Jürgen in der Schmitten

Implementing an Advance Care Planning Program in German Nursing Homes: Results of an Inter-Regionally Controlled Intervention Trial

BACKGROUND Advance Care Planning (ACP) is a systematic approach to ensure that effective advance directives (ADs) are developed and respected. We studied the effects of implementing a regional ACP program in Germany. METHODS In a prospective, inter-regionally controlled trial focusing on nursing homes (n/hs), we compared the number, relevance and validity of new ADs completed in the intervention region versus the control region. Intervention n/h residents and their families were offered professional facilitation including standardized documentation. RESULTS Data from 136 residents of three intervention n/hs were compared with data from 439 residents of 10 control n/hs over a study period of 16.5 months. In the intervention region, 49 (36.0%) participating residents completed a new AD over the period of the study, compared to 18 (4.1%) in the control region; these ADs included 30 ADs by proxy in the intervention region versus 10 in the control region. Proxies were designated in 94.7% versus 50.0% of cases, the AD was signed by a physician in 93.9% versus 16.7%, and an emergency order was included in 98.0% versus 44.4%. Resuscitation status was addressed in 95.9% versus 38.9% of cases (p<0.01 for all of the differences mentioned above). In the intervention region, new ADs were preceded by an average of 2.5 facilitated conversations (range, 2–5) with a mean total duration of 100 minutes (range, 60–240 minutes). CONCLUSION The implementation of an ACP program in German nursing homes led, much more frequently than previously reported, to the creation of advance directives with potential relevance to medical decision-making. Future research should assess the effect of such programs on clinical and structural outcomes.

Does facilitated Advance Care Planning reduce the costs of care near the end of life? Systematic review and ethical considerations

Background: While there is increasing evidence that Advance Care Planning has the potential to strengthen patient autonomy and improve quality of care near the end of life, it remains unclear whether it could also reduce net costs of care. Aim: This study aims to describe the cost implications of Advance Care Planning programmes and discusses ethical conflicts arising in this context. Design: We conducted a systematic review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Data sources: We systematically searched the databases PubMed, NHS EED, EURONHEED, Cochrane Library and EconLit. We included empirical studies (no limitation to study type) that investigated the cost implications of Advance Care Planning programmes involving professionally facilitated end-of-life discussions. Results and discussion: Seven studies met our inclusion criteria. Four of them used a randomised controlled design, one used a before-after design and two were observational studies. Six studies found reductions in costs of care ranging from USD1041 to USD64,827 per patient, depending on the study period and the cost measurement. One study detected no differences in costs. Studies varied considerably regarding the Advance Care Planning intervention, patient selection and costs measured which may explain some of the variations in findings. Normative appraisal: Looking at the impact of Advance Care Planning on costs raises delicate ethical issues. Given the increasing pressure to reduce expenditures, there may be concerns that cost considerations could unduly influence the sensitive communication process, thus jeopardising patient autonomy. Safeguards are proposed to reduce these risks. Conclusion: The limited data indicate net cost savings may be realised with Advance Care Planning. Methodologically robust trials with clearly defined Advance Care Planning interventions are needed to make the costs and returns of Advance Care Planning transparent.

Advance directives in nursing homes: prevalence, validity, significance, and nursing staff adherence.

BACKGROUND The German Advance Directives Act of 2009 confirms that advance directives (ADs) are binding. Little is known, however, about their prevalence in nursing homes, their quality, and whether they are honored. METHODS In 2007, we carried out a cross-sectional survey in all 11 nursing homes of a German city in the state of North Rhine-Westphalia (total nursing home population, 1089 residents). The ADs were formally analyzed and assessed by 3 raters with respect to 5 clinical decision-making scenarios. The specifications of the ADs were compared with what the nurses reported that they would do in each scenario. RESULTS 11% of the nursing home residents had a personal AD, and a further 1.4% an AD by proxy. 52% of the 119 ADs that we analyzed contained no documentation of the patients decision-making capacity and/or voluntariness, and only 3% contained documentation of a medical consultation. Most ADs failed to state what should be done in case the patient acutely became incapable of consenting to treatment (inter-rater agreement [IRA] >83%). For the case of permanent decisional incapacity, many ADs contained ambiguous information (IRA<43%). 23 directives stated that the patient should not have cardiopulmonary resuscitation in case an arrest occurred in the patients current clinical condition, but the nurses reported a corresponding do-not-resuscitate agreement for only 9 of these 23 patients. CONCLUSION In 2007, ADs were rare in these German nursing homes, and most of the existing ones were invalid, of little meaning, and/or disregarded by the nursing staff. There is little reason to believe that the Advance Directives Act of 2009 will bring about any major change in this miserable status quo. Advance care planning, a system-oriented concept still uncommon in Germany, could give new impulses to promote a cultural change in this respect.

