Effects of Two COVID-19 Lockdowns on HbA1c Levels in Patients with Type 1 Diabetes and Associations with Digital Treatment, Health Literacy, and Diabetes Self-Management: A Multicenter, Observational Cohort Study Over 3 Years.

INTRODUCTION: Short-term studies reported improved glycemic control and a decrease in eHbA1c (estimated hemoglobin A1c) in patients with type 1 diabetes during COVID-19 lockdown, but long-term changes are unknown. Therefore, the main objectives are to (1) analyze whether laboratory-measured HbA1c changed during and after two lockdowns and (2) investigate potential variables influencing HbA1c change. METHODS: In this cohort study, 291 adults with type 1 diabetes were followed over 3 years including the prepandemic phase and two lockdowns. The data from medical records and validated questionnaires assessing health literacy (HLS-EU-Q16), diabetes self-management (DSMQ-R27), general self-efficacy (GSE), and social support (F-SOZU-K14) were used to analyze associations with HbA1c levels (N = 2370) by performing multivariable linear regressions. RESULTS: The median age was 54 (38-63) years and 159 (54.6%) were male. All phases of the COVID-19 pandemic were associated with a significant increase in laboratory-measured HbA1c levels in percent (e.g., during first lockdown ß = 0.23, 95% confidence interval (CI) 0.07-0.39, p = 0.005; during the second lockdown, ß = 0.27, 95% CI 0.15-0.38, p < 0.001). HbA1c change during lockdowns was significantly affected by the number of checkups (ß = -0.03, 95% CI -0.05 to -0.01, p = 0.010), the value of HbA1c at previous observation (ß = 0.33, 95% CI 0.29-0.36, p < 0.001), educational level (secondary versus tertiary: ß = 0.22, 95% CI 0.06-0.38, p = 0.008; primary versus tertiary: ß = 0.31, 95% CI 0.10-0.52, p = 0.004), health literacy score (for each point: ß = -0.03, 95% CI -0.05 to - 0.002, p = 0.034), and diabetes self-management score (for each point: ß = -0.03, 95% CI -0.04 to -0.02, p < 0.001). The use of continuous glucose monitoring or insulin pump had no effect on HbA1c change. CONCLUSIONS: Lockdowns can lead to worsening glycemic control in patients with type 1 diabetes. Particularly patients with few check-ups, poor blood glucose values, deficits in diabetes self-management, low health literacy, and a low level of education seem to be at greater risk of worsening glycemic control during lockdowns and, therefore, require special medical care, e.g., through telemedicine. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04821921.

Mobile health interventions in multiple sclerosis: A systematic review.

BACKGROUND: Persons with multiple sclerosis (pwMS) might be particularly well suited to benefit from digital health applications because they are, on average, younger and less severely disabled than patients with many other chronic diseases. Many digital health applications for pwMS have been developed. OBJECTIVES: Analysis of the evidence of digital health applications to improve health outcomes from a patient perspective. METHODS: A systematic review was performed on all randomized controlled trials (RCTs) that have studied mobile health interventions for pwMS, that is, which can be applied with a smartphone, tablet, or laptop to improve patient-reported outcomes. RESULTS: Of the 1127 articles identified in the literature search, 13 RCTs fit the inclusion criteria. Two trials studied messaging systems, two depression interventions, one addressed MS fatigue, five cognition, and three mobility issues, of which two focused on spasticity management. One trial aimed to enhance physical activity. Most were pilot studies that cannot yield definitive conclusions regarding efficacy. One depression intervention and one fatigue intervention showed significant results across several outcomes. CONCLUSION: Several mobile self-guided digital health applications for pwMS have been tested in RCTs, and two interventions targeting depression and fatigue have demonstrated significant effects. Challenges remain regarding implementation into routine care.

Expanded nursing competencies to improve person-centred care for nursing home residents with complex health needs (Expand-Care): study protocol for an exploratory cluster-randomised trial.

