Occupational Therapy in Complex Patients: a Pilot Study
Phase: NA
Conditions: Complex Patients in Rehabilitation Phase
Sponsor: Stefania Costi

 
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Identifiers: NCT02677766 
Official title: Occupational Therapy in Complex Patients: a Pilot Study 
Date of the document: 19/03/2014 
 

 
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The original study protocol of this trial, approved by the Ethical Commette of Reggio Emilia 
(Italy) is in Italian language. 
 
A translated English version of the original protocol is shown below. 
 
 
 
Introduction 
Since the introduction of the International Classification of Functioning, Disability and 
Health (ICF) in 2001, the World Health Organization has been promoting the implementation 
of a client-centered, biopsychosocial approach in healthcare programs and rehabilitation 
services [1]. This conceptual framework focuses on individual functioning more than on 
disease and contemplates the health condition as a dynamic status resulting from a 
comprehensive view of biological, individual and social perspectives [1].   
The ICF approach is particularly appropriate for patients during rehabilitation, as the latter 
relies on the interaction between functions, activities, participation and contextual factors 
[2,3]. Indeed, regardless of the underlying pathology, patients undergoing rehabilitation 
habitually manifest similar basic needs, while their level of functioning and advanced needs, 
namely those related to leisure, productivity, and social role, may be different [4]. This was 
brought to light also by Phipps S. et al.’s work [5], which showed that when rehabilitation 
focuses on individual significant activities, gains in performance and satisfaction are 
noticeable both in patients with traumatic brain injury and in those with stroke. Similarly, 
occupational therapy (OT) has proven to be beneficial in patients with different types of 
cancer when based on patient requests [6].  
In line with this approach, an assessment tool based on the complexity of patients’ care needs 
has been validated to classify individuals who require rehabilitation interventions [7-8].  This 

 
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classification makes it possible to create homogeneous populations according to the 
complexity of their care needs, not to their diagnosis. Moreover, this approach may facilitate 
conducting valid rehabilitative studies, whose results may be highly generalizable. 
A complex patient suffers from a disease that affects clinical stability and functional 
autonomy. This patient is dependent on others when carrying out daily activities and 
manifests regular need for medical monitoring, for specialized nursing care and for two or 
more specialized interventions, e.g., occupational therapy, physiotherapy, or speech therapy. 
Frequently, complex patients need special aids to carry out tasks.  Thus, complex patients 
benefit from multiprofessional rehabilitation, which may include client-centered OT 
interventions.   
Our research group recently conducted an observational study aimed at identifying the needs 
of complex inpatients in a rehabilitation ward to develop a client-centered OT intervention 
targeted at this population [9]. To our knowledge, no well-designed randomized clinical trial 
on the efficacy of OT in the rehabilitation process of complex patients has yet been 
published.  
We thus decided to conduct this ICF concept-based pilot randomized controlled trial (RCT) 
in order to detect the effect size of an experimental, client-centered OT intervention in a 
population of complex patients in their rehabilitation phase.  
Materials and Methods 
 
This single-center, open-label RCT with two parallel groups was designed in accordance with 
the CONSORT statement and the Helsinki declaration. The study was approved by the local 
Ethics Committee (19/03/2014, n.325). 
 
Study objectives 

 
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The primary aim of this exploratory study was to estimate the effects of experimental OT on 
complex patients’ perception of occupational performance during relevant activities. If the 
experimental OT proved beneficial, its effect size estimate would be used to plan a powered 
randomized controlled trial.  
The secondary aim was to verify the feasibility of the OT experimental intervention in a 
mixed hospital-home-based setting for a population of complex patients undergoing 
rehabilitation.  
Further objectives were to estimate the effects of experimental OT on: a) complex patients’ 
self-perception of occupational satisfaction with the way they perform their relevant 
occupational activities; b) mood disturbances; c) independence in basic and instrumental 
activity of daily living (ADL); d) reintegration to normal social activities and quality of life 
(QoL). 
 
Participants 
All adult patients admitted to the Physical and Rehabilitation Medicine ward (PRM) of the 
Local Health Authority - Research Institute (AUSL–IRCCS) of Reggio Emilia, Italy and 
deemed complex on the basis of the Rehabilitation Complexity Scale-Extended (RCS-E) 
were screened for eligibility. The RCS-E score ranges from zero to 22, with the cut-off value 
for complexity set at nine [7].  
Exclusion criteria were the presence of severe cognitive impairment, verified by the 
physiatrist through direct observation and exploratory interview (evaluating memory, 
orientation in time and space, adequacy to the context, absence of disinhibition or frontal 
disorders, risk evaluation), primary psychiatric disorders, communication disability and 
language barriers that, in the opinion of the healthcare team, would prevent the patient from 
participating in the experimental OT program. Furthermore, to allow assessment of the 

 
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feasibility of the experimental intervention, patients living over 30 km from the hospital and 
patients for whom it was known a priori that they would be discharged to a retirement home 
were excluded. 
We also excluded complex patients already recruited in a competing clinical trial 
(ISRCTN75290225). 
Informed consent was obtained from all participants by physicians during the admission 
process.  
 