A complex regional intervention to implement advance care planning in one town's nursing homes: Protocol of a controlled inter-regional study

AbstractBackgroundAdvance Care Planning (ACP) is an emerging strategy to ensure that well-reflected, meaningful and clearly documented treatment preferences are available and respected when critical decisions about life-sustaining treatment need to be made for patients unable to consent. In Germany, recent legislation confirms that advance directives (AD) have to be followed if they apply to the medical situation, but implementation of ACP has not yet been described.Methods/DesignIn a longitudinal controlled study, we compare 1 intervention region (4 nursing homes [n/hs], altogether 421 residents) with 2 control regions (10 n/hs, altogether 985 residents). Inclusion went from 01.02.09 to 30.06.09, observation lasted until 30.06.10. Primary endpoint is the prevalence of ADs at follow-up, 17 (12) months after the first (last) possible inclusion. Secondary endpoints compare relevance and validity of ADs, process quality, the rate of life-sustaining interventions and, in deceased residents, location of death and intensity of treatment before death. The regional multifaceted intervention on the basis of the US program Respecting Choices® comprises training of n/h staff as facilitators, training of General Practitioners, education of hospital and ambulance staff, and development of eligible tools, including Physician Orders for Life-Sustaining Treatment in case of Emergency (POLST-E). Participation data: Of 1406 residents reported to live in the 14 n/hs plus an estimated turnover of 176 residents until the last possible inclusion date, 645 (41%) were willing to participate. Response rates were 38% in the intervention region and 42% in the control region. Non-responder analysis shows an equal distribution of sex and age but a bias towards dependency on nursing care in the responder group. Outcome analysis of this study will become available in the course of 2011.DiscussionImplementing an ACP program for the n/hs and related health care providers of a region requires a complex community intervention with the effect of nothing less than a cultural shift in this health care sector. This study is to our knowledge the first to develop a strategy for regional implementation of ACP, and to evaluate its feasibility in a controlled design.Trial RegistrationISRCTN: ISRCTN99887420

Fluoroquinolones to treat uncomplicated acute cough in primary care: predictors for unjustified prescribing of antibiotics

BACKGROUND Despite efforts to ensure more accurate prescribing of antibiotics for respiratory tract infections, inappropriate selection of antibiotic treatment remains a big issue. We tried to ascertain which factors best predict the nature of fluoroquinolone prescribing for acute cough in primary care. METHODS Random effects logistic regression models were applied to the baseline prescription data taken from a cluster-randomized controlled trial based on 104 general practitioners (GPs) and 2745 patients. RESULTS Significant predictors for the prescription of fluoroquinolones from both patient and GP data were identified. Predictors from a patients perspective were the severity of illness {odds ratio (OR) 3.56 [95% confidence interval (CI) 2.45-5.19] P < 0.001}, the duration of illness before seeing the GP [OR 1.09 (95% CI 1.04-1.14) P < 0.020] and the individual patients age [OR 1.01 (95% CI 1.00-1.01) P < 0.015]. Predictors from the GPs perspective were extent/lack of specific vocational training [OR 3.10 (95% CI 1.54-6.22) P < 0.001], status as a general internist [OR 2.00 (95% CI 1.10-3.70) P < 0.002], the physicians overall antibiotic prescription rate for acute cough [OR 1.02 (95% CI 1.01-1.04) P < 0.001], the duration of illness before contact with patient [OR 0.81 (95% CI 0.69-0.95) P < 0.010] and the severity of illness [OR 0.27 (95% CI 0.12-0.63) P < 0.002]. DISCUSSION Whether a fluoroquinolone is prescribed by a GP seems to be determined not only by the patients characteristics but also by the GPs vocational training and overall antibiotic prescribing rate. As the prescription of fluoroquinolones for the treatment of acute coughing can rarely be justified, such prescriptions may serve as a quality indicator for antibiotic prescribing in primary care.

Implementation of palliative care as a mandatory cross-disciplinary subject (QB13) at the Medical Faculty of the Heinrich-Heine-University Düsseldorf, Germany.