INTRODUCTION: Older age is associated with multimorbidity, chronic diseases and acute deteriorations and leads to complex care needs. Nursing home residents are more often unnecessarily transferred to emergency departments or hospitals than community dwellers-largely due to a lack of qualified staff and diffusion of responsibility in the institutions. In Germany, only few academically trained nurses work in nursing homes, and their potential roles are unclear. Therefore, we aim to explore feasibility and potential effects of a newly defined role profile for nurses with bachelors' degree or equivalent qualification in nursing homes. METHODS AND ANALYSIS: A pilot study (Expand-Care) with a cluster-randomised controlled design will be conducted in 11 nursing homes (cluster) in Germany, with an allocation ratio of 5:6 to the intervention or control group, aiming to include 15 residents per cluster (165 participants in total). Nurses in the intervention group will receive training to perform role-related tasks such as case reviews and complex geriatric assessments. We will collect data at three time points (t0 baseline, t1 3 months and t2 6 months after randomisation). We will measure on residents' level: hospital admissions, further health services use and quality of life; clinical outcomes (eg, symptom burden), physical functioning and delivery of care; mortality, adverse clinical incidents and changes in care level. On nurses' level, we will measure perception of the new role profile, competencies and implementation of role-related tasks as part of the process evaluation (mixed methods). An economic evaluation will explore resource use on residents' (healthcare utilisation) and on nurses' level (costs and time expenditure). ETHICS AND DISSEMINATION: The ethics committees of the University of Lübeck (Nr. 22-162) and the University Clinic Hamburg-Eppendorf (Nr. 2022-200452-BO-bet) approved the Expand-Care study. Informed consent is a prerequisite for participation. Study results will be published in open-access, peer-reviewed journals and reported at conferences and in local healthcare providers' networks. TRIAL REGISTRATION NUMBER: DRKS00028708.

Compliance and patient satisfaction with treatment settings recommended by the medical on-call service 116117 in Germany using computer-assisted structured initial assessment: a cross-sectional observational study accompanying the demand intervention.

OBJECTIVES: In order to reduce the use of emergency departments, computer-assisted initial assessment was implemented at the medical on-call service 116117. Our study assessed compliance and patient satisfaction. DESIGN: Cross-sectional observational postal survey. SETTING: Medical on-call service 116117 by eight Associations of Statutory Health Insurance Physicians in Germany. PARTICIPANTS: The intervention was observed between January 2020 and March 2021. Minors and patients with invalid contact data were excluded. A random sample of eligible patients received standardised questionnaires by mail. OUTCOME MEASURES: We analysed associations of sociodemographic data, health status, previous service use, health literacy, and recommended settings with compliance and patient satisfaction by multivariable, multilevel logistic regression. INTERVENTIONS: Based on symptoms and context factors, the computer software suggested service levels. Staff and patient discussed if higher levels were indicated, services were available and self-transport was possible. They then agreed on recommendations for treatment settings. RESULTS: Of 9473 contacted eligible patients, 1756 patients (18.5%) participated. Median age was 66 years (IQR=50-79), and 986 (59.0%) were women. At least one recommended setting was used by 1397 patients (85.4%). General practitioner (GP) practices were used by 143 patients (68.4%). Generally, better compliance was associated with lower depression levels (OR 1.59, 95% CI 1.17 to 2.17, p=0.003), fewer previous hospital stays (OR 2.02, 95% CI 1.27 to 3.23, p=0.003) and recommendations for any setting other than GP practices (OR 0.13, 95% CI 0.06 to 0.29, p<0001, to OR 0.37, 95% CI 0.19 to 0.72, p=0.003). A total of 606 patients (50.7%) were completely satisfied. Patient satisfaction was associated with higher age (OR 1.30, 95% CI 1.13 to 1.49, p<0.001), better self-rated health (OR 1.30, 95% CI 1.10 to 1.53, p=0.002), not having musculoskeletal disorders (OR 0.68, 95% CI 0.49 to 0.94, p=0.021), better health literacy (OR 0.69, 95% CI 0.54 to 0.89, p=0.005, and OR 0.49, 95% CI 0.36 to 0.67, p<0.001) and receiving no recommendation for GP practices (OR 0.61, 95% CI 0.43 to 0.87, p=0.006). CONCLUSIONS: Most patients were compliant and satisfied. Lowest compliance and satisfaction were found in GP practices, but nonetheless, two of three patients with respective recommendations were willing to use this setting. TRIAL REGISTRATION NUMBER: German Clinical Trials Register DRKS00017014.

Validation of patient- and GP-reported core sets of quality indicators for older adults with multimorbidity in primary care: results of the cross-sectional observational MULTIqual validation study.

