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STRONGER 60+: study protocol for a mixed-methods randomised controlled trial assessing the clinical effectiveness and delivery of an adapted FINGER model for brain health in primary care

Por: Welmer · A.-K. · Leavy · B. · Thunborg · C. · Holleman · J. · Karlsson · P. · Hallinder · H. · Aspö · M. · Bergström · C. · Akesson · E. · Kulmala · J. · Kivipelto · M.
Background

The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was the first to show that multidomain lifestyle interventions can enhance brain health and reduce cognitive decline. However, the clinical effectiveness and delivery of the FINGER model within primary care settings remain unexplored. This paper presents the protocol for the STRONGER 60+trial, which aims to evaluate both the clinical effectiveness and real-world delivery of an adapted FINGER-based intervention in primary care.

Methods and analysis

This 6-month randomised controlled clinical effectiveness trial will be conducted in primary care and will include adults aged 60 and older with vascular or lifestyle-related risk factors for dementia. A total of 80 participants will be randomised to either a structured, supervised multidomain lifestyle intervention or a self-guided version of the same programme. The intervention includes nutritional guidance, physical exercise, cognitive training, social engagement and management of vascular and metabolic risk factors. Data will be collected at baseline, 6 months (primary endpoint) and 12 months post-randomisation. The primary outcome is the change in a composite healthy lifestyle score at 6 months. In addition, the study will explore delivery processes and stakeholder (participant and healthcare professional) perspectives using both qualitative and quantitative methods.

Ethics and dissemination

The study has been approved by the Swedish Ethical Review Authority (approval numbers: 2020–05785, 2021–06413-02, 2022–05454-02) and will follow the principles of the Declaration of Helsinki. Ethical procedures for informed consent, confidentiality and data management will be strictly observed. Results will be disseminated through scientific publications, conferences and targeted outreach to healthcare professionals and the general public.

Trial registration number

NCT07117916.

Prediction of adverse events after acute myocardial infarction: derivation and external validation of an extended CHA2DS2-VASc score model

Por: Carlsson · L. · Leppert · J. · Selmeryd · J. · Christersson · C. · Hedberg · P.
Background

The CHA2DS2-VASc score predicts poor prognosis in patients with acute myocardial infarction (AMI), with or without atrial fibrillation. In this observational study, we aimed to evaluate the CHA2DS2-VASc score by itself and extended with clinical data to predict adverse events in patients after AMI.

Methods

In this longitudinal observational study, we used a cohort of 955 patients hospitalised for AMI at Västmanland County Hospital, Västerås, Sweden, to derive prediction models. The CHA2DS2-VASc score alone and combined with clinical data (systolic blood pressure, creatinine level, ST-segment elevation and diuretic use at discharge) was analysed using Cox regression to evaluate the risk of major adverse events (MAE), defined as all-cause death or hospitalisation due to recurrent MI, heart failure or ischaemic stroke. Discriminatory performance was presented as the time-dependent area under the curve (tdAUC). The prediction models were validated in 416 patients with AMI hospitalised at Uppsala University Hospital, Uppsala, Sweden.

Results

During a median of 2.5 years, 287 (30.1%) patients experienced MAE. CHA2DS2-VASc scores of 2, 4 and 6 were associated with fourfold, ninefold and 18-fold increases in the relative risk of MAE, respectively, with a tdAUC of 0.76 at a 2-year follow-up. Extending the CHA2DS2-VASc score with clinical data significantly improved the prediction model (p

Conclusion

The addition of clinical data to the CHA2DS2-VASc score was superior to a model with CHA2DS2-VASc alone in predicting adverse events in patients after AMI, and the model performed well in external validation.

