Implementation and evaluation of participatory advisory boards in mental health research: a research protocol of the 'PART-Beirat' project.

BACKGROUND: The use of participatory research approaches in the field of dementia and forensic mental health research has been on the rise. Advisory board structures, involving people with lived experience (PWLE), have frequently been used for guiding and leading research. Yet, there has been limited guidance on the establishment, retention and use of advisory boards in the field of dementia and forensic mental health research. OBJECTIVE: This project outlined in this research protocol will investigate the benefits and challenges of establishing three patient advisory boards, involving PWLE, practitioners and researchers with the purpose to guide research. Data will be used to develop guidelines for best practice in involving PWLE in dementia and forensic mental health research through advisory boards. METHODS: The research project will be divided into three phases: Phase I will involve two topic-specific systematic reviews on the use of participatory research with PWLE, followed by an initial study exploring PWLE's, practitioners' and researchers' expectations on research involvement. Phase II will consist of the establishment of three advisory boards, one focusing on dementia, one on forensic mental health and one overarching coordinating advisory board, which will involve PWLE from both fields. Phase III, will consist of interviews and focus groups with advisory board members, exploring any challenges and benefits of involving PWLE and practitioners in advisory boards for guiding research. To capture the impact of involving PWLE in different research phases and tasks, interviews and focus groups will be conducted at four different points of time (0, 6, 12, 18 months). Reflexive thematic analysis will be used for the analysis of data. DISCUSSION: The project aims to explore the involvement of PWLE and practitioners in guiding research and aims to develop guidelines for best practice in establishing and using patient advisory boards in dementia and forensic mental health research and involving PWLE and practitioners in research.

There is an increasing involvement of people with mental health issues in research, especially in the form of advisory boards. So far People With Lived Experience [PWLE] of mental health issues acquired either from first person experience or through family members, and mental health practitioners' involvement in research has been found to benefit research and society. This is because it increases reach and quality of research, whilst raising the voice of people commonly excluded from decision making (e.g. research, care provision). This research protocol describes the design of a three-year research project. The project aims to establish and use patient advisory boards, involving PWLE, practitioners and researchers, to guide research. The project will consist of three phases: (1) a review of previous studies on the use of participatory research with PWLE of dementia and forensic mental health care, followed by an initial study exploring PWLE's, practitioners' and researchers' expectations in research involvement, (2) the establishment of three advisory boards, one focusing on dementia, one on forensic mental health and one overarching coordinating advisory board, and (3) an exploration of challenges, barriers and benefits of involving PWLE of dementia/forensic mental health care and practitioners in advisory boards for research through interviews and focus groups. Interviews with PWLE and practitioners involved in the advisory boards will be conducted at four different points of time (0, 6, 12, 18 month). At the end, we aim to develop guidelines for establishing advisory board structures, involving PWLE and practitioners in research.

HbA1c as a shared treatment goal in type 2 diabetes? A secondary analysis of the DEBATE trial.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a major health problem in the western world. Despite a widespread implementation of integrated care programs there are still patients with poorly controlled T2DM. Shared goal setting within the process of Shared Decision Making (SDM) may increase patient's compliance and adherence to treatment regimen. In our secondary analysis of the cluster-randomized controlled DEBATE trial, we investigated if patients with shared vs. non-shared HbA1c treatment goal, achieve their glycemic goals. METHODS: In a German primary care setting, we collected data before intervention at baseline, 6, 12 and 24 months. Patients with T2DM with an HbA1c ≥ 8.0% (64 mmol/mol) at the time of recruitment and complete data at baseline and after 24 months were eligible for the presented analyses. Using a generalized estimating equation analysis, we analysed the association between the achievement of HbA1c goals at 24 months based on their shared vs. non-shared status, age, sex, education, partner status, controlled for baseline HbA1c and insulin therapy. RESULTS: From N = 833 recruited patients at baseline, n = 547 (65.7%) from 105 General Practitioners (GPs) were analysed. 53.4% patients were male, 33.1% without a partner, 64.4% had a low educational level, mean age was 64.6 (SD 10.6), 60.7% took insulin at baseline, mean baseline HbA1c was 9.1 (SD 1.0). For 287 patients (52.5%), the GPs reported to use HbA1c as a shared goal, for 260 patients (47.5%) as a non-shared goal. 235 patients (43.0%) reached the HbA1c goal after two years, 312 patients (57.0%) missed it. Multivariable analysis shows that shared vs. non-shared HbA1c goal setting, age, sex, and education are not associated with the achievement of the HbA1c goal. However, patients living without a partner show a higher risk of missing the goal (p = .003; OR 1.89; 95% CI 1.25-2.86). CONCLUSIONS: Shared goal setting with T2DM patients targeting on HbA1c-levels had no significant impact on goal achievement. It may be assumed, that shared goal setting on patient-related clinical outcomes within the process of SDM has not been fully captured yet. TRIAL REGISTRATION: The trial was registered at ISRCTN registry under the reference ISRCTN70713571.