BACKGROUND: Older adults with multimorbidity represent a growing segment of the population. Metrics to assess quality, safety and effectiveness of care can support policy makers and healthcare providers in addressing patient needs. However, there is a lack of valid measures of quality of care for this population. In the MULTIqual project, 24 general practitioner (GP)-reported and 14 patient-reported quality indicators for the healthcare of older adults with multimorbidity were developed in Germany in a systematic approach. This study aimed to select, validate and pilot core sets of these indicators. METHODS: In a cross-sectional observational study, we collected data in general practices (n = 35) and patients aged 65 years and older with three or more chronic conditions (n = 346). One-dimensional core sets for both perspectives were selected by stepwise backward selection based on corrected item-total correlations. We established structural validity, discriminative capacity, feasibility and patient-professional agreement for the selected indicators. Multilevel multivariable linear regression models adjusted for random effects at practice level were calculated to examine construct validity. RESULTS: Twelve GP-reported and seven patient-reported indicators were selected, with item-total correlations ranging from 0.332 to 0.576. Fulfilment rates ranged from 24.6 to 89.0%. Between 0 and 12.7% of the values were missing. Seventeen indicators had agreement rates between patients and professionals of 24.1% to 75.9% and one had 90.7% positive and 5.1% negative agreement. Patients who were born abroad (- 1.04, 95% CI = - 2.00/ - 0.08, p = 0.033) and had higher health-related quality of life (- 1.37, 95% CI = - 2.39/ - 0.36, p = 0.008), fewer contacts with their GP (0.14, 95% CI = 0.04/0.23, p = 0.007) and lower willingness to use their GPs as coordinators of their care (0.13, 95% CI = 0.06/0.20, p < 0.001) were more likely to have lower GP-reported healthcare quality scores. Patients who had fewer GP contacts (0.12, 95% CI = 0.04/0.20, p = 0.002) and were less willing to use their GP to coordinate their care (0.16, 95% CI = 0.10/0.21, p < 0.001) were more likely to have lower patient-reported healthcare quality scores. CONCLUSIONS: The quality indicator core sets are the first brief measurement tools specifically designed to assess quality of care for patients with multimorbidity. The indicators can facilitate implementation of treatment standards and offer viable alternatives to the current practice of combining disease-related metrics with poor applicability to patients with multimorbidity.

Integrated care for older multimorbid heart failure patients: protocol for the ESCAPE randomized trial and cohort study.

ESCAPE: Evaluation of a patient-centred biopsychosocial blended collaborative care pathway for the treatment of multimorbid elderly patients. THERAPEUTIC AREA: Healthcare interventions for the management of older patients with multiple morbidities. AIMS: Multi-morbidity treatment is an increasing challenge for healthcare systems in ageing societies. This comprehensive cohort study with embedded randomized controlled trial tests an integrated biopsychosocial care model for multimorbid elderly patients. HYPOTHESIS: A holistic, patient-centred pro-active 9-month intervention based on the blended collaborative care (BCC) approach and enhanced by information and communication technologies can improve health-related quality of life (HRQoL) and disease outcomes as compared with usual care at 9 months. METHODS: Across six European countries, ESCAPE is recruiting patients with heart failure, mental distress/disorder plus ≥2 medical co-morbidities into an observational cohort study. Within the cohort study, 300 patients will be included in a randomized controlled assessor-blinded two-arm parallel group interventional clinical trial (RCT). In the intervention, trained care managers (CMs) regularly support patients and informal carers in managing their multiple health problems. Supervised by a clinical specialist team, CMs remotely support patients in implementing the treatment plan-customized to the patients' individual needs and preferences-into their daily lives and liaise with patients' healthcare providers. An eHealth platform with an integrated patient registry guides the intervention and helps to empower patients and informal carers. HRQoL measured with the EQ-5D-5L as primary endpoint, and secondary outcomes, that is, medical and patient-reported outcomes, healthcare costs, cost-effectiveness, and informal carer burden, will be assessed at 9 and ≥18 months. CONCLUSIONS: If proven effective, the ESCAPE BCC intervention can be implemented in routine care for older patients with multiple morbidities across the participating countries and beyond.

Expectations and Prior Experiences Associated With Adverse Effects of COVID-19 Vaccination.

