Implementation of integrated care for type 2 diabetes Mellitus and Periodontitis in Germany: study protocol for a practice-based and cluster-randomized trial.

BACKGROUND: Type 2 Diabetes mellitus (T2DM) and periodontitis share common risk factors and influence one another. However, primary care and oral health care continue to operate separate from each other and fail to synchronize care for patients with T2DM and periodontitis. The purpose of this practice-based trial is to evaluate the implementation of a new integrated care pathway for patients with T2DM and periodontitis. The new approach integrates a screening for T2DM risk in dental care settings in patients with periodontitis, a screening for periodontitis risk in primary care settings in patients with T2DM, and mutual referrals between dentists and primary care physicians. METHODS: Two practice-based studies will be carried out in parallel: (i) In dental care settings: a practice-based, multi-centric, cluster-randomized, controlled trial with a control and an intervention group; (ii) in primary care settings: a practice-based, multi-centric, non-randomized, controlled trial with a synthetic control group calculated from claims data. Following a two-step recruitment approach, 166 dentists and 248 general practitioners will be recruited, who themselves will recruit a total of 3808 patients in their practices. Patient data will be collected at baseline, 12 months, and 24 months after study enrollment. The evaluation comprises: (i) impact evaluation, using a hierarchical linear mixed model; (ii) process evaluation, based on surveys alongside the trials; (iii) economic evaluation. In addition, a Discrete-Choice-Experiment will identify provider's payment preferences for the new care approach. DISCUSSION: Upon successful implementation, the intervention will enable health care providers to detect a risk for T2DM and periodontitis in patients at an early stage, thus providing patients an opportunity for timely diagnosis and therapy. Ultimately, this can lead to increased quality of life and reduced health care expenditures. On a methodologic level, the project provides novel insights into a complex intervention on the intersection of general practice and dental care. TRIAL REGISTRATION: The study was prospectively registered at the German Clinical Trials Register ( https://drks.de/search/de/trial/DRKS00030587 ) on 3. July 2023 under ID "DRKS00030587".

Navigating the Future of Organisational Health Services Research in Germany and beyond: a Position Paper. / Die Zukunft der organisationalen Versorgungsforschung in Deutschland und darüber hinaus ­ ein Positionspapier.

BACKGROUND: Recent analyses have shown that in health services research in Germany, healthcare organisations are often considered primarily as a study setting, without fully taking their complex organisational nature into account, neither theoretically nor methodologically. Therefore, an initiative was launched to analyse the state of Organisational Health Services Research (OHSR) in Germany and to develop a strategic framework and road map to guide future efforts in the field. This paper summarizes positions that have been jointly developed by consulting experts from the interdisciplinary and international scientific community. METHODS: In July 2023, a scoping workshop over the course of three days was held with 32 (inter)national experts from different research fields centred around OHSR topics using interactive workshop methods. Participants discussed their perspectives on OHSR, analysed current challenges in OHSR in Germany and developed key positions for the field's development. RESULTS: The seven agreed-upon key positions addressed conceptual and strategic aspects. There was consensus that the field required the development of a research agenda that can guide future efforts. On a conceptual level, the need to address challenges in terms of interdisciplinarity, terminology, organisation(s) as research subjects, international comparative research and utilisation of organisational theory was recognized. On a strategic level, requirements with regard to teaching, promotion of interdisciplinary and international collaboration, suitable funding opportunities and participatory research were identified. CONCLUSIONS: This position paper seeks to serve as a framework to support further development of OHSR in Germany and as a guide for researchers and funding organisations on how to move OHSR forward. Some of the challenges discussed for German OHSR are equally present in other countries. Thus, this position paper can be used to initiate fruitful discussions in other countries.

The role of patient-related factors in the implementation of a multimodal home-based rehabilitation intervention after discharge from inpatient geriatric rehabilitation (GeRas): a qualitative process evaluation.

