Informed Decision-Making with and for People with Dementia-Efficacy of the PRODECIDE Education Program for Legal Representatives: A Randomized Controlled Trial (PRODECIDE-RCT) and Process Evaluation.

Legal representatives take a major role in healthcare decisions with and for people with dementia, but only a minority has a qualification in this field. The aim was to evaluate the efficacy of the PRODECIDE education program for legal representatives. In a prospective randomized controlled trial, legal representatives (volunteers and professionals, representing at least one person with dementia) were allocated (1:1 computer-generated block randomization) to the intervention (PRODECIDE education program) and control (standard care) groups. The primary outcome measure was knowledge, operationalized as the understanding of decision-making processes and in setting realistic expectations. Only data entry and analyses were blinded. A process evaluation in a mixed methods design was performed. We enrolled 218 legal representatives, and 216 were included in the primary analysis (intervention n = 109, control n = 107). The percentage of correct answers in the knowledge test post intervention was 69.0% in the intervention and 43.4% in the control group (difference 25.6%; CI 95%, 21.3 to 29.8; p < 0.001). In the comparison of professional and voluntary representatives, professionals had 13.6% (CI 95%, 8.0 to 19.2; p < 0.001) more correct answers. The PRODECIDE education program can improve the knowledge of legal representatives, an important prerequisite for evidence-based, informed decision-making.

Intervention for sleep problems in nursing home residents with dementia: a cluster-randomized study.

OBJECTIVE: To reduce sleep problems in people living with dementia using a multi-component intervention. DESIGN: Cluster-randomized controlled study with two parallel groups and a follow-up of 16 weeks. SETTING: Using external concealed randomization, 24 nursing homes (NH) were allocated either to the intervention group (IG, 12 clusters, 126 participants) or the control group (12 clusters, 116 participants). PARTICIPANTS: Participants were eligible if they had dementia or severe cognitive impairment, at least two sleep problems, and residence of at least two weeks in a NH. INTERVENTION: The 16-week intervention consists of six components: (1) assessment of sleep-promoting activities and environmental factors in NHs, (2) implementation of two "sleep nurses," (3) basic education, (4) advanced education for staff, (5) workshops to develop sleep-promoting concepts, and (6) written information and education materials. The control group (CG) received standard care. MEASUREMENTS: Primary outcome was ≥ two sleep problems after 16 weeks assessed with the Sleep Disorders Inventory (SDI). RESULTS: Twenty-two clusters (IG = 10, CG = 12) with 191 participants completed the study. At baseline, 90% of people living with dementia in the IG and 93% in the CG had at least two sleep problems. After 16 weeks, rates were 59.3% (IG) vs 83.8% (CG), respectively, a difference of -24.5% (95% CI, -46.3% - -2.7%; cluster-adjusted odds ratio 0.281; 95% CI 0.087-0.909). Secondary outcomes showed a significant difference only for SDI scores after eight and 16 weeks. CONCLUSIONS: The MoNoPol-Sleep intervention reduced sleep problems of people living with dementia in NH compared to standard care.

Epidemiology of distal radius fractures in Germany - incidence rates and trends based on inpatient and outpatient data.

We examined incidence rates (IR) for all distal radius fracture (DRF) events based on inpatient and outpatient data from a large statutory health insurance in Germany. Of all DRF, 56% were treated as inpatients, and thus, 44% treated as outpatients. IR were higher in women than in men. PURPOSE: Although a distal radius fracture (DRF) is one of the most common fractures in the elderly population, epidemiological data are limited. Many studies examine only hospitalized patients, do not analyze time trends, or include only small populations. In this retrospective population-based observational study, routine data on inpatient and outpatient care of persons aged ≥ 60 years insured by a large statutory health insurance in Germany were analyzed from 2014 to 2018. METHODS: DRF were identified by ICD-10 codes. All DRF events of an individual were considered with a corresponding individual washout period. Incidence rates (IR) and time trends were estimated assuming a Poisson distribution per 100,000 person-years, with 95% confidence intervals [95% CI] and age-sex standardization to the German population in 2018. Associations of calendar year, age, sex, and comorbidity with IR were examined using Poisson regression estimating incidence rate ratios (IRR) with CI. RESULTS: The study population consists of 974,332 insured individuals, with 16,557 experiencing one or more DRF events during the observation period. A total of 17,705 DRF events occurred, of which 9961 (56.3%) were hospitalized. Standardized IR were 439 [424-453] (inpatient: 240 [230-251], outpatient: 199 [189-209]) in 2014 and 438 [423-452] (inpatient: 238 [227-249], outpatient: 200 [190-210]) in 2018. Female sex, older age, and comorbidity were associated with higher IR and adjusted Poisson regression showed no significant time trend (IRR overall 0.994 [0.983-1.006]). CONCLUSION: A relevant proportion of DRF were treated in outpatient settings, so both inpatient and outpatient data are necessary for a valid estimate.

