Improving continuity of patient care across sectors: study protocol of a quasi-experimental multi-centre study regarding an admission and discharge model in Germany (VESPEERA).

BACKGROUND: Hospitalisations are a critical event in the care process. Insufficient communication and uncoordinated follow-up care often impede the recovery process of the patient resulting in a high number of rehospitalisations and increased health care costs. The overall aim of this study is the development, implementation and evaluation of a structured programme (VESPEERA) to improve the admission and discharge process. METHODS: We will conduct an open quasi-experimental multi-centre study with four intervention arms. A cohort selected from insurance claims data will serve as a control group reflecting usual care. The intervention will be implemented in 25 hospital departments and 115 general practices in 9 districts in Baden-Wurttemberg. Eligibility criteria for patients are: age > 18 years, hospital admission or hospitalisation, insurance at the sickness fund "AOK Baden-Wurttemberg", enrolment in general practice-centred care contract. Each study arm will receive different intervention components based on the point of study enrolment and the patient's medical need. The interventions comprise a) a structured assessment in the general practice prior to admission resulting in an admission letter b) a discharge conversation by phone between hospital and general practice, c) a structured assessment and care plan post-discharge and d) telephone monitoring for patients with a high risk of rehospitalisation. The assessments are supported by a software tool ("CareCockpit"), originally developed for structured case management programmes. The primary outcome (rehospitalisation due to the same indication within 90 days) and a range of secondary outcomes (rehospitalisation due to the same indication within 30 days; hospitalisations due to ambulatory care-sensitive conditions; delayed prescription of medication and medical products/ devices and referral to other health practitioner/s after discharge; utilisation of emergency or rescue services within 3 months; average care cost per year and patient participating in the VESPEERA programme) and quality indicators will be determined based on insurance claims data and CareCockpit data. Additionally, a patient survey on satisfaction with cross-sectoral care and health related quality of life will be conducted. DISCUSSION: Based on the results, area-wide implementation in usual care is well sought. This study will contribute to an improvement of cross-sectoral care during the admission and discharge process. TRIAL REGISTRATION: DRKS00014294 on DRKS / Universal Trial Number (UTN): U1111-1210-9657, Date of registration 12/06/2018.

German healthcare professionals' perspective on implementing recommendations about polypharmacy in general practice: a qualitative study.

Background: Key recommendations for the management of patients with polypharmacy are structured medication counselling (SMC), medication lists and systematic medication reviews. Objective: The aim of this study was to identify determinants (hindering and facilitating factors) for the implementation of the recommendations in general practice. Methods: This study was linked to a tailored intervention aimed at improving the implementation of the recommendations in German general practice. Interviews and focus groups with different healthcare professionals were carried out in the design phase and after delivery of the intervention. The material from both data collections was analysed separately in a content analytical approach resulting in two sets of categories. For this study, the subcategories of both sets were assigned to the Tailoring Interventions for Chronic Diseases (TICD) checklist, a comprehensive framework of determinants of practice. Results: Interviews with 24 general practitioners (GPs), 4 other medical specialists, 1 pharmacist, 3 nurses and 6 medical assistants as well as 2 mixed focus groups with 17 professionals were conducted. We identified 93 determinants: 29 referred to medication counselling, 21 to the use of medication lists, 20 to medications reviews and 23 to all recommendations. The determinants were related to all 7 main domains and to 25 of the 57 subdomains on the TICD checklist including guideline factors, patient factors, individual healthcare professional factors, social, political and legal factors, incentives and resources, and capacity for organizational change. Conclusion: While many interventions to improve polypharmacy focus on the provision of pharmacological knowledge, a much wider range of domains need to be addressed, such as communication skills, patient involvement and practice organization.

Medical Assistant-Based Care Management for High-Risk Patients in Small Primary Care Practices: A Cluster Randomized Clinical Trial.