BACKGROUND: Structured aftercare programs are implemented to facilitate the transition from rehabilitation centers to patients' home environments. Taking the program GeRas as an example, this paper aims to evaluate the influence of patient-related factors on the implementation of the geriatric aftercare program GeRas from patients' and providers' perspectives. METHODS: To capture patients' and providers' perspectives, qualitative interviews were conducted using a semi-structured interview guide. The analysis was inductive-deductive and based on the thematic analysis by Braun and Clarke and guided by Domain IV of the CFIR. RESULTS: 16 participants (10 patients, 4 providers, 2 family members) were interviewed from May 2023 to November 2023. Patient-related factors were perceived as an important aspect during the implementation of the GeRas program. The results were allocated to the four Constructs of Domain IV of the CFIR (Motivation, Opportunity, Capability, Needs). Especially patients' intrinsic motivation, social environment, and physical capabilities seemed to be crucial for successful implementation. While extrinsic motivation can mitigate missing personal capabilities, it cannot replace the presence of intrinsic motivation and capabilities. The results showed that patient-related factors are interlinked. DISCUSSION/CONCLUSION: The relevance of patient-related factors during the implementation of the GeRas program shows that such programs must consider these factors during intervention planning.

Strategies, processes, outcomes, and costs of implementing experience sampling-based monitoring in routine mental health care in four European countries: study protocol for the IMMERSE effectiveness-implementation study.

BACKGROUND: Recent years have seen a growing interest in the use of digital tools for delivering person-centred mental health care. Experience Sampling Methodology (ESM), a structured diary technique for capturing moment-to-moment variation in experience and behaviour in service users' daily life, reflects a particularly promising avenue for implementing a person-centred approach. While there is evidence on the effectiveness of ESM-based monitoring, uptake in routine mental health care remains limited. The overarching aim of this hybrid effectiveness-implementation study is to investigate, in detail, reach, effectiveness, adoption, implementation, and maintenance as well as contextual factors, processes, and costs of implementing ESM-based monitoring, reporting, and feedback into routine mental health care in four European countries (i.e., Belgium, Germany, Scotland, Slovakia). METHODS: In this hybrid effectiveness-implementation study, a parallel-group, assessor-blind, multi-centre cluster randomized controlled trial (cRCT) will be conducted, combined with a process and economic evaluation. In the cRCT, 24 clinical units (as the cluster and unit of randomization) at eight sites in four European countries will be randomly allocated using an unbalanced 2:1 ratio to one of two conditions: (a) the experimental condition, in which participants receive a Digital Mobile Mental Health intervention (DMMH) and other implementation strategies in addition to treatment as usual (TAU) or (b) the control condition, in which service users are provided with TAU. Outcome data in service users and clinicians will be collected at four time points: at baseline (t0), 2-month post-baseline (t1), 6-month post-baseline (t2), and 12-month post-baseline (t3). The primary outcome will be patient-reported service engagement assessed with the service attachment questionnaire at 2-month post-baseline. The process and economic evaluation will provide in-depth insights into in-vivo context-mechanism-outcome configurations and economic costs of the DMMH and other implementation strategies in routine care, respectively. DISCUSSION: If this trial provides evidence on reach, effectiveness, adoption, implementation and maintenance of implementing ESM-based monitoring, reporting, and feedback, it will form the basis for establishing its public health impact and has significant potential to bridge the research-to-practice gap and contribute to swifter ecological translation of digital innovations to real-world delivery in routine mental health care. TRIAL REGISTRATION: ISRCTN15109760 (ISRCTN registry, date: 03/08/2022).

A counselling intervention for individual strategies to prevent complications and strengthen resources during pregnancy in gynaecological care (AOK-Family +): study protocol for a cluster-randomised controlled trial.