Importance: Uptake of vaccination against COVID-19 is strongly affected by concerns about adverse effects. Research on nocebo effects suggests that these concerns can amplify symptom burden. Objective: To investigate whether positive and negative expectations prior to COVID-19 vaccination are associated with systemic adverse effects. Design, Setting, and Participants: This prospective cohort study analyzed the association of expected benefits and risks of vaccination, adverse effects at first vaccination, and observed adverse effects in close contacts with severity of systemic adverse effects among adults receiving a second dose of messenger RNA (mRNA)-based vaccines between August 16 and 28, 2021. A total of 7771 individuals receiving the second dose at a state vaccination center in Hamburg, Germany, were invited to participate; of these, 5370 did not respond, 535 provided incomplete information, and 188 were excluded retrospectively. The mobile application m-Path was used for data collection. Main Outcomes and Measures: Primary outcome was a composite severity index of systemic adverse effects in 12 symptom areas measured once daily with an electronic symptom diary over 7 consecutive days. Data were analyzed by mixed-effects multivariable ordered logistic regression adjusted for prevaccine symptom levels and observation times. Results: A total of 10 447 observations from 1678 individuals receiving vaccinations (BNT162b2 [Pfizer BioNTech] in 1297 [77.3%] and mRNA-1273 [Moderna] in 381 [22.7%]) were collected. The participants' median age was 34 (IQR, 27-44) years, and 862 (51.4%) were women. The risk for more severe adverse effects was higher for persons expecting a lower benefit of vaccination (odds ratio [OR] for higher expectations, 0.72 [95% CI, 0.63-0.83]; P < .001), expecting higher adverse effects of vaccination (OR, 1.39 [95% CI, 1.23-1.58]; P < .001), having experienced higher symptom burden at the first vaccination (OR, 1.60 [95% CI, 1.42-1.82]; P < .001), scoring higher on the Somatosensory Amplification Scale (OR, 1.21 [95% CI, 1.06-1.38]; P = .004), and if the vaccine mRNA-1273 was given rather than BNT162b2 (OR, 2.45 [95% CI, 2.01-2.99]; P < .001). No associations were seen for observed experiences. Conclusions and Relevance: In this cohort study, several nocebo effects occurred in the first week after COVID-19 vaccination. The severity of systemic adverse effects was associated not only with vaccine-specific reactogenicity but also more negative prior experiences with adverse effects from the first COVID-19 vaccination, more negative expectations regarding vaccination, and tendency to catastrophize instead of normalize benign bodily sensations. Clinician-patient interactions and public vaccine campaigns may both benefit from these insights by optimizing and contextualizing information provided about COVID-19 vaccines.

Association between patient-related factors and avoided consultations due to fear of COVID-19 during the first lockdown in northern Germany: Results of a cross-sectional observational study.

INTRODUCTION: During the COVID-19 pandemic, many people were anxious about a coronavirus infection due to the high infection rate and the mortality risk associated with the disease. Fear of COVID-19 might have influenced patients' utilisation of medical services, even if it meant that a postponed therapy had severe consequences. Our aims were to analyse (a) to what extent fear of COVID-19 contributes to forgone consultations, (b) if patient characteristics, health literacy and social support influence the effect of fear of COVID-19 on the utilisation behaviour and (c) whether interactions between these possible predictor variables are responsible for a higher extent of avoided consultations due to fear of COVID-19. METHODS: We conducted a retrospective, cross-sectional observational study in an emergency department. The study was based on personal standardized interviews of patients. The interviews took place between July 15 and August 5, 2020. Patients over the age of 18 were included if there was no urgent need for treatment on the day of the interview, no severe functional limitations, sufficient knowledge of German, ability to consent and health problems requiring treatment between March 13 and June 13, 2020. Differences between patient subgroups were described and analysed using the t-test and chi2 test. Data were analysed by logistic regression including socio-demographic data, health literacy and social support assessed by standardised instruments. Additionally, we assessed interactions between possible predictor variables by a descriptive tree analysis. RESULTS: 103 patients participated in personal standardized interviews. 46 patients (44.6%) reported that at least one necessary consultation did not take place in the observation period. Among those, 29 patients (63.0%) avoided consultations due to fear of COVID-19. Women had 3.36 times higher odds (95% confidence interval: 1.25 to 9.04, p = 0.017) for avoiding a consultation due to fear of COVID-19. There were no other statistically significant predictors in our analysis. DISCUSSION: Almost half of the required consultations did not take place. Avoidance of consultations needs to be closely monitored during the pandemic. Policy makers as well as health care providers should give consideration to the collateral effects of COVID-19 and COVID-19-related reactions of patients, especially women. CONCLUSION: In the course of the COVID-19 pandemic, physicians should ensure that their patients take advantage of necessary consultations in order to avoid negative effects of a delayed examination or treatment. Particular attention should be paid to anxious female patients. Studies are needed to analyse the association between health literacy, social support and avoidance of consultations triggered by fear of COVID-19.

Vaccination Intention Following Receipt of Vaccine Information Through Interactive Simulation vs Text Among COVID-19 Vaccine-Hesitant Adults During the Omicron Wave in Germany.