BACKGROUND: Patients with multiple chronic conditions are at high risk for potentially avoidable hospitalizations, which may be reduced by care coordination and self-management support. Medical assistants are an increasingly available resource for patient care in primary care practices. OBJECTIVE: To determine whether protocol-based care management delivered by medical assistants improves care in patients at high risk for future hospitalization in primary care. DESIGN: Two-year cluster randomized clinical trial. (Current Controlled Trials: ISRCTN56104508). SETTING: 115 primary care practices in Germany. PATIENTS: 2076 patients with type 2 diabetes, chronic obstructive pulmonary disease, or chronic heart failure and a likelihood of hospitalization in the upper quartile of the population, as predicted by an analysis of insurance data. INTERVENTION: Protocol-based care management, including structured assessment, action planning, and monitoring delivered by medical assistants, compared with usual care. MEASUREMENTS: All-cause hospitalizations at 12 months (primary outcome) and quality-of-life scores (12-Item Short Form Health Survey [SF-12] and EuroQol instrument [EQ-5D]). RESULTS: Included patients had an average of 4 co-occurring chronic conditions. All-cause hospitalizations did not differ between groups at 12 months (risk ratio [RR], 1.01 [95% CI, 0.87 to 1.18]) and 24 months (RR, 0.98 [CI, 0.85 to 1.12]). Quality of life (differences, 1.16 [CI, 0.24 to 2.08] on SF-12 physical component and 1.68 [CI, 0.60 to 2.77] on SF-12 mental component) and general health (difference on EQ-5D, 0.03 [CI, 0.00 to 0.05]) improved significantly at 24 months. Intervention costs totaled $10 per patient per month. LIMITATION: Small number of primary care practices and low intensity of intervention. CONCLUSION: This low-intensity intervention did not reduce all-cause hospitalizations but showed positive effects on quality of life at reasonable costs in high-risk multimorbid patients. PRIMARY FUNDING SOURCE: AOK Baden-Württemberg and AOK Bundesverband.

Assessing self-management in patients with diabetes mellitus type 2 in Germany: validation of a German version of the Summary of Diabetes Self-Care Activities measure (SDSCA-G).

BACKGROUND: One of the most widely used self-reporting tools assessing diabetes self-management in English is the Summary of Diabetes Self-Care Activities (SDSCA) measure. To date there is no psychometric validated instrument in German to assess self-management in patients with diabetes mellitus. Therefore, this study aimed to translate the SDSCA into German and examine its psychometric properties. METHODS: The English version of the SDSCA was translated into German following the guidelines for cultural adaptation. The German version of the SDSCA (SDSCA-G) was administered to a random sample of 315 patients with diabetes mellitus type 2. Reliability was analyzed using Cronbach's alpha coefficient and item characteristics were assessed. Exploratory and confirmatory factor analysis (EFA and CFA) were carried out to explore the construct validity. A multivariable linear regression model was used to identify the influence of predictor variables on the SDSCA-G sum score. RESULTS: The Cronbach's alpha for the SDSCA-G (all items) was α = 0.618 and an acceptable correlation between the SDSCA-G and Self-management Diabetes Mellitus-Questionnaire (SDQ) (ρ = 0.664) was identified. The EFA suggested a four factor construct as did the postulated model. The CFA showed the goodness of fit of the SDSCA-G. However, item 4 was found to be problematic regarding the analysis of psychometric properties. The omission of item 4 yielded an increase in Cronbach's alpha (α = 0.631) and improvements of the factor structure and model fit. No statistically significant influences of predictor variables on the SDSCA-G sum score were observed. CONCLUSION: The revised German version of the SDSCA (SDSCA-G) is a reliable and valid tool assessing self-management in adults with type 2 diabetes in Germany.

Health-related quality of life and risk factor control: the importance of educational level in prevention of cardiovascular diseases.

BACKGROUND: This study aimed to describe and to analyse the importance of educational level for controlled risk factors and health-related quality of life (HRQoL). METHODS: This observational study was conducted in nine European countries (5632 patients in 249 practices). We compared patients with a low level of education (up to 9 years) with patients with a high level of education (>9 years), with regard to controlled cardiovascular disease risk factors and HRQoL. A multilevel approach was used for statistical analysis. RESULTS: Patients with a low level of education were older (P < 0.001), more often female (P < 0.001), more often single (P < 0.001) and had a higher number of other conditions (e.g. heart failure) (P < 0.001). Significant differences in terms of controlled risk factors were revealed for blood pressure (RR) ≤ 140/90 mmHg (P = 0.039) and the sum of controlled risk factors (P = 0.027). Higher age, lower education, female gender, living as single, patient group (coronary heart disease patients) and the number of other conditions were negatively associated with HRQoL. A higher sum of controlled risk factors were positively associated with higher HRQoL in the whole sample (r = 0.0086, P < 0.001) as well as in both educational-level groups (r = 0.0075, P = 0.038 in the low-level group and r = 0.0082, P = 0.001 in the high-level group). CONCLUSION: Patients with a lower educational level were more often females, singles, had a higher number of other conditions, a higher number of uncontrolled risk factors and a lower HRQoL. However, the higher the control of risk factors was, the higher the HRQoL was overall as well as in both educational-level groups.

