Implementation of shared decision making by physician training to optimise hypertension treatment. Study protocol of a cluster-RCT.

BACKGROUND: Hypertension is one of the key factors causing cardiovascular diseases which make up the most frequent cause of death in industrialised nations. However about 60% of hypertensive patients in Germany treated with antihypertensives do not reach the recommended target blood pressure. The involvement of patients in medical decision making fulfils not only an ethical imperative but, furthermore, has the potential of higher treatment success. One concept to enhance the active role of patients is shared decision making. Until now there exists little information on the effects of shared decision making trainings for general practitioners on patient participation and on lowering blood pressure in hypertensive patients. METHODS/DESIGN: In a cluster-randomised controlled trial 1800 patients receiving antihypertensives will be screened with 24 h ambulatory blood pressure monitoring in their general practitioners' practices. Only patients who have not reached their blood pressure target (approximately 1200) will remain in the study (T1 - T3). General practitioners of the intervention group will take part in a shared decision making-training after baseline assessment (T0). General practitioners of the control group will treat their patients as usual. Primary endpoints are change of systolic blood pressure and change of patients' perceived participation. Secondary endpoints are changes of diastolic blood pressure, knowledge, medical adherence and cardiovascular risk. Data analysis will be performed with mixed effects models. DISCUSSION: The hypothesis underlying this study is that shared decision making, realised by a shared decision making training for general practitioners, activates patients, facilitates patients' empowerment and contributes to a better hypertension control. This study is the first one that tests this hypothesis with a (cluster-) randomised trial and a large sample size.

Effectiveness of a web-based, individually tailored decision aid for depression or acute low back pain: a randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of a web-based, individually tailored decision aid (Patient Dialogue) on depression or acute low back pain for insurees of a German sickness fund. METHODS: Patient Dialogue (PD) was compared to the non-tailored Static Patient Information (SPI) in an online randomized controlled trial (RCT). The primary outcome was decisional conflict; secondary outcomes included knowledge, preparation for decision-making, preference for participation, involvement in decision-making, decision regret, and adherence. RESULTS: Out of 2480 randomized participants, 657 (26.5%) provided analyzable data immediately after using the system. Three months later, data from 131 (5.3%) participants could be included in the analysis. The PD group reported a significantly lower overall decisional conflict than the SPI group (38.7 vs. 45.1; p=0.028 via multiple imputation estimator). The largest standardized effect (Cohen's d 0.56) resulted from the preparation for decision-making (PD 59.4 vs. SPI 46.8; p<0.001). CONCLUSION: PD may be an effective tool to reduce decisional conflict and prepare participants for treatment decision-making. However, the large dropout rate needs to be taken into account. PRACTICE IMPLICATIONS: This study shows how a health insurance fund can support shared decision-making and how a decision aid can be evaluated in a RCT under routine care conditions.

Continuing professional development for interprofessional teams supporting patients in healthcare decision making.

Healthcare professionals and organizations, policy makers, and the public are calling for safe and effective care that is centered on patients' needs, values, and preferences. The goals of interprofessional shared decision making and decision support are to help patients and professionals agree on choices that are effective, health promoting, realistic, and consonant with patients' and professionals' values and preferences. This requires collaboration among professionals and with patients and their family caregivers. Continuing professional development is urgently needed to help healthcare professionals acquire the knowledge, skills, and attitudes necessary to create and sustain a culture of collaboration. We describe a model that can be used to design, implement, and evaluate continuing education curricula in interprofessional shared decision making and decision support. This model aligns curricular goals, objectives, educational strategies, and evaluation instruments and strategies with desired learning and organizational outcomes. Educational leaders and researchers can institutionalize such curricula by linking them with quality improvement and patient safety initiatives.

Becoming a general practitioner--which factors have most impact on career choice of medical students?