Conclusions and Relevance: In this cross-sectional study, vaccine-hesitant adults presented with an interactive risk ratio simulation were more likely to show positive change in COVID-19 vaccination intention and benefit-to-harm assessment than those presented with a conventional text-based information format. These findings suggest that the interactive risk communication format can be an important tool in addressing vaccination hesitancy and fostering public trust. Design, Setting, and Participants: Cross-sectional study conducted online with 1255 COVID-19 vaccine-hesitant adult residents of Germany in April and May 2022, surveyed using a probability-based internet panel maintained by respondi, a research and analytics firm. Participants were randomized to 1 of 2 presentations on the benefits and adverse events associated with vaccination. Exposure: Participants were randomized to a text-based description vs an interactive simulation presenting age-adjusted absolute risks of infection, hospitalization, ICU admission, and death after exposure to coronavirus in vaccinated vs unvaccinated individuals relative to the possible adverse effects as well as additional (population-level) benefits of COVID-19 vaccination. Importance: Hesitancy toward COVID-19 vaccination is a major factor in stagnating uptake rates and in the risk of health care systems becoming overwhelmed. Main Outcomes and Measures: Absolute change in respondents' COVID-19 vaccination intention category and benefit-to-harm assessment category. Objective: To compare an interactive risk ratio simulation (intervention) with a conventional text-based risk information format (control) and analyze change in participants' COVID-19 vaccination intention and benefit-to-harm assessment. Results: Participants were 1255 COVID-19 vaccine-hesitant residents of Germany (660 women [52.6%]; mean [SD] age, 43.6 [13.5] years). A total of 651 participants received a text-based description, and 604 participants received an interactive simulation. Relative to the text-based format, the simulation was associated with greater likelihood of positive change in vaccination intentions (19.5% vs 15.3%, respectively; absolute difference, 4.2%; adjusted odds ratio [aOR], 1.45; 95% CI, 1.07-1.96; P = .01) and benefit-to-harm assessments (32.6% vs 18.0%; absolute difference, 14.6%; aOR, 2.14; 95% CI, 1.64-2.80; P < .001). Both formats were also associated with some negative change. However, the net advantage (positive - negative change) of the interactive simulation over the text-based format was 5.3 percentage points for vaccination intention (9.8% vs 4.5%) and 18.3 percentage points for benefit-to-harm assessment (25.3% vs 7.0%). Positive change in vaccination intention (but not in benefit-to-harm assessment) was associated with some demographic characteristics and attitudes to COVID-19 vaccination; negative changes were not.

Disentangling the relationship of subjective cognitive decline and depressive symptoms in the development of cognitive decline and dementia.

INTRODUCTION: Subjective cognitive decline (SCD) and depressive symptoms (DS) frequently co-occur prior to dementia. However, the temporal sequence of their emergence and their combined prognostic value for cognitive decline and dementia is unclear. METHODS: Temporal relationships of SCD, DS and memory decline were examined by latent difference score modeling in a high-aged, population-based cohort (N = 3217) and validated using Cox-regression of dementia-conversion. In 334 cognitively unimpaired SCD-patients from memory-clinics, we examined the association of DS with cognitive decline and with cerebrospinal fluid (CSF) Alzheimer's disease (AD) biomarkers. RESULTS: In the population-based cohort, SCD preceded DS. High DS were associated with increased risk of dementia conversion in individuals with SCD. In SCD-patients from memory-clinics, high DS were associated with greater cognitive decline. CSF Aß42 predicted increasing DS. DISCUSSION: SCD typically precedes DS in the evolution to dementia. SCD-patients from memory-clinics with DS may constitute a high-risk group for cognitive decline. HIGHLIGHTS: Subjective cognitive decline (SCD) precedes depressive symptoms (DS) as memory declines. Emerging or persistent DS after SCD reports predict dementia. In SCD patients, more amyloid pathology relates to increasing DS. SCD patients with DS are at high risk for symptomatic progression.

Impact of two COVID-19 lockdowns on HbA1c levels in patients with type 2 diabetes and associations with patient characteristics: a multicentre, observational cohort study over three years.