Strategies for reducing potentially avoidable hospitalizations for ambulatory care-sensitive conditions.

PURPOSE: Hospitalizations for ambulatory care-sensitive conditions (ACSCs) are seen as potentially avoidable with optimal primary care. Little is known, however, about how primary care physicians rate these hospitalizations and whether and how they could be avoided. This study explores the complex causality of such hospitalizations from the perspective of primary care physicians. METHODS: We conducted semistructured interviews with 12 primary care physicians from 10 primary care clinics in Germany regarding 104 hospitalizations of 81 patients with ACSCs at high risk of rehospitalization. RESULTS: Participating physicians rated 43 (41%) of the 104 hospitalizations to be potentially avoidable. During the interviews the cause of hospitalization fell into 5 principal categories: system related (eg, unavailability of ambulatory services), physician related (eg, suboptimal monitoring), medical (eg, medication side effects), patient related (eg, delayed help-seeking), and social (eg, lack of social support). Subcategories frequently associated with physicians' rating of hospitalizations for ACSCs as potentially avoidable were after-hours absence of the treating physician, failure to use ambulatory services, suboptimal monitoring, patients' fearfulness, cultural background and insufficient language skills of patients, medication errors, medication nonadherence, and overprotective caregivers. Comorbidities and medical emergencies were frequent causes attributed to ACSC-based hospitalizations that were rated as being unavoidable. CONCLUSIONS: Primary care physicians rated a significant proportion of hospitalizations for ACSCs to be potentially avoidable. Strategies to avoid these hospitalizations may target after-hours care, optimal use of ambulatory services, intensified monitoring of high-risk patients, and initiatives to improve patients' willingness and ability to seek timely help, as well as patients' medication adherence.

Targeting patients for multimorbid care management interventions: the case for equity in high-risk patient identification.

Targeting patients for multimorbid care management interventions requires accurate and comprehensive assessment of patients' need in order to direct resources to those who need and can benefit from them the most. Multimorbid patient selection is complicated due to the lack of clear criteria--unlike disease management programs for which patients with a specific condition are identified. This ambiguity can potentially result in inequitable selection, as biases in selection may differentially affect patients from disadvantaged population groups. Patient selection could in principal be performed in three ways: physician referral, patient screening surveys, or by statistical prediction algorithms. This paper discusses equity issues related to each method. We conclude that each method may result in inequitable selection and bias, such as physicians' attentiveness or familiarity, or prediction models' reliance on prior resource use, potentially affected by socio-cultural and economic barriers. These biases should be acknowledged and dealt with. We recommend combining patient selection approaches to achieve high care sensitivity, efficiency and equity.

Comparison of physician referral and insurance claims data-based risk prediction as approaches to identify patients for care management in primary care: an observational study.

BACKGROUND: Primary care-based care management (CM) could reduce hospital admissions in high-risk patients. Identification of patients most likely to benefit is needed as resources for CM are limited. This study aimed to compare hospitalization and mortality rates of patients identified for CM either by treating primary care physicians (PCPs) or predictive modelling software for hospitalization risk (PM). METHODS: In 2009, a cohort of 6,026 beneficiaries of a German statutory health insurance served as a sample for patient identification for CM by PCPs or commercial PM (CSSG 0.8, Verisk Health). The resulting samples were compared regarding hospitalization and mortality rates in 2010 and in the two year period before patient selection. No CM-intervention was delivered until the end of 2010 and PCPs were blinded for the assessment of hospitalization rates. RESULTS: In 2010, hospitalization rates of PM-identified patients were 80% higher compared to PCP-identified patients. Mortality rates were also 8% higher in PM-identified patients if compared to PCP-identified patients (10% vs. 2%). The hospitalization rate of patients independently identified by both PM and PCPs was numerically between PM- and PCP-identified patients. Time trend between 2007 and 2010 showed decreasing hospitalization rates in PM-identified patients (-15% per year) compared to increasing rates in PCP-identified patients (+34% per year). CONCLUSIONS: PM identified patients with higher hospitalization and mortality rates compared to PCP-referred patients. But the latter showed increasing hospitalization rates over time thereby suggesting that PCPs may be able to predict future deterioration in patients with relatively good current health status. These patients may most likely benefit from preventive services like CM.