BACKGROUND: Lifestyle-related risk factors can increase complications during pregnancy and negatively impact the health of a mother and her child. Knowledge about these compliances among many pregnant women and women of childbearing age is lacking. In the study AOK-Family + , we propose the evaluation of a newly developed counselling intervention. The intervention aims to raise awareness and to provide relevant information about the impact of lifestyle-related risk factors during pregnancy. The aim of the proposed study is to evaluate the effect of this counselling intervention on women's knowledge of lifestyle-related risk factors during pregnancy and the concomitant healthy behaviours. METHODS: A cluster-randomised trial with three arms in Baden-Wuerttemberg, Germany, is proposed. Pregnant women and women of childbearing age will be allocated to one of three groups: online intervention, on-site intervention, or a waiting-list control. Trained counsellors from AOK Baden-Wuerttemberg, a German statutory health insurer, will conduct the counselling sessions. Data collection is conducted throughout validated questionnaires administered at three intervals: before counselling (t0), directly after counselling (t1), and at a 6-week follow-up (t2). The primary outcomes will be health knowledge and healthy behaviours relating to LRFFs during pregnancy. A process evaluation will examine the processes, used resources, and future implementations through additional quantitative questions and qualitative interviews and focus groups. DISCUSSION: Based on this study, an implementation strategy for future conduction of lifestyle consultation during pregnancy could be developed with the aim of reducing pre- and post-mortem mobility and mortality. TRIAL REGISTRATION: The German Clinical Trials Register DRKS00027804. Registered on 2022/01/12.

Counseling lifestyle medicine in oncology: A qualitative analysis of interprofessional patient-nurse-physician interactions.

OBJECTIVES: Counseling plays a key role in promoting health behaviors, providing evidence-based information, and supporting patients with cancer during and after treatment. This study aimed to evaluate an interprofessional counseling service on Complementary and Integrative Health (CIH) for patients being treated at Comprehensive Cancer Centers (CCCs) in Southern Germany. METHODS: Patients participating in the CCC-Integrativ study received three CIH counseling sessions within three months in addition to their conventional cancer treatment. Medical and nursing staff participated in a study-specific blended learning training program before conducting the counseling. As part of the process evaluation, 30 audio-recorded counseling sessions were transcribed verbatim and analyzed by conducting a content analysis using MAXQDA 2020. RESULTS: Throughout the counseling, patients were conceded to address various health issues, which mainly revolved around symptom management interlaced with the areas of nutrition, exercise, and relaxation. The interprofessional teams conducted the counseling in a structured and patient-oriented manner. They worked together to motivate the patients to apply procedures from the CIH field independently, even if patients sometimes experienced difficulties in implementation. CONCLUSIONS: Interprofessional collaboration improved healthcare quality, as patients received comprehensive and evidence-based advice on their supportive needs and lifestyle issues. Both professions could equally contribute their areas of knowledge and expertise and apply them to the benefit of the patients. PRACTICE IMPLICATIONS: Providing an integrative counseling service and adequate training on interpersonal communication and CIH for healthcare professionals will improve patient-centered care.

Provision and use of assistive products in patients after stroke and spinal cord injury in Germany: a qualitative interview study.

PURPOSE: Mobility impairments are a common consequence of stroke and spinal cord injury (SCI). Assistive products (APs) such as wheelchairs are often needed for activities and participation. The aim of the study was to explore the provision and use of APs in Germany and to identify associated factors underlying this practice. MATERIALS AND METHODS: Semi-structured interviews were conducted with 19 professionals from outpatient neurorehabilitation services (three general practitioners, five physical therapists, five occupational therapists, one speech therapist, one neuropsychologist, two outpatient nurses, one rehab technician and one social worker), two patient advocates (long-term survivors, each stroke and SCI) and 20 patients (10 each after stroke and SCI with mobility impairment, and first-ever affected). Analysis was performed by qualitative content analysis. RESULTS: Reported experiences were mixed, varying from high satisfaction to unusable APs and unmet needs. Identified factors associated with these experiences were related to care pathways, care coordination, inter-professional collaboration, professionals' knowledge and patient information, cost coverage, and approval procedures. CONCLUSION: Overall, patients seem satisfied with the APs they receive, but patients with more severe mobility impairments in particular experience deficits in the provision and use of APs. Further research is needed to develop and test strategies for the provision and use of APs.

