The role of qualification and quality management in the prescription of antipsychotics and potentially inappropriate medication (PIM) in nursing home residents in Germany: results of the HIOPP-3-iTBX study.

BACKGROUND: Nursing home residents (NHR) show high rates of polypharmacy. The HIOPP-3-iTBX study is the first cRCT on medication optimization in nursing homes (NH) in Germany. The intervention did not result in a reduction of PIM and/or antipsychotics. This analysis looks at structure quality in the HIOPP-3-iTBX study participants. AIMS: Evaluation of structure quality as part of a cluster-randomized controlled intervention study. METHODS: Structure quality in multiprofessional teams from n = 44 NH (n = 44 NH directors, n = 91 family doctors (FD), and n = 52 pharmacies with n = 62 pharmacists) was assessed using self-designed questionnaires at baseline. Main aspects of the questionnaires related to the qualification of participants, quality management, the medication process and size of the facilities. All completed questionnaires were included. number of PIM/antipsychotics was drawn from the baseline medication analysis in 692 NHR. Data were analyzed by descriptive statistics and mixed model logistic regression. RESULTS: The presence of a nurse with one of the additional qualifications pain nurse or Zertifiziertes Curriculum (Zercur) Geriatrie in the participating NH was associated with a lower risk for the prescription of PIM/antipsychotics. No association between any characteristic in the other participants at baseline was observed. CONCLUSIONS AND DISCUSSION: The results support the known role of nursing qualification in the quality and safety of care. Further studies need to look more closely at how use is made of the additional qualifications within the multiprofessional teams. Perspectively, the results can contribute to the development of quality standards in NH in Germany.

Generic instruments for drug discontinuation in primary care: A systematic review.

AIMS: The aim of this systematic review was to identify generic instruments for drug discontinuation in patients with polypharmacy in the primary care setting. METHODS: We systematically searched PubMed and EMBASE, 8 guideline databases (AWMF, NICE, NGC, SIGN, NHMRC, CPG, KCE), the Cochrane Library and grey literature (Google) in 2016 and 2017. Two independent researchers screened and analysed data. The drug discontinuation instruments of the included publications were described and classified. RESULTS: We identified 16 relevant publications. Here we found complex algorithms as well as instruments composed of distinct sequential steps. Two guidelines are constructed as electronic web-applications. Instruments revealed diverging emphases on the stages of deprescribing, i.e. preparation, drug evaluation, decision-making and implementation. Accordingly, 3 types of instruments emerged: general frameworks, detailed drug assessment tools and comprehensive discontinuation guidelines. CONCLUSION: Diverse generic instruments exist for different areas of applications in regard to drug discontinuation. However, there is still a need for practical and user-friendly tools that support physicians in communicational aspects, visualise trade-offs and also enhance patient involvement.

European Collaborative and Interprofessional Capability Framework for Prevention and Management of Frailty-a consensus process supported by the Joint Action for Frailty Prevention (ADVANTAGE) and the European Geriatric Medicine Society (EuGMS).

BACKGROUND: Interprofessional collaborative practice (ICP) is currently recommended for the delivery of high-quality integrated care for older people. Frailty prevention and management are key elements to be tackled on a multi-professional level. AIM: This study aims to develop a consensus-based European multi-professional capability framework for frailty prevention and management. METHODS: Using a modified Delphi technique, a consensus-based framework of knowledge, skills and attitudes for all professions involved in the care pathway of older people was developed within two consultation rounds. The template for the process was derived from competency frameworks collected in a comprehensive approach from EU-funded projects of the European Commission (EC) supported best practice models for health workforce development. RESULTS: The agreed framework consists of 25 items structured in 4 domains of capabilities. Content covers the understanding about frailty, skills for screening and assessment as well as management procedures for every profession involved. The majority of items focused on interprofessional collaboration, communication and person-centred care planning. DISCUSSION: This framework facilitates clarification of professionals' roles and standardizes procedures for cross-sectional care processes. Despite a lack of evidence for educational interventions, health workforce development remains an important aspect of quality assurance in health care systems. CONCLUSIONS: The multi-professional capability framework for frailty prevention and management incorporated interprofessional collaborative practice, consistent with current recommendations by the World Health Organization, Science Advice for Policy by European Academies and the European Commission.