Introduction: Glycemic effects of COVID-19 lockdowns on patients with type 2 diabetes (T2D) are controversial. In this long-term observation, we aimed (1) to analyze changes in HbA1c levels during lockdowns in Germany, and (2) to investigate whether diabetes medication, comorbidities, and sociodemographic data influenced these changes. Materials and methods: This cohort study observed 1,089 patients aged ≥18 years over the years 2019 to 2021. Patients were recruited from 14 physicians specialized on diabetes. As dependent variable, 7,987 HbA1c values were analyzed by multivariable linear regression adjusted for random effects of physicians and patients. Results: Patients had a median age of 68 (60/76) years and 623 (57.2%) were male. Before the pandemic, median HbA1c level (in %) was 6.9 (6.3/7.7). Average HbA1c level increased during first lockdown (0.21,0.11/0.31,p < 0.001), after first lockdown (0.23,0.18/0.28,p < 0.001), during second lockdown (0.40,0.33/0.47,p < 0.001) and after second lockdown (0.27,0.18/0.36,p < 0.001). The increase of HbA1c levels was more pronounced in male patients (0.08,0.01/0.15,p = 0.019), if patients did not have German as native language (0.12,0.01/0.23,p = 0.041) and if they were widowed (0.19,0.05/0.32,p = 0.008). End organ damages (0.12,0.01/0.23,p = 0.039), atherosclerotic cardiovascular disease (ASCVD; 0.23,0.10/0.36,p = 0.001) and cardiovascular events (0.25,0.10/0.40,p = 0.001) as well as oral medication (0.09,0.03/0.15,p = 0.002), intermediate- or long-acting insulins (0.24,0.16/0.32,p < 0.001), and fast-acting or mixed insulins (0.30,0.23/0.36,p < 0.001) were also related to a greater increase in HbA1c levels. Conclusion: Both lockdowns resulted in a significant increase in HbA1c levels. In particular, patients with ASCVD, cardiovascular events, and insulin therapy appear to be at risk for worsening glycemic control in crisis and thus require special medical attention. Clinical Trial Registration: ClinicalTrials.gov (NCT04821921).

Experiences of patients with multimorbidity with primary care and the association with patient activation: a cross-sectional study in Germany.

OBJECTIVES: This study aimed to explore the association between patient activation and patients' experience of care among an elderly multimorbid population in Germany. DESIGN: Cross-sectional study. SETTING: Primary care practices in two German settings. PARTICIPANTS: 346 patients with 3 or more chronic conditions aged 65 years and over from 36 primary care practices. OUTCOME MEASURES: Patient activation was measured with the patient activation measure (PAM). To assess patient experiences with primary care, a set of questions concerning domains of primary care were included. Multilevel regression analyses were performed to examine which domains of care were associated with patient activation. RESULTS: Out of 1243 invited patients, a total of 346 took part in the study (participation rate 27.8 %). Mean PAM score was 76.1. Across all patients, 3.8% achieved PAM level 1, 7.5% level 2, 27.2% level 3% and 60.7% level 4. PAM scores suggest a highly activated patient group. In the regression analysis, three out ten domains of patients' experiences showed an association with patient activation. The domains 'being involved in decision as much as desired' (B=-8.56, p=0.012) and 'receiving a self-management plan' (B=6.51, p=0.051) were associated with higher patient activation scores. Patients with an up-to-date medication plan had lower patient activation scores (B=-12.01, p=0.041). CONCLUSION: Specific domains of primary care were found to be associated with patient activation. To enhance patient activation, primary care physicians may increase involvement of patients in decisions. Future research should examine the causality of these associations. TRIAL REGISTRATION NUMBER: DRKS00015718.

Patient satisfaction with computer-assisted structured initial assessment facilitating patient streaming to emergency departments and primary care practices: results from a cross-sectional observational study accompanying the DEMAND intervention in Germany.

BACKGROUND: Patient numbers in emergency departments are on the rise. The DEMAND intervention aims to improve the efficacy of emergency services by computer-assisted structured initial assessment assigning patients to emergency departments or primary care practices. The aims of our study were to evaluate patient satisfaction with this intervention and to analyse if reduced patient satisfaction is predicted by sociodemographic data, health status or health literacy. METHODS: We conducted a cross-sectional patient survey in emergency departments and co-located primary care practices. Each intervention site was planned to participate for two observation periods, each with a duration of one full week. Study participants were recruited by the local staff. The patients filled out a written questionnaire during their waiting time. Patient satisfaction was assessed by agreement to four statements on a four point Likert scale. Predictors of patient satisfaction were identified by multilevel, multivariable logistic regression models adjusted for random effects at the intervention site level. RESULTS: The sample included 677 patients from 10 intervention sites. The patients had a mean age of 38.9 years and 59.0% were women. Between 67.5% and 55.0% were fully satisfied with aspects of the intervention. The most criticised aspect was that the staff showed too little interest in the patients' personal situation. Full satisfaction ("clearly yes" to all items) was reported by 44.2%. Reduced patient satisfaction (at least one item rated as "rather yes", "rather no", "clearly no") was predicted by lower age (odds ratio 0.79 for ten years difference, 95% confidence interval 0.67/0.95, p = 0.009), presenting with infections (3.08,1.18/8.05,p = 0.022) or injuries (3.46,1.01/11.82,p = 0.048), a higher natural logarithm of the symptom duration (1.23,1.07/1.30,p = 0.003) and a lower health literacy (0.71 for four points difference, 0.53/0.94,p = 0.019). CONCLUSIONS: The patients were for the most part satisfied with the intervention. Assessment procedures should be evaluated a) regarding if all relevant patient-related aspects are included; and whether patient information can be improved b) for patients with strong opinions about cause, consequences and treatment options for their health problem; and c) for patients who have problems in the handling of information relevant to health and healthcare. TRIAL REGISTRATION: German Clinical Trials Register ( https://www.drks.de/drks_web/setLocale_EN.do ) no. DRKS00017014.

