Supporting Error Management and Safety Climate in Ambulatory Care Practices: The CIRSforte Study.

BACKGROUND: To improve patient safety, it is important that healthcare facilities learn from critical incidents. Tools such as reporting and learning systems and team meetings structure error management and promote learning from incidents. To enhance error management in ambulatory care practices, it is important to promote a climate of safety and ensure personnel share views on safety policies and procedures. In contrast to the hospital sector, little research has been dedicated to developing feasible approaches to supporting error management and safety climate in ambulatory care. In this study, we developed, implemented, and evaluated a multicomponent intervention to address how error management and safety climate can be improved in ambulatory care practices. METHODS: In a prospective 1-group pretest-posttest implementation study, we sought to encourage teams in German ambulatory practices to use proven methods such as guidelines, workshops, e-learning, (online) meetings, and e-mail newsletters. A pretest-posttest questionnaire was used to evaluate level and strength of safety climate and psychological behavioral determinants for systematic error management. Using 3 short surveys, we also assessed the state of error management in the participating practices. In semistructured interviews, we asked participants for their views on our intervention measures. RESULTS: Overall, 184 ambulatory care practices nationwide agreed to participate. Level of safety climate and safety climate strength (rwg) improved significantly. Of psychological behavioral determinants, significant improvements could be seen in "action/coping planning" and "action control." Seventy-six percent of practices implemented a new reporting and learning system or modified their existing system. The exchange of information between practices also increased over time. Interviews showed that the introductory workshop and provided materials such as report forms or instructions for team meetings were regarded as helpful. CONCLUSIONS: A significant improvement in safety climate level and strength, as well as participants' knowledge of how to analyze critical incidents, derive preventive measures and develop concrete plans suggest that it is important to train practice teams, to provide practical tips and tools, and to facilitate the exchange of information between practices. Future randomized and controlled intervention trials should confirm the effectiveness of our multicomponent intervention.Trial registration: Retrospectively registered on 18. November 2019 in German Clinical Trials Register No. DRKS00019053.

Strength of Safety Measures Introduced by Medical Practices to Prevent a Recurrence of Patient Safety Incidents: An Observational Study.

OBJECTIVE: The aim of this study was to analyze the strength of safety measures described in incident reports in outpatient care. METHODS: An incident reporting project in German outpatient care included 184 medical practices with differing fields of specialization. The practices were invited to submit anonymous incident reports to the project team 3 times for 17 months. Using a 14-item coding scheme based on international recommendations, we deductively coded the incident reports and safety measures. Safety measures were classified as "strong" (likely to be effective and sustainable), "intermediate" (possibly effective and sustainable), or "weak" (less likely to be effective and sustainable). RESULTS: The practices submitted 245 incident reports. In 160 of them, 243 preventive measures were described, or an average of 1.5 per report. The number of documented measures varied from 1 in 67% to 4 in 5% of them. Four preventive measures (2%) were classified as strong, 37 (15%) as intermediate, and 202 (83%) as weak. The most frequently mentioned measures were "new procedure/policy" (n = 121) and "information/notification/warning" (n = 45). CONCLUSIONS: The study provides examples of critical incidents in medical practices and for the first time examines the strength of ensuing measures introduced in outpatient care. Overall, the proportion of weak measures is (too) high, indicating that practices need more support in identifying strong measures.

Moving towards patient-centered care and shared decision-making in Germany.

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.

Patient Safety and the COVID-19 Pandemic in Germany: A Repeated Population-Based Cross-Sectional Survey.

The coronavirus (COVID-19) has presented Germany with major challenges and has led to concerns about patient safety. We conducted an observational, population-based, nationwide, repeated cross-sectional survey on patient safety in Germany in 2019, 2020, and 2021. Each of the three samples consisted of 1000 randomly recruited adults. Self-reported data via computer-assisted telephone interviews were taken from TK Monitor of Patient Safety. Perceptions, experience, and knowledge relating to patient safety were assessed. The majority of respondents considered medical treatment to involve risks to patient safety. This proportion decreased during the pandemic. The majority also had a high degree of self-efficacy regarding the prevention of medical errors, whereby the percentage that felt well informed with regard to patient safety rose throughout the pandemic. The proportion of persons that suspected they had in the past experienced an error in their treatment remained steady at one third as well as the reported errors. In 2020, 65% of respondents thought health communication with service providers (e.g., extent and comprehensibility of information) remained unchanged during the pandemic, while 35% reported that medical appointments had been cancelled or postponed. This study is the first to assess patient safety from a general population perspective during the coronavirus pandemic in Germany. COVID-19 had a positive impact on perceived patient safety but no impact on suspected and reported errors. Self-efficacy with regard to medical error prevention steadily increased in the general population, and people considered themselves well informed.