Interprofessional collaboration between the multiple stakeholders and the involvement of end users is needed to realise the full potential of specific assistive products (APs).A care pathway should be implemented for the provision of appropriate APs.Professionals' expertise in both APs and end user empowerment needs to be improved.The approval process of the public health insurance should be accelerated and geared more towards the individual needs of patients.

Resilience of the primary healthcare system: perspectives of German stakeholders at primary care interfaces during the second wave of the COVID-19 pandemic.

Introduction: Worldwide, the primary care sector played a key role in coping with the challenges of the SARS-CoV-2 pandemic. Methods: The aim of this study was to explore the resilience of the German primary healthcare system during the second wave of the pandemic from the perspective of identified interface stakeholders, i.e., representatives of hospitals, district offices, and medical associations. Qualitative data from interviews and focus groups were analyzed according to a resilience framework. Results: The main findings include a gap in knowledge transfer, unstructured allocation of responsibilities, and a resulting unregulated flow of patients. Social brokers supported care coordination and knowledge transfer. The response to the capacity to cope with uncertainties was slow and chaotic at the system level and heterogeneous at the individual level. Building on previous relationships fostered functioning communication, while competition in primary care was identified as a barrier to resilience. Conclusion: Implications for further research and for strengthening the resilience of primary care can be derived based on this study.

An integrated mental health video consultations model for patients with somatic symptom disorder in primary care: The randomized VISION pilot trial.

OBJECTIVE: Symptoms of somatic symptom disorder (SSD) are one of the most common reasons for consultations in primary care. However, specialized psychological services are mostly unavailable. This pilot trial aimed to determine the feasibility, acceptability, and safety of the integrated mental health video consultations VISION model for patients with SSD in primary care. METHODS: We conducted a parallel group, randomized controlled pilot trial involving fifty-one patients with SSD from ten primary care practices in Germany, who we randomized to the VISION model or enhanced treatment-as-usual (eTAU). The VISION model comprised five video consultations which featured diagnostic clarification, psychoeducation (acknowledging and legitimizing of symptoms), and brief psychological therapy. eTAU included training primary care practice teams on the DSM-5 concept of SSD and on current guideline recommendations for its treatment in primary care. We assessed feasibility as the primary outcome at 6-months, measuring efficiency of recruitment, intervention acceptability, and safety. RESULTS: Recruitment was efficient reflected in an overall recruitment yield (number randomized per number screened) of 55% (51/92) and a consent rate (number randomized per number eligible) of 94% (51/54). Acceptability of the intervention was high with 98% (123/125) of the video consultations conducted as planned. No serious adverse events were reported in either group. CONCLUSION: An integrated mental health video consultations VISION model for patients with SSD presenting to primary care is feasible, acceptable, and safe. Potential clinical effectiveness of the model should be evaluated in confirmatory trial implementing the multifaceted approach tailored to the individual patient with SSD directly into primary care practice. TRIAL REGISTRATION: The trial protocol was registered at German Clinical Trials Register (number: DRKS00026075, https://www.drks.de).

Building climate resilience: awareness of climate change adaptation in German outpatient medical practices.

BACKGROUND: Climate change is seen as the biggest health threat of the twenty-first century. Making outpatient medical practices resilient is therefore crucial to protect vulnerable groups and maintain quality of care. Awareness is a precondition for action. This study aims to explore awareness (knowledge, experience and attention) of climate change adaptation among stakeholders of outpatient medical practices. METHODS: Semi-structured interviews and focus groups with stakeholders of outpatient medical practices were conducted. The qualitative data were analysed in a two-step Thematic Analysis process. RESULTS: In total, n = 40 stakeholders participated in two focus groups and 26 interviews. The findings show a mixed degree of awareness in outpatient medical practices. The spectrum ranged from a passive role with curative acting only, handing over responsibility to others and a low perceived self-efficacy to a proactive and responsible implementation of adaptation strategies. Participants who saw the need and responsibility of climate change adaptation in medical practices perceived low additional workload. In general, implementation of climate change adaptation measures and general awareness of climate change adaptation appeared to be depending on a certain tension for change and a higher self-efficacy. CONCLUSION: Medical practices, and specifically primary care, plays a crucial role in climate change adaptation, and awareness needs to be increased further in order to cope with consequences of climate change. To facilitate this, there should be a strong emphasis on climate change adaptation strategies being part of outpatient care provider roles rather than being perceived as an "add-on" to already high workloads.

