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Study protocol for a hybrid I randomised clinical trial to evaluate an audit and feedback and a pharmacist-led intervention to reduce potentially inappropriate medications in older adults: the AIM study

Por: Leiva · A. · Gallardo Alfaro · L. · Bejarano · F. · Sempere · E. · Soler · A. · Huguet · A. · Llarena · M. · Lekue · I. · Campabadal Prats · C. · Salom · C. · Solaz · R. B. · Socias Canellas · C. · Gonzalez · A. · Campins · G. M. · Vanrell · A. · Rovira · M. · Ponsa Mir · G. · Vicens-Cal
Introduction

Potentially inappropriate prescriptions (PIPs) in older adults, such as long-term use of benzodiazepines, proton pump inhibitors without indication or antipsychotics in dementia, are associated with adverse events and increased healthcare utilisation. Despite clinical guidelines discouraging their use, PIPs remain frequent in primary care. An audit and feedback (A&F) intervention of PIPs to general practitioners (GPs), led by pharmacists, may reduce the prescription of PIPs in primary care.

Methods and analysis

A two-arm, pragmatic, controlled trial will be conducted to evaluate the effectiveness of an A&F-based intervention and a pharmacist-led intervention to reduce the proportion of patients aged ≥65 years receiving inappropriate prescriptions. A total of 170 participating GPs, 85 per group, are required. GPs will be randomised into intervention or control groups (1:1). The intervention includes feedback reports, pharmacist-led academic detailing and access to online training modules. The primary outcome is the proportion of older adults receiving at least one PIP at 12 months as well as the total number of PIPs. A random effects Tobit regression model, censored at 0 and 100, will be used to estimate between-group differences adjusted for baseline prescribing. Subgroup analyses will explore heterogeneity of effect by baseline prescribing level and healthcare region. Implementation outcomes, including reach, fidelity, engagement and maintenance, will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, combining quantitative and qualitative data.

Ethics and dissemination

Ethical approval was obtained by the Balearic Island Committee Ethics (IB5219/23PI). Study findings, including primary and secondary outcomes and qualitative implementation results, will be disseminated through peer-reviewed publications and stakeholder reports.

Trial registration number

ISRCTN14449434.

Influence of Social Determinants of Health on Adherence to Lifestyle Modifications in Individuals With Prediabetes: A Mixed Methods Study

ABSTRACT

Aim

To explore the relationship between social determinants of health and adherence to lifestyle recommendations, and how these determinants can help explain contextual and interpersonal factors contributing to adherence among individuals with prediabetes.

Design

Explanatory sequential mixed methods study integrating a cross-sectional quantitative analysis with an ethnomethodological qualitative approach grounded in critical social paradigm.

Methods

The quantitative phase used data from the intervention arm (n = 86) of the PREDIPHONE trial, a randomised controlled study evaluating the effectiveness of a nurse-led telephone intervention for lifestyle changes in glycaemic control. Adherence was measured using a composite index, analysed as both a continuous and categorical variable. Correlation analysis examined adherence and age. Chi-square and ANOVA tests were used to analyse differences in participant characteristics across adherence quartiles. The qualitative phase included individual semi-structured interviews and a focus group with participants showing high or low adherence. Thematic content and discourse analysis were employed, ensuring validity through triangulation, reflexivity and discourse saturation.

Results

Employment status was identified as a significant factor, with unemployed or retired participants showing better adherence. Although no statistical differences in adherence were found by social class or gender, lower social class participants reported financial barriers to healthy eating and time constraints limiting physical activity (PA). Women reported facing greater challenges due to caregiving responsibilities, whereas men benefited from household support.

Conclusions

Employment status emerged as a determinant of time availability for self-care, alongside social class and gender in adherence to lifestyle modifications. Women, especially those from lower social classes, experienced heightened barriers to adherence, underscoring the need for tailored, gender-sensitive and equity-focused interventions.

Implications

Addressing social determinants is essential for effective lifestyle advice among individuals with prediabetes.

Impact

The study highlights the role of social class and gender in adherence.

Reporting Method

STROBE and COREQ guidelines.

Patient Contribution

Through interviews and focus group.

Comparing high-flow nasal cannula oxygen and non-invasive ventilation to standard oxygenation in non-selected intensive care unit patients admitted for acute hypoxaemic respiratory failure: protocol for the KISS (Key oxygenation Interventions in Surgical

Por: Jaber · S. · Huguet · H. · Molinari · N. · De Jong · A.
Introduction

Hypoxaemic acute respiratory failure (ARF) in intensive care unit (ICU) patients is associated with high mortality. Three main devices are used to provide oxygen to hypoxaemic ARF patients: non-invasive ventilation (NIV), high-flow nasal cannula oxygen (HFNO) and standard oxygen (first-attempt device in usual care). To date, no multicentre randomised controlled study has compared NIV and HFNO to standard oxygen with day 28 mortality rate as primary outcome in hypoxaemic ARF in non-selected patients. Our hypothesis is that NIV and/or HFNO is superior to standard oxygen to reduce day 28 mortality rate in hypoxaemic ARF.

Methods and analysis

The Key oxygenation Interventions in Surgical and non-Surgical patients (KISS) trial is an adaptive investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system–based randomisation. Patients with hypoxaemic ARF were randomly assigned to one of three groups: the ‘NIV-group’ to receive curative NIV combined with HFNO delivered between NIV trials, or the ‘HFNO’ group to receive HFNO alone, or the ‘standard oxygen-group’ to receive oxygen therapy alone.

The primary endpoint is day 28 all-cause mortality. The main secondary endpoint is intubation rate at day 28. The exploratory endpoints are intubation rates at day 3 and day 7; oxygenation up to day 7; need for other rescue oxygen therapy up to day 7; ICU and hospital length of stay; and mortality rates in ICU, hospital and at day 90.

The main objective is to assess if NIV and/or HFNO is superior to standard oxygen to reduce day 28 mortality rate in hypoxaemic ARF. Additional comparisons between predefined stratum following randomisation will be performed: (1) medical versus postoperative admissions, (2) among medical (immunocompromised vs non-immunocompromised) and (3) among postoperative (abdominal vs cardio-thoracic).

An adaptive design will be used. Two interim analyses will be performed after 700 and 1400 included patients among the 2100 planned.

Ethics and dissemination

The study project has been approved by the appropriate ethics committee ‘Comité-de-Protection-des-Personnes Sud-Est V-23-CHUM-01 Cat2 2022-A02761-42/1’. Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If NIV and/or HFNO reduce the mortality at day 28, NIV and/or HFNO could be proposed to become one of the first-line therapies in hypoxaemic ARF patients.

Trial registration number

NCT05812911.

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