BACKGROUND: In Germany, there is a shortage of young physicians in several specialties, the situation of general practitioners (GP) being especially precarious. The factors influencing the career choice of German medical students are poorly understood. This study aims to identify factors influencing medical students' specialty choice laying a special focus on general practice. METHODS: The study was designed as a cross-sectional survey. In 2010, students at the five medical schools in the federal state of Baden-Wuerttemberg (Germany) filled out an online-questionnaire. On 27 items with 5-point Likert scales, the students rated the importance of specified individual and occupational aspects. Furthermore, students were asked to assign their intended medical specialty. RESULTS: 1,299 students participated in the survey. Thereof, 1,114 students stated a current choice for a specialty, with 708 students choosing a career in one of the following 6 specialties: internal medicine, surgery, gynaecology and obstetrics, paediatrics, anaesthetics and general practice. Overall, individual aspects ('Personal ambition', 'Future perspective', 'Work-life balance') were rated as more important than occupational aspects (i.e. 'Variety in job', 'Job-related ambition') for career choice. For students favouring a career as a GP individual aspects and the factor 'Patient orientation' among the occupational aspects were significantly more important and 'Job-related ambition' less important compared to students with other specialty choices. CONCLUSIONS: This study confirms that future GPs differ from students intending to choose other specialties particularly in terms of patient-orientation and individual aspects such as personal ambition, future perspective and work-life balance. Improving job-conditions in terms of family compatibility and work-life balance could help to increase the attractiveness of general practice. Due to the shortage of GPs those factors should be made explicit at an early stage at medical school to increase the number of aspirants for general practice.

Confirmatory factor analysis and recommendations for improvement of the Autonomy-Preference-Index (API).

OBJECTIVE: Validation of the German version of the Autonomy-Preference-Index (API), a measure of patients' preferences for decision making and information seeking. METHODS: Stepwise confirmatory factor analysis was conducted on a sample of patients (n = 1592) treated in primary care for depression (n = 186), surgical and internal medicine inpatients (n = 811) and patients with minor trauma treated in an emergency department (n = 595). An initial test of the model was done on calculation and validation halves of the sample. Both local and global indexes-of-fit suggested modifications to the scale. The scale was modified and re-tested in the calculation sample and confirmed in the validation sample. Subgroup analyses for age, gender and type of treatment setting were also performed. RESULTS: The confirmatory analysis led to a modified version of the API with better local and global indexes-of-fit for samples of German-speaking patients. Two items of the sub-scale, 'preference for decision-making', and one item of the sub-scale, 'preference for information seeking', showed very low reliability scores and were deleted. Thus, several global indexes-of-fit clearly improved significantly. The modified scale was confirmed on the validation sample with acceptable to good indices of fit. Results of subgroup analyses indicated that no adaptations were necessary. DISCUSSION AND CONCLUSIONS: This first confirmatory analysis for a German-speaking population showed that the API was improved by the removal of several items. There were theoretically plausible explanations for this improvement suggesting that the modifications might also be appropriate in English and other language versions.

The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample.

OBJECTIVE: To develop and psychometrically test a brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. METHODS: We revised an existing instrument (Shared Decision Making Questionnaire; SDM-Q), including the generation of new items and changing the response format. A 9-item version (SDM-Q-9) was developed and tested in a German primary care sample of 2351 patients via face validity ratings, investigation of acceptance, as well as factor and reliability analysis. Findings were cross-validated in a randomly selected subsample. RESULTS: The SDM-Q-9 showed face validity and high acceptance. Factor analysis revealed a clearly one-dimensional nature of the underlying construct. Both item difficulties and discrimination indices proved to be appropriate. Internal consistency yielded a Cronbach's alpha of 0.938 in the test sample. CONCLUSION: The SDM-Q-9 is a reliable and well accepted instrument. Generalizability of the findings is limited by the elderly sample living in rural areas of Germany. While the current results are promising, further testing of criterion validity and administration in other populations is necessary. PRACTICE IMPLICATIONS: The SDM-Q-9 can be used in studies investigating the effectiveness of interventions aimed at the implementation of SDM and as a quality indicator in health services assessments.