Outcomes 
The primary outcome measure for this study was the performance score of the Canadian 
Occupational Performance Measure (COPM) [10]. The COPM is a standardized client-
centered measure designed to detect changes in occupational performance and satisfaction 
over time, based on patient perception. The COPM is administered by a semi-structured 
interview resulting in a list of up to five priority occupational activities, suited to satisfy 
relevant needs in three areas: self-care, productivity, and leisure.  
The feasibility of the experimental OT intervention was assessed by calculating the ratio 
between the number of patients who completed it according to the predefined posology and 
the total number of patients enrolled in the intervention group (IG). We established a priori 
that the study would be judged feasible if 75% of patients randomized to the intervention 
group completed the experimental OT. Given the complex nature of these patients, we also 
collected information on the appropriateness of estimates made a priori regarding the timing 
of achievement of treatment goals and the level of independence achieved by any participant 
enrolled in the IG. 
Further outcome measures applied to verify the effects of experimental OT in complex 
patients were the satisfaction score of the COPM [10], the Hospital Anxiety and Depression 

 
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Scale (HADS) [11], the modified Barthel Index (MBI) [12], the Instrumental Activity Daily 
Living scale (IADL) [13], the Reintegration to Normal Living Index (RNLI) [14] and the 
Short-Form 12 (SF-12) [15]. 
Assessments  
Study participants were assessed at baseline (T0), upon discharge (T1), and at follow up (T2) 
(Table1).  
 
 
 
 
Table 1: Clinical outcome measures and study assessments. 
 
 
 
 
Legend: PMR= Physical Medicine and Rehabilitation; COPM= Canadian Occupational Performance Measure; 
CCI= Charlson Comorbidity Index; HADS= Hospital Anxiety and Depression Scale; B-ADL= Basic-Activities 
of Daily Living; MBI= Modified Barthel Index; I-ADL= Instrumental – Activities of Daily Living; IADL= 
Instrumental Activities of Daily Living; RNLI= Reintegration to Normal Living Index; SF-12= Short Form-12. 
 
Baseline assessment (T0) was carried out within 1 week from admission to the PRM ward 
and before randomization. At T0 the degree of comorbidity was assessed using the Charlson 
Comorbidity Index (CCI), which is also a measure of burden of disease [16]. T0 also 
 
T0 
Baseline 
(within one week from 
admission to PRM ward) 
Randomization 
T1 
Discharge 
(within 3 days up to 
discharge) 
T2 
Follow up 
(45 ± 15 days from 
discharge) 
Comorbidities (CCI) 
X 
 
 
Performance in carrying out 
occupational activities (COPM) 
X 
X 
X 
Satisfaction in carrying out 
occupational activities (COPM) 
X 
X 
X 
Mood disturbances (HADS)  
X 
X 
X 
B-ADL (MBI) 
X 
X 
X 
I-ADL (IADL) 
X 
X 
X 
Reintegration to Normal Living 
Index (RNLI) 
 
X 
X 
Quality of life (SF-12) 
 
X 
X 

 
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included the assessments of occupational performance and satisfaction, mood disturbances, 
B-ADL, and I-ADL.   
T1 took place within three days before discharge from the PRM ward. Except for 
comorbidities assessment, it included all the above-mentioned measurements plus the RNLI 
and QoL assessments.  
The follow up (T2) took place at the patient's domicile 45 ± 15 days from discharge and 
included all the assessments administered at T1.  
T2 assessments and all the COPM interviews were collected by the occupational therapists. 
Given the aim of this study, the rehabilitation team was integrated with two occupational 
therapists working specifically on this trial. T0 and T1 assessments were collected by 
members of the rehabilitation health care team (physiatrists, physiotherapists, occupational 
therapists, and nurses), as per habit of the ward. 
Data regarding the feasibility of the experimental OT intervention in this specific hospital-
home-based setting were collected by researchers throughout the trial and were unified at T2. 
Randomization  
Shortly after T0, patients were randomly assigned to the control group (CG) or to the IG, 
with a 1:1 allocation ratio. The Research and Statistics unit of the AUSL – IRCCS generated 
the computerized random allocation lists and proceeded with the concealed allocation of 
patients to groups, once the patients had been enrolled by clinicians and after T0 assessment.  
Patients assigned to CG were provided with the standard care already in place in the PRM 
ward. Patients assigned to IG followed the experimental OT intervention delivered in 
addition to standard care.  
Control group 
The CG underwent standard care, which consisted of task-oriented rehabilitation targeted at 
the recovery of autonomy in B-ADL (basic activity of daily life). Patients were cared for by 