Professional roles of general practitioners, community pharmacists and specialist providers in collaborative medication deprescribing - a qualitative study.

BACKGROUND: Collaborative care approaches between general practitioners (GPs) and pharmacists have received international recognition for medication optimization and deprescribing efforts. Although specialist providers have been shown to influence deprescribing, their profession so far remains omitted from collaborative care approaches for medication optimization. Similarly, while explorative studies on role perception and collaboration between GPs and pharmacists grow, interaction with specialists for medication optimization is neglected. Our qualitative study therefore aims to explore GPs', community pharmacists' and specialist providers' role perceptions of deprescribing, and to identify interpersonal as well as structural factors that may influence collaborative medication optimization approaches. METHOD: Seven focus-group discussions with GPs, community pharmacists and community specialists were conducted in Hesse and Lower Saxony, Germany. The topic guide focused on views and experiences with deprescribing with special attention to inter-professional collaboration. We conducted conventional content analysis and conceptualized emerging themes using the Theoretical Domains Framework. RESULTS: Twenty-six GPs, four community pharmacists and three community specialists took part in the study. The main themes corresponded to the four domains 'Social/professional role and identity' (1), 'Social influences' (2), 'Reinforcement' (3) and ´Environmental context and resources' (4) which were further described by beliefs statements, that is inductively developed key messages. For (1), GPs emerged as central medication managers while pharmacists and specialists were assigned confined or subordinated tasks in deprescribing. Social influences (2) encompassed patients' trust in GPs as a support, while specialists and pharmacists were believed to threaten GPs' role and deprescribing attempts. Reinforcements (3) negatively affected GPs' and pharmacists' effort in medication optimization by social reprimand and lacking reward. Environmental context (4) impeded deprescribing efforts by deficient reimbursement and resources as well as fragmentation of care, while informational and gate-keeping resources remained underutilized. CONCLUSION: Understanding stakeholders' role perceptions on collaborative deprescribing is a prerequisite for joint approaches to medication management. We found that clear definition and dissemination of roles and responsibilities are premise for avoiding intergroup conflicts. Role performance and collaboration must further be supported by structural factors like adequate reimbursement, resources and a transparent continuity of care.

Post-discharge adjustment of medication in geriatric patients : A prospective cohort study.

BACKGROUND: Little is known to what extent general practitioners (GP) change hospital discharge medications in older patients. OBJECTIVE: This prospective cohort study aimed to analyze medication changes at the interface between hospital and community in terms of quality, quantity and type of drugs. METHODS: A total of 121 out of 248 consecutively enrolled patients admitted to an acute geriatric hospital unit participated in the study. Medication regimens were recorded at admission and discharge and 4 weeks after hospital discharge the general practitioners in charge were contacted to provide the current medication charts. Changes in the extent of polypharmacy, in the type of drugs using anatomical therapeutic chemical classification (ATC) codes and potentially inappropriate medications (PIM) were analyzed. RESULTS: Medication charts could be obtained for 98 participants in primary care. Only 21% of these patients remained on the original discharge medication. Overall, the average number of medications rose from hospital admission (6.58 SD ± 3.45) to discharge (6.96 SD ± 3.49) and again post-discharge in general practice (7.22 SD ± 3.68). The rates of patients on excessive polypharmacy (≥10 drugs) and on PIM were only temporarily reduced during hospital stay. The GPs stopped anti-infective drugs (ATC-J) and prescribed more antirheumatic drugs (ATC-M). Although no significant net changes occurred in other ATC groups, a substantial number of drugs were interchanged regarding the subgroups. CONCLUSION: The study found that GPs extensively adjusted geriatric discharge medications. Whereas some changes may be necessary due to alterations in patients' state of health, a thorough communication between hospital doctors and GPs may level off different prescribing cultures and contribute to consistency in medication across sectors.

How older patients prioritise their multiple health problems: a qualitative study.