Training physicians in shared decision-making-who can be reached and what is achieved?

OBJECTIVE: To report on experiences with a general shared decision-making (SDM) physician training program offered to physicians throughout Germany. METHODS: This study enrolled 150 physicians in an 8-h SDM training program. Physicians were assessed with standardized instruments before and after training. Main variables of interest were physician professional attributes, personality characteristics, attitudes, measures of training success (quality rating, knowledge, competency ratings), and variables associated with training success. RESULTS: The SDM training obtained positive quality ratings, led to an amelioration in an objective SDM knowledge test (p<.001), and highly improved physicians' confidence in their SDM competencies (p<0.001). It attracted experienced, middle-aged (45 years), male and female (46%) physicians, mostly office-based (2/3) general practitioners and internists (2/3). Most physicians (94%) reported positive attitudes towards SDM. They were securely attached (63%) with predominant social career choice motives (46%). Physicians with personality characteristics clashing with the SDM concept benefited mostly from the training. CONCLUSION: A voluntary SDM training program is attractive to practicing physicians and effective in increasing SDM-related confidence and knowledge. PRACTICE IMPLICATIONS: Even physicians who are highly motivated to use SDM can improve their skills and benefit from SDM training. The dissemination of SDM training programs should be encouraged.

Participation preferences of patients with acute and chronic conditions.

BACKGROUND: There is little knowledge as to whether the chronicity of a disease affects patients' desire for participation. AIM: To study whether participation preferences vary according to the type of disease. DESIGN, PARTICIPANTS AND METHODS: Data of 1,393 patients from six trials with different medical conditions (hypertension, depression, breast cancer, schizophrenia, multiple sclerosis, minor traumas) were pooled and analysed, using multiple regression analysis controlling for socio-demographic variables. RESULTS: Younger age, better education as well as female gender accounted for a small but statistically significantly greater desire to participate. Patients suffering from multiple sclerosis (MS) exhibited significantly higher participation preferences than the other diagnostic groups. There were no major differences between the other diagnostic groups. Age, gender, education and diagnosis explained only 14% of the variance. CONCLUSIONS: We found no clear differences between chronic and acute conditions. However, patients suffering from MS, a chronic condition, were clearly different from all other diagnostic groups. The reasons for this difference remain unclear. The predictive value of socio-demography and type of illness is low.

Patient and citizen participation in German health care--current state and future perspectives.

Patient participation within the German healthcare system is described at three different levels: the macro level as active patient influence on the regulation of medical care, the meso level in terms of institutions enhancing patient information and counselling, and the micro level focusing on the actual treatment decision-making process in the medical encounter. The main focus of the present publication is on the health care system-specific influences on patient participation in medical decision-making and on the current state of research and implementation of shared decision-making in Germany. We describe institutions promoting patient involvement, their aims and initiatives as well as recent changes in German legislation. Against the background of German health politics' endorsement of patient participation the German Ministry of Health funded a research consortium with shared decision-making intervention projects in various disease areas. The present state of the intervention projects' results is outlined as well as subsequently funded transfer projects and future perspectives of research grants. Supported by health politics and the utilisation of scientific evidence shared decision-making's transfer into practice is considered to be relevant to the German health care system.

Measuring (shared) decision-making--a review of psychometric instruments.

In recent years shared decision-making (SDM) has gained importance as an appropriate approach to patient-physician communication and decision-making. However, there is a conceptual variety that implies problems of inconsistent measurement, of defining relationships of SDM and outcome measures, and of comparisons across different studies. This article presents the results of a literature search of psychometric instruments measuring aspects of decision-making. Altogether 18 scales were found. The majority covers the patients' perspective and relates to preferences for information and participation, decisional conflict, self-efficacy as well as to the evaluation of decision-making process and outcomes. The scales differ widely in their extent of validation. Although this review is not exhaustive, it presents a variety of available decision-making instruments. Yet, many of them still need to show their psychometric quality for other settings in further studies.

