Arbetsgruppsmaterial inför SDM-workshop 21 augusti 2013
5. Shared decision making for in-patients with schizophrenia.
Hamann J, Langer B, Winkler V, Busch R, Cohen R, Leucht S, Kissling W Acta Psychiatry Scand. 2006 Oct;114(4): 265-73
SDM har i denna studie använts för att engagera patienterna i heldygnsvård i medicinska beslut för att förbättra resultatet av den medicinska behandlingen. Genom psykopedagogisk undervisning om såväl sjukdomen som om olika medicinska alternativ bevisas i denna studie att patienterna fått en bättre kunskap om sjukdom, en bättre följsamhet till läkemedel och en högre delaktighet i beslut kring behandlingen. Dessutom visar studien att genom att arbeta med SDM tar det inte mer utan mindre tid för läkarna. I slutsatsen står dessutom att SDM sänker stigmatiseringen avsevärt.
Postadress: Psykosvård och rättspsykiatrisk vård, Akademiska sjukhuset, ing 15, 751 85 Uppsala
Besöksadress: Stora Gråmunkegränd 3, 111 27 Stockholm, e-post: email@example.com
Acta Psychiatr Scand 2006: 114: 265–273
Journal Compilation Ó 2006 Blackwell Munksgaard
Shared decision making for in-patients withschizophrenia
Hamann J, Langer B, Winkler V, Busch R, Cohen R, Leucht S,
Kissling W. Shared decision making for in-patients with schizophrenia.
V. Winkler1, R. Busch2, R. Cohen1,S. Leucht1 and W. Kissling1
Objective: PatientsÕ participation in treatment planning is being
1Psychiatric Department, Technische Universität
increasingly advocated in mental health. The model of ÔShared
München, Germany and 2Institut für medizinische
Decision MakingÕ (SDM) is proposed as a promising method of
Statistik und Epidemiologie, Technische Universität
engaging patients in medical decisions and improving health-related
outcomes. In the present study, the feasibility and eﬀects of SDM forin-patients with schizophrenia should be evaluated.
Method: Randomized controlled trial comparing a SDM programwith routine care (n ¼ 107).
Results: The intervention studied was feasible for most of the patientsand did not take up more of the doctorsÕ time. Patients in the
Key words: schizophrenia; shared decision making;
intervention group had a better knowledge about their disease
(P ¼ 0.01) and a higher perceived involvement in medical decisions
Johannes Hamann, Klinik und Poliklinik für Psychiatrie
(P ¼ 0.03). The intervention increased the uptake of psychoeducation
und Psychotherapie der TU München, Mçhlstraße 26,
81675 München, Germany.
Conclusion: Sharing medical decisions with acutely ill in-patients withschizophrenia is in many cases possible and improves importanttreatment patterns. This might help in destigmatizing this group ofpatients and improving schizophrenia-related health outcomes.
Accepted for publication February 14, 2006
• The intervention studied was feasible for most patients and did not take up more of the doctorsÕ time.
• The intervention increased patientsÕ perceived involvement in medical decisions.
• The uptake of psychoeducation was increased.
• This was a one time intervention only; repeated administration might have boosted effects.
• We scheduled the intervention to take place Ôas soon as possibleÕ; feasibility might have been even
illness can be engaged in medical decisions and
whether this procedure has positive eﬀects on
PatientsÕ participation in treatment planning is
increasingly being advocated in mental health (e.g.
1 and 2), and there is good evidence that most
MakingÕ (SDM) has been proposed as the proper
patients wish to be involved in medical decisions
way of patient participation. Most authors classify
concerning their treatment (3). It is however still
SDM somewhere between the so-called Ôtraditional
unclear to what extent patients with severe mental
medicalÕ and the Ôinformed choiceÕ model (4, 5).
Neither the patient nor the physician should decide
attitudes toward treatment as well as on treatment
alone on the treatment, but they should try to
patterns and physiciansÕ perceptions should be
reach an agreement jointly on the treatment.