[Patient perspectives on patient safety: Results of a population-based survey in Germany]. / Subjektive Informiertheit von Patient*innen zum Thema Patientensicherheit: Ergebnisse einer Bevölkerungsbefragung in Deutschland.

INTRODUCTION: The growing number of people with multimorbidity and polypharmacy in Germany has led to increasing complexity in health care and risks to patient safety. A high priority should therefore be placed on identifying and preventing avoidable adverse events. The patient perspective plays an important role in improving patient safety. In this study, we conducted a representative, population-based survey of knowledge, perceptions and experiences of patient safety, especially of subjectively experienced errors in health care. Our aim was, in particular, to assess patient safety from the patients' point of view, and to analyze differences in assessments of risk and preventability between persons that felt well or poorly informed about patient safety topics. METHODS: In 2019, computer-assisted telephone interviews were conducted nationwide as part of the "TK-Monitor Patient Safety" project. Recruitment was carried out by using multistage selection and forming a stratified random sample. Adults (18 years and older) with sufficient knowledge of German were included. The survey was conducted using a structured guideline containing 21 questions concerning perceptions and experiences of patient safety, and 12 questions on sociodemographic factors. The results were analyzed both descriptively and using inferential statistical methods. RESULTS: Of a total of 1,000 respondents (51% female), approx. half (52%) were gainfully employed, and 57% rated their state of health as "very good" or "good". The patients regarded data protection, medication errors, hospital infections and diagnostic (un)certainty as of major relevance to patient safety. Overall, 55% of the respondents rated their knowledge of patient safety as "very good" or "good". The results showed that subjective knowledge was negatively associated with important outcome parameters such as having experience of medication errors or suspecting errors had been made in a medical examination or treatment. Patients that considered themselves well-informed also reckoned they could contribute towards increasing safety in health care. DISCUSSION: The respondents considered diagnostic uncertainty to be one of the greatest risks to their person. This shows that they recognized a need for further information and felt this need was inadequately satisfied in the German research landscape. With regard to the correlation between subjective knowledge and outcome parameters, it is also necessary to analyze whether the respondents' subjective knowledge reflects their actual knowledge, as this would be necessary for preventive measures to be effective. This question will be the subject of further studies. CONCLUSION: The patient perspective is an important addition to the study of the safety of medical care in Germany. Factors influencing subjective knowledge should be investigated. Furthermore, regular surveys would be desirable in order to gain greater insight into the topic.

Assessing Patients' Perceptions of Safety Culture in the Hospital Setting: Development and Initial Evaluation of the Patients' Perceptions of Safety Culture Scale.

OBJECTIVES: Both patient satisfaction and hospital safety culture have been recognized as key characteristics of healthcare quality and patient safety. Thus, both characteristics are measured widely to support quality and safety improvement efforts. However, because safety culture surveys focus exclusively on the perspective of hospital staff, the complimentary information to be gained from patients' perceptions of safety culture has received little research attention so far. We aimed to develop a measure explicitly focusing on patients' perceptions of safety culture in the hospital setting and perform an initial evaluation of its measurement properties. METHODS: We employed a multistep development approach including (a) literature review of survey instruments for patient experience and safety culture and (b) item categorization and selection. We evaluated the measurement properties of the final item set focusing on factor structure, internal consistency, item difficulty, and discrimination. Data were collected from June to December 2015 via an online patient survey conducted routinely by a health insurer. RESULTS: Overall, 112,814 insured persons participated in the online survey (response rate = 19.7%). The final 11-item set formed a single scale that was named Patients' Perceptions of Safety Culture scale. Its measurement properties were deemed satisfactory based on this initial evaluation. CONCLUSIONS: The Patients' Perceptions of Safety Culture scale contributes to both a more comprehensive view of patients' experience of healthcare and a more balanced approach to safety culture measurement in healthcare. It contributes to an increased recognition of patients' views on safety-relevant aspects of their care that provide important inputs to patient safety improvement.