Effects of advance care planning in care dependent community-dwelling older persons (STADPLAN): A cluster-randomised controlled trial.

BACKGROUND: Most randomised controlled trials on advance care planning were conducted in people with advanced, life-limiting illnesses or in institutional settings. There are few studies on its effect in older people living in the community. AIM: To determine the effects of advance care planning in older community dwelling people. DESIGN: The STADPLAN study was a cluster-randomised trial with 12 months follow-up. The complex intervention comprised a 2-days training for nurse facilitators that delivered a formal advance care planning counselling and a written information brochure. Patients in the control group received optimised usual care, that is, provision of a short information brochure. SETTING/PARTICIPANTS: Home care services in three regions of Germany were randomised using concealed allocation. Care dependent clients of participating home care services, aged 60 years or older, and rated to have a life-expectancy of at least 4 weeks were included. Primary outcome was active participation in care at 12 months, assessed by blinded investigators using the Patient Activation Measure (PAM-13). RESULTS: Twenty-seven home care services and 380 patients took part. Three hundred seventy-three patients were included in the primary analysis (n = 206 in the intervention and n = 167 in the control group). There was no statistically significant difference between the intervention and control group with regard to the PAM-13 after 12 months (75.7 vs 78.4; p = 0.13). No differences in quality of life, anxiety and depression, advance care planning engagement, and in proportion of participants with advance directives were found between groups. CONCLUSIONS: The intervention showed no relevant effects on patient activation or quality of life in community dwelling older persons, possibly indicating the need for more tailored interventions. However, results are limited by a lack of statistical power. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886.

Effect of alternatively designed hospital birthing rooms on the rate of vaginal births: Multicentre randomised controlled trial Be-Up.

BACKGROUND: There is limited research into the effects of the birth environment on birth outcomes. AIM: To investigate the effect of a hospital birthing room designed to encourage mobility, self-determination and uptake of upright maternal positions in labour on the rate of vaginal births. METHODS: The multicentre randomised controlled trial Be-Up, conducted from April 2018 to May 2021 in 22 hospitals in Germany, included 3719 pregnant women with a singleton pregnancy in cephalic position at term. In the intervention birthing room, the bed was removed or covered in a corner of the room and materials were provided to promote upright maternal positions, physical mobility and self-determination. No changes were made in the control birthing room. The primary outcome was probability of vaginal births; secondary outcomes were episiotomy, perineal tears degree 3 and 4, epidural anaesthesia, "critical outcome of newborns at term", and maternal self-determination (LAS). ANALYSIS: intention-to-treat. FINDINGS: The rate of vaginal births was 89.1 % (95 % CI 87.5-90.4%; n = 1836) in the intervention group and 88.5 % (95 % CI 87.0-89.9 %; n = 1863) in the control group. The risk difference in the probability of vaginal birth was + 0.54 % (95 % CI - 1.49 % to 2.57 %), the odds ratio was 1.06 (95 % CI 0.86-1.30). Neither the secondary endpoints nor serious adverse events showed significant differences. Regardless of group assignment, there was a significant association between upright maternal body position and maternal self-determination. CONCLUSION: The increased vaginal birth rates in both comparison groups can be explained by the high motivation of the women and the staff.

Prevention of physical restraints in the acute care setting (PROTECT): study protocol for a cluster-randomised controlled pilot study.

