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Providing care management, treatment and support to patients with Alzheimer’s Disease and Related Dementias (ADRD) is a difficult task for health systems. Over the past 20 years, interventions designed to improve outcomes for patients living in the community with dementia and their care partners have moved progressively, but separately, from large scale trials and pragmatic models of collaborative care. Given the projected increase in the number of people living with dementia coupled with the realignment of payment for services to be value-based and provided in the community, system-level approaches are needed to address the complex needs of patients with a dementia diagnosis and their care partners. We designed a statewide, pragmatic trial to evaluate virtual delivery of an evidence-based dementia collaborative care program on patient healthcare utilization and medication use.
The Aging Brain Care Virtual (ABCV) program is a 12-month embedded, cluster randomized, usual care controlled trial designed to test the effectiveness of a virtual dementia collaborative care program in 24 Indiana University Health primary care clinics (12 intervention, 12 control) across the state of Indiana, enrolling 860 persons living with dementia (430 intervention, 430 control) and their care partners. ABCV relies on a tailored approach in which dyad needs are identified during virtual visits and addressed with standardized protocols previously tested in a randomized controlled trial delivered in person. The ABCV trial will measure emergency department utilization (primary outcome) and appropriate medication use (secondary outcome) at 12 months using electronic medical record data. Additionally, this study will use semi-structured interviews with care partners and clinicians to explore the implementation context, process and outcomes of the ABCV program.
Ethics approval was obtained from the Indiana University Institutional Review Board (20249). Research findings will be published in peer-reviewed journals and presented at scientific conferences.
Combined vascular endothelial growth factor/programmed death-ligand 1 blockade through atezolizumab/bevacizumab (A/B) is the current standard of care in advanced hepatocellular carcinoma (HCC). A/B substantially improved objective response rates compared with tyrosine kinase inhibitor sorafenib; however, a majority of patients will still not respond to A/B. Strong scientific rationale and emerging clinical data suggest that faecal microbiota transfer (FMT) may improve antitumour immune response on PD-(L)1 blockade. Early trials in melanoma with FMT and reinduction of immune checkpoint blockade (ICI) therapy in patients with anti-PD-1-refractory metastatic melanoma were reported in 2021 and demonstrated reinstatement of response to ICI therapy in many patients. Due to anatomical vicinity and the physiological relevance of the gut-liver axis, we hypothesise HCC to be a particularly attractive cancer entity to further assess a potential benefit of FMT in combination with ICI towards increased antitumour immunity. Additionally, HCC often occurs in patients with liver cirrhosis, where liver function is prognostically relevant. There is evidence that FMT may increase hepatic function and therefore could positively affect outcome in this patient population.
This prospective, multicentre, randomised, placebo-controlled, double-blind phase II clinical trial has been designed to assess immunogenicity and safety of FMT via INTESTIFIX 001 combined with A/B in advanced HCC in comparison to A/B with placebo. Primary endpoints are measured as tumour CD8+ T cell infiltration after 2 cycles of treatment with vancomycin, A/B+INTESTIFIX 001 in comparison to vancomycin-placebo, A/B+INTESTIFIX 001-placebo and safety of the therapeutic combination in advanced HCC. INTESTIFIX 001 is an encapsulated FMT preparation by healthy donors with a high alpha-diversity in their gut microbiome for oral administration, manufactured by the Cologne Microbiota Bank (CMB). Sample size was calculated to achieve a specific expected accuracy for the primary immunological endpoint. 48 subjects will be randomised to reach a goal of 42 usable measurements in the modified intention-to-treat set. Subjects will be randomised in a 2:1 ratio to A/B or placebo (28 A/B, 14 placebo).
The study was approved by ethics committee review and the German Federal Ministry of Drugs and Medical Devices. The trial is registered under EU CT no. 2023-506887-15-00. The outcome of the study will be disseminated via peer-reviewed publications and at international conferences.
To investigate the psychosocial impact of the COVID-19 pandemic on children with chronic health conditions (CHC) and their legal guardians (LG) living in Germany.
Qualitative interview study based on the transcripts of semistructured individual telephone interviews.