BACKGROUND: Patients with multimorbidity often receive diverse treatments; they are subjected to polypharmacy and to a high treatment burden. Hence it is advocated that doctors set individual health and treatment priorities with their patients. In order to apply such a concept, doctors will need a good understanding of what causes patients to prioritise some of their problems over others. This qualitative study explores what underlying reasons patients have when they appraise their health problems as more or less important. METHODS: We undertook semi-structured interviews with a purposive sample of 34 patients (aged 70 years and over) in German general practices. Initially, patients received a comprehensive geriatric assessment, on the basis of which they rated the importance of their uncovered health problems. Subsequently, they were interviewed as to why they considered some of their problems important and others not. Transcripts were analysed using qualitative content analysis. RESULTS: Patients considered their health problems important, if they were severe, constant, uncontrolled, risky or if they restricted daily activities, autonomy and social inclusion. Important problems often correlated with negative feelings. Patients considered problems unimportant, if they were related to a bearable degree of suffering, less restrictions in activities, or psychological adjustment to diseases. Altogether different reasons occurred on the subject of preventive health issues. CONCLUSIONS: Patients assess health problems as important if they interfere with what they want from life (life values and goals). Psychological adjustment, by contrast, facilitates a downgrading of the importance. Asking patients with multimorbidity, which health problems are important, may guide physicians to treatment priorities and health problems in need of empowerment.

Multidisciplinary intervention to improve medication safety in nursing home residents: protocol of a cluster randomised controlled trial (HIOPP-3-iTBX study).

BACKGROUND: Medication safety is an important health issue for nursing home residents (NHR). They usually experience polypharmacy and often take potentially inappropriate medications (PIM) and antipsychotics. This, coupled with a frail health state, makes NHR particularly vulnerable to adverse drug events (ADE). The value of systematic medication reviews and interprofessional co-operation for improving medication quality in NHR has been recognized. Yet the evidence of a positive effect on NHR' health and wellbeing is inconclusive at this stage. This study investigates the effects of pharmacists' medication reviews linked with measures to strengthen interprofessional co-operation on NHR' medication quality, health status and health care use. METHODS: Pragmatic cluster randomised controlled trial in nursing homes in four regions of Germany. A total of 760 NHR will be recruited. Inclusion: NHR aged 65 years and over with an estimated life expectancy of at least six months. Intervention with four elements: i) introduction of a pharmacist's medication review combined with a communication pathway to the prescribing general practitioners (GPs) and nursing home staff, ii) facilitation of change in the interprofessional cooperation, iii) educational training and iv) a "toolbox" to facilitate implementation in daily practice. ANALYSIS: primary outcome - proportion of residents receiving PIM and ≥ 2 antipsychotics at six months follow-up. Secondary outcomes - cognitive function, falls, quality of life, medical emergency contacts, hospital admissions, and health care costs. DISCUSSION: The trial assesses the effects of a structured interprofessional medication management for NHR in Germany. It follows the participatory action research approach and closely involves the three professional groups (nursing staff, GPs, pharmacists) engaged in the medication management. A handbook based on the experiences of the trial in nursing homes will be produced for a rollout into routine practice in Germany. TRIAL REGISTRATION: Registered in the German register of clinical studies (DRKS, study ID DRKS00013588 , primary register) and in the WHO International Clinical Trials Registry Platform (secondary register), both on 25th January 2018.

A geriatric assessment in general practice: prevalence, location, impact and doctor-patient perceptions of pain.

BACKGROUND: To investigate what a geriatric assessment in general practice adds towards previous findings of prevalence, location, impact and the dyadic doctor-patient perception of pain in this age group. METHODS: Cross-sectional study. Consecutive patients aged 70 and over underwent a comprehensive geriatric assessment in general practice that included a basic pain assessment (severity, sites and impact). Patients with pain and their doctors then independently rated its importance. Pain was correlated with further findings from the assessment, such as overall health, physical impairments, everyday function, falls, mood, health related lifestyle, social circumstances, using bivariate and multivariate statistics. Patient-doctor agreement on the importance of pain was calculated using kappa statistics. RESULTS: 219 out of 297 patients (73.7 %) reported pain at any location. Pain was generally located at multiple sites. It was most often present at the knee (33.9%), the lumbar spine (33.5%) as well as the hip (13.8%) and correlated with specific impairments such as restrictions of daily living (knee) or sleep problems (spine). Patients with pain and their physicians poorly agreed on the importance of the pain problem. CONCLUSIONS: A basic pain assessment can identify older patients with pain in general practice. It has resulted in a high prevalence exceeding that determined by encounters in consultations. It has been shown that a geriatric assessment provides an opportunity to address pain in a way that is adapted to older patients' needs - addressing all sites, its specific impact on life, and the patients' perceived importance of pain. Since there is little doctor-patient agreement, this seems a valuable strategy to optimize concrete treatment decisions and patient centered care. TRIAL REGISTRATION: This study is registered in the German Clinical Trial Register ( DRKS00000792 ).

