Efficacy of shared decision making on treatment satisfaction for patients with first-admission schizophrenia: study protocol for a randomised controlled trial
Efficacy of shared decision making on treatment satisfaction for patients with first-admission schizophrenia: study protocol for a randomised controlled trial
Mio Ishii 0 1
Naoya Sugiyama 0
Hana Hasegawa 0
Toshie Noda 0
Yoshio Hirayasu 0
0 Numazu Chuo Hospital , 24-1 Nakase-cho, Numazu, Shizuoka 410-8575 , Japan
1 Department of Psychiatry, Yokohama City University School of Medicine , 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 , Japan
Background: Shared decision making is a promising model for patient-centred medicine, resulting in better clinical outcomes overall. In the mental health field, interventions that consider the patient-centred perspective-such as patient quality of life, involvement in the treatment, treatment satisfaction, and working alliance-have increased and better clinical outcomes discovered for patients with schizophrenia. However, few studies have examined the efficacy of shared decision making for schizophrenia treatment. The objective of this study is to evaluate the effect of a shared decision making intervention compared to treatment as usual on patient satisfaction at discharge for first-admission patients with schizophrenia. Methods/Design: This is a randomised, parallel-group, two-arm, open-label, single-centre study currently being conducted in an acute psychiatric ward of Numazu Chuo Hospital, Japan. We are recruiting patients between 16 and 65 years old who are admitted to the ward with a diagnosis of schizophrenia without prior experience of psychiatric admission. Fifty-eight participants are being randomised into a shared decision making intervention group or a treatment as usual control group in a 1:1 ratio. The intervention program was developed based on a shared decision making model and is presented as a weekly course lasting the duration of the patients' acute psychiatric ward stay. The primary outcome measure is patient satisfaction at discharge as assessed by the Client Satisfaction Questionnaire. Due to the study's nature, neither the patient nor staff can be blinded. Discussion: This is the first randomised controlled trial to evaluate the efficacy of shared decision making for patients with early-treatment-stage schizophrenia. The intervention program in this study is innovative in that it includes both of the patient and staff who are involved in the treatment. Trial registration: The study has been registered with ClinicalTrials.gov as NCT01869660.
Schizophrenia; Shared decision making; Patient satisfaction; Randomised controlled trial; Study protocol
The healthcare systems in developed countries are
evolving from a paternalistic to a patient-centred approach in
which patients are more informed and take more active
roles in decision making [1,2]. Shared decision making
(SDM) is a promising model for the movement in which
patients and clinicians share all information and
individual preferences regarding the treatment through the
entire decision making process . A systematic review of
86 randomised trials found that SDM, when compared
to usual care, resulted in patients gaining more
knowledge, increased confidence in decisions, and more active
patient involvement. These results were found across
several fields of medicine, such as cancer treatment .
In the mental health field, treatment adherence has
remained a common issue over several decades,
particularly for patients with schizophrenia. A systematic review
found that 49.5% of patients with schizophrenia were
estimated to be non-adherent to antipsychotic medication
. Numerous interventions have attempted to address
this issue, including psychoeducation, motivational and
behavioural therapy, family therapy, and telephone call
prompts. However, randomised controlled trials and
reviews of those interventions have not found enough
evidence regarding how to increase adherence, particularly in
long-term follow-up studies [6-11]. Therefore,
interventions that do not only focus on improvement to adherence
but also consider the patient-centred perspectivesuch as
the patients quality of life, involvement in the treatment,
treatment satisfaction, and working alliancehave
increased, thereby resulting in better clinical outcomes
for patients with schizophrenia [12-14]. Attempts to
find appropriate approaches for better clinical outcomes
for patients with schizophrenia are being undertaken
and SDM is expected to be one of them.
To the best of our knowledge, there are only three
randomised controlled trials examining the efficacy of
SDM for schizophrenia treatment. Hamann conducted
of them [15,16], comparing SDM intervention with usual
care for inpatients with schizophrenia. In the first study,
patients (n = 107) in the intervention group were given
decision aids that contained information about
pharmacological and psychoeducational treatment options.