INTRODUCTION: Physical restraints (PR) are regularly used in acute care settings, although evidence for their effectiveness and safety (eg, for prevention of falls) is lacking. Their use is associated with adverse events, such as decreased mobility and injuries for patients. We developed a complex intervention to prevent PR in acute care settings according to the UK Medical Research Council Framework, and investigated the feasibility. The intervention comprised the qualification of key nurses as multipliers and a short interprofessional information session. The intervention has proven to be feasible. It also became apparent that further development of the intervention and the study procedures is necessary. Therefore, this study aims to refine and pilot the complex intervention. Furthermore, the objective of this pilot study is to improve study procedures. METHODS AND ANALYSIS: In a preparatory phase, we will conduct focus groups and individual interviews with the target groups to explore the possibilities for adaption of the intervention and implementation strategies. Subsequently, a cluster-randomised controlled trial with a 6-month follow-up period will be conducted. It is planned to recruit eight general hospitals in Germany (area of Halle (Saale) and Leipzig) with 28 wards and 924 patients per observation period (2772 overall). Primary outcome is the proportion of patients with at least one PR after 6 months. Data will be collected by direct observation over a period of seven consecutive days and three times a day. Secondary outcomes are falls, interruptions in therapy and prescription of psychotropic medication. A comprehensive process evaluation will accompany the study. ETHICS AND DISSEMINATION: The Ethics committee of the Medical Faculty of the University of Halle (Saale) approved the study protocol. Results will be published in a peer-reviewed journal and presented at conferences. Study information and additional material will be freely available on an already existing website. TRIAL REGISTRATION NUMBER: DRKS00027989.

Postpartum screening of women with GDM in specialised practices: Data from 12,991 women in the GestDiab register.

BACKGROUND: Gestational diabetes (GDM) in the short term is associated with various complications during pregnancy; however, in the long run, women have an increased risk of type 2 diabetes mellitus (T2DM). Therefore, short- and long-term follow-up postpartum is recommended. METHODS: We assessed the proportion of postpartum diabetes screening among 12,991 women with their first GDM-diagnosed pregnancy in the study period in the nationwide German GestDiab register between 2015 and 2017. In addition to assessing prevalence, we assessed if the probability of postpartum screening was associated with maternal characteristics or pregnancy outcomes. RESULTS: In total, 38.2% (95% CI 32.8%-43.7%) of our sample underwent postpartum diabetes screening, irrespective of its timing. Around 50% of women (19.3% of the total sample) undertook the screening in the recommended time frame of 6-12 weeks postpartum. We found that age, native language, pre-pregnancy BMI, smoking status, number of previous pregnancies, fasting plasma glucose and HbA1c levels as well as previous pregnancies with GDM and treatment with insulin were associated with participation in the postpartum diabetes screening in our sample. CONCLUSION: In our study, more than 60% of the women with GDM did not participate in postpartum diabetes screening. This is a missed opportunity in a high-risk population to detect glucose intolerance. Consequently, appropriate interventions to prevent the progression to T2DM cannot be initiated. Further research should investigate barriers and enabling factors and allow developing a multilevel approach for GDM postpartum care.

An Integrated Psychosomatic Treatment Program for People with Diabetes (psy-PAD).

BACKGROUND: Many people with diabetes have permanently elevated blood sugar concentrations and a high level of diabetes-related psychological stress, also called "diabetes distress." In clinical practice, diabetes distress is often an impediment to successful self-management. psy-PAD is a psychodynamically oriented short-term therapy program whose goal is to reduce diabetes distress and improve glycemic control. METHODS: A randomized controlled trial was conducted with 143 patients with either type 1 or type 2 diabetes who were being treated in eleven specialized diabetological practices. psy-PAD in the intervention group (eight sessions) was compared with optimized standard care as the control condition. The inclusion criteria were HbA1c ≥ 7.5% combined with diabetes distress (PAID >35, or doctor's determination). The primary endpoint was the HbA1c at six months (t1). Diabetes-related distress (PAID), depressive symptoms (HADS-D, PHQ-9), anxiety symptoms (HADS-A), health-related quality of life (SF-36), panic (short form of the PHQ-D), body mass index (BMI), and triglyceride levels were secondary endpoints. Follow-ups were conducted at six (t1) and 12 months (t2) (trial registration: DRKS00003247). RESULTS: The intergroup comparison at t1 revealed a significant, clinically relevant reduction of HbA1c by -0.53 percentage points (95% confidence interval [-0.89; -0.16], p = 0.005). The secondary analyses revealed relevant differences in the point estimators for diabetes distress at t1 and t2, depressive symptoms at t2 and BMI at t1. CONCLUSION: For people with diabetes and diabetes distress who do not achieve satisfactory glycemic control despite intensive treatment in specialized diabetological practices, integrated psychosomatic-psychotherapeutic treatment can lower blood sugar levels over the intermediate term and also reduce diabetes distress and depressive symptoms over a one-year period.

Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial.

BACKGROUND: Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehensive support services for affected families. The aim of this project is to implement and evaluate a complex psychosocial intervention for these families by providing advice, information, and care on an emotional, psycho-social, and communicative level during and after the cancer experience and across healthcare sectors. METHODS: Family-SCOUT is a project supported by the German Innovation Fund ( https://innovationsfonds.g-ba.de/ ). The evaluation is based on a mixed-methods quasi-experimental design with the intervention and control groups. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months of follow-up; T2: 9 months of follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. The study aim is to include n=560 families. Data will be analyzed according to the intention-to-treat principle. The primary analysis is the comparison of the Hospital Anxiety and Depression Scale (HADS) response rates (minimal important difference (MID) ≥ 1.6 in at least one of the two parents) at T2 between the intervention and control group using Fisher's exact test. The conduct of the study as well as the development and implementation of the intervention will be accompanied by comprehensive study monitoring following the principles of an effectiveness-implementation hybrid study. DISCUSSION: The results will allow to test the effectiveness and efficiency of the intervention for the target group. The first experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as the basis to assess the need of including the intervention in the catalog of services of the statutory health insurance funds in Germany. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04186923. Retrospectively registered on 4 December 2019.

High Depressive Symptoms in Previously Undetected Diabetes - 10-Year Follow-Up Results of the Heinz Nixdorf Recall Study.

AIM: To determine the 10-year cumulative incidence of high depressive symptoms in people with diagnosed and, in particular, previously undetected diabetes compared to those without diabetes in a population-based cohort study in Germany. MATERIALS AND METHODS: We included 2813 participants (52.9% men, mean age (SD) 58.9 (7.7) years, 7.1% diagnosed diabetes, 5.6% previously undetected diabetes) from the Heinz Nixdorf Recall study. We calculated the odds ratios (OR) with 95% confidence intervals (CI) using multiple logistic regression analyses for diagnosed and undetected diabetes. RESULTS: Cumulative 10-year incidences (95%-CI) of high depressive symptoms in participants with diagnosed diabetes, previously undetected diabetes, and without diabetes were 15.4% (10.7-21.2), 10.1% (5.9-15.9), and 12.4% (11.1-13.8), respectively. Age-sex-adjusted ORs were 1.51 (1.01-2.28) in participants with diagnosed diabetes compared to those without, 1.40 (0.92-2.12) after adjustment for BMI, physical activity, education, and smoking, and 1.33 (0.87-2.02) after further adjustment for stroke and myocardial infarction. ORs in participants with previously undetected diabetes were 0.96 (0.56-1.65), 0.85 (0.49-1.47), and 0.85 (0.49-1.48), respectively, and lower in men than in women. CONCLUSION: As expected, we found an increased odds of developing high depressive symptoms in participants with diagnosed diabetes. However, the odds ratios decreased when we considered comorbidities and other covariates. Interestingly, in participants with previously undetected diabetes, the odds was not increased, even 10 years after detection of diabetes. These results support the hypothesis that high depressive symptoms develop due to diabetes-related burdens and comorbidities and not due to hyperglycemia or hyperinsulinemia.

Evaluation of a multi-component, non-pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol-sleep): study protocol for a cluster-randomized exploratory trial.