Data were collected from October to December 2021 and the time frame of reference was January–June 2021 with two interviewers. Discussed aspects were, for example, socioeconomic information, daily life, thoughts and feelings of both children and LG, as well as family communication, unmet needs and possible advantages. Data were analysed using qualitative content analysis. The category system and subsequent coding schemes with anchor examples were based on interviews and the interview guide. It was tested for integrity and feasibility with one interview and finalised. To ensure classification reliability within all 11 interviews, 1 specifically trained rater (who did not participate in the interviewing to separate data collection and analysis) coded all transcripts.
11 LG of children with CHC participating in the ikidS (ich komme in die Schule) study.
The three aspects that were mentioned most often in the interviews were a psychological impact on children, a psychological impact on LG and an impact on the daily routines of LG. The majority of children and LG were burdened, had changed their activities and spent more time together, while having more conflicts. Children did not worry about becoming infected with COVID-19, but were worried about the health of their relatives. It was further reported that children had become more autonomous. LG additionally reported unmet needs such as opportunities for childcare or psychotherapy.
While the changes brought about by the COVID-19 pandemic and their impact were often seen as negative, the LG in our study also perceived some opportunities for personal development both in their children and themselves, underlining that future research on the impact of the COVID-19 pandemic should focus not only on negative consequences but also on opportunities and positive change. Qualitative methods can be used on an exploratory basis to inform quantitative studies, as they are able to delve deeper into the area being examined and provide greater insight into which aspects interviewees focus on.
Psychosis, characterised by chronic symptoms often emerging in youth, imposes a substantial burden on individuals and healthcare systems. While early detection and intervention can mitigate this burden, there is limited evidence on the cost-effectiveness of such approaches. To address this lack of evidence, this study protocol outlines the health economic implications of an artificial intelligence (AI)-based intervention, the Computer-Assisted Risk-Evaluation (CARE), designed to prevent psychosis. The intervention uses AI technologies to enhance the diagnosis and treatment quality for individuals at high risk of psychosis.
The health economic evaluation has been designed alongside a 12-month multicentre randomised controlled trial comparing CARE with treatment as usual from both payer and societal perspectives. An implementation cost analysis will complement the evaluation, and long-term consequences beyond the trial will be explored descriptively. Based on a literature review, an initial economic logic model will guide subsequent analyses by depicting CARE’s programme theory.
The cost-effectiveness assessment will include averted cases of manifest psychosis and quality-adjusted life-years using the EuroQol 5-Dimensions 3-Level instrument. Other effectiveness outcomes will also be incorporated into a cost–consequence analysis. Cost-effectiveness acceptability curves reflecting statistical uncertainty will be constructed, incorporating various payer and societal willingness-to-pay values. The implementation cost analysis will follow a mixed-methods approach to capture facility-specific costs.
A dark logic model, emphasising negative outcomes, will be developed to investigate long-term consequences. Further, the initial economic logic model will be refined using trial data and expert interviews. This comprehensive approach aims to provide decision-makers not only with evidence on the cost-effectiveness of CARE, but also with a broader understanding of the implications of the intervention.
The study has received ethical approval and plans to disseminate its findings through publication in a peer-reviewed journal and conference presentations.
Persistent acute kidney injury (AKI) is associated with an increased morbidity and mortality. In patients with an already established AKI, the new urinary biomarker C-C motif chemokine ligand 14 (CCL14) can predict a persistent AKI. However, it is still unknown whether the implementation of nephroprotective measures in patients with an already established moderate/severe AKI can positively influence the trajectory of AKI and patients’ outcome.
The PrevProgAKI trial is a randomised, controlled, single-centre trial designed to evaluate the effectiveness of nephroprotective measures in patients with established moderate/severe AKI. We aim to enrol 480 patients with moderate or severe AKI (Kidney Disease: Imroving Global Outcomes, KDIGO, stage 2 or 3) within 72 hours of major surgery. Eligible patients will be randomised to receive either standard of care (control group) or an extended therapeutic strategy that consists of different supportive measures (intervention group). The randomisation will be stratified by urinary CCL14 results (CCL14
The PrevProgAKI trial has been approved by the Ethics Committee of the Chamber of Physicians Westfalen-Lippe and the University of Muenster (no. 2021-569 f-S). Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.
NCT05275218 (clinicaltrials.gov), first posted 11 March 2022.
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