Family Conferences to Facilitate Deprescribing in Older Outpatients With Frailty and With Polypharmacy: The COFRAIL Cluster Randomized Trial.

Importance: For older adults with frailty syndrome, reducing polypharmacy may have utility as a safety-promoting treatment option. Objective: To investigate the effects of family conferences on medication and clinical outcomes in community-dwelling older adults with frailty receiving polypharmacy. Design, Setting, and Participants: This cluster randomized clinical trial was conducted from April 30, 2019, to June 30, 221, at 110 primary care practices in Germany. The study included community-dwelling adults aged 70 years or older with frailty syndrome, daily use of at least 5 different medications, a life expectancy of at least 6 months, and no moderate or severe dementia. Interventions: General practitioners (GPs) in the intervention group received 3 training sessions on family conferences, a deprescribing guideline, and a toolkit with relevant nonpharmacologic interventions. Three GP-led family conferences for shared decision-making involving the participants and family caregivers and/or nursing services were subsequently held per patient at home over a period of 9 months. Patients in the control group received care as usual. Main Outcomes and Measures: The primary outcome was the number of hospitalizations within 12 months, as assessed by nurses during home visits or telephone interviews. Secondary outcomes included the number of medications, the number of European Union list of the number of potentially inappropriate medication (EU[7]-PIM) for older people, and geriatric assessment parameters. Both per-protocol and intention-to-treat analyses were conducted. Results: The baseline assessment included 521 individuals (356 women [68.3%]; mean [SD] age, 83.5 [6.17] years). The intention-to-treat analysis with 510 patients showed no significant difference in the adjusted mean (SD) number of hospitalizations between the intervention group (0.98 [1.72]) and the control group (0.99 [1.53]). In the per-protocol analysis including 385 individuals, the mean (SD) number of medications decreased from 8.98 (3.56) to 8.11 (3.21) at 6 months and to 8.49 (3.63) at 12 months in the intervention group and from 9.24 (3.44) to 9.32 (3.59) at 6 months and to 9.16 (3.42) at 12 months in the control group, with a statistically significant difference at 6 months in the mixed-effect Poisson regression model (P = .001). After 6 months, the mean (SD) number of EU(7)-PIMs was significantly lower in the intervention group (1.30 [1.05]) than in the control group (1.71 [1.25]; P = .04). There was no significant difference in the mean number of EU(7)-PIMs after 12 months. Conclusions and Relevance: In this cluster randomized clinical trial with older adults taking 5 or more medications, the intervention consisting of GP-led family conferences did not achieve sustainable effects in reducing the number of hospitalizations or the number of medications and EU(7)-PIMs after 12 months. Trial Registration: German Clinical Trials Register: DRKS00015055.

Development of a deprescribing manual for frail older people for use in the COFRAIL study and in primary care.

