be applied by the evaluator at day 90 from the initiation of MV.

Sociodemographic data and clinical information will be gathered.

The first four secondary outcomes are identified as relevant by intensive care research teams (Duprey et al., 2020; Pandharipande et al., 2017), in addition to being suggested by the Trial Steering Committee (TSC). The following outcomes have been reported in studies of early rehabilitation (Álvarez et al., 2017)

Participant timeline

Our research has considered different moments (Figure 2): it begins with the eligibility evaluation; once patients have been found who meet the inclusion and exclusion criteria, the responsible family member is invited to the study, where informed consent is obtained; once obtained, the allocation, being the day considered this as day 0.

Figure 2.

Schedule of enrolment, interventions, and assessments.

On day 0, information is also obtained on the patient’s baseline and sociodemographic variables.

From day 1 to day 15, the protocols for the control and intervention groups are implemented, and at the same time, variables of the hospitalization process are evaluated, such as the presence of delirium, sedation,

On day 28, evaluations are carried out to determine the functional, cognitive, and motor status.

And at the follow-up on day 90, the functional and cognitive status and quality of life are evaluated.

Sample size

It was calculated based on the independence functional score (primary outcome), evaluated with the motor FIM. The results obtained by the RCT that measured the independence of MV patients in an ICU were considered, and they were treated with early mobilization and training in ADL by physiotherapists and occupational therapists (Schweickert et al., 2009). It was determined that functional independence is achieved with five or more points in five activities of the motor FIM.

Considering this, it is expected that the intervention group will be effective if 20% more of functional independence than that of control group is obtained. In order to test this two-tailed hypothesis, with a significance of 5% and power of 80%, it is necessary to enroll 206 patients, 103 in each group. Considering a possible loss of 10% of patients per branch (such as death, change of center, or withdrawal from the protocol), we seek to enroll 226 patients, 118 per group (see Figure 3).

Figure 3.

Flow diagram of randomized controlled trial.

Recruitment

Recruitment will be carried out by one professional responsible for each center’s healthcare team. They must meet the requirements of being a professional from the ICU, not participate as interveners of the control group or intervention group, or as evaluators (being possibly pharmacist chemists, speech therapists, or psychologists).

For recruitment, a search will be carried out from Monday to Friday in the hospital registration and admission system of patients who meet the requirements. At the same time, the ICU staff will be informed of the research through biannual clinical meetings, and they will also have reminders about using posters in strategic places.

The three centers will implement the strategy.

Assignment of interventions

Allocation sequence generation

Randomization was performed with computer-generated random permuted blocks using a centralized, secure Web-based randomization service. They will be stratified in a 1: 1 ratio.

There will be blocks of 10 separated by each of the 3 centers. There will be a simple randomization with two groups (control and intervention).

Allocation concealment mechanism

This will be carried out by a professional external to the three hospitals (independent statistician). That person will carry out the registration and randomization process, saving the information on his/her personal computer. It is important to keep in mind that all patients, once recruited, will begin to receive ASDM measure care.

Implementation

The recruiter will identify potential patients, once informed consent is obtained, and the recruiter will inform the person in charge of randomization via telephone message. The person in charge of the randomization will notify the coordinator of each center as to which group the patient was assigned to.

The coordinator of each center that carries out this process will not have contact with the evaluators, interventionists, and the person responsible for the data analysis.

Blinding

In this study, researchers, recruiters, evaluators, control group team, and data analyst will be masked. These teams will not have contact with the interventionists of the experimental group. In the case of the evaluators who have contact with the patients of both groups, they will be professionals from other medical units, who do not know the ICU team, and will only be able to maintain their dialogue, according to the guideline of each evaluation.

It is not possible to mask the treating occupational therapist and patient receiving OT.

Data collection, management, and analysis

Data collection methods

For data collection, a team of evaluators will work in each center, trained previously for the following: (i) to implement the different study instruments, (ii) to know the stages of application of each instrument, (iii) to know the data registration in Google Drive (spreadsheets). In addition, monthly meetings will be held to monitor the process. The instruments used in the study are as follows:

(a) FIM. This instrument measures the functional level in 13 ADL, divided motor FIM with eight levels and cognitive FIM with five levels, which has a scale from 1 to 7 (from less to more independence). The range scores from 18 to 126 points (Young et al., 2009). This instrument has internal consistency Cronbach’s alpha of 0.89 to 0.90, ICC inter-rater = 0.94, ICC intra-rater = 1.00, Test–retest r = 0.83. Regarding validity, an adequate correlation was found between the motor subscale of the FIM and the 10-item version of the Barthel Index; r = 0.92. This instrument is used on day 28 and day 90 of the study.

(b) CAM-ICU. This evaluation allows to make a diagnosis in ICU patients who are undergoing MV (Ho et al., 2020). This has a sensitivity of 80% and a specificity of 96% (Tobar et al., 2010). The validity of the instrument is of a Cronbach alpha of 0.84; k = 0.91, which will be carried out in the ICU and will begin when the patient begins to receive the research protocols of the study. This register will be implemented for 15 days or during the stay in the ICU.