BACKGROUND: Sleep problems are highly prevalent in people with dementia. Nevertheless, there is no "gold standard" intervention to prevent or reduce sleep problems in people with dementia. Existing interventions are characterized by a pronounced heterogeneity as well as insufficient knowledge about the possibilities and challenges of implementation. The aim of this study is to pilot and evaluate the effectiveness of a newly developed complex intervention to prevent and reduce sleep problems in people with dementia living in nursing homes. METHODS: This study is a parallel group cluster-randomized controlled trial. The intervention consists of six components: (1) the assessment of established sleep-promoting interventions and an appropriate environment in the participating nursing homes, (2) the implementation of two "sleep nurses" as change agents per nursing home, (3) a basic education course for nursing staff: "Sleep problems in dementia", (4) an advanced education course for nursing staff: "Tailored problem-solving" (two workshops), (5) workshops: "Development of an institutional sleep-promoting concept" (two workshops with nursing management and sleep nurses) and (6) written information and education material (e.g. brochure and "One Minute Wonder" poster). The intervention will be performed over a period of 16 weeks and compared with usual care in the control group. Overall, 24 nursing homes in North, East and West Germany will be included and randomized in a 1:1 ratio. The primary outcome is the prevalence of sleep problems in people with dementia living in nursing homes. Secondary outcomes are quality of life, quality of sleep, daytime sleepiness and agitated behavior of people with dementia, as well as safety parameters like psychotropic medication, falls and physical restraints. The outcomes will be assessed using a mix of instruments based on self- and proxy-rating. A cost analysis and a process evaluation will be performed in conjunction with the study. CONCLUSIONS: It is expected that the intervention will reduce the prevalence of sleep problems in people with dementia, thus not only improving the quality of life for people with dementia, but also relieving the burden on nursing staff caused by sleep problems. TRIAL REGISTRATION: Current controlled trials: ISRCTN36015309 . Date of registration: 06/11/2020.

Thoughts about health and patient-reported outcomes among people with diabetes mellitus: results from the DiaDec-study.

BACKGROUND: There is considerable evidence that repetitive negative thoughts are often associated with adverse health outcomes. The study aims are (i) to identify the frequency and valence of thoughts about health in people with diabetes mellitus using questions based on the day reconstruction method (DRM) and (ii) to analyse associations between thoughts about health and health-related quality of life (HRQoL), diabetes-related distress and depressive symptoms. METHODS: Cross-sectional study of a random sample of a German statutory health insurance population with diabetes aged between 18 and 80 linking questionnaire and claims data. Associations between frequency and valence of thoughts about health on a previous day and HRQoL assessed by a 12-Item Short-Form Health Survey, diabetes-related distress assessed using the Problem Areas in Diabetes scale and depressive symptoms assessed by Patient Health Questionnaire-9 were analysed using linear and logistic regression analysis, adjusting for sociodemographic and clinical characteristics. RESULTS: Thoughts about health were analysed in 726 participants (86% type 2 diabetes, 62% male, mean age 67.6 ± 9.7 years). A total of 46% had not thought about their health the day before, 17.1% reported low frequency and negative thoughts, 21.4% low frequency and positive thoughts, 12.1% high frequency and negative thoughts and 3.4% high frequency and positive thoughts. The presence of thoughts about health irrespective of their frequency and valence is associated with a lower physical and mental component summary score of the 12-Item Short-Form Health Survey. Negative thoughts are associated with high diabetes-related distress. Frequent or negative thoughts are associated with depressive symptoms. CONCLUSIONS: Thoughts about health are a part of everyday life for a substantial number of people with diabetes. Surprisingly, even positive thoughts are associated with poorer HRQoL in our study. Further research within the DRM paradigm is needed to understand how thoughts about health may affect people's (assessment of) state of health. Thoughts about health should be considered in diabetes education and patient counselling with a view to preventing and treating emotional disorders. More attention should be paid to the outcomes of interventions that may themselves lead to an increase in the frequency of thoughts about health.

New prescription of antihyperglycemic agents among patients with diabetes in Germany: Moderate concordance between health insurance data and self-reports.

PURPOSE: To analyze the concordance of new prescription of antihyperglycemic agents between two data sources: patients' self-reports and statutory health insurance (SHI) data among patients with diabetes. METHODS: Within a cross-sectional study, 494 patients with diabetes were interviewed if and which new prescriptions of diabetes medication they received within the last 3 or 6 months. SHI data for 12 months were linked to cover these periods. For the agreement measurement, SHI data was set as reference, and kappa, positive predictive value (PPV), and sensitivity were calculated for single Anatomical Therapeutic Chemical (ATC) codes and cumulated code groups. RESULTS: The number of new prescriptions within 3 or 6 months was low, with 5.5% (n = 27) for Metformin/self-report being the highest. Contingency tables were unbalanced and showed large numbers in the no/no-cells. Regarding non-agreement, we found new prescriptions slightly more often in SHI data only than in self-reports only, with insulin and metformin representing an exception. Agreement results were moderate with large confidence intervals (CI). The values for cumulated "all drugs in diabetes" were: kappa = 0.58 (95% CI: 0.51-0.65), PPV = 62.0 (53.4-70.2), sensitivity = 55.6 (47.3-63.6). CONCLUSIONS: Patients reported a low number of new prescriptions within the last 3 or 6 months. In general we found moderate agreement and in case of non-agreement that self-report no/SHI yes was slightly more frequent than vice versa. These results were based on small case numbers, but could nevertheless be considered when collecting self-reported information on the prescription of antihyperglycemic agents.