Introduction: Many older adults are affected by multimorbidity and subsequent polypharmacy which is associated with adverse outcomes. This is especially relevant for frail older patients. Polypharmacy may be reduced via deprescribing. As part of the complex intervention in the COFRAIL study, we developed a deprescribing manual to be used by general practitioners (GPs) in family conferences, in which GPs, patients and caregivers jointly discuss treatments. Methods: We selected indications with a high prevalence in older adults in primary care (e.g. diabetes mellitus, hypertension) and conducted a literature search to identify deprescribing criteria for these indications. We additionally reviewed clinical practice guidelines. Based on the extracted information, we created a deprescribing manual which was then piloted in an expert workshop and in family conferences with volunteer patients according to the inclusion and exclusion criteria of the study protocol. Results: Initially, 13 indications/topics were selected. The literature search identified deprescribing guides, reviews and clinical trials as well as lists of potentially inappropriate medication and systematic reviews on the risk and benefits of specific drugs and drug classes in older patients. After piloting and revisions, the deprescribing manual now covers 11 indications/topics. In each chapter, patient- and medication-related deprescribing criteria, monitoring and communication strategies, and information about concerns related to the use of specific drugs in older patients are provided. Discussion: We found varying deprescribing strategies in the literature, which we consolidated in our deprescribing manual. Whether this approach leads to successful deprescribing in family conferences is being investigated in the cluster-randomised controlled COFRAIL study. Plain Language Summary: Development of a manual to help doctors to identify which medications can be withdrawn Many older adults suffer from chronic diseases and take multiple medications concurrently. This can lead to side effects and other undesired events. We developed a manual to help doctors identify which medications can be withdrawn, so that they can discuss this with their patients. This manual was used in the COFRAIL study where doctors, patients and caregivers met in family conferences to discuss their preferences and decide together how future treatments should be handled. The manual contains information on common medications, symptoms and diseases in older patients such as diabetes and high blood pressure. Before the manual was used in the study, it was tested by volunteer patients and their doctors and caregivers to make sure that it is user-friendly.

[Qualification requirements for the re-delegation of medical activities to nursing professionals (with extended competencies)]. / Qualifikationsbedarf für Pflegefachpersonen (mit erweiterten Kompetenzen) bei einer Aufgabenneuverteilung ärztlicher Tätigkeiten.

BACKGROUND: For many years, the redistribution of tasks and thus a transfer of medical activities to nursing professionals with extended competencies has been discussed in Germany and is currently being regulated by the federal government. OBJECTIVES: The aim of this study was to record the opinions of GPs and nurses on the qualification requirements for possible delegable and substitutable medical activities to nurses using the example of outpatient dementia care. METHOD: In the context of a quantitative survey, the qualification requirements for the delegation of 30 different activities to nurses were collected from primary care physicians and nurses. A total of 1,634 questionnaires was distributed. The response rate was 28.0 % (primary care physicians: n=225, and nursing specialists: n=232). The analyses were carried out descriptively using SPSS software (version 25, IBM Corp., 2017). RESULTS: 45.1% of the respondents said they needed additional qualification prior to such a task transfer. This need primarily relates to further training (37.3%). Those seeking a university education (36.2%), will either pursue a Bachelor's (15.6%) or a Master's degree (20.6%) to obtain the necessary qualification. CONCLUSION: The results of this study can help define the activity profiles of academically qualified nursing professionals and inform the development of curricula for their university education. Furthermore, they will support the further development of the legal framework.

[Transfer of Physicians' Tasks to Nurses in the Care of People with Dementia]. / Aufgabenübertragung ärztlicher Tätigkeiten in der Versorgung von Menschen mit Demenz auf Pflegefachpersonen in Substitution und Delegation.

THE AIM OF THE STUDY: A transfer of medical activities to nurses and thus the redistribution of tasks has been discussed for almost 15 years. A legal base for model projects has been enacted. However, clearly defined tasks for substitution are still lacking. The aim of this study was to solicit opinions of general practitioners, nurses, people with dementia (PwD) and their relatives about the possibility of a large number of specific General practitioner (GP) tasks being performed by nurses in outpatient dementia care. METHODS: A mixed-methods study with a sequential in-depth design was conducted. The analysis presented here refers to the quantitative survey of the four participant groups. 865 participants were asked about the acceptance of substitution of assessments, primary and follow-up prescriptions, health monitoring measures and other activities currently performed by physicians. RESULTS: Across all groups of subjects, the highest level of approval for substitution was achieved for the assessment of mobility restrictions, everyday competencies, nutritional abnormalities, prescription of transportation, nursing aids, home nursing services and drawing of blood samples. Among PwD and relatives, the level of acceptance for substitution was very high. 88% of the PwD and relatives indicated that many activities can be substituted while the general practitioner remained their first point of contact. More GPs (63.2%) than nurses (56.7%) would accept the substitution. CONCLUSION: The results indicate that a large number of GPs, nurses, patients and their relatives welcome substitution. However, PwD and relatives have a significantly more positive attitude towards substitution.

[Task sharing in outpatient dementia care - Focus groups with GPs and nurses]. / Aufgabenteilung in der ambulanten Versorgung von Menschen mit Demenz.