[Patients' need for consultation after a geriatric assessment in family practice : Survey]. / Patientenseitiger Gesprächsbedarf nach einem geriatrischen Assessment in Hausarztpraxen : Survey.

BACKGROUND: During a doctor-patient consultation patients usually seek information by disclosing their reasons for requesting the encounter. Geriatric assessment allows a proactive examination of patients' overall health and function and provides an opportunity to broach issues beyond the initial purposes of the consultation. OBJECTIVES: The study aimed at investigating older patients' information seeking behavior following a geriatric assessment and the kind of topics they wished to discuss, taking a variety of patient and health-related factors into account. MATERIAL AND METHODS: A total of 317 patients (≥ 70 years) underwent a geriatric assessment in 40 general practices. Subsequently they obtained a list of the problems uncovered and rated the relevance and information needs for each problem. Analyses consisted of determining the prevalence of information need for each health topic and identifying predictors in a mixed model (multilevel regression analysis). RESULTS: The 317 patients presented with a median of 11 health problems (interquartile range, IQR 8-14) and 80 % of the patients had information needs concerning only a few of the problems. High information needs were present for physical complaints and for vaccination issues. Little information seeking behavior was evident for unhealthy lifestyles, falls, limitations in daily activities and psychosocial problems. In the mixed model the personal relevance and the type of health problem both had a significant and independent effect on information seeking behavior. CONCLUSION: A geriatric assessment generates a moderate need for information. It provides physicians with an opportunity to focus on those health problems that are important to older patients but not usually addressed in normal consultations. This particularly applies to limitations in daily activities and psychosocial problems.

"It's MAGIC"--development of a manageable geriatric assessment for general practice use.

BACKGROUND: Geriatric assessments are established tools in institutional care since they enable standardized detection of relevant age-related disorders. Geriatric assessments could also be helpful in general practice. However, they are infrequently used in this setting, mainly due to their lengthy administration. The aim of the study was the development of a "manageable geriatric assessment--MAGIC", specially tailored to the requirements of daily primary care. METHODS: MAGIC was developed based on the comprehensive Standardized Assessment for Elderly People in Primary Care (STEP), using four different methodological approaches: We relied on A) the results of the PRISCUS study by assessing the prevalence of health problems uncovered by STEP, the importance of the respective problems rated by patients and general practitioners, as well as the treatment procedures initiated subsequently to the assessment. Moreover, we included findings of B) a literature analysis C) a review of the STEP assessment by experienced general practitioners and D) focus groups with general practitioners. RESULTS: The newly created MAGIC assessment consists of 9 items and covers typical geriatric health problems and syndromes: function, falls, incontinence, cognitive impairment, impaired ears and eyes, vaccine coverage, emotional instability and isolation. CONCLUSIONS: MAGIC promises to be a helpful screening instrument in primary care consultations involving elderly multimorbid patients. Applicable within a minimum of time it still covers health problems highly relevant with regard to a potential loss of autonomy. Feasibility will be tested in the context of a large, still ongoing randomized controlled trial on "reduction of potentially inadequate medication in elderly patients" (RIME study; DRKS-ID: DRKS00003610) in general practice.

Impact of a priority-setting consultation on doctor-patient agreement after a geriatric assessment: cluster randomised controlled trial in German general practices.