Health related quality of life and comorbidity. A descriptive analysis comparing EQ-5D dimensions of patients in the German disease management program for type 2 diabetes and patients in routine care.

BACKGROUND: The co-occurance of multiple medical conditions has a negative impact on health related quality of life (HRQoL) for patients with type 2 diabetes. These patients demand for intensified care programs. Participation in a disease management program (DMP) for type 2 diabetes has shown to counterbalance this effect. However, it remains unclear which dimensions of HRQoL are influenced by the DMP. The aim of this study was to explore the HRQoL dimensions of patients with type 2 diabetes in the German DMP and patients in routine care (RC). METHODS: This analysis is part of a comparative evaluation of the German DMP for patients with type 2 diabetes. A questionnaire, including the HRQoL measure EQ-5D, was mailed to a random sample of 3,546 patients with type 2 diabetes (59.3% female). The EQ-5D dimensions were analyzed by grouping patients according to their participation in the German DMP for diabetes into DMP and RC. RESULTS: Compared to patients in DMP, patients in RC reported more problems for the dimensions mobility (P < 0.05), self care (P < 0.05) and performing usual activities (P < 0.01). Depending on the number of other conditions, remarkable differences for reporting "no problems" exist for patients with six or more comorbid conditions regarding the dimensions mobility (RC = 8.7%, DMP = 32.3%), self care (RC = 43.5%, DMP = 64.5%), usual activities (RC = 13.0%, DMP = 33.9%) and anxiety or depression (RC = 37.0%, DMP = 48.4%). CONCLUSION: Patients participating in the German DMP for type 2 diabetes mellitus show significantly higher ratings of their HRQoL in the dimensions mobility, self care and performing usual activities compared to patients in RC. This difference can also be observed in patients with significant comorbidities. As these dimensions are known to be essential for diabetes care, the German DMP may contribute to improved care even for comorbid diabetes patients.

Primary care practice-based care management for chronically ill patients (PraCMan) in German healthcare: Outcome of a propensity-score matched cohort study.

BACKGROUND: Growing prevalence of chronic diseases is a rising challenge for healthcare systems. The Primary Care Practice-Based Care Management (PraCMan) programme is a comprehensive disease management intervention in primary care in Germany aiming to improve medical care and to reduce potentially avoidable hospitalisations for chronically ill patients. OBJECTIVES: This study aimed to assess the effect of PraCMan on hospitalisation rate and related costs. METHODS: A retrospective propensity-score matched cohort study was performed. Reimbursement data related to patients treated in general practices between 1st July 2013 and 31st December 2017 were supplied by a statutory health insurance company (AOK Baden-Wuerttemberg, Germany) to compare hospitalisation rate and direct healthcare costs between patients participating in the PraCMan intervention and propensity-score matched controls following usual care. Outcomes were determined for the one-year-periods before and 12 months after beginning of participation in the intervention. RESULTS: In total, 6148 patients participated in the PraCMan intervention during the observation period and were compared to a propensity-score matched control group of 6148 patients from a pool of 63,446 eligible patients. In the one-year period after the intervention, the per-patient hospitalisation rate was 8.3% lower in the intervention group compared to control (p = 0.0004). Per-patient hospitalisation costs were 9.4% lower in favour of the intervention group (p = 0.0002). CONCLUSION: This study showed that the PraCMan intervention may be associated with a lower rate of hospital admissions and hospitalisation costs than usual care. Further studies may assess long-term effects of PraCMan and its efficacy in preventing known complications of chronic diseases.

Effectiveness and efficiency of primary care based case management for chronic diseases: rationale and design of a systematic review and meta-analysis of randomized and non-randomized trials [CRD32009100316].