Shared Decision Making explicitly goes beyond
informed consent; thus it aims to decrease theinformational and power asymmetry between doc-
tors and patients by increasing patientsÕ informa-
tion and control over treatment decisions thataﬀect their well-being (4). Important prerequisites
The study was carried out in 12 acute psychiatric
for making this model work are an adequate
wards of two German state hospitals (Bezirkskran-
informing of the patient as to treatment options
kenhaus Haar, Klinikum Agatharied), which are
with their pros and cons and an adequate inform-
responsible for the psychiatric treatment of the
ing of the physician as to the patientsÕ values and
greater Munich area (approx. 2.5 million inhabit-
attitudes. Usually, various decision aids (informa-
ants). Selection of the wards was made so as to
tion brochures, audio cassettes, videos, internet
ensure that there were six pairs of wards, with one
pages, etc.) are provided in order to inform the
member of each pair being randomly assigned to the
patients on the available treatment options and
control or to the interventional condition. The two
associated risk-beneﬁt relations (6). Decision aids
wards of each pair were under the same management
have been proved to improve patientsÕ knowledge,
and were responsible for the same catchment area.
to decrease decisional conﬂict and – in some cases –
They were comparable with regard to distribution of
to improve the patient’s satisfaction with care (7).
diagnoses, number of beds, number of physicians
The ﬁeld of schizophrenia treatment seems to be
and nursing staﬀ, and usual route of admission.
Patients admitted to the hospital were sent to thatward of a pair that had free beds available, without
• for most therapeutic decisions there exists
patients being selected according to any character-
• the different treatment options are often accom-
Broad inclusion criteria were used. Thus during
panied by different unpleasant side-effects (8);
the enrolment period (intermittently between
• in view of the necessity of long-term adher-
February 2003 and January 2004) all men and
ence, the involvement of the patients and an
women aged 18–65 years who had an ICD-10
inclusion of subjective views of patients
diagnosis of schizophrenia or schizophreniform
regarding their medication appears to be a
disorder (F20/F23) were included. The only exclu-
promising way of eliciting and strengthening
sion criteria were (i) severe mental retardation,
(ii) lack of ﬂuency in German, and (iii) refusal to
However, questions inevitably arise with regard
give written informed consent. Acute psychotic
to the patientsÕ capability to understand and to
derangement was not considered an exclusion
rationally evaluate the information provided by
criterion; rather, physicians were instructed to
their doctors with regard to treatment options,
include all patients at the earliest stage possible.
especially considering the severe mistrust of para-
The study was approved by the ethics committee of
noid patients and the severe diﬃculties in focusing
the Technische Universita¨t, Mu¨nchen.
attention in patients with deﬁcit symptoms. There
Of the 301 patients with a diagnosis of schizo-
is overwhelming literature showing that that
phrenia screened during the enrolment period, a
psychoeducation or cognitive behavioral therapy
total of 113 were eligible for the study. But 88 left
are feasible and eﬀective for these patients (e.g.
the wards too early to be included in the protocol;
Ref. 10); but with the exception of one pilot-study
21 did not speak German ﬂuently; 45 did not
with stable out-patients (11), there has been no
consent to participate and 4 suﬀered from mental
attempt to date to evaluate SDM making in
retardation. About 31 patients were considered by
their physicians to be too ill to participate,although they fulﬁlled all the inclusion criteria. Afurther six patients withdrew consent or left the
hospital early against advice (Fig. 1).
The study reported here aimed at assessing anintervention designed to facilitate SDM among
acutely ill in-patients with schizophrenia. Thefeasibility of SDM and the eﬀects on patientsÕ
The study was designed as a controlled trial within
perceived involvement, patientsÕ knowledge and
a naturalistic psychiatric in-patient setting with a
Each pair consisted of 2 wards having the same
long-term follow up of the patients (still continu-
with respect to comprehensibility and coverage by
ing) for 18 months after discharge. Randomization
was done at the level of the wards to avoid
patients currently hospitalized in two diﬀerent
intervention and control conditions being confoun-
psychiatric hospitals. The ﬁnal version of the
ded (e.g. the same physician oﬀering SDM and
decision aid was a 16-page booklet covering the
usual care at the same time). Patients eligible for
pros and cons of oral vs. depot formulation, ﬁrst
the study were consecutively recruited in the wards
vs. second generation antipsychotics, psychoedu-
and were approached for participation as soon as
cation, and type of socio-therapeutic intervention.
possible according to their doctorsÕ rating with
These booklets were presented to the patients
through the head nurse of the ward as soon as the
Ômoderate severeÕ) in a German version of the
psychiatrist in charge considered them able to
cooperate. The nurses had been trained in assisting
After informed consent was obtained, baseline
the patient to work through the booklet and in
data were collected via self-report questionnaires
answering any requests for information. Within the
and clinical ratings of psychopathology in the
decision aid, patients were asked to write down
PANSS. In addition, data on the patientsÕ history
their experiences with previous antipsychotic medi-
and socio-demographic status were recorded. Fur-
cation and to indicate their preferences regarding
ther data were obtained on discharge (Fig. 2).
the diﬀerent options on each topic.