Core values of employed general practitioners in Germany - a qualitative study.

BACKGROUND: "Core values" help to guide practice of health care delivery. The core values of general practice are described in the European definition of general practice by WONCA, e.g. a holistic, comprehensive and continuous care. They may be associated with the idea that the general practitioner is the owner of the practice rather than an employee. OBJECTIVES: The objective was to examine the core values of employed GPs in their professional setting and their practical manifestation. METHODS: From April to May 2021, we conducted 17 semi-structured telephone-interviews with employed GPs in two districts in Baden-Wuerttemberg, Germany. The data were analysed using qualitative content analysis. RESULTS: We identified twelve core values, including values relevant to patient care and values relevant to the lives of employed GPs. Values with high relevance were job satisfaction, the professional distance from patients, collaboration and collegial exchange, comprehensive care, adequate consultation time and availability to patients. Values with heterogeneous relevance were continuity of care, waiting times and medical autonomy. The value "availability" of employed GPs to patients was associated with both patient care and personal life. The limited availability of employed GPs was accompanied by tensions between these two trends and other values. CONCLUSION: The values of employed GPs are partly consistent with the current WONCA definition of general practice. There were also indications of new values. The increase in the proportion of employed GPs implies a need to reflect on the core values of general practice, taking into account factors on the part of employed GPs, patients, and practice organisation.

Trajectories of post-traumatic stress in sepsis survivors two years after ICU discharge: a secondary analysis of a randomized controlled trial.

BACKGROUND: Post-traumatic stress has been identified as a frequent long-term complication in survivors of critical illnesses after sepsis. Little is known about long-term trajectories of post-traumatic stress and potentially modifiable risk factors following the ICU stay. Study objective was to explore and compare different clinical trajectories of post-traumatic stress symptoms in sepsis survivors up to two years after discharge from ICU. METHODS: Data on post-traumatic stress symptoms by means of the Post-traumatic Symptom Scale (PTSS-10) were collected in sepsis survivors at one, six, 12 and 24 months after discharge from ICU. Data on chronic psychiatric diagnoses prior ICU were derived from the primary care provider's health records, and data on intensive care treatment from ICU documentation. Trajectories of post-traumatic symptoms were identified ex post, discriminating patterns of change and k-means clustering. Assignment to the trajectories was predicted in multinomial log-linear models. RESULTS: At 24 months, all follow-up measurements of the PTSS-10 were completed in N = 175 patients. Three clusters could be identified regarding clinical trajectories of PTSS levels: stable low symptoms (N = 104 patients [59%]), increasing symptoms (N = 45 patients [26%]), and recovering from symptoms (N = 26 patients [15%]). Patients with initially high post-traumatic symptoms were more likely to show a decrease (OR with 95% CI: 1.1 [1.05, 1.16]). Females (OR = 2.45 [1.11, 5.41]) and patients reporting early traumatic memories of the ICU (OR = 4.04 [1.63, 10]) were at higher risk for increasing PTSS levels. CONCLUSION: Post-traumatic stress is a relevant long-term burden for sepsis patients after ICU stay. Identification of three different trajectories within two years after ICU discharge highlights the importance of long-term observation, as a quarter of patients reports few symptoms at discharge yet an increase in symptoms in the two years following. Regular screening of ICU survivors on post-traumatic stress should be considered even in patients with few symptoms and in particular in females and patients reporting traumatic memories of the ICU.