Cumulative long-term recurrence of diabetic foot ulcers in two cohorts from centres in Germany and the Czech Republic.

AIMS: Our aim was to comprehensively estimate the incidence of diabetic foot ulcer (DFU) recurrence and corresponding risk factors in two cohorts. METHODS: Prospective data from patients with active DFU from two diabetes centres in Germany (GER, n = 222) and the Czech Republic (CZ, n = 99) were analysed. Crude cumulative incidences were obtained. Additionally, time to recurrence and risk factors were investigated using multivariate Cox models. RESULTS: 69%(154) of patients in GER and 70%(69) in CZ experienced at least one DFU recurrence; 25%(56) in DEU and 15%(15) in CZ died; 5%(11) and 9%(9) were lost to follow-up. The crude cumulative incidence in the first year was 28% in GER and 25% in CZ; 68%/70% within ten years, and 69%/70% in 15 years. In GER, renal replacement therapy was associated with shorter time to recurrence (HR = 3.71, 95%CI:1.26-10.87); no history of DFU before the index lesion with longer time to recurrence (HR = 0.62, 0.42-0.92). In CZ, type 2 diabetes (HR = 2.57, 1.18-5.62) and index ulcer treatment by minor amputation (HR = 2.11, 1.03-4.33) were associated with shorter time to recurrence. CONCLUSIONS: Cumulative DFU recurrence was approximately 70% in 15 years in both cohorts. We found a significantly higher risk of future recurrence in patients having a consecutive ulcer compared with the first ever ulcer.

Efficacy of a training programme to support the application of the guideline evidence-based health information: study protocol of a randomised controlled trial.

BACKGROUND: The evidence-based guideline entitled guideline evidence-based health information emerged from the German Network for Evidence-based Medicine (DNEbM) and was published in February 2017. The guideline addresses providers of health information and its goal is to improve the quality of health information. In addition, we explored the competences of providers of health information and developed a training programme. The aim of this study is to evaluate the efficacy of a training programme addressing providers of health information to support the application of the guideline evidence-based health information. We expected the intervention to improve the quality of health information in comparison to the provision of the guideline on its own. METHODS/DESIGN: The trial uses a superiority randomised control group design with 10 months' follow-up. Twenty-six providers of health information (groups with up to ten members) will be enrolled to compare the intervention (guideline and training programme) with usual care (a publicly available guideline). The 5-day training programme comprises an evidence-based medicine training module and a module to prepare the application of the guideline. The primary outcome parameter is the quality of the health information. Quality is operationalised as the extent of adherence to the guideline's recommendations. Each provider will prepare a single health information item informing a health-related decision on a topic freely chosen before randomisation. The quality of this information will be rated using the Mapping Health Information Quality (MAPPinfo) Checklist. An accompanying process evaluation will then be conducted. DISCUSSION: The study results should show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers' competences in evidence-based medicine and to ensure high-quality evidence-based health information (EBHI) in the long term. TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN96941060. Registered on 7 March 2019.

Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial.

BACKGROUND: In Germany, advance care planning (ACP) was first introduced by law in 2015. However, ACP is still uncommon in Germany and only few people have advance directive forms. This study aims to evaluate an ACP program in care dependent community-dwelling persons, compared to optimised usual care. METHODS: A cluster-randomised controlled trial of 12 months duration will be conducted in 3 German study sites comparing the pretested ACP-counselling offered by trained nurses with a control group receiving optimised usual care. Using external concealed randomisation, 16 home care services each will be included in the intervention and the control group (30 participants per cluster; n = 960). Eligibility criteria for patients are: ≥60 years, somehow care dependent, adequate German language skills, assumed life-expectancy of ≥4 weeks, and cognitive ability for participation. ACP will be delivered by trained nurse facilitators of the respective home care services and communication will include proxy decision-makers. The primary endpoint will be patient activation, assessed by the Patient Activation Measure (PAM-13). Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety. Further, comprehensive economic and process evaluations will be conducted. DISCUSSION: STADPLAN is the first study in Germany that assesses an adapted ACP intervention with trained nurses in home care services and the first international study focusing on cost effectiveness of ACP in community-dwelling older persons. The results will help to improve the understanding and communicating of patients' preferences regarding medical treatment and care and thereby contribute to patients' autonomy. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 (Date of registration: 04.06.2019).

