Psychosis Clinical Trial
Official title:
Shared Decision Making in Psychiatric Inpatient Care to Enhance Patient Participation
Introduction
National guidelines and The Patient Act from 2014 call for an active role for the patient in
the decision making process. The role of the doctor is not only to give advice and to
prescribe treatments, but also to present different alternatives with pros and cons. The
method of Shared Decision Making (SDM) is meant to improve patient participation in line with
ethical guidelines and legal demands. In summary, SDM consists of three steps:
1. To introduce a choice.
2. To discuss the options.
3. To make a shared decision. Systematic studies on SDM show patients becoming better
informed and less uncertain regarding decisions made, and decisions closer to clinical
guidelines compared to treatment as usual (TAU). It is still unresolved if SDM leads to
improved clinical outcomes.
Aim
The aim of the study is to investigate outcomes of SDM carried out in psychiatric inpatient
care: the patients' perceived participation (primary outcome) and health related outcomes
(secondary).
Method
The decision situation in focus for this project is the planning of hospital discharge and
future outpatient care. The participants are randomized to either SDM or TAU. Patient
participation will be measured by questionnaires, interviews with patients and recorded
decision talks. Clinical outcomes will be measured 12 months after discharge.
Preliminary results
A pilot study conducted in 2017-2018 clarified the feasibility of instruments and the
intervention, and gave data for power estimation.
TITLE
DEAL Shared Decision Making in psychiatric inpatient care to enhance participation and
autonomy.
PURPOSE AND AIMS
The purpose is to investigate patients' participation and autonomy in psychiatric inpatient
care and the potential of Shared Decision Making (SDM) to strengthen patients' participation
in clinical decision making.
PRIMARY OUTCOME:
Does SDM improve patient participation?
SECONDARY OUTCOMES:
Does the use of SDM improve clinical outcomes (length of inpatient days, length of
involuntary care, number of inpatient episodes and completed outpatient visits)?
Does outcomes of SDM relate to gender, socio-economical background, severity of disease,
level of function, diagnosis and compulsory/voluntary care?
How does patients and doctors experience SDM in psychiatric inpatient care regarding
discharge planning?
What are the ethical and legal implications of practicing SDM in Swedish psychiatric care?
SDM DEFINED
SDM as it will be pursued in this project consists of three steps: To introduce choice. To
discuss the options. To make a shared decision.
SDM aims to help patients to explore personal preferences, make informed decisions and
achieve active participation in the decision-making process. From the perspective of patient
autonomy, SDM goes beyond mere informed consent. The practice of SDM is meant to empower the
patient to active participation.
METHOD
SDM in psychiatric inpatient care will be evaluated in a randomized controlled trial with SDM
vs treatment as usual (TAU). The decision studied is the planning of care in the process of
discharge from hospital.
Quantitative methodology is used to measure the level of perceived participation and clinical
outcomes. The qualitative parts of the study will focus on the process of implementing SDM in
inpatient psychiatric care, and to identify ethically and legally complex situations in the
use of SDM.
RECRUITMENT PROCESS
Informed consent will be obtained from all participants. The participants will be randomized
to either SDM or TAU. The randomization is conducted by slots of 40 persons per ward (20 SDM
and 20 TAU) by SPSS random number series.
RESEARCH QUESTIONS
The primary outcome of patient perceived participation (including the decision making
process) will be answered quantitatively with the questionnaires Dyadic OPTION, SURE,
Collaborate and SDM-Q-9, and qualitatively with interviews by phone 3 weeks after discharge.
The interviews will be audio recorded and analyzed using qualitative content analysis.
Perceived participation will be measured at inclusion at the ward and after the discharge
planning conversation in both the SDM and TAU group with the questionnaires.
Clinical effects (secondary outcomes) will be studied by number of: inpatient days, days of
compulsory care, inpatient episodes, completed outpatient visits, completed decisions and
emergency visits one year after the discharge. Information will be obtained from clinical
records.
Clinical and social factors will be related to level of participation. Data collected:
gender, level of education, severity of illness (CGI-S), level of function (GAF) and
voluntary/compulsory admission at inclusion, quality of life at discharge (EQ-5D) and
clinical diagnosis at discharge (clinical records).
The patient-doctor decision talks will be recorded and analyzed using qualitative content
analysis, focusing on ethical and legal questions.
STUDY PLAN
The study starts in the fall of 2019 with a short education for the doctors and staff at the
wards in the form of a seminar on SDM in a recovery perspective. The written decision
support, a step-by-step manual to facilitate SDM is used in role plays and simulations to
prepare the staff. Patients receive an illustrated and easy-to-read information and decision
guide.
During 2019-2021 patients will be recruited. This will include informed consent to
participate in the study, to collect clinical data from medical records (12 months in
retrospect and 12 months prospective from day of discharge), to recorded decision talks and
to conduct a telephone interview three weeks after discharge.
Follow up data will be collected in 2021-2022, publication of results is planned in 2022.
DATA ANALYSIS
A power estimation based on the results of the pilot study with a power of 80% and an α error
probability of 0.05 gave a Cohens d of 0,672.
G*Power was also used for an a priori estimation with a power of 80% and an α error
probability of 0.05. A Cohen´s d of 0.5 was chosen since there is a greater risk of
contamination between groups in the randomized study. This gave a group size of n=53 persons
needed in each group. The dropout rate in the pilot study of 50% is with adjustments and new
approaches still reasonable to estimate to approximately 30%. Group sizes were estimated to
n=80 persons and the total inclusion number of N=160 persons.
The groups (SDM vs TAU) will be compared for difference in mean rank, using a
Wilcoxon-Mann-Whitney test, regarding their perceived participation in the decision process,
which is the primary outcome. For the secondary outcomes comparison between the two groups
with t-tests, comparing means will include number of inpatient days, number of inpatient
episodes, number of involuntary inpatients days and completed outpatient visits.
For other secondary outcomes, such as the relation between patient perceived participation
and social/clinical factors, a multifactor analysis will be used.
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