The effects of a shared decision-making intervention in primary care of depression: a cluster-randomized controlled trial.

OBJECTIVE: Patient-centred depression care approaches should better address barriers of insufficient patient information and involvement in the treatment decision process. Additional research is needed to test the effect of increased patient participation on outcomes. The aim of this study was to assess, if patient participation in decision-making via a shared decision-making intervention leads to improved treatment adherence, satisfaction, and clinical outcome without increasing consultation time. METHODS: Cluster-randomized controlled intervention study based on physician training and patient-centered decision aid compared to usual care in primary care settings in Südbaden region of Germany. Twenty-three primary care physicians treating 405 patients with newly diagnosed depression were enrolled. Patient involvement was measured with the patient perceived involvement in care scale (PICS) and a patient participation scale (MSH-scale). Patient satisfaction was measured by the CSQ-8 questionnaire. Treatment adherence was evaluated by patient and provider self-report. Depression severity and remission outcomes were assessed with the Brief PHQ-D. RESULTS: Physician facilitation of patient participation improved significantly and to a greater extent in the intervention compared to the control group. There was no intervention effect for depression severity reduction. Doctor facilitation of patient participation, patient-rated involvement, and physician assessment of adherence improved only in the intervention group. Patient satisfaction at post-intervention was higher in the intervention group compared to the control group. The consultation time did not differ between groups. CONCLUSION: A shared decision-making intervention was better than usual care for improving patient participation in treatment decision-making, and patient satisfaction without increasing consultation time. Additional research is needed to model causal linkages in the decision-making process in regard to outcomes. PRACTICE IMPLICATIONS: The study results encourage the implementation of patient participation in primary care of depression.

Depressed patients' perceptions of depression treatment decision-making.

OBJECTIVE: Little is known about the feasibility and effects of patient-clinician shared decision-making (SDM) for depression treatment. Within a goal of informing the design of a SDM intervention, the objective of this study was to investigate depressed patients' perceptions of the treatment decision-making process with general practitioners (GPs). SETTING AND PARTICIPANTS: Data were gathered from a convenience sample of 40 depressed patients to understand key aspects of treatment decision-making from the patient perspective. The sample varied in depression severity and type of setting in which treatment was sought. MAIN VARIABLES STUDIED: Semi-structured interview questions focused on patients' prior experiences with depression and treatment, perceptions of the treatment decision-making process, and needs and expectations about treatment. Current depression severity was also assessed. RESULTS: Patient lack of insight regarding depression severity substantially delayed patient engagement in treatment seeking and decision-making. Patients expected their GPs to be a first and main source of objective information and discussion about depression and treatment and to provide emotional support for decision-making. Patients also identified needs for additional information about depression and its treatment, as well as concerns about certain aspects of treatment. CONCLUSIONS: The depression treatment context has some aspects that differ from treatment decision-making for other types of health conditions. SDM approaches for depression treatment should be adapted based on depression severity and patient-identified needs.

The impact of patient participation on adherence and clinical outcome in primary care of depression.

OBJECTIVE: Patient participation in shared treatment decision-making is hypothesized to improve depression treatment adherence and clinical outcomes in depressed patients. The study aim was to evaluate the impact of patient participation on these factors and to determine the variance of clinical outcome as the primary outcome variable. METHODS: A survey was administered to 30 general practitioners and 207 depressed patients, at initial consultation and 6-8 weeks later. General practitioners documented their clinical practice and patients completed questionnaires including Brief-PHQ for depression and clinical outcome, patient participation scale, and visual analogue scales for treatment adherence. Assessment of correlations was followed by the development of a structural equation model (as a latent variable analysis) to define a model to explain the entire set of the variables' relationships. RESULTS: Sixty percent of the variance in clinical outcome was attributable to patient adherence (beta=0.41) and baseline depression severity (beta=0.65). Depression severity predicted clinical outcome but not patient participation. Participation predicted adherence (beta=0.39) but did not directly affect clinical outcome. Adherence was explainable by physician- (beta=0.57) and patient-reported treatment adherence (beta=0.66). CONCLUSION: In a specific pathway via adherence, patient participation in decision-making influences clinical outcome in primary care of depression. PRACTICE IMPLICATIONS: The research findings reveal the significance of patient participation as a key factor to address for improving treatment adherence and clinical outcome. Quality improvement strategies for depression treatment should emphasize patient participation.