Background: By means of the revision of the Medical Licensure Act for Physicians (ÄAppO) in 2009, undergraduate palliative care education (UPCE) was incorporated as a mandatory cross sectional examination subject (QB13) in medical education in Germany. Its implementation still constitutes a major challenge for German medical faculties. There is a discrepancy between limited university resources and limited patient availabilities and high numbers of medical students. Apart from teaching theoretical knowledge and skills, palliative care education is faced with the particular challenge of imparting a professional and adequate attitude towards incurably ill and dying patients and their relatives. Project description: Against this background, an evidence-based longitudinal UPCE curriculum was systematically developed following Kern’s Cycle [1] and partly implemented and evaluated by the students participating in the pilot project. Innovative teaching methods (virtual standardised/simulated patient contacts, e-learning courses, interdisciplinary and interprofessional collaborative teaching, and group sessions for reflective self-development) aim at teaching palliative care-related core competencies within the clinical context and on an interdisciplinary and interprofessional basis. Results: After almost five years of development and evaluation, the UPCE curriculum comprises 60 teaching units and is being fully implemented and taught for the first time in the winter semester 2014/15. The previous pilot phases were successfully concluded. To date, the pilot phases (n=26), the subproject “E-learning in palliative care” (n=518) and the blended-learning elective course “Communication with dying patients” (n=12) have been successfully evaluated. Conclusion: All conducted development steps and all developed programmes are available for other palliative care educators (Open Access). The integrated teaching formats and methods (video, e-learning module, interprofessional education, group sessions for reflexive self-development) and their evaluations are intended to make a contribution to an evidence-based development of palliative care curricula in Germany.

Summative assessment of undergraduates' communication competence in challenging doctor-patient encounters. Evaluation of the Dusseldorf CoMeD-OSCE

OBJECTIVE To evaluate the summative assessment (OSCE) of a communication training programme for dealing with challenging doctor-patient encounters in the 4th study year. METHODS Our OSCE consists of 4 stations (breaking bad news, guilt and shame, aggressive patients, shared decision making), using a 4-item global rating (GR) instrument. We calculated reliability coefficients for different levels, discriminability of single items and interrater reliability. Validity was estimated by gender differences and accordance between GR and a checklist. RESULTS In a pooled sample of 456 students in 3 OSCEs over 3 terms, total reliability was α=0.64, reliability coefficients for single stations were >0.80, and discriminability in 3 of 4 stations was within the range of 0.4-0.7. Except for one station, interrater reliability was moderate to strong. Reliability on item level was poor and pointed to some problems with the use of the GR. CONCLUSION The application of the GR on regular undergraduate medical education shows moderate reliability in need of improvement and some traits of validity. Ongoing development and evaluation is needed with particular regard to the training of the examiners. PRACTICE IMPLICATIONS Our CoMeD-OSCE proved suitable for the summative assessment of communication skills in challenging doctor-patient encounters.

Management of low back pain in general practice – is it of acceptable quality: an observational study among 25 general practices in South Tyrol (Italy)

BackgroundThere are several guidelines dealing with the management of low back pain (LBP), but only few studies on the quality of care provided within General Practices as judged against those guidelines.The objective of this study is to analyse the management of LBP in Italian General Practice and compare it with guideline recommendations.MethodsIn this observational study, all patients visiting their General Practitioners (GPs) for treatment of LBP within a 8-week period were monitored for at least four weeks with regard to symptoms and diagnostic and therapeutic interventions. Management of LBP was judged by pre-defined quality indicators based on guideline recommendations.ResultsTwenty-five of 114 eligible GPs participated in the study, representing a total of 43,012 registered patients. Of the 475 patients complaining of LBP and monitored for four weeks, 55.8% were diagnosed as having acute lumbar pain, 13.5% chronic lumbar pain, 17.1% acute sciatica, and 12.6% chronic sciatica; 76.0% underwent no technical investigations, 21.7% underwent x-rays, 5.5% MRI and 4% CT scans; 20.4% were referred to secondary care; 93.3% of all patients received some medication. In those receiving a medication, in 88.3% it was an NSAID, in 6.3% Paracetamol, in 10.4% Paracetamol combined with Codeine, and in 9% a muscle relaxants. When physiotherapy was prescribed (17,1%), it was mostly massage. Hardly more than 50% of GPs (partially) followed locally established guidelines, while the remainder seemed not to follow guidelines at all.ConclusionsOur study reveals gross deviations of GP management of LBP from current guidelines and points to two different types of deviators: those who partially follow guidelines, and those who do not follow them at all. Further research should evaluate whether these two types of deviation are best addressed by different foci of education, i.e. on knowledge versus attitudes, respectively.