Task sharing in outpatient dementia care - Focus groups with GPs and nurses Abstract. Background: Caring for people with dementia (PWD) is challenging for the health system and family carers and can only be managed through interprofessional medical and nursing care. AIM: The AHeaD study investigated attitudes of general practitioners (GPs) and nurses towards the transfer of activities previously performed by GPs to advanced nurses in the outpatient care of PWDs. METHODS: In four focus group discussions with 10 GPs and 13 nurses, qualitative content analysis was used to investigate attitudes towards the transfer of certain tasks and to identify opportunities and barriers to their introduction. RESULTS: GPs primarily preferred the transfer of nursing activities such as blood sampling, assessments, their monitoring or follow-up prescriptions for nursing aids. "Classical" medical tasks (e. g. diagnosis of diseases, initial prescription of medication) are still seen in the hands of GPs. Nurses demanded more appreciation and recognition for the relationship between GPs and nurse and criticised the lack of trust and insufficient communication. Both sides pointed to tight time budgets that were hardly oriented towards the actual needs of the PWD. CONCLUSIONS: The implementation of a redistribution of tasks requires the creation of legal and financial framework conditions, time resources, concrete task descriptions as well as a stronger cooperation between the professional groups involved. Innovative concepts could contribute to the sensible use of the resources GP and nurses and strengthen the care of PWDs.

Shared decision making and patient-centeredness for patients with poorly controlled type 2 diabetes mellitus in primary care-results of the cluster-randomised controlled DEBATE trial.

BACKGROUND: We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? METHODS: We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. RESULTS: Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups. CONCLUSIONS: The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness. TRIAL REGISTRATION: The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571 .

Attitudes towards advanced nursing roles in primary dementia care - Results of an observational study in Germany.

AIMS: To demonstrate the attitudes of general practitioners (GPs), nurses, persons with dementia, and caregiver towards suitable tasks and qualification needs for and the acceptance and impact of advanced nursing roles in German dementia primary care. DESIGN: Observational study using a questionnaire survey with 225 GPs, 232 nurses, 211 persons with dementia, and 197 caregivers, conducted between December 2017-August 2018. METHODS: A questionnaire was generated that includes specific assessment, prescription, and monitoring tasks of advanced nursing roles in dementia primary care as well as qualification requirements for and the acceptance and the impact of advanced nursing roles. Data were analysed using descriptive statistics. Group differences were assessed using the Fisher's exact test. RESULTS: Advanced nursing roles were highly appreciated across all groups. Assessment and monitoring tasks were rated as highly suitable, and prescription authorities as moderately suitable. Nurses felt less confident in assessment and monitoring, but more confident in prescribing as practitioners expected. Patients and caregivers would appreciate a takeover of tasks by nurses; nurses and practitioners preferred a delegation. A dementia-specific qualification was rated as best suitable for advanced nursing roles, followed by 'no specific qualification' if medical tasks that only can be carried out by practitioners were delegated and an academic degree if tasks were substituted. Advanced nursing roles were rated as beneficial, strengthening the confidence in nursing care and improving the cooperation between professionals and the treatment. Practitioners assumed that advanced nursing roles would improve job satisfaction of nurses, which was not confirmed by nurses. CONCLUSION: There is an extended consensus towards the enlargement of advanced nursing roles, represented by high endorsement, acceptance, and willingness to reorganize tasks. IMPACT: Results debunk the common notion that German practitioners would be reluctant towards advanced nursing roles and a takeover of current practitioner tasks, supporting the implementation of advanced nursing roles in Germany.

Use of an electronic decision support tool to reduce polypharmacy in elderly people with chronic diseases: cluster randomised controlled trial.