Communication and patient safety in gynecology and obstetrics - study protocol of an intervention study.

BACKGROUND: Patient safety is a key target in public health, health services and medicine. Communication between all parties involved in gynecology and obstetrics (clinical staff/professionals, expectant mothers/patients and their partners, close relatives or friends providing social support) should be improved to ensure patient safety, including the avoidance of preventable adverse events (pAEs). Therefore, interventions including an app will be developed in this project through a participatory approach integrating two theoretical models. The interventions will be designed to support participants in their communication with each other and to overcome difficulties in everyday hospital life. The aim is to foster effective communication in order to reduce the frequency of pAEs. If communication is improved, clinical staff should show an increase in work satisfaction and patients should show an increase in patient satisfaction. METHODS: The study will take place in two maternity clinics in Germany. In line with previous studies of complex interventions, it is divided into three interdependent phases. Each phase provides its own methods and data. Phase 1: Needs assessment and a training for staff (n = 140) tested in a pre-experimental study with a pre/post-design. Phase 2: Assessment of communication training for patients and their social support providers (n = 423) in a randomized controlled study. Phase 3: Assessment of an app supporting the communication between staff, patients, and their social support providers (n = 423) in a case-control study. The primary outcome is improvement of communication competencies. A range of other implementation outcomes will also be assessed (i.e. pAEs, patient/treatment satisfaction, work satisfaction, safety culture, training-related outcomes). DISCUSSION: This is the first large intervention study on communication and patient safety in gynecology and obstetrics integrating two theoretical models that have not been applied to this setting. It is expected that the interventions, including the app, will improve communication practice which is linked to a lower probability of pAEs. The app will offer an effective and inexpensive way to promote effective communication independent of users' motivation. Insights gained from this study can inform other patient safety interventions and health policy developments. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03855735; date of registration: February 27, 2019.

Improving critical incident reporting in primary care through education and involvement.

BACKGROUND: Critical incident reporting systems (CIRS) can be an important tool for the identification of organisational safety needs and thus to improve patient safety. In German primary care, CIRS use is obligatory but remains rare. Studies on CIRS implementation in primary care are lacking, but those from secondary care recommend involving management personnel. OBJECTIVE: This project aimed to increase CIRS use in 69 practices belonging to a local practice network. METHODS: The intervention consisted of the provision of a web-based CIRS, accompanying measures to train practice teams in error management and CIRS, and the involvement of the network's management. Three measurements were used: (1) number of incident reports and user access rates to the web-based CIRS were recorded, (2) staff were given a questionnaire addressing incident reporting, error management and safety climate and (3) qualitative reflection conferences were held with network management. RESULTS: Over 20 months, 17 critical incidents were reported to the web-based CIRS. The number of staff intending to report the next incident online decreased from 42% to 20% of participants. In contrast, the number of practices using an offline CIRS (eg, incident book) increased from 23% to 49% of practices. Practices also began proactively approaching network management for help with incidents. After project completion, participants scored higher in the patient safety climate factor 'perception of causes of errors'. For many practices, the project provided the first contact with structured error management. CONCLUSION: Specific measures to improve the use of CIRS in primary care should focus on network management and practice owners. Practices need basic training on safety culture and error management. Continuing, practices should implement an offline CIRS, before they can profit from the exchange of reports via web-based CIRS. It is crucial that practices receive feedback on incidents, and trained network management personnel can provide such support.

[Digital health literacy in Germany - requested, but not supported? Results of the empirical study TK-DiSK]. / Digitale Gesundheitskompetenz in Deutschland - gefordert, aber nicht gefördert? Ergebnisse der empirischen Studie TK-DiSK.

In Germany, the digital transformation is considered the key to "growth and prosperity". Beyond the debate on the required technical conditions, digital health literacy is seen as a prerequisite for a democratic and patient oriented digitization of the health system. The study "TK-DiSK: digital - self-determined - competent" aimed at examining the perspectives and status of stakeholders in the German health system and of further developing the concept of digital health literacy. Document analysis, surveys and interviews revealed a paradox about digital health literacy: though it is generally seen as a "highly relevant' issue, there is hardly any substantial discussion of it. Interviewed experts did not share a common understanding of its content, disagreed on ways of promoting it, and disputed the agencies to be held responsible for ensuring digital health literacy. Focus groups with patients clearly showed that the facilitation of patient autonomy is a central aspect for their assessment of digital health technologies. This article develops a timely definition of digital health literacy and argues for a comprehensive and targeted promotion addressing individuals as well as organizations.