The assessment of depressive patients' involvement in decision making in audio-taped primary care consultations.

OBJECTIVE: In primary care of depression treatment options such as antidepressants, counseling and psychotherapy are reasonable. Patient involvement could foster adherence and clinical outcome. However, there is a lack of empirical information about the extent to which general practitioners involve patients in decision making processes in this condition, and about the consultation time spent for distinct decision making tasks. METHODS: Twenty general practice consultations with depressive patients prior to a treatment decision were audio-taped and transcribed. Patient involvement in decision making was assessed with the OPTION-scale and durations of decision making stages were measured. RESULTS: Mean duration of consultations was 16 min, 6s. The mean of the OPTION-items were between 0.0 and 26.9, in a scale range from 0 to 100. Overall, 78.6% of the consultation time was spent for the step "problem definition" (12 min, 42 s). CONCLUSION: Very low levels of patient involvement in medical decisions were observed in consultations about depression. Physicians used the majority of their time for the definition of the patient's medical problem. PRACTICE IMPLICATIONS: To improve treatment decision making in this condition, general practitioners should enhance their decision making competences and be more aware of the time spent in each decision making stage.

[Information and participation interests of patients with depression in clinical decision making in primary care]. / Informations- und Partizipationsinteressen depressiver Patienten bei der medizinischen Entscheidungsfindung in der hausärztlichen Versorgung.

A main flaw in the primary care of depression is the patients' skepticism about adequate treatment. Despite effective treatment options patients' medical demand is poor and their information insufficient. The present study aims to improve patients' information and their participation in decision making to enhance treatment motivation and satisfaction with treatment and clinical outcome. It is unclear, though, if patients are able to show interest in information and participation because of depression-specific deficits (e.g. an impairment of cognition and concentration). In a controlled study 232 patients with depression from 30 GP practices completed questionnaires assessing information and participation needs. Patients with all severity grades of depression are highly interested in information (mean = 85.2; range 0-100) and moderately interested in participating in decision making (mean = 46.8; range 0-100). Perceived involvement in care achieved a mean of 68.4 (range 0-100). The implementation of shared decision making in the primary care of depressive patients is reasonable and will be realised and evaluated within the scope of a targeted continuing education program for general practitioners.

[Measuring shared decision making]. / Messung der partizipativen Entscheidungsfindung.

Since October 2001 the German Ministry of Health and Social Security has been funding 10 projects to introduce shared decision making in clinical practice. A national meeting was held on assessment procedures to achieve consensus on a core set of instruments for the measurement of process and outcome of shared decision making. Project collaboration is co-ordinated through the methodological centre in Freiburg. Currently there are no validated measuring instruments available for German-speaking countries. Thus four international questionnaires were translated into German. In a second step the questionnaires were validated on a sample of 646 patients across 10 different diseases. To this purpose, the data of these 10 projects were combined in one database. Comprehensibility of the questionnaires used was checked in patient interviews. Moreover, the semantic structure of the questionnaires was tested by the Centre for Surveys. Methods and Analyses (ZUMA) in Mannheim. The results of this assessment process point towards problems of both comprehensibility and lack of specification of reference points for clinical decision. The statistical results for two of these questionnaires deviate from previous studies. These data indicate a potential for improving the instruments currently used for shared decision making. Separate validation across different languages and health care systems is needed in the field of shared decision making. Further research efforts on the methodological field now focus on the integration of these results with a new measuring instrument and the validation of this tool.