Social Isolation and Incident Dementia in the Oldest-Old-A Competing Risk Analysis.

Purpose: Social isolation is considered a risk factor for dementia. However, less is known about social isolation and dementia with respect to competing risk of death, particularly in the oldest-old, who are at highest risk for social isolation, dementia and mortality. Therefore, we aimed to examine these associations in a sample of oldest-old individuals. Methods: Analyses were based on follow-up (FU) 5-9 of the longitudinal German study AgeCoDe/AgeQualiDe. Social isolation was assessed using the short form of the Lubben Social Network Scale (LSNS-6), with a score ≤ 12 indicating social isolation. Structured interviews were used to identify dementia cases. Competing risk analysis based on the Fine-Gray model was conducted to test the association between social isolation and incident dementia. Results: Excluding participants with prevalent dementia, n = 1,161 individuals were included. Their mean age was 86.6 (SD = 3.1) years and 67.0% were female. The prevalence of social isolation was 34.7% at FU 5, 9.7% developed dementia and 36.0% died during a mean FU time of 4.3 (SD = 0.4) years. Adjusting for covariates and cumulative mortality risk, social isolation was not significantly associated with incident dementia; neither in the total sample (sHR: 1.07, 95%CI 0.65-1.76, p = 0.80), nor if stratified by sex (men: sHR: 0.71, 95%CI 0.28-1.83, p = 0.48; women: sHR: 1.39, 95%CI 0.77-2.51, p = 0.27). Conclusion: In contrast to the findings of previous studies, we did not find an association between social isolation and incident dementia in the oldest-old. However, our analysis took into account the competing risk of death and the FU period was rather short. Future studies, especially with longer FU periods and more comprehensive assessment of qualitative social network characteristics (e.g., loneliness and satisfaction with social relationships) may be useful for clarification.

The Link Between Health Literacy and Three Conditions of Metabolic Syndrome: Obesity, Diabetes and Hypertension.

Purpose: Health literacy (HL) intervention could be a potential prevention strategy to reduce the risk of metabolic syndrome (MS), but the association between low HL and MS is controversial. Therefore, the aim of this study was to investigate whether low HL is associated with obesity, diabetes, and hypertension, considering them as one cluster. Methods: We used data from the Hamburg Diabetes Prevention Survey, a population-based cross-sectional study in Germany. The 1349 eligible subjects were 18-60 years old. The European Health Literacy Questionnaire (HLS-EU-Q16) was used to assess HL. Depending on the reported number of metabolic syndrome conditions (CMS), four groups were categorized as follows: "0", any "1", any "2" and "3" CMS. Ordered logistic regression was used to analyze the relationship between HL level (independent variable) and the reported number of CMS (dependent variable) adjusted for age, gender and education. Results: 63.9% of subjects (n=862) reported having "0", 25.7% (n=346) only "1", 8.2% (n=111) only "2" and 2.2% (n=30) "3" of the three CMS. In the group with sufficient HL, rates of "1," "2," or "3" CMS were lower than in the group with problematic or inadequate HL. Subjects with inadequate HL showed a 1.62-fold higher risk of having a higher number of CMS than subjects with sufficient HL (OR 1.62; 95% CI 1.13 to 2.31). The risk increased with each life year (OR 1.05; 95% CI 1.04 to 1.06), and was higher in persons with low education (OR 2.89; 95% CI 2.08 to 4.01) than in highly educated persons. Women showed lower risk (OR 0.73; 95% CI 0.58 to 0.91) than men. Conclusion: Lower HL was associated with a higher number of MS conditions. Our findings suggest that HL intervention on health-promoting behaviors could help reduce MS risk in people with limited HL.