[Developing a recommendation for handling risks through digital transformation in patient care]. / Entwicklung einer Handlungsempfehlung zum Umgang mit Risiken in der Patientenversorgung durch Entwicklungen im Rahmen der digitalen Transformation.

Digital transformation in healthcare presents enormous challenges as it partially redefines care processes and interaction between patients and doctors. In order to seize opportunities to improve patient care as well as patient safety by using digital innovations, arising patient safety risks due to these changes have to be considered and addressed. The German Coalition for Patient Safety, the Austrian Network for Patient Safety and the Swiss Foundation for Patient Safety decided to develop a recommendation for members of all professional groups in healthcare to sensitize for arising risks, inform about cause-effect relationships and to empower professionals to perform an individual risk-benefit-assessment for existing and upcoming digital innovations. In May 2017 the German Coalition on Patient Safety implemented its working group Digitization and Patient Safety with its subgroup Digitization and Risk Management. Based on open brainstorming of experts followed by a nominal group technique process the most relevant risks for patient safety arising from digitization were identified and assessed by using a modified scenario analysis. After internal consultation of all members of the German Coalition for Patient Safety and all executive boards of participation associations, the recommendation was published at the annual meeting of the German Coalition for Patient Safety in May 2018. We identified six core risks that were assessed by modified scenario technique: insufficient protection of the IT system from external attacks, insufficient protection of the IT system from unauthorized access, non-availability of IT system or patient data, handing over data to external service providers, unsafe embedding of medical devices in IT systems and insufficient digital literacy of healthcare professionals. In addition, we developed a checklist for the self-assessment of risks arising from implementing digital innovation, using risk criteria according to ONR 49002-2:2014, and provided key questions for decision makers. On the basis of the approach described a multiprofessional and intersectoral recommendation for clinical core risks associated with digitization in healthcare was developed within a 12-month period. The dissemination of this recommendation in German language can be regarded as very successful since the German Coalition for Patient Safety received more than 22,000 requests for paper copies, and 1,200 downloads of this open-access publication have been registered. An English version of this recommendation will soon be available.

[Position Paper of The AG Digital Health DNVF on Digital Health Applications: Framework Conditions For Use in Health Care, Structural Development and Science]. / Digitale Gesundheitsanwendungen ­ Rahmenbedingungen zur Nutzung in Versorgung, Strukturentwicklung und Wissenschaft ­ Positionspapier der AG Digital Health des DNVF.

The term "digital health" is currently the most comprehensive term that includes all information and communication technologies in healthcare, including e-health, mobile health, telemedicine, big data, health apps and others. Digital health can be seen as a good example of the use of the concept and methodology of health services research in the interaction between complex interventions and complex contexts. The position paper deals with 1) digital health as the subject of health services research; 2) digital health as a methodological and ethical challenge for health services research. The often-postulated benefits of digital health interventions should be demonstrated with good studies. First systematic evaluations of apps for "treatment support" show that risks are higher than benefits. The need for a rigorous proof applies even more to big data-assisted interventions that support decision-making in the treatment process with the support of artificial intelligence. Of course, from the point of view of health services research, it is worth participating as much as possible in data access available through digital health and "big data". However, there is the risk that a noncritical application of digital health and big data will lead to a return to a linear understanding of biomedical research, which, at best, accepts complex conditions assuming multivariate models but does not take complex facts into account. It is not just a matter of scientific ethical requirements in health services care research, for instance, better research instead of unnecessary research ("reducing waste"), but it is primarily a matter of anticipating the social consequences (system level) of scientific analysis and evaluation. This is both a challenge and an attractive option for health services research to present itself as a mature and responsible scientific discipline.

The long way of implementing patient-centered care and shared decision making in Germany.