BACKGROUND: Case management is an important component of structured and evidence-based primary care for chronically ill patients. Its effectiveness and efficiency has been evaluated in numerous clinical trials. This protocol describes aims and methods of a systematic review of research on the effectiveness and efficiency of case management in primary care. METHODS/DESIGN: According to this protocol Medline, Embase, CINAHL, PsychInfo, the Cochrane Central Register of Controlled trials, DARE, NHS EED, Science Citation Index, The Royal College of Nursing Database, Dissertation Abstracts, registers of clinical trials and the reference lists of retrieved articles will be searched to identify reports on randomized and non-randomized controlled trials of case management interventions in a primary care setting without limitations on language or publication date. We will further ask experts in the field to avoid missing relevant evidence. Study inclusion and data extraction will be performed independently by two reviewers. After assessing risk of bias according to predefined standards, included studies will be described qualitatively. Subgroup analyses are planned for different chronic diseases and intervention strategies. If appropriate, a quantitative synthesis of data will be performed to provide conclusive evidence about the effectiveness and efficiency of primary care based case management in chronic care. REVIEW REGISTRATION: Centre for Reviews and Dissemination (University of York): CRD32009100316.

Lipopolysaccharide stimulation of dendritic cells induces interleukin-10 producing allergen-specific T cells in vitro but fails to prevent allergic airway disease.

Dendritic cells (DCs) play an important role in directing naive T cells towards a Th1/Th2 or regulatory T cells (Treg) cell phenotype. In this context, interleukin (IL)-10 has been shown to exhibit immune regulatory capacities. The aim of this study was to delineate the influence of high-IL-10-producing DCs on DC-T-cell interactions in inhibiting allergen-induced airway inflammation and hyperreactivity in a murine model of allergic airway disease. Bone marrow-derived dendritic cells (BMDCs) were generated from hemopoietic progenitors by culture with granulocyte-macrophage colony-stimulating factor (GM-CSF), and stimulated with ovalbumin (OVA) +/- lipopolysaccharide (LPS). The effects of ovalbumin-pulsed BMDCs on cytokine production by allergen-specific naive T cells were studied in vitro. The development of airway inflammation in Balb/c mice was determined after intranasal administration of BMDCs in vivo. LPS stimulation of BMDCs strongly enhanced IL-10 production. Coculture of LPS-modulated DCs exhibiting increased IL-10 production with allergen-specific naive T cells reduced the production of interferon (IFN)-gamma and IL-5, but enhanced the production of IL-10. After blockade with anti-IL-10 plus anti-IL-10-receptor antibodies, the level of IFN-gamma and IL-5 production by cocultured T cells was restored, underlining the regulatory function of IL-10. Intranasal administration of high-IL-10-producing LPS-stimulated, OVA-primed BMDCs prior to repetitive airway allergen challenges resulted in an even enhanced airway inflammation. These data demonstrate that increased IL-10 production by DCs may be a critical element for T-cell activation and differentiation in the context of allergen-induced immune responses in vitro. However, this DC modulation did not translate into suppression of allergic airway disease in vivo.

Correction: Care management intervention to strengthen self-care of multimorbid patients with type 2 diabetes in a German primary care network: A randomized controlled trial.

[This corrects the article DOI: 10.1371/journal.pone.0214056.].

Care management intervention to strengthen self-care of multimorbid patients with type 2 diabetes in a German primary care network: A randomized controlled trial.

PURPOSE: This study aimed to assess the effectiveness of a care management intervention in improving self-management behavior in multimorbid patients with type 2 diabetes; care was delivered by medical assistants in the context of a primary care network (PCN) in Germany. METHODS: This study is an 18-month, multi-center, two-armed, open-label, patient-randomized parallel-group superiority trial (ISRCTN 83908315). The intervention group received the care management intervention in addition to the usual care. The control group received usual care only. The primary outcome was the change in self-care behavior at month 9 compared to baseline. The self-care behavior was measured with the German version of the Summary of Diabetes Self-Care Activities Measure (SDSCA-G). A multilevel regression analysis was applied. RESULTS: We assigned 495 patients to intervention (n = 252) and control (n = 243). At baseline, the mean age was 68 ±11 years, 47.8% of the patients were female and the mean HbA1c was 7.1±1.2%. The primary analysis showed no statistically significant effect, but a positive trend was observed (p = 0.206; 95%-CI = -0.084; 0.384). The descriptive analysis revealed a significantly increased sum score of the SDSCA-G in the intervention group over time (P = 0.012) but not in the control group (p = 0.1973). CONCLUSION: The sum score for self-care behavior markedly improved in the intervention group over time. However, the results of our primary analysis showed no statistically significant effect. Possible reasons are the high baseline performance in our sample and the low intervention fidelity. The implementation of this care management intervention in PCNs has the potential to improve self-care behavior of multimorbid patients with type 2 diabetes.