Patients in the intervention group did not differ in their
results from the patients in the control group who were
given treatment as usual (TAU) in terms of overall
treatment satisfaction, but it did improve their treatment
knowledge. In the second study (n = 61), patients in the
intervention group attended a shared decision making
training program consisting of five one-hour group
sessions. The intervention yielded higher participation
preferences and increased patients desire to have greater
responsibility in treatment decisions than in the TAU
program; this continued to the six-month follow-up. Krieke
 evaluated an Internet-based decision aid for
schizophrenia (n = 250) in an outpatient setting. Patients in
the intervention group were offered the opportunity to
make use of the Internet-based information and
decision tool. This tool was designed to support patients in
acquiring an overview of their needs and appropriate
treatment options as provided by their mental health
care organisation. Patients in the control group were
given their usual care. No differences were found between
the intervention and control groups regarding perceived
involvement in medical decision making.
More studies are needed to determine the efficacy of
SDM for schizophrenia treatment. To confirm what former
studies have notnamely, reducing patients heterogeneity
and developing an intervention that targets both patients
and staffwe are conducting this study of SDM for
firstadmission patients with schizophrenia.
The objective of this study is to evaluate the effect of an
SDM intervention compared to TAU on patient satisfaction
at discharge and treatment continuation six months
postdischarge for first-admission patients with schizophrenia.
This is a randomised, parallel-group, two-arm, open-label,
single-centre study currently being conducted in an acute
psychiatric ward in Japan. It has been approved by the
Yokohama City University Medical Research Ethics
Committee and registered at ClinicalTrials.gov (registration
number: NCT01869660). To avoid biased allocation,
randomisation is undertaken by central allocation using
a computerized random number generator at the
Internet Data and Information Center for Medical Research
(INDICE), provided by the University Hospital Medical
Information Network (UMIN) in Japan. After written
informed consent has been obtained, randomisation is
performed to assign patients, in a 1:1 allocation ratio, to
either the SDM model intervention or TAU with
stratification by sex, age (under or over 20 years old), and
assumed duration of illness (less or more than one year)
via the minimisation method. Due to the nature of the
study, neither the patient nor staff can be blinded. Figure 1
provides an overview of the trial flow. Additional file 1
depicts a summary of the study parts and their timing
in the intervention and control groups. We estimate
that data gathering will be completed in March 2015.
We are conducting our study in an acute psychiatric
ward of Numazu Chuo Hospital, a psychiatric hospital
with five wards (286 beds in total) in a suburban area of
Shizuoka prefecture, Japan. Serving a catchment area of
Nominate candidates for the study from all
patients attend to the acute ward
Assessing eligibility of candidates
Shared decision making
Primary outcome at the discharge
6 months after discharge
Figure 1 Flow diagram; it provides an overview of the trial flow from baseline assessment at the admission to the follow-up at 6
months after the discharge.
830,000 people, it is the only psychiatric hospital in the
area that accepts emergency admissions 24 hours a day,
365 days a year. On average, approximately 400 people
are admitted to the ward in a year and two-thirds of these
people are diagnosed with schizophrenia (ICD-10 codes:
F20F29). Approximately 90% of admissions are legally
involuntary. The average duration of hospitalisation in
the ward is 45 days.
Participants will be eligible for inclusion in the study if
they meet the following criteria: (1) admittance to the
acute ward at Numazu Chuo Hospital, (2) schizophrenia
diagnosis (ICD-10 codes: F20F29), (3) aged 16 to 65
years old at admission, and (4) has no prior experience
of psychiatric admission (first admission).
Participants are excluded if they (1) are diagnosed with
moderate to severe mental retardation, (2) are diagnosed
with any of the organic mental disorders (ICD-10 codes:
F00F09), (3) do not have sufficient Japanese language
knowledge, or (4) have severe conceptual
disorganisation as measured by the Japanese version of the Brief
Psychiatric Rating Scale (BPRS; rating of five or more)
[18,19]. The cut-off point was decided by referring to
prior studies of SDM for inpatients with schizophrenia
by Hamann [15,16].
We developed the SDM model program as an inpatient
intervention that focuses on the very basics SDM; that
is, how patients and medical staff share information
and patients own preferences regarding the on-going
The program is a weekly course lasting the duration of
the patients acute psychiatric ward stay, with a maximum
of 90 days. Sessions are held on a certain day and time
every week during the hospitalisation. They involve three
sequential elements: (1) the patient answers the
questionnaire regarding their perception of on-going
treatment, (2) the patient and staff hold the session in which
they share information and their preferences, and (3) the
patient and staff create a weekly care plan sheet.
First, participants are asked to complete a six-item
self-reported questionnaire that assesses patients
perceptions of their treatment at the time. The
questionnaire (Additional file 2) is an initial intervention tool
allowing patients to express themselves more easily and
prepare for the following session. Each question is written
in a simple sentence, and is designed to be answered using
a five-point Likert scale. In order to avoid perceived
pressure from staff, the patient is asked to answer in
private setting or with the help of a staff member if the
patient requests assistance.