The main focus of the paper is on the description of the development and current state of research and implementation of patient-centered care (PCC) and shared decision making (SDM) after fifteen years of substantial advances in health policy and health services research. What is the current state of SDM in health policy? The "Patients' Rights Act" from 2013 standardizes all rights and responsibilities within the framework of medical treatment for German citizens and legal residents. This comprises the right to informed decisions, comprehensive and comprehensible information for patients, and decisions based on a clinician-patient-partnership. What is the current state of SDM interventions and patient decision support tools? SDM training programs for healthcare professionals have been developed. Their implementation in medical schools has been successful. Several decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care, specifically for national cancer screening programs. What is the current state of research and routine implementation? The German government and other public institutions are constantly funding research programs in which patient-centered care and shared decision-making are important topics. The development and implementation of decision tools for patients and professionals as well as the implementation of CME trainings for healthcare professionals require future efforts. What does the future look like? With the support of health policy and scientific evidence, transfer of PCC and SDM to practice is regarded as meaningful. Research can help to assess barriers, facilitators, and needs, and subsequently to develop and evaluate corresponding strategies to successfully implement PCC and SDM in routine care, which remains challenging.

[jeder-fehler-zaehlt.de: Content of and prospective benefits from a critical incident reporting and learning system (CIRS) for primary care]. / Das hausärztliche Fehlerberichts- und Lernsystem 'jeder-fehler-zaehlt.de' - Berichtsbestand und Nutzungsperspektiven.

Critical incident reporting and learning systems (CIRS) have been recommended as an instrument to promote patient safety for a long time. However, both their scientific value and their actual impact have been disputed. The nationwide German CIRS for primary care has been in operation since September 2004. Incident reports are available online, and the question is how to make use of this large database to promote patient safety. A descriptive analysis of the content was performed, classifying, in particular, types of error and contributing factors. Its usage is presented for the period from 2004 to 2013 where a total of 483 complete reports have been recorded. Their severity ranges from 35.6 % with no tangible harm to patients to 14.6 % with important harm (or errors contributing to mortality). The majority of them (74.2 %) were process errors, compared to 25.8 % knowledge/skills errors. The main areas involved were treatment/medication (54.2 %) and diagnosis/tests (16.4 %). The results of the analysis of the CIRS cannot be used as an epidemiological data source. And yet they will generate hypotheses for further research in the field of patient safety. Moreover, they will enable practice teams to make themselves familiar with and learn from critical incident analysis. In spite of the specific difficulties in ambulatory care, CIRS should be promoted in this sector to enable learning. Participation in CIRS can be increased by enhanced feedback.

Socioeconomic factors and effect of evidence-based patient information about primary prevention of type 2 diabetes mellitus--are there interactions?

BACKGROUND: Having shown in a recent randomized controlled trial that evidence-based patient information (EBPI) significantly increased knowledge on primary prevention of diabetes compared to standard patient information, we now investigated interaction between socioeconomic status (SES) and the effect of an EBPI. FINDINGS: 1,120 visitors (aged 40-70 years, without known diabetes) to the "Techniker Krankenkasse" and the "German Diabetes Center" websites were randomized. The intervention group received a newly developed on-line EBPI, the control group standard on-line information. The primary outcome measure was knowledge, classified as "good/average/poor". We analyzed associations of knowledge with socioeconomic variables (education, vocational training, employment, subjective social status) combined with intervention effect including interactions, adjusted for possible confounding by knowledge before intervention, self-reported blood glucose measurements, blood pressure, blood lipid levels, age and gender. Logistic regression models were fitted to the subpopulation (n = 647) with complete values in these variables.Education (high vs. low) was significantly associated with knowledge (good vs. average/poor); however, there was no significant interaction between education and intervention. After adjustment, the other socioeconomic variables were not significantly associated with knowledge. CONCLUSIONS: Socioeconomic variables did not significantly change the effect of the intervention. There was a tendency towards a lower effect where lower educated individuals were concerned. Possibly the power was too low to detect interaction effects. Larger studies using SES-specific designs are needed to clarify the effect of SES. We suggest considering the socioeconomic status when evaluating a decision aid, e.g. an EBPI, to ensure its effectiveness not only in higher socioeconomic groups. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22060616 (Date assigned: 12 September 2008).

Replacement of endoprosthetic implants within a two years follow-up period: a statutory health insurance routine data analysis.