CRISTOPH - A cluster-randomised intervention study to optimise the treatment of patients with hypertension in General Practice

BackgroundRecent guidelines for the management of hypertension focus on treating patients according to their global cardiovascular risk (CVR), rather than strictly keeping blood pressure, or other risk factors, below set limit values. The objective of this study is to compare the effect of a simple versus a complex educational intervention implementing this new concept among General Practitioners (GPs).Methods/designA prospective longitudinal cluster-randomised intervention trial with 94 German GPs consecutively enroling 40 patients each with known hypertension. All GPs then received a written manual specifically developed to transfer the global concept of CVR into daily General Practice. After cluster-randomisation, half of the GPs additionally received a clinical outreach visit, with a trained peer discussing with them the concept of global CVR referring to example study patients from the respective GP. Main outcome measure is the improvement of calculated CVR six months after intervention in the subgroup of patients with high CVR (but no history of cardiovascular disease), defined as 10-year-mortality ≥ 5% employing the European SCORE formula. Secondary outcome measures include the interventions effect on single risk factors, and on prescription rates of drugs targeting CVR. All outcome measures are separately studied in the three subgroups of patients with 1. high CVR (defined as above), 2. low CVR (SCORE < 5%), and 3. a history of cardiovascular disease. The influence of age, sex, social status, and the perceived quality of the respective doctor-patient-relation on the effects will be examined.DiscussionTo our knowledge, no other published intervention study has yet evaluated the impact of educating GPs with the goal to treat patients with hypertension according to their global cardiovascular risk.Trial registrationISRCTN44478543

Advance care planning: putting an end to the agonizing perpetuation of a pointless debate.