OBJECTIVE: To evaluate the effects of a computerised decision support tool for comprehensive drug review in elderly people with polypharmacy. DESIGN: Pragmatic, multicentre, cluster randomised controlled trial. SETTING: 359 general practices in Austria, Germany, Italy, and the United Kingdom. PARTICIPANTS: 3904 adults aged 75 years and older using eight or more drugs on a regular basis, recruited by their general practitioner. INTERVENTION: A newly developed electronic decision support tool comprising a comprehensive drug review to support general practitioners in deprescribing potentially inappropriate and non-evidence based drugs. Doctors were randomly allocated to either the electronic decision support tool or to provide treatment as usual. MAIN OUTCOME MEASURES: The primary outcome was the composite of unplanned hospital admission or death by 24 months. The key secondary outcome was reduction in the number of drugs. RESULTS: 3904 adults were enrolled between January and October 2015. 181 practices and 1953 participants were assigned to electronic decision support (intervention group) and 178 practices and 1951 participants to treatment as usual (control group). The primary outcome (composite of unplanned hospital admission or death by 24 months) occurred in 871 (44.6%) participants in the intervention group and 944 (48.4%) in the control group. In an intention-to-treat analysis the odds ratio of the composite outcome was 0.88 (95% confidence interval 0.73 to 1.07; P=0.19, 997 of 1953 v 1055 of 1951). In an analysis restricted to participants attending practice according to protocol, a difference was found favouring the intervention (odds ratio 0.82, 95% confidence interval 0.68 to 0.98; 774 of 1682 v 873 of 1712, P=0.03). By 24 months the number of prescribed drugs had decreased in the intervention group compared with control group (uncontrolled mean change -0.42 v 0.06: adjusted mean difference -0.45, 95% confidence interval -0.63 to -0.26; P<0.001). CONCLUSIONS: In intention-to-treat analysis, a computerised decision support tool for comprehensive drug review of elderly people with polypharmacy showed no conclusive effects on the composite of unplanned hospital admission or death by 24 months. Nonetheless, a reduction in drugs was achieved without detriment to patient outcomes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN10137559.

Family conferences and shared prioritisation to improve patient safety in the frail elderly (COFRAIL): study protocol of a cluster randomised intervention trial in primary care.

BACKGROUND: Frailty in elderly patients is associated with an increased risk of poor health outcomes, including falls, delirium, malnutrition, hospitalisation, and mortality. Because polypharmacy is recognised as a possible major contributor to the pathogenesis of geriatric frailty, reducing inappropriate medication exposure is supposed to be a promising approach to improve health-related quality of life and prevent adverse outcomes. A major challenge for the process of deprescribing of inappropriate polypharmacy is to improve the communication between general practitioner (GPs), patient and family carer. This study investigates the effects of a complex intervention in frail elderly patients with polypharmacy living at home. METHODS: This is a cluster randomised controlled trial including 136 GPs and 676 patients. Patients with a positive clinical screening for frailty are eligible if they are aged 70 years or older, receiving family or professional nursing care at home, and taking in five or more drugs per day. Exclusion criteria are higher grade of dementia and life expectancy of 6 months or less. The GPs of the intervention group receive an educational training promoting a deprescribing guideline and providing information on how to conduct a family conference focussing on prioritisation of treatment goals concerning drug therapy. During the 1-year intervention, GPs are expected to perform a total of three family conferences, each including a structured medication review with patients and their family carers. GPs of the control group will receive no training and will deliver care as usual. Geriatric assessment of all patients will be performed by study nurses during home visits at baseline and after 6 and 12 months. The primary outcome is the hospitalisation rate during the observation period of 12 months. Secondary outcomes are number and appropriateness of medications, mobility, weakness, cognition, depressive disorder, health-related quality of life, activities of daily living, weight, and costs of health care use. DISCUSSION: This study will provide evidence for a pragmatic co-operative and patient-centred educational intervention using family conferences to improve patient safety in frail elderly patients with polypharmacy. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00015055 (WHO International Clinical Trials Registry Platform [ICTRP]). Registered on 6 February 2019.

Reduction of inappropriate medication in older populations by electronic decision support (the PRIMA-eDS project): a survey of general practitioners' experiences.

OBJECTIVE: We sought to investigate the experiences of general practitioners (GPs) with an electronic decision support tool to reduce inappropriate polypharmacy in older patients (the PRIMA-eDS [Polypharmacy in chronic diseases: Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support] tool) in a multinational sample of GPs and to quantify the findings from a prior qualitative study on the PRIMA-eDS-tool. MATERIALS AND METHODS: Alongside the cluster randomized controlled PRIMA-eDS trial, a survey was conducted in all 5 participating study centers (Bolzano, Italy; Manchester, United Kingdom; Salzburg, Austria; Rostock, Germany; and Witten, Germany) between October 2016 and July 2017. Data were analyzed using descriptive statistics and chi-square tests. RESULTS: Ninety-one (n = 160) percent of the 176 questionnaires were returned. Thirty-two percent of the respondents reported that they did not cease drugs because of the medication check. The 68% who had discontinued drugs comprise 57% who had stopped on average 1 drug and 11% who had stopped 2 drugs or more per patient. The PRIMA-eDS tool was found to be useful (69%) and the recommendations were found to help to increase awareness (86%). The greatest barrier to implementing deprescribing recommendations was the perceived necessity of the medication (69%). The majority of respondents (65%) would use the electronic medication check in routine practice if it was part of the electronic health record. CONCLUSIONS: GPs generally viewed the PRIMA-eDS medication check as useful and as informative. Recommendations were not always followed due to various reasons. Many GPs would use the medication check if integrated into the electronic health record.