Adaptation and validation of a German version of the Multimorbidity Treatment Burden Questionnaire.

BACKGROUND: Patients with multiple long-term conditions often face a variety of challenges arising from the requirements of their health care. Knowledge of perceived treatment burden is crucial for optimizing treatment. In this study, we aimed to create a German version of the Multimorbidity Treatment Burden Questionnaire (MTBQ) and to evaluate its validity. METHODS: The steps to translate the MTBQ included forward/back translation, cognitive interviews (n = 6) and a pilot test (n = 7). Psychometric properties of the scale were assessed in a cross-sectional survey with primary care patients aged 65 and older with at least 3 long-term conditions (n = 344). We examined the distribution of responses, dimensionality, internal reliability and construct validity. RESULTS: Cognitive interviewing and piloting led to minor modifications and showed overall good face validity and acceptability. As expected, we observed a positively skewed response distribution for all items. Reliability was acceptable with McDonald's omega = 0.71. Factor analysis suggested one common factor while model fit indices were inconclusive. Predefined hypotheses regarding the construct validity were supported by negative associations between treatment burden and health-related quality of life, self-rated health, social support, patient activation and medication adherence, and positive associations between treatment burden and number of comorbidities. Treatment burden was found to be higher in female participants (Mdn1 = 6.82, Mdn2 = 4.55; U = 11,729, p = 0.001) and participants with mental health diagnoses (Mdn1 = 9.10, Mdn2 = 4.55; U = 3172, p = 0.024). CONCLUSIONS: The German MTBQ exhibited good psychometric properties and can be used to assess the perceived treatment burden of patients with multimorbidity.

Measuring the Quality of Care for Older Adults With Multimorbidity: Results of the MULTIqual Project.

BACKGROUND AND OBJECTIVES: Providing health care for older adults with multimorbidity is often complex, challenging, and prone to fragmentation. Although clinical decision making should take into account treatment interactions, individual burden, and resources, current approaches to assessing quality of care mostly rely on indicators for single conditions. The aim of this project was to develop a set of generic quality indicators for the management of patients aged 65 and older with multimorbidity that can be used in both health care research and clinical practice. RESEARCH DESIGN AND METHODS: Based on the findings of a systematic literature review and eight focus groups with patients with multimorbidity and their family members, we developed candidate indicators. Identified aspects of quality were mapped to core domains of health care to obtain a guiding framework for quality-of-care assessment. Using nominal group technique, indicators were rated by a multidisciplinary expert panel (n = 23) following standardized criteria. RESULTS: We derived 47 candidate quality indicators from the literature and 4 additional indicators from the results of the focus groups. The expert panel selected a set of 25 indicators, which can be assigned to the levels of patient factors, patient-provider communication, and context and organizational structures of the conceptual framework. DISCUSSION AND IMPLICATIONS: We developed a comprehensive indicator set for the management of multimorbidity that can help to highlight areas with potential for improving the quality of care and support application of multimorbidity guidelines. Furthermore, this study may serve as a blueprint for participatory designs in the development of quality indicators.

Do oldest old individuals perceive receipt of informal care as a restriction or support of their autonomy?

OBJECTIVES: Autonomy (defined as self-governance; not equivalent to independence) is relevant to well-being and psychological functioning. However, there is a lack of research on individuals aged >85 years and their perception of autonomy when receiving informal care. This study aims to answer the question if and how the receipt of informal care is associated with perceived autonomy of individuals aged over 85 years. METHOD: A cross-sectional study was conducted with data from follow-up 9 of the AgeQualiDe study (2015/2016), which is a multi-centric prospective cohort study in Germany. The analytical sample included 570 participants aged >85 years and with a score of ≥ 19 on the Mini-Mental-State-Examination. Perceived autonomy was assessed with the Perceived Autonomy in Old Age Scale. Receipt of care was assessed as performance of at least one care task (help with basic and instrumental activities of daily living, and supervision) by relatives or friends. Sociodemographic information, mental health, functional level and receipt of professional ambulatory care were controlled for. RESULTS: Unadjusted and adjusted linear regression analyses indicated a significant negative association between receipt of informal care and perceived autonomy. The results remained stable in sensitivity analyses; no significant interaction effect was found for gender or education. CONCLUSION: Findings indicate that informal care recipients aged >85 years perceive lower autonomy compared to those not receiving care. Additional or other forms of support, and improving the care relationship and communication might be considered to support autonomy of care recipients aged >85 years.