BACKGROUND: General Practitioners (GPs) often have to simultaneously tackle multiple health problems of older patients. A patient-centred process that engages the patient in setting health priorities for treatment is needed. We investigated whether a structured priority-setting consultation reconciles the often-differing doctor-patient views on the importance of problems. DESIGN: Cluster randomised controlled trial with 40 GPs and their 317 consecutively recruited older patients. PROCEDURE: Following a geriatric assessment, patients and doctors independently rated the importance of each uncovered problem. GPs then selected priorities with their patients in a consultation. Trained intervention GPs held a structured consultation and utilised the list of uncovered patient problems with their importance ratings to agree priorities. Untrained control GPs only used the patient's problem list without importance ratings. MAIN OUTCOME: Doctor-patient agreement on independent importance ratings two weeks after the priority-setting consultation. ANALYSIS: Weighted kappa (κw) and multilevel logistic regression model. RESULTS: Intervention GPs and their patients determined mutual priorities for 20% of individual problems. In this process, GPs often succeeded in convincing their patients of the importance of vaccinations, lifestyle and cognitive issues. Likewise, patients convinced their GPs to prioritise their social and functional problems. Further treatment plans ensued in 84% of these priority areas. The regression model adjusting for clusters and baseline characteristics did not demonstrate significant differences in doctor-patient agreement on problems between groups a two weeks later. CONCLUSION: Differing views on the importance of health problems between GPs and older patients were not sustainably reconciled. The special consultation facilitated identification of priority problems for treatment despite differences in perceived importance of problems between patients and GPs. German clinical trials register drks 00000792.

MediQuit - an electronic deprescribing tool: a pilot study in German primary care; GPs' and patients' perspectives.

BACKGROUND: General practitioners (GPs) are the central coordinators for patients with multimorbidity and polypharmacy in most health care systems. They are entrusted with the challenging task of deprescribing when inappropriate polypharmacy is present. MediQuit (MQu) is a newly developed electronic tool that guides through a deprescribing consultation. It facilitates the identification of a medicine to be discontinued (stage 1), a shared decision-making process weighing the pros and cons (stage 2), and equips patients with take-home instructions on how to discontinue the drug and monitor its impact (stage 3). We here aim to evaluate utility and acceptance of MQu from GPs' and patients' perspectives. METHODS: Uncontrolled feasibility study, in which 16 GPs from two regions in Germany were invited to use MQu in consultations with their multimorbid patients. We collected quantitative data on demography, utility and acceptance of MQu and performed descriptive statistical analyses. RESULTS: Ten GPs performed 41 consultations using MQu. Identification (step 1) and implementation elements (Step 3) were perceived most helpful by GPs. Whereas, shared-decision making elements (step 2) revealed room for improvement. Patients appreciated the use of MQu. They were broadly satisfied with the deprescribing consultation (85%) and with their decision made regarding their medication (90%). CONCLUSIONS: Implementation of MQu in general practice generally seems possible. Patients welcome consultations targeting medication optimization. GPs were satisfied with the support of MQu and likewise gave important hints for future development.

Health and treatment priorities of older patients and their general practitioners: a cross-sectional study.

BACKGROUND: General practitioners (GPs) deal with the multiple health needs of older patients. During patient encounters GPs are often only able to manage a limited number of problems and tend to focus on single diseases resulting in fragmented and overloaded care. A systematic approach that considers multiple health problems simultaneously and sets priorities for treatment is necessary. AIM: To disclose patients' and doctors' perspectives on individual health and treatment priorities. METHODS: Cross-sectional study in which 123 older patients and their 11 GPs evaluated the importance and severity of patients' individual health problems. Patients were systematically enrolled to receive a geriatric assessment. This generated a problem list on the basis of which patients and their GPs independently rated the importance and components of severity (in relation to emotional experience, hindrance in everyday life and prognosis) of each problem. The proportion of important problems and the chance corrected agreement (Cohen's Kappa) of importance between doctors and patients were assessed. Multilevel logistic regression models were used to relate the importance of a problem with its severity components - from the perspective of both the patient and the doctor. RESULTS: Patients and GPs considered about two-thirds of all disclosed health problems important (69% and 64% respectively). However, they perceived different problems as important (Kappa 0.11). Doctors and patients also related different components of severity to the importance of a problem: the strongest predictor of a problem's importance for patients was the emotional experience, whereas for doctors it was an unfavourable prognosis. CONCLUSION: Patients and doctors have different perspectives on the importance of health problems. Setting priorities for treatment necessitates an open exchange of views on what to treat.