A novel superior medication-based chronic disease score predicted all-cause mortality in independent geriatric cohorts.

OBJECTIVES: On the basis of current treatment guidelines, we developed and validated a medication-based chronic disease score (medCDS) and tested its association with all-cause mortality of older outpatients. STUDY DESIGN AND SETTING: Considering the most prevalent chronic diseases in the elderly German population, we compiled a list of evidence-based medicines used to treat these disorders. Based on this list, a score (medCDS) was developed to predict mortality using data of a large longitudinal cohort of older outpatients (training sample; MultiCare Cohort Study). By assessing receiver-operating characteristics (ROC) curves, the performance of medCDS was then confirmed in independent cohorts (ESTHER, KORA-Age) of community-dwelling older patients and compared with already existing medication-based scores and a score using selected anatomical-therapeutic-chemical (ATC) codes. RESULTS: The final medCDS score had an ROC area under the curve (AUC) of 0.73 (95% CI 0.70-0.76). In the validation cohorts, its ROC AUCs were 0.79 (0.76-0.82, KORA-Age) and 0.74 (0.71-0.78, ESTHER), which were superior to already existing medication-based scores (RxRisk, CDS) and scores based on pharmacological ATC code subgroups (ATC3) or age and sex alone (Age&Sex). CONCLUSIONS: A new medCDS, which is based on actual treatment standards, predicts mortality of older outpatients significantly better than already existing scores.

Evaluation of the short form of "Experience in Close Relationships" (Revised, German Version "ECR-RD12") - A tool to measure adult attachment in primary care.

Attachment theory helps us to understand patients´ health behavior. Attachment styles might explain patient differences in coping behavior, self-treatment, or patient-provider relationships. In primary care time constrains are relevant. A short instrument may facilitate screening and assessment in daily medical practice. The aim of this study was to evaluate a 12-item short version of the Experience in Close Relationships-revised (ECR-R-D) to be used in primary care settings. We included 249 patients from ten general practices in central Germany into a cross-sectional study. Exploratory factor analysis was performed to evaluate the factor structure of the ECR-items. Cronbach's alpha was used to assess internal consistency. The results related to the short form of the ECR are in line with those of the German full-length version of the measure (ECR-RD 36). Internal consistencies were in an adequate range. The ECR short form can be recommended as a screening measure of attachment styles in primary care.

A tailored programme to implement recommendations for multimorbid patients with polypharmacy in primary care practices-process evaluation of a cluster randomized trial.

BACKGROUND: We developed and evaluated a tailored programme to implement three evidence-based recommendations for multimorbid patients with polypharmacy into primary care practices: structured medication counselling including brown bag reviews, the use of medication lists and medication reviews. No effect on the primary outcome was found. This process evaluation aimed to identify factors associated with outcomes by exploring nine hypotheses specified in the logic model of the tailored programme. METHODS: The tailored programme was developed with respect to identified determinants of practice and consisted of a workshop for practice teams, elaboration of implementation action plans, aids for medication reviews, a multilingual info-tool for patients on a tablet PC, posters and brown paper bags as reminders for patients. The tailored programme was evaluated in a cluster randomized trial. The process evaluation was based on various data sources: interviews with general practitioners and medical assistants of the intervention group and a survey with general practitioners of the intervention and control group, written reports on the implementation action plans, documentation forms for structured medication counselling and the log file of the info-tool. RESULTS: We analyzed 12 interviews, 21 questionnaires, 120 documentation forms for medication counselling, 5 implementation action plans and one log file of the info-tool. The most frequently reported effect of the tailored programme was the increase of awareness for the health problem and the recommendations, while implementation of routine processes was only reported for structured medication counselling. The survey largely confirmed the usefulness of the applied strategies, yet the interviews provided a more detailed understanding of the actual use of the strategies and several suggestions for modifications of the tailored programme. CONCLUSIONS: The tailored programme seemed to have induced awareness as a first step of behaviour change. Several modifications of the tailored programme may enhance its effectiveness such as conducting outreach visits instead of a workshop, improved targeting, provision of evidence, integration of tools into the practice software and information materials in tailored formats. TRIAL REGISTRATION: This study is linked to an outcome evaluation study with the registration ISRCTN34664024 , assigned 14/08/2013.