(c) SAS. This scale records the level of sedation of the patient. This seven-point scale assesses patient behavior, from unreadable (1) to dangerously agitated (7). The reliability has a weighted kappa of 0.82. Intraclass correlations for individual measures (r = 0.921, p < 0.001) and average measures (r = 0.959, p < 0.001; Ryder-Lewis and Nelson 2008). The evaluation will be carried out during the first 15 days or during the patient’s stay in the ICU.

(d) MoCA. Measures cognitive status and considers visuospatial aspects/executive functions, denomination, memory, attention, language, abstraction, delayed recall, and orientation. Its score ranges from 0 to 30. It is described as having a 90% sensitivity for mild cognitive impairment (Nasreddine et al., 2005). The best performance cutoff point for MCI-a was <21 and for mild dementia <20; sensitivity/specificity. Internal consistency was good (Cronbach’s α 0.772), outstanding inter-rater reliability (Spearman’s coefficient of connection 0.846 (p < 0.01)), and intra-rater reliability (test–retest) was 0.922 bilateral (p < 0.001; Gaete et al., 2020). This instrument is used on day 28 and day 90 of the study.

(e) Hand grip. The grip strength will be evaluated using the Jamar Dynamometer. This has a sensitivity of 86.7% and a specificity of 70.2%, with a Cronbach’s alpha of 0.956–0.982 in the right upper limb. The “American Association of Hand Therapist” protocol will be used with the ICU patient adaptation (Baldwin et al., 2013). This instrument is used on day 28 of the study.

(f) EQ-5D-5L is an instrument that measures quality of life, where it considers the following dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (Zhou et al., 2021). This instrument in its internal consistency with a Cronbach’s alpha of 0.79 (Seng et al., 2020).

(g) In addition, at the beginning of the study, sociodemographic data such as age, sex, schooling will be collected; clinical data such as admission diagnosis, APACHE II (Acute Physiology and Chronic Health disease Classification System II), SOFA, (Sepsis related Organ Failure Assessment), and Charlson Comorbidity Index also will be collected.

Data management

The participant files will be stored in numerical order and code at each center. Files will be retained for 5 years after completion of the study. Data will be kept online (institution’s Google Drive), where only investigations have key access. The updating of the data will be carried out biweekly. The Ethics Committee has accepted the entire procedure.

Statistical methods

The data will be analyzed with the intention to treat. For the descriptive analysis of the continuous numerical variables with normal distribution, the average and standard deviation will be used, otherwise the median and the 25–75 percentiles will be used. As for the qualitative, categorical and ordinal variables, the absolute and relative frequency (number and percentage) will be used.

Analytical statistics: for the primary outcome, the comparison of proportions of percentages of independent patients of the FIM will be carried out between the two groups, using the Fisher’s exact test. Secondly, the Cox survival analysis will be performed, evaluating time to functional independence. For the other secondary outcomes, the comparison of medians considering Mann–Whitney-Wilcoxon will be used. For all the tests that are used, the significance level p < 0.05, two-tailed, will be used.

Monitoring

A record in paper and Google Drive of the interventions implemented in the patients will be kept, including (i) ASDM to both groups, which the evaluators will observe, and (ii) OT intervention. The same providers of interventions will note these.

In addition, a TSC was formed with three international experts in the area and will ensure the following aspects (i) monitor scientific integrity, (ii) advise on protocol, recruitment progress, and data quality, and (iii) recommendations to the data monitoring and analysis committee. To fulfill these objectives, the TSC will meet prior to recruitment, halfway through the planned study and at the end of recruitment.

Harms

About harms and maintaining the safety of patients of both groups, physiological parameters in early mobilization interventions will be fulfilled (Supplemental Material 1; Devlin et al., 2018).

Auditing

The research audit is implemented in two instances: the Clinical Research Support Office of the Clinical Hospital of the University of Chile and the National Health Research and Development Fund. These are carried out once a year for each instance.

Ethics

Research ethics approval

The research protocol was approved by the Ethics Committee of the HCUCH with No. 068. This project was funded by the Agencia Nacional de Investigación y Desarrollo with the number FONIS SA19I0138. The commission did not participate in any stages but only regulated aspects of financing and scientific rigor.

Protocol amendments

In case of modifying the protocol at the level of objectives, design, eligibility criteria, procedures, or evaluations, they will be discussed by the research team, and the Ethics Committee of the HCUCH will be informed; additionally, the changes will be notified to the registration of the clinical trial.

Consent

Informed consent will be given by a family member or person responsible since the patient who enters the study is expected to find himself with conscientious knowledge.

Confidentiality

The personal information of the participants and the study will be stored securely, considering the use of computers and internet passwords, which the researchers will only manage. All records that contain names or other personal identifiers (location data, informed consent, etc.) will be stored in separate documents and will also have an identification code.

The information about the study of the participants will not be disclosed outside the study. In case specific information is required, it must be authorized in writing by the participant.