MediQuit, an Electronic Deprescribing Tool for Patients on Polypharmacy: Results of a Feasibility Study in German General Practice.

BACKGROUND: Deprescribing is an important task for general practitioners (GPs) in the face of risky polypharmacy. The electronic tool "MediQuit" was developed to guide GPs and patients through a deprescribing consultation that entails a drug-selection phase, shared decision making, and advice on safe implementation. OBJECTIVES: A pilot study was conducted to determine the target group of patients that is selected for consultation and to assess the impact, patient involvement, and feasibility of the tool. METHODS: This was an uncontrolled pilot study. GPs from two German regions were invited to use MediQuit in consultations with a view to deprescribing one drug, if appropriate. They selected patients on the basis of broad inclusion criteria. Collected data entailed participants' characteristics, patients' medication lists, deprescribed drugs, and feasibility assessments. Patients were contacted shortly after the consultation and again after 4 weeks. RESULTS: In total, 16 GPs agreed to participate, of whom ten actually performed deprescribing consultations. They selected 41 predominately older patients on excessive polypharmacy. Deprescribing was achieved in 70% of consultations in agreement with patients. Drugs deprescribed were symptom-lowering and preventive drugs (mainly anatomical therapeutic chemical classes A and C). GPs found MediQuit useful in initiating communication on this issue and enhancing deliberations for a deprescribing decision. The median consultation length was 15 min (interquartile range 10-20). At follow-up, GPs and patients infrequently disagreed on which drug(s) was discontinued, and GPs rated patient involvement higher than did patients themselves. DISCUSSION: MediQuit assists in identifying concrete deprescribing opportunities, patient involvement, and shared decision making. The three-step deprescribing procedure is well-accepted once initial organizational efforts are overcome. After revision, further studies are needed to enhance the quality of evidence on acceptance and effectiveness.

Reduction of Potentially Inappropriate Medication in the Elderly.

BACKGROUND: Medications with an unfavorable risk-benefit profile in the elderly, and for which there are safer alternatives, are designated as potentially inappropriate medications (PIM). The RIME trial (Reduction of Potentially Inappropriate Medication in the Elderly) was based on PRISCUS, a list of PIM that was developed in 2010 for the German pharmaceuticals market. In this trial, it was studied whether special training and the PRISCUS card could lessen PIM and undesired drug-drug interactions (DDI) among elderly patients in primary care. METHODS: A three-armed, cluster-randomized, controlled trial was carried out in two regions of Germany. 137 primary care practices were randomized in equal numbers to one of two intervention groups-in which either the primary care physicians alone or the entire practice team received special training-or to a control group with general instructions about medication. The primary endpoint was the percentage of patients with at least one PIM or DDI (PIM/DDI) per practice. The primary hypothesis was that at 1 year this endpoint would be more effectively lowered in the intervention groups compared to the control group. RESULTS: Among 1138 patients regularly taking more than five drugs, 453 (39.8%) had at least one PIM/DDI at the beginning of the trial. The percent - ages of PIM/DDI at the beginning of the trial and 1 year later were 43.0% and 41.3% in the intervention groups and 37.0% and 37.6% in the control group. The estimated intervention effect of any intervention (69 practices) versus control (68 practices) was 2.3% (p = 0.36), while that of team training (35 practices) versus physician training (34 practices) was 4.3% (p = 0.22). CONCLUSION: The interventions in the RIME trial did not significantly lower the percentage of patients with PIM or DDI.

Drug Safety for Nursing-Home Residents-Findings of a Pragmatic, Cluster-Randomized, Controlled Intervention Trialin 44 Nursing Homes.