the years 2008–2010. The German law on ADs, however, involves no incentive or even recommendation for individuals to draw up an AD, or for health care providers to encourage and support anyone doing so. Considering the disappointing experience with the – at the time much more ambitious – US Patient Self Determination Act of 1991 [5], it seems little realistic to expect a major effect of the law on the prevalence of ADs beyond what Hubert et al. have found already, or even that this moderate effect will be sustained. Moreover, this survey confirms a gap between patients’ expectations towards physicians and physicians’ factual support with regard to ADs already known from other studies: Of the patients with an AD, less than 10% drew it up following physician advice, 26% desired more information, and only 1 of 4 ADs was written with the assistance of a physician. Of the patients without an AD, only 1 in 10 indicated that they were not interested in doing so, whereas more than 2 in 3 desired more information. Of all 377 patients whose physician had not addressed the topic, 52% wanted their physician to do so. In their discussion, the authors conclude that ‘further investigations are required to identify and remedy the discrepancy’ between patient expectations on the one hand and factual physician support on the other. But, frankly speaking, is there any realistic prospect that after 4 decades of research and circular debate on ADs more of the same is likely to ‘remedy the discrepancy’ between what we wish ADs to achieve, and what they actually do? After all, the data of Hubert and colleagues point only to the tip of an iceberg. Since ADs are often not at hand when needed, the true availability of ADs in this sample is likely to be lower than the self-reported 1 in 3. Furthermore, physician-assisted advance planning is rare, so it remains unclear in how far the ADs represent an informed refusal. In addition, most of such ADs have shown to be forms [6] that in Germany often remain fairly vague, and do not help to guide clinically relevant treatment decisions. Moreover, in the absence of forms specifically designed for emergencies (i.e., physician’s orders for life-sustaining treatment, POLST), poorly informed relatives or professional carers as well as emergency staff are likely to Advance Directives (ADs) or living wills were first proposed in 1969 by a lawyer [1], appreciating the uncertain outcome and possible devastating burden and sequelae of potentially life-prolonging treatments initiated in patients incapable of consenting at that moment, and the necessity to offer individuals advance involvement in the hypothetical decision whether and under which circumstances to initiate, withhold, or withdraw such treatments. Since then, ADs have been subject of constant debate. Countless papers have pointed out that ADs (the way they are traditionally conceived) have numerous theoretical flaws, and constitute an empirical failure. In the US, legislation of 1991 strengthened the role of ADs and directed public resources to advance their distribution, but the results were disappointing. Summing up the overwhelming evidence failing to support traditional ADs, ethicists have declared ‘the failure of the living will’ and consequently suggested to abandon the concept of ADs altogether [2]. The debate, however, runs in a circle. Our perplexity facing decisions to withhold or withdraw life-sustaining treatments in incompetent patients has grown, not diminished since 1969. As a secular, pluralistic society we seem to be committed to an ‘imperative of the feasible’, principally prepared to provide every treatment not literally futile to every incapable patient, almost regardless of age, state, and prognosis – despite the empirical fact that many patients would have opted otherwise had we given them the choice [3]. As flawed as ADs may be, no better means of allowing patients to opt out of the maximal treatment default have been suggested, therefore they remain in the debate. This has to be borne in mind when appreciating the study by Hubert and colleagues presented in this issue [4]. In a selfdesigned questionnaire survey, a remarkable 81.5% of the invited 617 patients of a German university hospital’s oncologic outpatient department answered questions relating to ADs. 31% stated to have a written AD, an increase compared with earlier surveys among comparable populations which the authors attribute to the German legislation on ADs of 2009 and/or the related extraordinary media coverage on ADs inthe years 2008–2010. The German law on ADs, however, involves no incentive or even recommendation for individuals to draw up an AD, or for health care providers to encourage and support anyone doing so. Considering the disappointing experience with the – at the time much more ambitious – US Patient Self Determination Act of 1991 [5], it seems little realistic to expect a major effect of the law on the prevalence of ADs beyond what Hubert et al. have found already, or even that this moderate effect will be sustained. Moreover, this survey confirms a gap between patients’ expectations towards physicians and physicians’ factual support with regard to ADs already known from other studies: Of the patients with an AD, less than 10% drew it up following physician advice, 26% desired more information, and only 1 of 4 ADs was written with the assistance of a physician. Of the patients without an AD, only 1 in 10 indicated that they were not interested in doing so, whereas more than 2 in 3 desired more information. Of all 377 patients whose physician had not addressed the topic, 52% wanted their physician to do so. In their discussion, the authors conclude that ‘further investigations are required to identify and remedy the discrepancy’ between patient expectations on the one hand and factual physician support on the other. But, frankly speaking, is there any realistic prospect that after 4 decades of research and circular debate on ADs more of the same is likely to ‘remedy the discrepancy’ between what we wish ADs to achieve, and what they actually do? After all, the data of Hubert and colleagues point only to the tip of an iceberg. Since ADs are often not at hand when needed, the true availability of ADs in this sample is likely to be lower than the self-reported 1 in 3. Furthermore, physician-assisted advance planning is rare, so it remains unclear in how far the ADs represent an informed refusal. In addition, most of such ADs have shown to be forms [6] that in Germany often remain fairly vague, and do not help to guide clinically relevant treatment decisions. Moreover, in the absence of forms specifically designed for emergencies (i.e., physician’s orders for life-sustaining treatment, POLST), poorly informed relatives or professional carers as well as emergency staff are likely to Advance Directives (ADs) or living wills were first proposed in 1969 by a lawyer [1], appreciating the uncertain outcome and possible devastating burden and sequelae of potentially life-prolonging treatments initiated in patients incapable of consenting at that moment, and the necessity to offer individuals advance involvement in the hypothetical decision whether and under which circumstances to initiate, withhold, or withdraw such treatments. Since then, ADs have been subject of constant debate. Countless papers have pointed out that ADs (the way they are traditionally conceived) have numerous theoretical flaws, and constitute an empirical failure. In the US, legislation of 1991 strengthened the role of ADs and directed public resources to advance their distribution, but the results were disappointing. Summing up the overwhelming evidence failing to support traditional ADs, ethicists have declared ‘the failure of the living will’ and consequently suggested to abandon the concept of ADs altogether [2]. The debate, however, runs in a circle. Our perplexity facing decisions to withhold or withdraw life-sustaining treatments in incompetent patients has grown, not diminished since 1969. As a secular, pluralistic society we seem to be committed to an ‘imperative of the feasible’, principally prepared to provide every treatment not literally futile to every incapable patient, almost regardless of age, state, and prognosis – despite the empirical fact that many patients would have opted otherwise had we given them the choice [3]. As flawed as ADs may be, no better means of allowing patients to opt out of the maximal treatment default have been suggested, therefore they remain in the debate. This has to be borne in mind when appreciating the study by Hubert and colleagues presented in this issue [4]. In a selfdesigned questionnaire survey, a remarkable 81.5% of the invited 617 patients of a German university hospital’s oncologic outpatient department answered questions relating to ADs. 31% stated to have a written AD, an increase compared with earlier surveys among comparable populations which the authors attribute to the German legislation on ADs of 2009 and/or the related extraordinary media coverage on ADs in