Impact of a tailored program on the implementation of evidence-based recommendations for multimorbid patients with polypharmacy in primary care practices-results of a cluster-randomized controlled trial.

BACKGROUND: Multimorbid patients receiving polypharmacy represent a growing population at high risk for negative health outcomes. Tailoring is an approach of systematic intervention development taking account of previously identified determinants of practice. The aim of this study was to assess the effect of a tailored program to improve the implementation of three important processes of care for this patient group: (a) structured medication counseling including brown bag reviews, (b) the use of medication lists, and (c) structured medication reviews to reduce potentially inappropriate medication. METHODS: We conducted a cluster-randomized controlled trial with a follow-up time of 9 months. Participants were general practitioners (GPs) organized in quality circles and participating in a GP-centered care contract of a German health insurance. Patients aged >50 years, suffering from at least 3 chronic diseases, receiving more than 4 drugs, and being at high risk for medication-related events according to the assessment of the treating GP were enrolled. The tailored program consisted of a workshop for GPs and health care assistants, educational materials and reminders for patients, and the elaboration of implementation action plans. The primary outcome was the change in the degree of implementation between baseline and follow-up, measured by a summary score of 10 indicators. The indicators were based on structured surveys with patients and GPs. RESULTS: We analyzed the data of 21 GPs (10 - intervention group, 11 - control group) and 273 patients (130 - intervention group, 143 - control group). The increase in the degree of implementation was 4.2 percentage points (95% confidence interval: -0.3, 8.6) higher in the intervention group compared to the control group (p = 0.1). Two of the 10 indicators were significantly improved in the intervention group: medication counseling (p = 0.017) and brown bag review (p = 0.012). Secondary outcomes showed an effect on patients' self-reported use of medication lists when buying drugs in the pharmacy (p = 0.03). CONCLUSIONS: The tailored program may improve implementation of medication counseling and brown bag review whereas the use of medication lists and medication reviews did not improve. No effect of the tailored program on the combined primary outcome could be substantiated. Due to limitations of the study, results have to be interpreted carefully. The factors facilitating and hindering successful implementation will be examined in a comprehensive process evaluation. TRIAL REGISTRATION NUMBER: ISRCTN34664024 , assigned 14/08/2013.

Medication Lists and Brown Bag Reviews: Potential Positive and Negative Impacts on Patients Beliefs about Their Medicine.

INTRODUCTION: Medication lists and structured medication counselling (SMC) including "brown bag reviews" (BBR) are important instruments for medication safety. The aim of this study was to explore whether patients' use of a medication list is associated with their beliefs about their medicine and their memory of SMC. METHODS: Baseline data of 344 patients enrolled into the "Polypharmacy in Multimorbid Patients study" were analysed. Linear regression models were calculated for the "specific necessity subscale" (SNS) and the "specific concerns subscale" (SCS) of the German "Beliefs About Medicine Questionnaire," including self-developed variables assessing patients' use of a medication list, their memory of SMC, and sociodemographic data. RESULTS: 62.8% (n = 216) remembered an appointment for SMC and 32.0% (n = 110) BBR. The SNS correlated positively with regular receipt of a medication list (ß = 0.286, p < 0.01) and negatively with memory of a BBR (ß = -0.268; p < 0.01). The SCS correlated positively with memory of a BBR (ß = 0.160, p = 0.02) and negatively with the comprehensiveness of the mediation list (ß = -0.224; p < 0.01). CONCLUSIONS: A comprehensive medication list may reduce patients' concerns and increase the perceived necessity of their medication. A potential negative impact of BBR on patients' beliefs about their medicine should be considered and quality standards for SMC developed.