Healthcare provision, functional ability and quality of life after proximal femoral fracture - 'ProFem': Study protocol of a population-based, prospective study based on individually linked survey and statutory health insurance data.

INTRODUCTION: Proximal femoral fractures (PFF) are among the most frequent fractures in older people. However, the situation of people with a PFF after hospital discharge is poorly understood. Our aim is to (1) analyse healthcare provision, (2) examine clinical and patient-reported outcomes (PROs), (3) describe clinical and sociodemographic predictors of these and (4) develop an algorithm to identify subgroups with poor outcomes and a potential need for more intensive healthcare. METHODS AND ANALYSIS: This is a population-based prospective study based on individually linked survey and statutory health insurance (SHI) data. All people aged minimum 60 years who have been continuously insured with the AOK Rheinland/Hamburg and experience a PFF within 1 year will be consecutively included (SHI data analysis). Additionally, 700 people selected randomly from the study population will be consecutively invited to participate in the survey. Questionnaire data will be collected in the participants' private surroundings at 3, 6 and 12 months after hospital discharge. If the insured person considers themselves to be only partially or not at all able to take part in the survey, a proxy person will be interviewed where possible. SHI variables include healthcare provision, healthcare costs and clinical outcomes. Questionnaire variables include information on PROs, lifestyle characteristics and socioeconomic status. We will use multiple regression models to estimate healthcare processes and outcomes including mortality and cost, investigate predictors, perform non-responder analysis and develop an algorithm to identify vulnerable subgroups. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the Faculty of Medicine, Heinrich-Heine-University Düsseldorf (approval reference 6128R). All participants including proxies providing written and informed consent can withdraw from the study at any time. The study findings will be disseminated through scientific journals and public information. TRIAL REGISTRATION NUMBER: DRKS00012554.

Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial.

BACKGROUND: Despite clear evidence for the lack of effectiveness and safety, physical restraints are frequently applied in nursing homes. Multicomponent interventions addressing nurses' attitudes and organizational culture have been effective in reducing physical restraints. OBJECTIVE: To evaluate the effectiveness of two versions of a guideline and theory-based multicomponent intervention to reduce physical restraints in nursing homes. DESIGN: Pragmatic cluster randomized controlled trial. SETTING: The study was conducted in 120 nursing homes in four regions in Germany. PARTICIPANTS: All residents living in the participating nursing home during follow-up, newly admitted residents were also included. A total of 12,245 residents included in the primary analysis (4126 and 3547 residents in intervention group 1 and 2 and 4572 residents in the control group). METHODS: Intervention group 1 received an updated version of a successfully tested guideline-based multicomponent intervention (comprising brief education for the nursing staff, intensive training of nominated key nurses in each cluster, introduction of a least-restraint policy and supportive material), intervention group 2 received a concise version of the original program and the control group received optimized usual care (i.e. supportive materials only). Primary outcome was physical restraint prevalence at twelve months, assessed through direct observation by blinded investigators. Intervention and control groups were compared using baseline-adjusted linear regression on cluster level, Bonferroni-adjusted for double testing. Secondary outcomes included falls, fall-related fractures, and quality of life. We also described intervention costs and performed a comprehensive process analysis. RESULTS: At baseline, mean physical restraint prevalence was 17.4% and 19.6% in intervention groups 1 and 2, and 18.8% in the control group. After twelve months, mean prevalence was 14.6%, 15.7%, and 17.6%. Baseline-adjusted differences between mean prevalences were 2.0% (97.5% CI, -5.8 to 1.9) lower in intervention group 1 and 2.5% (97.5% CI, -6.4 to 1.4) lower in intervention group 2 compared to controls. Physical restraint prevalence showed a pronounced variation between the different clusters in all study groups. We found no significant differences in the secondary outcomes. According to the process evaluation, the intervention was mainly implemented as planned, but the expected change towards a least restraint culture of care was not achieved in all clusters. CONCLUSIONS: Neither intervention showed a clear advantage compared to control. The pronounced center variation in physical restraint prevalence indicates that other approaches like governmental policies are needed to sustainably change physical restraint practice and reduce center variations in nursing homes. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02341898.

