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.

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.

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.

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.

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.

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.

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.

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.

Skill mix, roles and remuneration in the primary care workforce: who are the healthcare professionals in the primary care teams across the world?

World-wide, shortages of primary care physicians and an increased demand for services have provided the impetus for delivering team-based primary care. The diversity of the primary care workforce is increasing to include a wider range of health professionals such as nurse practitioners, registered nurses and other clinical staff members. Although this development is observed internationally, skill mix in the primary care team and the speed of progress to deliver team-based care differs across countries. This work aims to provide an overview of education, tasks and remuneration of nurses and other primary care team members in six OECD countries. Based on a framework of team organization across the care continuum, six national experts compare skill-mix, education and training, tasks and remuneration of health professionals within primary care teams in the United States, Canada, Australia, England, Germany and the Netherlands. Nurses are the main non-physician health professional working along with doctors in most countries although types and roles in primary care vary considerably between countries. However, the number of allied health professionals and support workers, such as medical assistants, working in primary care is increasing. Shifting from 'task delegation' to 'team care' is a global trend but limited by traditional role concepts, legal frameworks and reimbursement schemes. In general, remuneration follows the complexity of medical tasks taken over by each profession. Clear definitions of each team-member's role may facilitate optimally shared responsibility for patient care within primary care teams. Skill mix changes in primary care may help to maintain access to primary care and quality of care delivery. Learning from experiences in other countries may inspire policy makers and researchers to work on efficient and effective teams care models worldwide.

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.

Partners for the optimal organisation of the healthcare continuum for high users of health and social services: protocol of a developmental evaluation case study design.

INTRODUCTION: Case management allows us to respond to the complex needs of a vulnerable clientele through a structured approach that promotes enhanced interaction between partners. Syntheses on the subject converge towards a need for a better description of the relationships between programmes and their local context, as well as the characteristics of the clienteles and programmes that contribute to positive impacts. The purpose of this project is thus to describe and evaluate the case management programmes of four health and social services centres in the Saguenay-Lac- Saint-Jean region of Québec, Canada, in order to inform their improvement while creating knowledge on case management that can be useful in other contexts. METHODS AND ANALYSIS: This research relies on a multiple embedded case study design based on a developmental evaluation approach. We will work with the case management programme for high users of hospital services of each centre. Three different units of analysis will be interwoven to obtain an in-depth understanding of each case, that is: (1) health and social services centre and local services network, (2) case management programme and (3) patients who are high users of services. Two strategies for programme evaluation (logic models and implementation analysis) will guide the mixed data collection based on qualitative and quantitative methods. This data collection will rely on: (1) individual interviews and focus groups; (2) participant observation; (3) document analysis; (4) clinical and administrative data and (5) questionnaires. Description and comparison of cases, and integration of qualitative and quantitative data will be used to guide the data analysis. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Research Boards of the four health and social services centres (HSSCs) involved. Findings will be disseminated by publications in peer-reviewed journals, conferences, and policy and practice partners in local and national government.

[Hospitalisations for ambulatory care sensitive conditions in Germany]. / Krankenhausfälle für ambulant behandelbare Erkrankungen in Deutschland.

BACKGROUND: On the basis of the assumption that a significant proportion of hospitalisations for so-called ambulatory care sensitive conditions (ACSCs) are potentially avoidable by ambulatory care measures, hospitalisation rates for ACSCs are used internationally as population based indicators for access to and quality of ambulatory care. The German Council of Health Experts proposes hospitalisation rates for diabetes, asthma, hypertension and chronic heart failure as ACSC measures in Germany. OBJECTIVES: This article focuses on regional differences in ACSC rates, describes the longitudinal development and explores potential determinants. MATERIAL AND METHODS: Descriptive statistical analyses as well as spatial regression analyses were performed on the basis of Federal Statistical Office data. We included data from the hospital and physician statistics. Bayesian spatial regression techniques were used. RESULTS: Whereas hospitalisation rates for asthma decreased between 2000 and 2010, hospitalisation rates for diabetes, hypertension and chronic heart failure increased. Comparing age-adjusted ACSC rates across all German federal states, the Eastern states as well as Saarland showed significantly higher ACSC rates over time. This observation can in part be explained by physician density and the number of hospital beds. CONCLUSION: Although not all ACSC hospitalisations can be avoided, these results display a potential for optimising care across healthcare sectors in Germany.

[Structured medication management in primary care - a tool to promote medication safety]. / Das strukturierte Medikamentenmanagement in der Hausarztpraxis - ein Beitrag zur Förderung der Arzneimitteltherapiesicherheit.