Second, to discuss patients and medical teams
perceptions of treatment, patients in the SDM intervention
attend a group session. The members of each session
are the patient, medical team (i.e. the primary doctor,
the primary nurse, and other staff ), and a facilitator
from the supervision team. Regarding the questionnaire
that the patient has answered, the patient and at least
three ward staff members discuss for 1520 minutes the
on-going treatment, including medication, ward
circumstances, and treatment goals. A facilitator from the study
supervision team presides, trying to create a comfortable
atmosphere both for the patient and staff members. Other
participants are free to discuss their own views and
preferences regarding the treatment.
Third, all the sessions participants draft the care plan
sheet in order to outline clearly what they have shared
in the session. The sheet displays the treatment
information at that point in time, including remaining symptoms,
diagnosis, the patients condition, medication, problems at
the ward and solutions, activities, and the goal of hospital
treatment. Additional file 3 indicates an example of the
care plan sheet.
To standardise and improve adherence to the study,
five staff members who are independent from the
patients treatment are organized into a project
supervision team. This team has four duties. First, the team
delivers a brief 20-minute lecture regarding the basic
theory of SDM to all of the psychiatrists, nurses, social
workers, and pharmacologists who work at the ward,
prior to their participation in the intervention. Second,
the team manages the intervention schedule and
facilitates sessions each week. Third, throughout the study
period, the team stays in the ward and occasionally
provides feedback to participating staff to establish the
integrity of the intervention. Fourth, before the weekly
intervention session, the team assesses the patients
condition. If the patients condition deteriorates and does
not meet the eligibility criteriafor example, conceptual
disorganisation worsens to a greater-than-five ranking as
per the BPRSthe team postpones the session until the
The control group receives TAU, which is mainly
medication treatment. During the hospitalisation period,
doctors examine patients daily and nurses care for patients
by assisting them in their self-care activities and
encouraging them to participate in the units daily activity
program. Although the primary doctor and nurses discuss
the patients overall progress and plan for discharge on a
regular basis, there is no fixed occasion for the patient
and staff to share all of the information. Moreover, there
is no specific chance for the patient to be introduced to
the concept of SDM or to actively participate in the
This is the patients satisfaction at discharge as assessed
by the Japanese version of the Client Satisfaction
Questionnaire (CSQ-8J) [20,21], a self-report scale containing
eight items clustered into four response categories. The
overall score is the sum of the item responses; it ranges
from 832, with higher scores indicating higher
satisfaction. The CSQ-8 has been used frequently in clinical
trials of schizophrenia [22,23,24], such as the
randomised controlled trials of SDM for schizophrenia by
Hamann [15,16]. The Japanese version has good
internal consistency (Cronbachs = 0.83) and moderate
convergent validity (r = .36.49) with another self-report
instrument for client satisfaction inquiry  when used
for psychiatric inpatients at discharge .
These are attitudes toward medication, symptom
severity, and treatment continuation. The Japanese version of
the Drug Attitude Inventory-10 (DAI-10) [25,26] is used
to measure attitudes toward medication. It is a 10-item
self-report instrument, with each item being rated as
either true or false with regard to the nature of patient
experiences with psychotropic drug use. Scores range
from -10 to 10, with higher scores indicating a more
positive attitude towards medication. The DAI-10 is
administered at discharge in the study. The Japanese
version of the BPRS, Oxford version, is used to assess
symptom severity, which the ward doctor undertakes
routinely for all the patients at admission and discharge.
Treatment continuation is assessed from their medical
records if the patient continues treatment at the Numazu
Chuo Hospital and, if not, by asking patients via a
telephone call six months post-discharge.
Sample size calculation
The primary outcome is the mean difference in treatment
satisfaction as measured by the CSQ-8J between the SDM
group and the TAU group at the time of discharge from
the acute psychiatric ward. In the study by Loh et al. ,
among patients with newly diagnosed depression in
primary care settings, the standardised mean difference
between a SDM intervention group and a TAU group for the
CSQ-8 was 0.92. We expect a smaller effect size of 0.80
because the study population of first-admitted patients
with schizophrenia is a potentially more complex problem.
Assuming a power of 80% and two-sided significance level
of 5%, we estimate that a sample size of 26 patients per
arm is required to detect an effect size of 0.80. In order to
adjust for loss of power due to an anticipated drop out of
10%, 58 patients will be included.