Diffusion policy

Through a dissemination day, the research team and the sponsor are committed to communicating the results to the three centers, specifically to the respective ICU teams, including patients and families. It is also expected to publish the results in rehabilitation or intensive care journals.

Discussion and implications

The impairment of functional independence that patients discharged from an ICU may present constitutes a current health problem. Its relevance is given by its frequency and its impact on patients, caregivers, and the health system. Long-term outcomes include higher mortality, lower quality of life, risk of hospitalization, and healthcare system costs (Desai et al., 2011; Herridge et al., 2016; Sacanella et al., 2011).

Therefore, it is necessary to elaborate strategies and interventions that reduce these losses of functionality and independence gaps. Early mobilization, which can improve functional status upon discharge from the ICU, has been the most studied strategy in the literature (Devlin et al., 2018; Li et al., 2013; Morris et al., 2016). These strategies are led by the physiotherapist team and coordinately seek, along with the rest of the actions, to favor mobilization and limit muscle and functional loss in these patients. This is achieved through physical interventions and mobilizations of the patient and their environment, which has shown important contributions in early rehabilitation (Devlin et al., 2018; Joseph and Jehan, 2017; Larsen, 2019). Although early physical therapy is recommended by PADIS guidelines, the evidence about its impact is inconclusive (Menges et al., 2021).

However, the OT interventions have been limited sequenced and protocolized. Therefore, there is limited knowledge and evidence of the contribution that these can make in patients under MV in the early stages of rehabilitation. This perspective is in accordance with the guidelines of the World Health Organization “Rehabilitation 2030: A call for action,” which has integrated the need to generate actions in early rehabilitation processes (Larsen, 2019) both in research and in improvements in interventions. Despite the suggestion of an interprofessional approach to rehabilitation, it is necessary to generate evidence to support the contribution of different professionals or interventions, such as in this case early OT in the MV ICU patients.

This study presents multidisciplinary and multicenter work as strengths, which has been theoretically based on current scientific evidence, implementing a strict standard intervention validated by the clinical and scientific community. On the other hand, the OT protocol has been rigorously organized, developed, and analyzed by experts in the area. Moreover, having a TSC allows for a general and objective perspective of the process and interventions. Regarding the weaknesses, these are related to carrying out a more extended long-term follow-up (6 months to 1 year) and the limitation of evaluations in other areas such as at work and on a social level.

Conclusion

Our research aims to contribute to the generation of systematized, organized, and feasible protocols that can be implemented in various ICUs, which could improve the outcomes of patients and their families in the short, medium and long term in different healthcare systems and countries.

Key findings

A detailed protocol for mechanically ventilated patients will be implemented.

It is expected to know the effects on functional independence, as well as effects on motor and cognitive status of patients at hospital discharge.

What the study has added

This work contributes to the theoretical and practical work of occupational therapists who work in the ICU.

Supplemental Material

sj-docx-1-bjo-10.1177_03080226231184992 – Supplemental material for Early occupational therapy in mechanically ventilated patients improves functional status: Study protocol

Supplemental material, sj-docx-1-bjo-10.1177_03080226231184992 for Early occupational therapy in mechanically ventilated patients improves functional status: Study protocol by Evelyn Álvarez, Maricel Garrido, Felipe Salech, Verónica Rojas, Nicole Jara, José I. Farías, Daniela Ponce and Eduardo Tobar in British Journal of Occupational Therapy

Footnotes

Acknowledgements

We appreciate the support of the research team of the Centro de Investigación Clínica Avanzada (CICA) and the Hospital Clınico Universidad de Chile. We also appreciate the critical patient units of centers of the Hospital Clínico Universidad de Chile, Hospital Base de Valdivia y Hospital, and Hospital Santiago Oriente—Dr. Luis Tisné Brousse. Special thanks to Ann Parker, Nathan Brummel, and Pratik Pandharipande, for contributing their knowledge and suggestions in order to deliver a better investigation. We appreciate the support of Universidad de Chile for its sponsorship.

Authors’ note

Verónica Rojas is also affiliated to International Research Project for the Humanisation of Intensive Care Units (HU-CI Project), Madrid, Spain.

Felipe Salech is also affiliated to Centro de Gerociencia, Salud Mental y Metabolismo, GERO,Santiago, Chile.

Research ethics

The research protocol was approved by the Ethics Committee of the Hospital Clínico de la Universidad de Chile with No 068, in Santiago of Chile.

Consent

Informed consent will be given by a family member or person responsible since the patient who enters the study is expected to find himself with conscientious knowledge.

Patient and public involvement data

During the development, progress, and reporting of the submitted research, Patient and Public Involvement in the research was not included at this stage of the research.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This project was funded by the Agencia Nacional de Investigación y Desarrollo with the number FONIS SA19I0138. The funder played no role in the design, conduct, or reporting of this study.

Contributorship

EA, ET, DP, and VR participated in the conception, literature review, and design of the study protocol. All authors contributed to the methodology of the project and the statistical analysis plan. All authors reviewed and edited the manuscript and approved the final version.

ORCID iDs

Evelyn Álvarez

Maricel Garrido

Supplemental material

Supplemental material for this article is available online.

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