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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: battre.psykosvard@akademiska.se 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.
E-mail: j.hamann@lrz.tum.de 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, Interventional group
Control group
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.
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