The data will be analysed on an intention-to-treat
principle. Multiple imputation methods  will be used
for imputing any missing information regarding outcome
measures. Unadjusted comparisons of outcome measures
between the groups (SDM vs. TAU) will be conducted
using Students t test or Mann-Whitney U test, depending
on the variable distribution for continuous variables (i.e.
treatment satisfaction, attitude toward medication, and
symptom severity) and chi-squared test for the categorical
variable (i.e. treatment continuation). To control
characteristics such as sex, age, and duration of illness, we will
use a general linear model or a generalised linear model
with log-link function, depending on the variable
distribution for the continuous variables and a logistic regression
model for a categorical variable. Analyses will be
performed using R version 3.0.2.
The project supervision team checks the medical records
of all patients admitted to the acute ward and nominates
candidates for the study within three days after admission.
After being verified to satisfy all of the inclusion criteria,
the patient is asked to give written informed consent by
the investigator (MI). The participant or, if the participant
is under 20 years of age, the legal guardian, must provide
written informed consent before any study procedures
Research ethics approval
This study is designed and undertaken in compliance
with the Helsinki Declaration and the Guidelines on
Clinical Research of Japanese Ministry of Health, Labour,
and Welfare. The protocol, informed consent forms,
and other requested documents, including any
subsequent modifications, were reviewed and approved by
the Yokohama City University Medical Research Ethics
Committee (21/03/2013). The Ethics Committee is
monitoring our study and we will withdraw the study
immediately on their direction of discontinuation. We will ensure
the protection of all participants rights during the study.
To address the issues associated with obtaining consent
from inpatients with schizophrenia who are symptomatic,
we exclude individuals who have conceptual
disorganisation as measured by the BPRS (rating of five or more).
Furthermore, the consent procedure is designed to
enhance the intake and retention of information.
This study is the first to evaluate the efficacy of SDM for
patients with early-treatment-stage schizophrenia. It is
significant that the study targets patients in the early stage
of treatment because the effect of psychosocial
interventions, such as SDM, would be influenced by past
treatment experience and the influence of treatment in the
early stages for a long-term outcome is considered strong
[12,29]. Another strength of the current study is that the
intervention includes both patients and staff. Since SDM
is a process based on cooperation between patients and
staff, an intervention that includes both sides is needed;
however, there were interventions that either focused on
the physicians understanding and communication skills or
on informing patients about treatment options . The
intervention program in this study is innovative in that it
includes the patient and staff who are involved in the
treatment, such as the psychiatrist, nurse, social worker,
There are some difficulties regarding the study
design. Performance bias can occur because a blind trial
at the intervention level is not possible. The
standardised execution of the intervention is another point of
concern. To address these issues, a study supervision
team that is not involved directly in the treatment
observes the protocol and facilitates staff training
programs and intervention sessions. Lastly, as the current
study is undertaken in a single centre, further research
is needed to assess generalizability.
Additional file 1: Parts and timing plot; it is a summary of the
study parts and their timing in the intervention and control groups.
Additional file 2: Questionnaire for the patient; a six-item
selfreported questionnaire that assesses patients perceptions of their
treatment at the time.
Additional file 3: Example of care plan sheet; it displays the
treatment information at that point in time, including remaining
symptoms, diagnosis, the patients condition, medication, problems
at the ward and solutions, activities, and the goal of hospital
SDM: Shared decision making; TAU: Treatment as usual; BPRS: Brief
psychiatric rating scale; DAI-10: Drug attitude inventory; CSQ: Client
satisfaction questionnaire; INDICE: Internet data and information center for
medical research; UMIN: University hospital medical information network.
MI is the principal investigator responsible for the initial draft of this
manuscript, and for organising and implementing the study. YO calculated
the sample size and decided the analytic strategy. YO, NS, and HI
contributed to development of the SDM intervention and the study design.
NS, TN, and HH contributed to the studys management. YO also revised
earlier versions of the manuscript. All authors read and approved the final
We are grateful to the dedicated colleagues at Numazu Chuo Hospital for
making this research possible, Dr Ryoji Miyata for providing the DAI-10
Japanese version, and Dr Fuminari Misawa and Dr Sayaka Sato for giving us
advice regarding the study design. This study is being supported by Health
and Labour Sciences Research Grant for Comprehensive Research on
Disability Health and Welfare from the Japanese Ministry of Health, Labour,
and Welfare. The funders played no role in the study design, the collection,
analysis, and interpretation of data, or in the decision to submit the
manuscript for publication.
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