Patients with chronic disease usually need to take multiple medications. Drug-related interactions, adverse events, suboptimal adherence, and self-medication are components that can affect medication safety and lead to serious consequences for the patient. At present, regular medication reviews to check what medicines have been prescribed and what medicines are actually taken by the patient or the structured evaluation of drug-related problems rarely take place in Germany. The process of "medication reconciliation" or "medication review" as developed in the USA and the UK aim at increasing medication safety and therefore represent an instrument of quality assurance. Within the HeiCare(®) project a structured medication management was developed for general practice, with medical assistants playing a major role in the implementation of the process. Both the structured medication management and the tools developed for the medication check and medication counselling will be outlined in this article; also, findings on feasibility and acceptance in various projects and experiences from a total of 200 general practices (56 HeiCare(®), 29 HiCMan,115 PraCMan) will be described. The results were obtained from questionnaires and focus group discussions. The implementation of a structured medication management intervention into daily routine was seen as a challenge. Due to the high relevance of medication reconciliation for daily clinical practice, however, the checklists - once implemented successfully - have been applied even after the end of the project. They have led to the regular review and reconciliation of the physicians' documentation of the medicines prescribed (medication chart) with the medicines actually taken by the patient.

[Developing a tailored intervention: implementing recommendations for polypharmacy in multimorbid patients (PomP)]. / Entwicklung einer maßgeschneiderten Intervention (Tailoring) am Beispiel der Implementierung von Empfehlungen zur Polypharmakotherapie bei multimorbiden Patienten (PomP).

INTRODUCTION: Implementation research deals with the question of how to ensure that evidence-based knowledge is put into practice. One approach is the development of "tailored interventions (TI)". These are designed to address previously identified barriers and enablers. A common definition or methodological concept for TI has not yet been established. In this paper, a concept for TI is introduced. We describe the stepwise development of an implementation intervention for GP settings where recommendations based on current evidence are provided for the treatment of multimorbid patients receiving polypharmacy. Each step will be explained and illustrated by original data. METHODS/RESULTS: A stepwise approach was used to develop a TI: problem analysis, identification and prioritisation of determinants, identification and prioritisation of strategies and the design of a complex intervention and its underlying logic model. DISCUSSION: The stepwise exemplary description of this tailoring strategy may support other researchers in this field when designing a TI.

Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial.

BACKGROUND: Care management interventions in the German health-care system have been evaluated with promising results, but further research is necessary to explore their full potential in the context of multi-morbidity. Our aim in this trial is to assess the efficacy of a primary care practice network-based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions. METHODS/DESIGN: The study is designed as a prospective, 18-month, multicentre, investigator-blinded, two-arm, open-label, individual-level, randomized parallel-group superiority trial. We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient. Data will be collected at baseline (T0), at the primary endpoint after 9 months (T1) and at follow-up after 18 months (T2). The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities (SDSCA-G). The secondary outcomes will be the differences between the intervention and control groups in: changes in scores on the SDSCA-G subscales, glycosylated haemoglobin A level, health-related quality of life, self-efficacy, differences in (severe) symptomatic hypoglycaemia, cost-effectiveness and financial family burden. The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements: (1) three home visits, including structured assessment of medical and social needs; (2) 24 structured telephone monitoring contacts; and (3) self-monitoring of blood glucose levels after T1 in 3-month intervals. The control group will receive usual care. The confirmatory primary analysis will be performed following the intention-to-treat (ITT) principle. The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G. Secondary analyses will be performed according to the ITT principle. In health economic evaluations, we will estimate the incremental cost-effectiveness ratios. DISCUSSION: We hope that the results of this study will provide insights into the efficacy of practice network-based care management among patients with complex health-care needs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 83908315 (ISRCTN assigned 25 February 2014).

Tailored Implementation for Chronic Diseases (TICD): a protocol for process evaluation in cluster randomized controlled trials in five European countries.

BACKGROUND: In the 'Tailored Implementation for Chronic Diseases (TICD)' project, five tailored implementation programs to improve healthcare delivery in different chronic conditions have been developed. These programs will be evaluated in distinct cluster-randomized controlled trials. This protocol describes the process evaluation across these trials, which aims to identify determinants of change in chronic illness care, to examine the validity of the tailoring methods that were applied, and to analyze the association of implementation activities and the effectiveness of the program. METHODS: A multilevel approach was used to develop five tailored implementation interventions. In order to guide the process evaluation in five distinct trials, the study protocols for the cluster randomized trials and the related process evaluations were developed simultaneously and iteratively. RESULTS: The process evaluation comprises three main components: a structured survey with health professionals in the trials, semi-structured interviews with a purposeful sample of this study population, and standardized documentation of organizational practice characteristics. Norway will only conduct the qualitative part of the analysis because the survey and documentation of practice characteristics are considered to be not feasible. The evaluation is guided by 'logic models' of the implementation programs: frameworks that specify the linkages between the strategies used, the determinants addressed by tailoring, and the anticipated outcomes. Standardization of measures across trials is sought to facilitate analysis of aggregated data from the trials. CONCLUSIONS: This process evaluation will need to find a balance between standardization of methods across trials and the tailoring of measures to the specificities of each trial.

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.