BACKGROUND: The statutory health insurance system embodies a large amount of data on the treatments of their members. Depending on joint, prosthesis type, patient activity and comorbidity, knee and hip replacements can last up to 20 years. Based on statutory health insurance data the main object of this analysis was to investigate how high the early revision rate of replacements actually is. METHODS: The number of replacements in the years 2005 and 2006 has been extracted from the TK database for hip (OPS-Code 5-820, n = 20,875), knee (OPS 5-822, n = 13,466), upper limbs (OPS 5-824, n = 901), and lower limbs (OPS 5-826) replacements. This data has then been related to each consecutive operation (i. e. change or excision of joint endoprosthesis) over a joint-specific observation period of two years. RESULTS: In 3.7% of the cases joint replacements stood for less than 2 years (hip 3.5%, knee 3.8%, upper limbs 6.5%, and lower limbs 5.5%). There is a significantly positive correlation between the treatment data of the hospitals and the outcome as to low rates of reoperations at early stages. The main reason for short lifetime (76 - 81%) is mechanical failure. CONCLUSION: The percentage of joint endoprostheses with significantly short lifetimes has been unexpectedly high. The de facto lifetimes of joint endoprostheses thus often do not match the manufacturers' information. The authors strongly support the idea of a national endoprosthesis register as such a register could give detailed information on firstly whether these deficits are due to material defects, osteolysis or dislocation and secondly which products are mainly affected.

Patient participation and shared decision making in Germany - history, agents and current transfer to practice.

The main focus of the present paper is to describe 1) the healthcare system specific influences on patient participation in medical decision making and 2) the current state of research and implementation of shared decision making (SDM) after ten years of substantial advances in health policy and research in this field. WHAT ABOUT POLICY REGARDING SDM? The "Medical Patients Rights Act" is to standardise all the rights and responsibilities within the scope of medical treatment. This also comprises the right to informed decisions, comprehensive and comprehensible information for patients, and decisions based on the partnership of clinicians and patients. WHAT ABOUT TOOLS - DECISION SUPPORT FOR PATIENTS? SDM training programmes for healthcare professionals have been developed and partly implemented. Several decision support interventions - primarily with support from health insurance funds - have been developed and evaluated. WHAT ABOUT PROFESSIONAL INTEREST AND IMPLEMENTATION? Against the background of the German health policy's endorsement of patient participation, the German government and other public institutions are currently funding different research programmes in which shared decision making is playing a substantial role. The development and implementation of decision support tools for patients and professionals as well as the implementation of trainings for healthcare professionals require stronger efforts. WHAT DOES THE FUTURE LOOK LIKE? With the support of health policy and with the utilisation of scientific evidence, the transfer of shared decision making into practice is considered to be meaningful in the German healthcare system. The translation into routine care will remain an important task for the future.

Blood glucose testing and primary prevention of diabetes mellitus type 2--evaluation of the effect of evidence based patient information.

BACKGROUND: Evidence-based patient information (EBPI) has been recognised as important tool for informed choice in particular in the matter of preventive options. An objective, on the best scientific evidence-based consumer information about subthreshold elevated blood glucose levels (impaired fasting glucose and impaired glucose tolerance) and primary prevention of diabetes, is not available yet. Thus we developed a web-based EBPI and aim to evaluate its effects on informed decision making in people 50 years or older. METHODS/DESIGN: We conduct a web-based randomised-controlled trial to evaluate the effect of information about elevated blood glucose levels and diabetes primary prevention on five specific outcomes: (i) knowledge of elevated blood glucose level-related issues (primary outcome); (ii) attitudes to a metabolic testing; (iii) intention to undergo a metabolic testing; (iv) decision conflict; (v) satisfaction with the information. The intervention group receives a specially developed EBPI about subthreshold elevated blood glucose levels and diabetes primary prevention, the control group information about this topic, available in the internet.The study population consists of people between 50 and 69 years of age without known diabetes. Participants will be recruited via the internet page of the cooperating health insurance company, Techniker Krankenkasse (TK), and the internet page of the German Diabetes Centre. Outcomes will be measured through online questionnaires. We expect better informed participants in the intervention group. DISCUSSION: The design of this study may be a prototype for other web-based prevention information and their evaluation. TRIAL REGISTRATION: Current Controlled Trial: ISRCTN22060616.