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SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres

Por: Del Fiol · G. · Orleans · B. · Kuzmenko · T. V. · Chipman · J. · Greene · T. · Martinez · A. · Wirth · J. · Meads · R. · Kaphingst · K. K. · Gibson · B. · Kawamoto · K. · King · A. J. · Siaperas · T. · Hughes · S. · Pruhs · A. · Pariera Dinkins · C. · Lam · C. Y. · Pierce · J. H. · Benson
Introduction

SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

Methods and analysis

The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2x2x2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2x2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

Ethics and dissemination

The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

Trial registration number

ClinicalTrials.gov: NCT05533918 and NCT05533359.

Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial

Por: Schlechter · C. R. · Del Fiol · G. · Jones · D. R. · Orleans · B. · Gibson · B. · Nahum-Shani · I. · Maxfield · E. · Locke · A. · Cornia · R. · Bradshaw · R. · Wirth · J. · Jaggers · S. J. · Lam · C. Y. · Wetter · D. W.
Introduction

Over 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management.

Methods and analysis

This study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness).

Ethics and dissemination

Study protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications.

Trial registration number

clinicaltrials.gov; NCT05666323.

Initial prescriptions and medication switches of biological products: an analysis of prescription pathways and determinants in the Swiss healthcare setting

Por: Wirth · K. · Boes · S. · Näpflin · M. · Huber · C. · Blozik · E.
Objectives

Biological products have contributed to extraordinary advances in disease treatments over the last decade. However, the cost-saving potential of imitator products, so-called biosimilars, is still under-researched in Switzerland. This study aims to assess biosimilars’ prescriptions at treatment initiation and their determinants, as well as biological therapy switches.

Design

The study included all patients who had at least one biosimilar available on the market at the time when they were prescribed a biological product. We analysed longitudinal data for biosimilar prescriptions in Switzerland using descriptive statistics and logistic regression to quantify the associations with individual, pharmaceutical and provider-related variables.

Setting

The analysis is based on de-identified claims data of patients with mandatory health insurance at Helsana, one of the Swiss health insurance companies with a substantial enrollee base in mandatory health insurance.

Participants

Overall, 18 953 patients receiving at least one biological product between 2016 and 2021 were identified.

Outcome measures

We differentiated between initial prescriptions and follow-up prescriptions. Our regression focused on initial prescriptions due to evidence indicating that patients tend to follow the medication prescribed at therapy initiation.

Results

Although biosimilars’ market share was low (28.6%), the number of prescriptions has increased (from 1016 in 2016 to 6976 in 2021). Few patients with medication switches (n=1492, 8.5%) were detected. Increased relative price difference (difference in the price of available biosimilars relative to price of corresponding reference product) was associated with decreased probability of biosimilar prescriptions, whereas male sex, an increase of available imitator drugs on the market, larger packaging sizes, and prescriptions from specialists or physicians in outpatient settings were associated with increased biosimilar use.

Conclusion

The low number of biosimilar prescriptions, despite the proliferating biosimilar market, indicates a high potential for biosimilar diffusion. The findings indicate that patients typically adhere to the therapy options initially chosen and are less inclined to make changes following the initiation of treatment. Our research highlights the need for awareness initiatives to improve understanding among patients and physicians, enabling informed, shared decision-making about biosimilar prescriptions.

Case Comparison of Preterm Infant Stability During Packed Red Blood Cell Transfusions

imageBackground Very preterm infants (less than 32 weeks gestational age) experience acute morbidity during their stay in a neonatal intensive care unit. Because of their prematurity and frequent laboratory testing, they experience anemia, requiring correction with packed red blood cell (PRBC) transfusion(s). PRBC transfusions have been linked to neonatal morbidity, such as necrotizing enterocolitis, but never signs and symptoms of physiological stability. Objective The secondary data analysis aimed to examine very preterm infants’ physiological stability before, during, and after PRBC transfusions. Methods A within-case, mixed-methods design was used in a secondary data analysis for 16 transfusion cases from 13 very preterm infants. Results The findings showed very preterm infants with physiological variables falling within defined limits based on gestational age during the transfusion. Two contrasting case exemplars will be presented. Discussion PRBC transfusions are necessary and prevent morbidity in very preterm infants. Observing instability during transfusions and prospectively studying hypothermia, cardiac instability, and thermal gradients is essential to design interventions to decrease morbidity associated with PRBC transfusions.
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