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Randomised hybrid type 1 pilot trial evaluating preliminary effectiveness and implementation of an emergency care action plan (ECAP) for infants with medical complexity within a rural health network: a study protocol

Por: Palaza · A. · Callas · P. · Dayan · P. S. · Kuo · D. Z. · Riney · L. · Spencer · S. P. · Stapleton · R. · Stevens · M. · Studts · C. R. · Pulcini · C. D.
Introduction

Children with medical complexity (CMC) are a subset of children with special healthcare needs, defined by high healthcare utilisation, severe single or multisystem organ dysfunction, and in many cases, reliance on medical technology. In the emergency care setting, known challenges for this population include poor quality of care, avoidable admissions and high caregiver and provider burden. While experts and professional societies recommend emergency care planning tools to address these concerns, evidence to support effectiveness and implementation of such tools is lacking. Through a human-centred design approach, we recently engaged key partners to create and optimise an emergency care action plan (ECAP) for infants with medical complexity. Here, we describe the protocol for a pilot type 1 hybrid effectiveness-implementation randomised controlled trial (RCT) for infants with medical complexity aimed to evaluate ECAP effectiveness and implementation.

Methods and analysis

Infants with medical complexity and their caregivers will be randomly assigned to the intervention group (ECAP) or control group (standard care) in a pilot type 1 hybrid effectiveness-implementation RCT. The primary outcome is number of inpatient hospital days for infant participants. Additional effectiveness outcomes include perceived avoidance of emergency department (ED) visits, healthcare costs, caregiver stress and self-efficacy. Preliminary implementation outcomes include acceptability, feasibility, appropriateness and usability, as well as contextual barriers and facilitators to reach, adoption and implementation. Key partners, including caregivers of CMC and healthcare providers, will be engaged throughout the implementation of the ECAP and execution of the trial.

Ethics and dissemination

This study was approved by the University of Vermont Institutional Review Board (STUDY00002937). Findings will be disseminated through peer-reviewed publications, conference presentations, and focus groups and interviews with key stakeholders.

Trial registration number

NCT06444282.

Nursing home nurses' opinions on the potential evolution of their role in antibiotic stewardship: A French national cross‐sectional survey

Abstract

Aims

To assess French nursing home nurses' opinions on the potential evolution of their antibiotic stewardship role, facilitators and barriers, and nurses' characteristics associated with their opinion toward new roles regarding antibiotic prescribing.

Design

We conducted a cross-sectional study in French nursing homes with ≥20 beds and for which an email address was available in a national database managed by the French government between May and June 2022.

Methods

A self-administered internet-based questionnaire of 43 closed-ended Likert items was sent to directors of eligible nursing homes by email asking them to forward the link to the questionnaire to the nurses and head nurses of their institution. Data analysis included descriptive statistics and χ2 tests.

Results

7215 nursing homes were sent the online questionnaire; 1090 participants completed it partially or totally and 923 fully filled in the questionnaire. A majority of nurses supported strengthening and expanding their antibiotic stewardship role. Regarding new roles, over 70% agreed that nurses could collect urine samples to perform a urine culture on their own initiative, prescribe microbiological laboratory tests, and change the drug formulation or the administration route of the antibiotic prescribed by the general practitioner.

One-third declared that they could initiate antibiotics for some infections and/or change the empirical antibiotic treatment prescribed by the general practitioner. Nurses from public nursing homes with connection to a hospital (27.5% vs. >35% for other status) and with recent experience in nursing homes (31% for <5 years of practice vs. 41% for 10 years or more) were less likely to agree to prescribe antibiotics.

Conclusions

This quantitative questionnaire survey identified potential new nurses' roles in antibiotic stewardship that seem to be acceptable and feasible for participants. These new nurses' roles need to be explored in future experimentations before considering implementation.

Reporting Method

The study adhered to relevant EQUATOR guidelines and followed the STROBE reporting guidelines.

Patient or Public Contribution

A self-administered internet-based questionnaire was sent to directors of eligible nursing homes by email asking them to forward the link to the questionnaire to the nurses and head nurses of their institution. Nurses and head nurses who were interested and willing could complete the questionnaire online partially or fully.

Trial and Protocol Registration

This study is not a clinical trial and is not eligible for trial registration. We used another suitable study registration site, the Center for Open Science.

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