Patient-centered communication and shared decision making to reduce HbA1c levels of patients with poorly controlled type 2 diabetes mellitus - results of the cluster-randomized controlled DEBATE trial.

BACKGROUND: Does an intervention designed to foster patient-centered communication and shared decision making among GPs and their patients with poorly controlled type 2 diabetes mellitus reduce the level of HbA1c. METHODS: The DEBATE trial is a cluster-randomized controlled trial conducted in German primary care and including patients with type 2 diabetes mellitus having an HbA1c level of 8.0% (64 mmol/mol) or above at the time of recruitment. Data was measured before intervention (baseline, T0), 6-8 months (T1), 12-14 months (T2), 18-20 months (T3), and 24-26 months (T4) after baseline. Main outcome measure is the level of HbA1c. RESULTS: In both, the intervention and the control group the decline of the HbA1c level from T0 to T4 was statistically significant (- 0.67% (95% CI: - 0.80,-0.54%; p < 0.0001) and - 0.64% (95% CI: - 0.78, - 0.51%; p < 0.0001), respectively). However, there was no statistically significant difference between both groups. CONCLUSIONS: Although the DEBATE trial was not able to confirm effectiveness of the intervention tested compared to care as usual, the results suggest that patients with poorly controlled type 2 diabetes are able to improve their blood glucose levels. This finding may encourage physicians to stay on task to regularly approach this cohort of patients. TRIAL REGISTRATION: The trial was registered at ISRCTN registry under the reference ISRCTN70713571 .

[Does place of residence have an influence on shared decision making for patients with type 2 diabetes in general practice?] / Beeinflusst der Wohnort die gemeinsame Entscheidungsfindung in der Hausarztpraxis bei Patienten mit Diabetes mellitus Typ 2?

OBJECTIVE: In the last 20 years, patient involvement in clinical decision-making has continuously gained traction in scientific and clinical (including general practice, GP) discussions. Patients with chronic conditions in particular may benefit from active involvement. Referring to existing studies on shared decision making and regional differences; patients with poorly controlled diabetes mellitus type 2 (DM2) were used as an example to investigate the perceived involvement during clinical decision making in general practice. Differences in treatment options based on the patients' place of residence (East- and West Germany) were compared. METHODS: 501 West- (North-Rhine-Westphalia, NRW) and 338 East-German (Mecklenburg-Western Pomerania, MWP) patients with DM2 and HbA1c levels≥8.0 were assessed during the cluster-randomised controlled trial DEBATE, which was conducted between 2011 and 2012. The questionnaire to measure participatory decision making (Q-PDM) was used in order to provide an estimate of their involvement in clinical decision making processes, and baseline data was analysed before intervention. The standardised Q-PDM summed value was compared among the different subgroups (i. e., place of residence, age, sex) using bivariate group analyses (t tests), and a multivariate regression analysis was conducted. RESULTS: Patients living in the MWP region perceived a higher level of involvement in GP decision making than NRW residents. Younger patients with DM2 showed higher Q-PDM summed values than older patients. When all variables, including 'GP practice' (number of patients per GP/cluster), were considered together in the multivariate regression analysis, the place of residence would no longer show an independent effect on perceived decision making. The expected difference between MWP and NRW (i. e. East/West Germany) could not be confirmed, while a significant difference remained with regard to age. Education, population density, sex and marital status did not show any relevant differences. CONCLUSION: Patient age remains an important factor influencing the perceived involvement in joint decision making and should be taken into account while implementing clinical decision making processes in the future. It is possible that patients of different age and with different chronic diseases may need different decision support offerings (e. g., educational videos, booklets or computer-based decision aids). Trainings in communication skills or in the implementation of patient-centred communication might be effective on the GP level to reduce possible barriers to shared decision making.