BACKGROUND: The safety of drug use by nursing-home residents can be impaired by polypharmacy, potentially inappropriate medications (PIM), and neuroleptics, as well as by a lack of adequate interprofessional coordination in the nursing home. The goal of the HIOPP-3-iTBX Trial was to improve drug safety in nursing-home residents, including a reduction of PIM and/or neu - roleptic use, by means of a complex interprofessional intervention. METHODS: This cluster-randomized, controlled trial was performed in nursing homes in Germany. Residents over age 65 were included in the trial. The intervention was carried out over six months and consisted of four elements: a drug review by trained pharmacists, educational sessions for general practitioners and nurses, a drug safety toolbox, and change management seminars for members of the three participating professions. The nursing homes in the control group continued to provide usual care. The primary endpoint was the prescription of at least one PIM and/or at least two neuroleptic drugs simultaneously. The secondary endpoints were the incidence of falls and hospitalizations, quality of life, and health-care costs. This trial is registered in the German Clinical Trials Registry (DRKS00013588). RESULTS: 44 nursing homes with 862 residents were randomized, 23 of them (with 452 residents) to the intervention group and 21 (with 410 residents) to the control group. 41% of all nursing-home residents initially took at least one PIM and/or at least two neuroleptic drugs simultaneously. Follow-up data (including, among other things, the current drug regimen) were obtained for 773 residents. The intention-to-treat analysis continued to show no difference between the intervention group and the control group with respect to the primary endpoint. CONCLUSION: This trial of an intervention to improve drug safety in nursing homes led neither to reduced prescribing of PIM and/or neuroleptic drugs, nor to any improvement in the overall health status of the nursing-home residents.

Typology of drug discontinuation trials - Methodological recommendations.

OBJECTIVE: Due to the increasing concerns about polypharmacy, there is a growing need for clinical recommendations for drug discontinuation. This requires studies investigating the process on several levels. This paper addresses the methodological problems of drug discontinuation trials (DDTs). To that end, we offer a new typology of research aims and corresponding methodological recommendations for trials evaluating drug discontinuation. STUDY DESIGN AND SETTING: Multi-stage development process, including literature search and expert panels. RESULTS: Clinical trials are only required in cases of scientific uncertainty. We identified three situations of uncertainty associated with drug discontinuation from which we derived three study types: 1) Uncertainty regarding the effectiveness and/or safety of a drug; 2) Uncertainty regarding the procedure of discontinuing a previously taken drug; 3) Uncertainty regarding the effectiveness of complex strategies used to discontinue one or more drugs. We developed specific methodological recommendations for each study type. CONCLUSION: We offer a comprehensive definition of research aims, study designs, and methodological recommendations regarding DDTs. The typology we propose can help investigators clarify their research aims and study design. The type-specific methodological recommendation should improve the quality of future drug discontinuation trials.

Priority setting in general practice: health priorities of older patients differ from treatment priorities of their physicians.

AIM: To ascertain health priorities of older patients and treatment priorities of their general practitioners (GP) on the basis of a geriatric assessment and to determine the agreement between these priorities. METHODS: The study included a sample of 9 general practitioners in Hannover, Germany, and a stratified sample of 35 patients (2-5 patients per practice, 18 female, average age 77.7 years). Patients were given a geriatric assessment using the Standardized Assessment for Elderly Patients in Primary Care (STEP) to gain an overview of their health and everyday problems. On the basis of these results, patients and their physicians independently rated the importance of each problem disclosed by the assessment. Whereas patients assessed the importance for their everyday lives, physicians assessed the importance for patients' medical care and patients' everyday lives. RESULTS: Each patient had a mean ± standard deviation of 18 ± 9.2 health problems. Thirty five patients disclosed a total of 634 problems; 537 (85%) were rated by patients and physicians. Of these 537 problems, 332 (62%) were rated by patients and 334 (62%) by physicians as important for patients' everyday lives. In addition, 294 (55%) were rated by physicians as important for patients' medical care. Although these proportions of important problems were similar between patients and physicians, there was little overlap in the specific problems that each group considered important. The chance-corrected agreement (Cohen κ) between patients and physicians on the importance of problems for patients' lives was low (κ=0.23). Likewise, patients and physicians disagreed on the problems that physicians considered important for patients' medical care (κ=0.18, P<0.001 for each). CONCLUSION: The low agreement on health and treatment priorities between patients and physicians necessitates better communication between the two parties to strengthen mutual understanding.