Multimodal home-based rehabilitation intervention after discharge from inpatient geriatric rehabilitation (GeRas): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Geriatric rehabilitation aims to maintain the functional reserves of older adults in order to optimize social participation and prevent disability. After discharge from inpatient geriatric rehabilitation, patients are at high risk for decreased physical capacity, increased vulnerability, and limitations in mobility. As a result, ageing in place becomes uncertain for a plethora of patients after discharge from geriatric rehabilitation and effective strategies to prevent physical decline are required. Collaboration between different health-care providers is essential to improve continuity of care after discharge from inpatient geriatric rehabilitation. The aim of this study is to evaluate the effectiveness of a multi-professional home-based intervention program (GeRas) to improve functional capacity and social participation in older persons after discharge from inpatient geriatric rehabilitation. METHODS: The study is a multicenter, three-arm, randomized controlled trial with a three-month intervention period. Two hundred and seventy community-dwelling older people receiving inpatient geriatric rehabilitation will be randomized with a 1:1:1 ratio to one of the parallel intervention groups (conventional IG or tablet IG) or the control group (CG). The participants of both IGs will receive a home-based physical exercise program supervised by physical therapists, a nutritional recommendation by a physician, and social counseling by social workers of the health insurance company. The collaboration between the health-care providers and management of participants will be realized within a cloud environment based on a telemedicine platform and supported by multi-professional case conferences. The CG will receive usual care, two short handouts on general health-related topics, and facultative lifestyle counseling with general recommendations for a healthy diet and active ageing. The primary outcomes will be the physical capacity measured by the Short Physical Performance Battery and social participation assessed by the modified Reintegration to Normal Living Index, three months after discharge. DISCUSSION: The GeRas program is designed to improve the collaboration between health-care providers in the transition from inpatient geriatric rehabilitation to outpatient settings. Compared to usual care, it is expected to improve physical capacity and participation in geriatric patients after discharge from inpatient geriatric rehabilitation. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00029559). Registered on October 05, 2022.

Risk factors for long-term invasive mechanical ventilation: a longitudinal study using German health claims data.

BACKGROUND: Long-term invasive mechanical ventilation (IMV) is a major burden for those affected and causes high costs for the health care system. Early risk assessment is a prerequisite for the best possible support of high-risk patients during the weaning process. We aimed to identify risk factors for long-term IMV within 96 h (h) after the onset of IMV. METHODS: The analysis was based on data from one of Germany's largest statutory health insurance funds; patients who received IMV ≥ 96 h and were admitted in January 2015 at the earliest and discharged in December 2017 at the latest were analysed. OPS and ICD codes of IMV patients were considered, including the 365 days before intubation and 30 days after discharge. Long-term IMV was defined as evidence of invasive home mechanical ventilation (HMV), IMV ≥ 500 h, or readmission with (re)prolonged ventilation. RESULTS: In the analysis of 7758 hospitalisations, criteria for long-term IMV were met in 38.3% of cases, of which 13.9% had evidence of HMV, 73.1% received IMV ≥ 500 h and/or 40.3% were re-hospitalised with IMV. Several independent risk factors were identified (p < 0.005 each), including pre-diagnoses such as pneumothorax (OR 2.10), acute pancreatitis (OR 2.64), eating disorders (OR 1.99) or rheumatic mitral valve disease (OR 1.89). Among ICU admissions, previous dependence on an aspirator or respirator (OR 5.13), and previous tracheostomy (OR 2.17) were particularly important, while neurosurgery (OR 2.61), early tracheostomy (OR 3.97) and treatment for severe respiratory failure such as positioning treatment (OR 2.31) and extracorporeal lung support (OR 1.80) were relevant procedures in the first 96 h after intubation. CONCLUSION: This comprehensive analysis of health claims has identified several risk factors for the risk of long-term ventilation. In addition to the known clinical risks, the information obtained may help to identify patients at risk at an early stage. Trial registration The PRiVENT study was retrospectively registered at ClinicalTrials.gov (NCT05260853). Registered at March 2, 2022.