Polypharmacy in older patients with chronic diseases: a cross-sectional analysis of factors associated with excessive polypharmacy.

BACKGROUND: Polypharmacy is common in older people and associated with potential harms. The aim of this study was to analyse the characteristics of an older multimorbid population with polypharmacy and to identify factors contributing to excessive polypharmacy in these patients. METHODS: This cross-sectional analysis is based on the PRIMA-eDS trial, a large randomised controlled multicentre study of polypharmacy in primary care. Patients' baseline data were used for analysis. A number of socioeconomic and medical data as well as SF-12-scores were entered into a generalized linear mixed model to identify variables associated with excessive polypharmacy (taking ≥10 substances daily). RESULTS: Three thousand nine hundred four participants were recruited. Risk factors significantly associated with excessive polypharmacy were frailty (OR 1.45; 95% CI 1.22-1.71), > 8 diagnoses (OR 2.64; 95% CI 2.24-3.11), BMI ≥30 (OR 1.18; 95% CI 1.02-1.38), a lower SF-12 physical health composite score (OR 1.47; 95% CI 1.26-1.72), and a lower SF-12 mental health composite score (OR 1.33; 95% CI 1.17-1.59) than the median of the study population (≤36.6 and ≤ 48.7, respectively). Age ≥ 85 years (OR 0.83; 95% CI 0.70-0.99) led to a significantly lower risk for excessive polypharmacy. No association with excessive polypharmacy could be found for female sex, low educational level, and smoking. Regarding the study centres, being recruited in the UK led to a significantly higher risk for excessive polypharmacy compared to being recruited in Germany 1/Rostock (OR 1.71; 95% CI 1.27-2.30). Being recruited in Germany 2/Witten led to a slightly significant lower risk for excessive polypharmacy compared to Germany 1/Rostock (OR 0.74; 95% CI 0.56-0.97). CONCLUSIONS: Frailty, multimorbidity, obesity, and decreased physical as well as mental health status are risk factors for excessive polypharmacy. Sex, educational level, and smoking apparently do not seem to be related to excessive polypharmacy. Physicians should especially pay attention to their frail, obese patients who have multiple diagnoses and a decreased health-related quality of life, to check carefully whether all the drugs prescribed are evidence-based, safe, and do not interact in an unfavourable way. TRIAL REGISTRATION: This trial has been registered with Current Controlled Trials Ltd. on 31 July 2014 (ISRCTN10137559).

Perceptions of interprofessional collaboration of general practitioners and community pharmacists - a qualitative study.

BACKGROUND: Despite numerous evidences for the positive effect of community pharmacists on health care, interprofessional collaboration of pharmacists and general practitioners is very often limited. Though highly trained, pharmacists remain an underutilised resource in primary health care in most western countries. This qualitative study aims at investigating pharmacists' and general practitioners' views on barriers to interprofessional collaboration in the German health care system. METHODS: A total of 13 narrative in-depth interviews, and two focus group discussions with 12 pharmacists and general practitioners in Mecklenburg-Western Pomerania, a predominantly rural region of North-Eastern Germany, were conducted. The interviews aimed at exploring general practitioners' and pharmacists' attitudes, views and experiences of interprofessional collaboration. At a second stage, two focus group discussions were performed. Fieldwork was carried out by a multi-professional team. All interviews and focus group discussions were audio taped and transcribed verbatim. The constant comparative method of analysis from grounded theory was applied to the data. RESULTS: There are three main findings: First, mutual trust and appreciation appear to be important factors influencing the quality of interprofessional collaboration. Second, in light of negative personal experiences, pharmacists call for a predefined, clear and straightforward way to communicate with physicians. Third, given the increasing challenge to treat a rising number of elderly patients with chronic conditions, general practitioners desire competent support of experienced pharmacists. CONCLUSIONS: On the ground of methodological triangulation the findings of this study go beyond previous investigations and are able to provide specific recommendations for future interprofessional collaboration. First, interventions and initiatives should focus on increasing trust, e.g. by implementing multi-professional local quality circles. Second, governments and health authorities in most countries have been and still are reluctant in advancing political initiatives that bring together physicians and pharmacists. Proactive lobbying and empowerment of pharmacists are extremely important in this context. In addition, future physician and pharmaceutical training curricula should focus on comprehensive pharmacist-physician interaction at early stages within both professional educations and careers. Developing and fostering a culture of continued professional exchange and appreciation is one major challenge of future policy and research.