Patients in the control group were then treated
Nurses were instructed in the use of the decision
as usual with no further instructions for physicians
aid and assisted all patients in working through the
and nursing staﬀ. Patients in the intervention
booklet. They were advised to answer any ques-
group received an experimental SDM intervention.
tions of the patients and to encourage them to stateany point of view contrary to that of the doctor.
They were also instructed to postpone the partici-
pation of patients in the study if serious thought
The purpose of the intervention was to inform
disturbances or delusional misinterpretations were
patients about their treatment options and to
detected while working through the booklet. The
prepare them for a Ôplanning talkÕ with their
average time for working through the booklet was
physicians. A printed decision aid was developed
in co-operation with a number of psychiatrists,
Patients met their physicians within 24 h after
psychiatric nurses, and former patients. A prelim-
having worked through the decision aid with their
inary version of the booklet had been evaluated
nurse. The aim of these meetings, Ôplanning talksÕ,
Recruitment to the trial as soon as the patient is capable to participate
(PANSS conceptual organization item < 5)
Evaluation immediately after the intervention:
1. Patients’ self report: perceived involvement (COMRADE), drugattitudes (DAI), knowledge, satisfaction with care (ZUF 8)2. Doctors’ report: doctor-patient-relationship (WAI), severity of illness(PANSS), satisfaction with treatment result3. Treatment regimen: medication at discharge, psychoeducation/socio-therapy performed, number of drug switches
was to reach an agreement between patient and
• Socio-demographic data and history of illness.
psychiatrist on the further treatment according to
• Psychopathology: Positive And Negative Syn-
the preferences indicated by the patient in the
drome Scale for Schizophrenia (PANSS) (13).
booklet. For a more detailed discussion, the
• Doctor–patient relationship: Working Alli-
psychiatrist and the patients had various charts
ance Inventory (14), therapist form, a 12-item
available with quasi-quantitative information on
the most common antipsychotics and their side-
between doctors and patients (e.g. ÔWe have
established a good understanding among our-
Similar to the training for the nurses, the
selves as to the kind of changes that would be
physicians of the intervention wards had attended
two information sessions on SDM and the required
• Rating of the patientsÕ performance in the
planning talk on 5-point scales (patientsÕcompetences: interest in information, under-standing, interest in participation, decisional
capability, etc.) (interventional group only).
The following data were provided by the physi-
• Rating of physiciansÕ overall satisfaction with
• Rating of time spent per week with the
COMRADE). A p-value <0.05 (two sided) was
• Therapies administered/decisions made (these
topics were discussed in the decision aid
• Type of antipsychotic at discharge (FGA/
A total of 107 patients were included in the trial
and completed the in-patient phase. There were 49
patients in the intervention and 58 in the control
• Socio-therapeutic interventions.
group (Table 1). Patients in the intervention group
• Number of drug switches during hospital-
had been hospitalized about a week longer during
their present stay than patients in the controlgroup; and PANSS ratings for positive symptoms
Nursing staﬀ rated patientsÕ capability to under-
were, accordingly, lower in the intervention group.
stand and process the information when working
Patients in the intervention group were slightly
through the decision aid, also using 5-point scales
younger (M ¼ 35.5 vs. M ¼ 39.6 years) and had
better knowledge about their disease. There were
Patients ﬁlled in the following self-report scales
more patients in the intervention group who had
• The Decision Making Preference subscale of
the Autonomy Preference Index (API) (15), a6 item self-report instrument devised to meas-
ure patientsÕ general wish to participate inmedical decisions (e.g. ÔThe important medical
The intervention (decision aid and planning talk)
decisions should be made by your doctor, not
was administered to all 49 patients included in the
• Attitudes toward treatment (Drug Attitude
NursesÕ ratings (Table 2) indicate that working
Inventory, DAI, short version) (16). This scale
through the decision aid was possible for most
patients. However, nurses indicated that nearly
response to neuroleptic medication, including
50% of the patients had diﬃculties making a
both positive drug eﬀects (e.g. prevention of
concrete choice. Similarly, they felt that only 62%
relapses) and negative ones (e.g. dysphoric
of the patients would hold/maintain their view
reactions). Higher scores (in the range from 0
to 10) reﬂect more positive attitudes.