Mindfulness-based mHealth intervention for pregnant black and Latina women at high risk of postpartum depression--the Healthy Mama and Baby study: protocol and data overview for a randomised controlled trial in an integrated healthcare delivery system

Por: Kubo · A. · Kurtovich · E. · Aghaee · S. · Rubin · M. V. · Gomez Chavez · L. · Brown · S. D. · Ridout · K. · Bhalala · M. · Williams · A. · Elmer · M. · Ramsey · M. · Suazo · S. · Chess · A. · Quesenberry · C. P. · Avalos · L. A.
Introduction

Postpartum depression (PPD) is a debilitating condition affecting over 20% of postpartum women, with disproportionately higher rates among black and Latina women compared with their white counterparts. Current recommendations for PPD prevention demand significant healthcare system resources, highlighting the need for alternative, evidence-based interventions that minimise strain on these systems. Mindfulness has been shown to effectively reduce depressive symptoms and prevent relapse across various populations. However, no studies to date have evaluated the efficacy of a digitally delivered mindfulness intervention specifically for black and Latina women at increased risk of PPD.

This article presents the protocol for the Healthy Mama and Baby study, a randomised controlled trial (RCT). This trial evaluates whether a mobile-based (mHealth) mindfulness intervention tailored for pregnant women reduces depressive symptoms among pregnant black and Latina women at high risk for PPD.

Methods and analysis

We are conducting a fully remote RCT, recruiting 600 pregnant black and/or Latina women at risk of PPD from Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system. Participants are enrolled before 30 weeks’ gestation. They are randomised into either an mHealth mindfulness intervention arm, which receives access to a mindfulness app tailored specifically for pregnant and postpartum women, or a time-matched and attention-matched active control arm, which receives access to an online program of calming nature sounds. Both arms are instructed to engage in their assigned program for 5–20 min per day for 6 weeks. Outcome assessments are conducted online at baseline, post intervention and post partum (~7 weeks post partum) using validated questionnaires. Outcomes include depressive symptoms (primary) and anxiety, sleep and perceived stress (secondary).

Ethics and dissemination

All study procedures have been approved by the KPNC Institutional Review Board. The findings will be disseminated widely through peer-reviewed publications and conference presentations.

Trial registration number

NCT05186272.

Nurses' Self‐Reported Practices and Prescribers' Expectations in Intravenous Fluid Therapy for Hospitalised Patients: A Survey Study and Clinical Documentation Review

ABSTRACT

Aims

To assess self-reported practices and knowledge of nurses and prescribers (i.e., physicians and nurse practitioners) on intravenous fluid therapy, and to evaluate how this is documented through a clinical documentation review.

Design

Multicentre cross-sectional study, between April 2022 and July 2022, across 13 wards from four Dutch hospitals.

Methods

A survey study was conducted to assess self-reported practices related to intravenous fluid therapy. A 12-item questionnaire evaluated knowledge. To gain insights into documentation practices, a retrospective chart review was performed. Data analysis involved descriptive statistics, with group differences analysed using the chi-squared test or Fisher's exact test, as appropriate.

Results

Three hundred and four healthcare professionals completed the questionnaire (92% nurses). The majority of prescribers (n = 20/25; 80%) expected that nurses would start, stop or change intravenous fluid therapy. Overall, the median number of correct answers to knowledge questions was eight (IQR 7–9, range 0–12); four participants (1%) answered all knowledge questions correctly. Knowledge about the composition of sodium chloride 0.9% solution was limited. Analysis of patient charts revealed that 54% (196/362) received intravenous fluids, most commonly 0.9% sodium chloride infusion (168/195; 86%), although the indication was described in 3% (6/196). Thirty-one percent (61/196) of patients received intravenous fluids to keep the vein open (< 30 mL/h).

Conclusion

The study identified shared responsibility, a knowledge gap, and limited documentation concerning intravenous fluids. Prescribers expect nurses to adjust intravenous fluids without consulting a prescriber, which aligns with what nurses do, although they are not legally authorised. Given the limited documentation of the indication for intravenous fluids, it is plausible that several patients received intravenous fluids unnecessarily.

Implications

The perceived shared responsibility presents an opportunity to develop a protocol engaging both prescribers and nurses, aiming to guide more targeted infusion therapy.

Impact

Reducing unnecessary infusions to keep-the-vein-open can help eliminate low-value care.

Reporting Method

CROSS guideline.

Patient or Public Contribution

No patient or public contribution.

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