[Approaches of general practitioners and patients to multimorbidity. Qualitative study]. / Multimorbidität aus Hausarzt- und Patientensicht. Qualitative Studie.

BACKGROUND: For general practioners (GP) the treatment of patients suffering from multimorbidity is an everyday challenge. For these patients guidelines which each focus on a specific chronic disease cannot be applied comprehensively and equally; therefore, it is necessary to prioritize. OBJECTIVE: Given this situation the study aimed at analyzing how GPs and patients deal with this challenge and what their priorities are. MATERIAL AND METHODS: Narrative interviews were conducted with 9 GPs and 19 of their multimorbid patients. The data were analyzed by means of content analysis. RESULTS: The majority of interviewed patients felt well or very well cared for by their GPs; however, GPs and multimorbid patients often had relatively different priorities. Whereas GPs mostly focused on the management of diseases that could lead to life-threatening situations, patients put an emphasis on maintaining autonomy and a social life. CONCLUSION: The results of this study suggest that there is room for development in the way GPs and multimorbid patients communicate with each other, particularly as far as shared priority setting is concerned.

Optimizing polypharmacy among elderly hospital patients with chronic diseases--study protocol of the cluster randomized controlled POLITE-RCT trial.

BACKGROUND: Treatment of patients with multimorbidity is challenging. A rational reduction of long-term drugs can lead to decreased mortality, less acute hospital treatment, and a reduction of costs. Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence. The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients. The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based, patient-centered medication review prior to the patient's discharge from hospital. METHODS: The POLITE-RCT trial is a cluster randomized controlled trial. Two major secondary health care providers of Mecklenburg-Western Pomerania, Germany, take part in the study. Clusters are wards of both medical centers. All wards where patients with chronic diseases and multimorbidity are regularly treated will be included. Patients aged 65+ years who take five or more prescribed long-term drugs and who are likely to spend at least 5 days in the participating hospitals will be recruited and included consecutively. Cluster-randomization takes place after a six-month baseline data collection period. Patients of the control group receive care as usual. The independent two main primary outcomes are (1) health-related quality of life (EQ-5D) and (2) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group. The secondary outcomes are appropriateness of prescribed medication (PRISCUS list, Beers Criteria, MAI), patient satisfaction (TSQM), patient empowerment (PEF-FB-9), patient autonomy (IADL), falls, re-hospitalization, and death. The points of measurement are at admission to (T0) and discharge from hospital (T1) as well as 6 and 12 months after discharge from the hospital (T2 and T3). In 42 wards, 1,626 patients will be recruited. DISCUSSION: In case of positive evaluation, the proposed study will provide evidence for a sustainable reduction of polypharmacy by enhancing patient-centeredness and patient autonomy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN42003273.

Improvement of primary health care of patients with poorly regulated diabetes mellitus type 2 using shared decision-making--the DEBATE trial.

BACKGROUND: Since 2004, a national Disease Management Program (DMP) has been implemented in Germany, which includes educational measures aimed at patients with type-2 diabetes (T2D). However, about 15-20% of T2D patients remain in poor metabolic control. Qualitative research shows that one reason for this might be an increasing frustration of general practitioners (GPs) with the management of their poorly regulated T2D patients over time. We aim at approaching this problem by improving the GP-patient-communication and fostering shared decision-making. METHODS/DESIGN: An educative intervention will be tested within a multi-centred cluster-randomized controlled trial (RCT) in Germany. We include 20 GPs in three regions. Each of the 60 GPs will recruit about 13 patients meeting the inclusion criteria (total of 780 patients). GPs allocated to the intervention group will receive a peer-visit from a specifically trained GP-colleague who will motivate them to apply patient-centred communication techniques including patient-centred decision aids. GPs allocated to the control group will not take part in any intervention program, but will provide care as usual to their patients. The primary inclusion criterion for patients at the time of the recruitment is an HbA1c-level of over 8.0. Primary outcome is the change of HbA1c at 6, 12, 18, and 24 months compared to HbA1c at baseline. Secondary outcomes include patient's participation in the process of shared decision-making and quality of life. DISCUSSION: If this intervention proves to be effective it may be integrated into the existing Disease Management Program for T2D in Germany.