Psychiatrists (Table 3) rated most patients as
• A questionnaire on patientsÕ knowledge about
interested in and capable of understanding the
their disease and its treatment (seven multiple
topics discussed. However they felt that only 51%
of the patients were capable of making ÔreasonableÕ
• The Combined Outcome Measure for Risk
Making Effectiveness (COMRADE) (17), ascale
n ¼ 107 unless otherwise stated Intervention (n ¼ 49) Control (n ¼ 58)
involvement in medical decisions (e.g. ÔThe
treatment I thought was best for meÕ).
patientsÕ overall satisfaction with care (18).
Groups were compared at baseline using unpaired
t-tests/chi2 tests. Group differences were analyzed
using a general linear model (for continuous
variables) and logistic regression (for dichotomous
variables) with adjustment for patientsÕ age,
PANSS positive scores at study entry, patientsÕ
knowledge and route of admission (time from
admission to study entry was used as an additional
PANSS: Positive and Negative Syndrome Scale; DAI: Drug Attitude Inventory; API:
Table 2. NursesÕ ratings of patientsÕ performance while using the decision aid
Patients who were regarded by their psychiatrists
as capable (scores 4 and 5) of making reasonable
decisions (n ¼ 25) did not diﬀer signiﬁcantly from
those they had rated as non-capable (score 1–3)(n ¼ 24) with regard to psychopathology (PANSS
total, positive and general score), attitudes toward
medication (DAI), age, sex, knowledge about the
disease, route of admission, legal guardianship,
and duration of illness. But those patients who
interested in participating inmedical decisions?
were considered highly capable indicated more
interest in participating in medical decisions
according to API (P ¼ 0.04, t-test) and had lower
scores in the PANSS negative score (P ¼ 0.05,
defend/maintain his view/positiontoward the doctor?
Table 3. PsychiatristsÕ ratings of patientsÕ performance during the planning talk
Patients in the intervention group reported signi-
ﬁcantly greater perceived involvement in medical
i.e. ÔpredominantlyÕ, or ÔcompletelyÕ
decisions (COMRADE) after the planning talkthan patients in the control group at a comparable
point in time (at study entry). This diﬀerence,
however, was no longer present at the time of
discharge. Patients in the intervention group knew
signiﬁcantly more about their disease and treat-
ment at the time of discharge. Patients in the
intervention group did not diﬀer from the patients
in the control group in regard to overall satisfac-
tion with treatment (ZUF 8), but there was a trend
view against your position as his doctor?
for more positive attitudes toward medication
(according to the DAI) (see Table 4).
from that you would have chosen hadyou decided alone?
According to the psychiatristsÕ ratings the patients
decisions. In 22% of the patients (n ¼ 11) the
of the intervention group did not diﬀer from those
psychiatrists indicated that they made a decision
in the control group in psychopathology (PANSS
on the basis of the exchange with the patients
which was diﬀerent from what they (the doctors)
cooperation as reﬂected in the Working Alliance
had intended [decisions: medication (four times),
Inventory (therapist version) (means 60.6/60.9,
P > 0.05), in the time spent in individual contacts
between psychiatrist and patient as reported by the
Table 4. Outcome data – the patientsÕ view
Group differences were analyzed using a general linear model with patientsÕ age, PANSS positive score at study entry, patientsÕ knowledge and route of admission ascovariates (time from admission to study entry was used as an additional covariate for the first measurement of COMRADE)COMRADE: Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness; DAI: Drug Attitude Inventory; ZUF8: PatientsÕ Satisfaction.