 
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an interdisciplinary multiprofessional rehabilitation team composed of physiatrists, nurses, 
physiotherapists, and speech therapists, as well as by a psychologist and social worker when 
necessary.   
During the post-acute phase, standard care was carried out daily, six days a week, during 
hospitalization. Standard care also included some (one to three) therapeutic authorizations to 
go home for the weekend in the pre-discharge phase. On the basis of pre-discharge 
assessment, rehabilitation was continued post-discharge on an outpatient basis when deemed 
necessary by the rehabilitation team. 
Intervention group 
The experimental OT intervention was provided by the occupational therapists in addition to 
standard care and was based on the Canadian Model of Occupational Performance and 
Engagement [17]. Experimental OT aimed at satisfying the occupational needs in the areas of 
self-care, productivity, and leisure that emerged through the COPM assessment at baseline. 
During the post-acute phase, experimental OT was delivered daily, five days a week, during 
hospitalization. In this setting, experimental OT was targeted at the accomplishment of 
occupational needs in the self-care area and, when needed, in the productivity and leisure 
areas.  
After discharge from the PRM ward, experimental OT was delivered at the patient's domicile 
for up to ten sessions over a period of one to two months. In this setting, experimental OT 
was targeted at the accomplishment of occupational needs related to productivity and leisure 
areas and to any residual goals of the self-care area. 
The experimental OT intervention was planned by the occupational therapists, was tailored to 
each patient, and was carried out according to the following phases:  
1) Identification of three to five subjective priority occupational needs, which become the 
focus of the experimental OT intervention; 

 
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2) Observation of patient while performing the activities related to the occupational needs in 
the hospital or at home after discharge; 
3) Setting the treatment goals (accomplishment of occupational activity) for each 
occupational need; 
Plus, for each goal set: 
5) Definition of the implementation time; 
6) Definition of the level of independence expected at the end of the treatment; 
7) Planning the appropriate OT intervention (i.e., content and modalities) according to a 
specific planning checklist (Table 2); 
 
Table 2. Planning checklist of OT intervention for each goal set. 
Phase 
Activity 
Options 
A 
Definition of the OT rehabilitative approach 
restorative 
compensative 
B 
Definition of treatment posology 
number of sessions 
frequency of sessions 
duration of each session 
C 
Definition of any supports and/or facilitation 
strategies to be used during sessions  
(e.g., aids, caregivers, facilities, etc.) 
  
 
D 
Definition of the intervention setting/s  
 
E 
Group sessions  
yes 
no 
 
Withdrawal from trial 
Participants were withdrawn from the study for any of the following reasons:  
a) Serious adverse events or death 
b) Patient referred to other wards for clinical reasons 
c) Patient discharged to a nursing home after in-hospital rehabilitation 
d) Patient lost to follow up 
e) Patient withdrawal of consent to participate 

 
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All withdrawals with specific reason were recorded. Data collected up to the patient's 
discontinuation of the study were analyzed with the intention-to-treat approach. 
 
Data analysis 
The analyses were carried out by the Research and Statistics units of the AUSL – IRCCS of 
Reggio Emilia. This was an exploratory study as there was no information to set the sample 
size based on statistical criteria. Thus, it was considered appropriate to randomly recruit 40 
subjects to estimate the average effect size of experimental OT measured by the performance 
score of the COPM. To compute the effect size, we compared the changes in COPM 
performance score between IG and CG in the T2-T0 time frame. Furthermore, to evaluate the 
clinical relevance of this finding, we matched it with the minimal clinically important 
difference of the COPM performance score, which was estimated equal to two points [18]. 
In addition, to estimate the effects of experimental OT in this population the mean variations 
of the all the outcome measures were compared between groups at T1-T0, T2-T1 and T2-T0 
time frames. 
Descriptive statistics were performed to investigate the sample characteristics; mean and 
standard deviation were chosen to summarize continuous variables, while absolute and 
relative frequencies (n, %) were used for categorical variables.  
The assumption of normality for continuous variables was verified statistically using the 
Shapiro-Wilk test.  
To test differences between the groups, numerical data were compared using the Student's t-
test and Mann-Whitney U test, and categorical data were compared using the Pearson’s chi-
squared test or the Fisher’s exact test. The threshold for statistical significance was set at 
p<0.05. IBM SPSS Statistics 23 for Windows (SPSS, Chicago, IL) was used for statistical 
analyses.  

 
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