Disclosure of new health problems and intervention planning using a geriatric assessment in a primary care setting.

AIM: To determine the prevalence of health problems uncovered by a Standardized Assessment for Elderly Patients in a Primary Care Setting (STEP), to explore how often STEP uncovered conditions new to general practitioners (GP) and ascertain how often STEP results led GPs to plan further interventions. METHODS: This descriptive, interim analysis was based on the data of 189 elderly patients (median age, 78 years; interquartile range [IQ], 74-81) and their 20 GPs collected in Hannover region, Germany, between June 2008 and April 2009. Study nurses in the practice setting applied the 44-item STEP instrument, based mainly on self-reporting, as well as a standardized patient interview. Subsequently, GPs indicated whether the problems were new to them, and whether they planned further action or health interventions on the basis of the problems identified by STEP. RESULTS: A median of 11 health problems (IQ, 8-14) were uncovered per patient, of which a median of 2 (IQ, 1-4) were new to the GP and interventions were planned for a median of 2 problems (IQ, 0-4). Many of the identified health problems are typical of old age. The following health problems uncovered by STEP were often new to the GPs (percentages differ to numbers due to missing GP ratings): cognitive impairment (33 of 64 affected by this problem, 73%), missing or unknown immunization status (84 of 160, 55%), and recent chest pain (19 of 37, 53%). Alcohol misuse was new in all 4 affected patients (100%) and recent falls were new in 5 of 7 patients (83%). Interventions for affected patients were frequently planned for problems of immunization (for 83 patients of 160 reporting the problem, 57%), current anxiety (4 of 9, 50%), and chest pain (14 of 37, 44%). Moreover, further management was frequently planned for depression (10 of 29, 39%) and cognitive impairment (16 of 64, 38%). CONCLUSION: Using a geriatric assessment in primary care discloses relevant heath problems and treatment needs that GPs may otherwise overlook.

[Lessons learned: Challenges faced in the recruitment process for the cluster-randomized nursing home study HIOPP-3 iTBX]. / "Lessons learned" ­ Herausforderungen im Rekrutierungsprozess in der cluster-randomisierten Pflegeheimstudie "HIOPP-3 iTBX".

INTRODUCTION: The cluster-randomized multicenter HIOPP-3 iTBX study ('General Practitioners' Initiative to optimize Medication safety for Nursing Home Residents - using an interprofessional toolbox') aims to improve medication safety in nursing home residents through a complex interprofessional intervention focusing on neuroleptics and potentially inadequate medications. A stepwise recruitment process was used for all study participants (nursing homes, general practitioners, pharmacists, nursing home residents). The aim of this article is to describe the underlying recruitment strategy, the results of the recruitment and the measures undertaken to recruit the necessary number of participants. METHODS: The recruitment strategy and the response rates of nursing homes, general practitioners, pharmacists and nursing home residents are described. Measures to improve recruitment at the study sites and reasons for refusal to participate were documented. RESULTS: The response rate in nursing homes was 8.4 % (n=44). Of the pharmacists contacted by these nursing homes 70.3 % (n=52) participated, and 43.5 % (n=91) of all contacted general practitioners. Twenty-three (33.0 %) nursing homes had to be excluded from the study because no interprofessional team could be formed. Of all nursing home residents under the care of the participating general practitioners 862 (43,5%) persons and/or their caregivers gave consent to participate in the study. The recruitment for the study took 14 months. In the course of recruitment, recruitment strategies had to be adapted to local circumstances at the study sites. Reasons for non-participation varied between the different groups. DISCUSSION AND CONCLUSION: The main challenge in the HIOPP-3 iTBX study was to form interprofessional teams in each cluster. A stepwise, partly dependent recruitment process in a large group of potential participants presents organizational challenges that should be taken into account while planning the study. In order to reach the calculated sample size in the HIOPP-3 iTBX study, a pragmatic and flexible approach, adapted to local circumstances, was required. Further studies may benefit from the experiences made in the HIOPP-3 iTBX study.