psychiatrist (means in min/weeks 64/60, P > 0.05)
• We used broad inclusion criteria, which resul-
and in the estimated compliance from the doctor’s
ted in many patients being included who were
point of view (means 1.7/2.0, P > 0.05). However,
psychiatrists in the intervention group were more
reasonable decisions, but which shed light on
satisﬁed with what had been achieved during
the percentage of patients that can successfully
hospitalization (5-point scale overall satisfaction,
• This trial was not performed in a university
setting but in state hospitals, which led on theone hand to a higher amount of lacking (self-
report) values and which limited the amount
There were no diﬀerences in the actually prescribed
of questionnaires that could be administered
antipsychotic class (ﬁrst or second generation
(e.g. an objective measure of the decision
antipsychotics) (P > 0.05) or the number of drug
making capacity), but which on the other hand
switches (P > 0.05). Due to the large variation in
now enables us to argue that the intervention
antipsychotics prescribed (20 diﬀerent agents or
is feasible in normal patient care and with
combinations of agents) an analysis of drug or dose
diﬀerences between the groups was not underta-
• The intervention took place as Ôsoon as poss-
ibleÕ. An intervention shortly before discharge
Patients in the intervention group received psy-
choeducation (P ¼ 0.003) and socio-therapeutic
needs of the patients in regard to long-term
interventions (P ¼ 0.04) signiﬁcantly more often.
care. On the other hand, many decisionsconcerning maintenance therapy (e.g. drugchoice) are made early during hospitalization.
In this ﬁrst controlled trial on SDM, studying
acutely ill patients with schizophrenia, it wasproved possible and feasible for most of the
Regarding feasibility, it appeared that most
patients to share important decisions with their
patients who fulﬁlled inclusion criteria were actu-
physicians. The intervention increased patientsÕ
ally recruited for the trial, although there were
perceived involvement, although this eﬀect dimin-
some who were not included due to their doctor’s
ished over time. PatientsÕ knowledge about their
refusal (31 patients were considered as permanently
disease was increased and attitudes toward treat-
Ôtoo illÕ to participate). It was possible to admin-
ment were improved. The structured intervention
ister the intervention to all patients in the inter-
increased participation in psychoeducation and
vention group, with both nurses and physicians
indicating that most patients were capable ofunderstanding and taking interest in the issuesdiscussed. Two topics raised concerns, however:
nurses indicated that many patients had diﬃculties
Since we placed emphasis on studying the topic
choosing among diﬀerent options, and doctors
under real-world conditions (state hospitals) and
rated many patients as being incapable of making
tried to avoid a study with highly selected patients,
reasonable decisions. It can only be speculated
many of the limitations from the one point of view
whether these numbers reﬂect incapacity on the
(internal validity) are thus strengths from another
part of the patients or the prejudices of doctors/
nurses. In our trial, ÔincapableÕ patients exhibitedvery few key characteristics: interestingly enough,
• We abstained from individual randomization
it is not the group of very psychotic or aggressive
patients who are ÔincapableÕ, but rather those with
control conditions and to avoid the situation
predominantly negative symptoms or those declar-
that the same physician had to practice SDM
ing no interest in participation. Thus the problem
and routine care at the same time. We believe,
might not be that these patients choose irrational
however, that our study does not suffer from
treatment options, but rather that they are not
the limitations of classical cluster trials (e.g.
interested in thinking about and deciding on these
selection bias), since individual patients were
issues. This fact is however no obstacle to SDM,
ÔrandomlyÕ sent to that ward of a pair that had
since SDM does not aim at forcing patients to be
free beds available and were not selected
active decision makers but rather wishes to oﬀer
according to any patient characteristics.
them a choice, which they need not to accept. For
anything more than disturbing their current treat-
those patients the paternalistic doctor is probably
ment practices or their relationship with their
It is very important to bear in mind that SDM
Finally, the intervention changed important
represented a new approach for both doctors and
treatment patterns as reﬂected in the higher parti-
patients and that this might be reﬂected in a rather
cipation in psychoeducation and socio-therapeutic
conservative behavior (paternalistic role of the
procedures. The intervention presumably had
physicians) on both sides. Thus the intervention
structured decisions that physicians would prob-
group patients were recruited one week later than
patients in the control group, which might indicate
patientsÕ right to participate in these decisions in
that their doctors wanted the most severe symp-
toms to be treated before they included theirpatients in medical decisions. The fact that the
What future steps should be undertaken to include patients with
intervention group patients felt more involved
severe mental illness in medical decisions?
shortly after the intervention than patients in thecontrol group but that both groups arrived at a
Since the eﬀect of the intervention on patientsÕ
similar level at discharge indicates that both –
perceived involvement diminished over time, more
patients and physicians – probably tend to switch
than a one-time ÔtriggerÕ intervention to change the
back to old habits when the stimulus (intervention)
behavior of physicians and patients is necessary.