Nurse-led coaching of shared decision-making for women with ductal carcinoma in situ in breast care centers: A cluster randomized controlled trial.

BACKGROUND: Women with breast cancer demand informed shared decision-making. Guidelines support these claims. OBJECTIVES: To investigate whether an informed shared decision-making intervention for women with 'ductal carcinoma in situ' comprising an evidence-based decision aid with nurse-led decision coaching enhances the extent of the mutual shared decision-making behavior of patients and professionals regarding treatment options, and to analyze implementation barriers. DESIGN: Cluster randomized controlled trial with accompanying process evaluation. SETTING: Certified breast care centers in Germany. PARTICIPANTS: Women with ductal carcinoma in situ and no previous history of breast cancer facing a primary treatment decision. METHODS: Sixteen breast centers were randomized to intervention or standard care to recruit 192 patients (partially-blinded). All coaching sessions and physician consultations were videotaped to assess the primary outcome 'extent of patient involvement in shared decision-making' using the MAPPIN-Odyad observer instrument (scores 0 to 4). Secondary endpoints included the sub-measures of the MAPPIN-inventory (MAPPIN-Onurse, MAPPIN-Ophysician, MAPPIN-Opatient, MAPPIN-Qnurse, MAPPIN-Qpatient and MAPPIN-Qphysician), 'informed choice', 'decisional conflict' and 'duration of consultations'. Primary intention-to-treat analyses were on cluster level comparing means of cluster values using t-tests. An accompanying process evaluation was conducted comprising 1) analysis of all video recordings with focus on procedures and intervention fidelity and 2) field notes of researchers and feedback from professionals and patients assessed by questionnaires and interviews with focus on barriers and facilitators for implementation at different time points. RESULTS: Due to protracted recruitment, the study was terminated after 14 centers had included 64 patients (intervention group 36, control group 28). Patient participation in informed shared decision-making was significantly higher in the intervention group (mean (SD) score 2.29 (0.56) vs. 0.42 (0.51) in the control group; difference 1.88 (95% CI 1.26-2.50, p < 0.0001). 47.7% women in the intervention group made informed choices, but none in the control group, difference 47.7% (95% CI 12.6-82.7%, p = 0.016). In the intervention group physician consultations lasted 12.8 (6.6) min. vs. 24.3 (6.3) min. in the control group. Physicians' attitudes, false incentives and structural barriers hindered implementation of informed shared decision-making. Nurses appreciated their new roles. CONCLUSIONS: Informed shared decision-making is not yet implemented in German breast care centers. Nurse-led decision coaching grounded on evidence-based patient information enhances informed shared decision-making. Trial registration No. ISRCTN46305518.

Effect of person-centred care on antipsychotic drug use in nursing homes (EPCentCare): a cluster-randomised controlled trial.

BACKGROUND: antipsychotic drugs are regularly prescribed as first-line treatment for neuropsychiatric symptoms in persons with dementia although guidelines clearly prioritise non-pharmacological interventions. OBJECTIVE: we investigated a person-centred care approach, which has been successfully evaluated in nursing homes in the UK, and adapted it to German conditions. DESIGN: a 2-armed 12-month cluster-randomised controlled trial. SETTING: nursing homes in East, North and West Germany. METHODS: all prescribing physicians from both study arms received medication reviews for individual patients and were offered access to 2 h of continuing medical education. Nursing homes in the intervention group received educational interventions on person-centred care and a continuous supervision programme. Primary outcome: proportion of residents receiving at least one antipsychotic prescription after 12 months of follow-up. Secondary outcomes: quality of life, agitated behaviour, falls and fall-related medical attention, a health economics evaluation and a process evaluation. RESULTS: the study was conducted in 37 nursing homes with n = 1,153 residents (intervention group: n = 493; control group: n = 660). The proportion of residents with at least one antipsychotic medication changed after 12 months from 44.6% to 44.8% in the intervention group and from 39.8 to 33.3% in the control group. After 12 months, the difference in the prevalence was 11.4% between the intervention and control groups (95% confidence interval: 0.9-21.9; P = 0.033); odds ratio: 1.621 (95% confidence interval: 1.038-2.532). CONCLUSIONS: the implementation of a proven person-centred care approach adapted to national conditions did not reduce antipsychotic prescriptions in German nursing homes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02295462.