Thus a repetitive intervention (e.g. planning talks
Our results concur with ﬁndings from related
once a week) might lead to even clearer diﬀerences
ﬁelds, which demonstrated that patientsÕ capability
between intervention and control conditions.
of giving informed consent is not generally
SDM interventions for those patients who were
impaired by their psychopathology and that exist-
not reached by the program presented here (e.g.
ing impairments can be overcome by adaptive
those not interested in participating or those
strategies (use of simple explanations, etc. (19, 20)).
judged incapable) need to be developed, especially
We believe that the decision aid used in this trial
approaches for patients with predominantly neg-
was both comprehensible by and appealing to the
ative symptoms. In addition, programs that facili-
patients since it was developed in cooperation with
tate SDM from the patientsÕ point of view alone
all relevant parties. Our intervention was feasible
require attention. ÔEmpowermentÕ strategies have
for performance in the setting studied (state
been shown to be feasible and eﬀective in somatic
hospitals); and it required no more time for the
medicine (21). They include training patients in
physicians to perform SDM than usual care, a fact
communication skills and aim to encourage
which allows the intervention to be performed
patients to be more assertive during consultation
under usual care conditions, in which doctors are
by asking more questions and by introducing their
point of view into the discussion. In contrast to a
Regarding the eﬀects of the intervention, SDM –
decision aid, these interventions do not focus on
as performed in our study – increases patientsÕ
selected decisions (e.g. drug choice) but rather
perceived involvement and improves their know-
enable patients to demand their rights more
ledge about and their attitudes toward treatment.
eﬀectively in any situation whatsoever.
It thus inﬂuences important variables that aﬀect
To conclude in this trial the feasibility and the
patientsÕ satisfaction, commitment to treatment
short term eﬀects of an intervention designed to
and long-term compliance. The fact that overall
facilitate SDM for in-patients with schizophrenia
satisfaction was not improved might result from
were studied. Results indicated positive prospects
the ceiling eﬀect of such questionnaires and the
for this new model of patient participation that are
various inﬂuences on this measure (e.g. contacts
especially encouraging for this group of patients,
with other patients, quality of meals, etc.).
who still are stigmatized as being incapable of
The intervention also had eﬀects on the physi-
making reasonable treatment decisions.
ciansÕ perception of the doctor–patient relation-ship. Although we detected no diﬀerences in the
Working Alliance Inventory (WAI), doctors in theinterventional group seemed more satisﬁed with
The authors would like to thank all participating patients,
overall treatment results than their colleagues in
physicians and nursing staﬀ of the participating hospitals Haarand Agatharied for their support. The authors would also like
the control group. This result need not necessarily
to thank Dr. Gabi-Pitschel-Walz and Holger Lieber for their
have been expected, since many physicians were
assistance with the doctorsÕ training. The trial was funded by
doubtful at the outset whether SDM would achieve
the German Ministry of Health and Social Security (217-
group psychoeducation in patients with schizophrenia.
43794-5/9) within the funding project ÔDer Patient als Partner
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Ultrasound guided prostate biopsy clopidogrel, dabigatran, prasugrel, dipyridamole or asasantin (for more Consumer Information information about these medications, go to NPS: http://www.nps.org.au/medicines ). Contributors: Blood thinning medications will need to be stopped for a period of days, or your normal dose reduced, before this procedure is carried out. It is ve
JOSHUA HARLAN HARRIS 74 Town Green Drive, Elmsford, NY 10523 • 646-660-0868 • firstname.lastname@example.org LEGAL EXPERIENCE Loeb & Loeb, L.L.P. , New York, NY Morgan & Finnegan, L.L.P. , New York, NY Associate , January 2009 to present Student Associate / Associate , June 2003 to January 2009 LITIGATION • Writing successful briefs on motions for summary judgment and