Assessment of the Humanisation of Care in Hospitals in Andalusia-Spain

Recruiting

• Conditions: Hospital Acquired Condition; PROM; Satisfaction, Personal; Stress; Nurse-Patient Relations; Adverse Event; Satisfaction, Patient; Burnout, Professional

• Registration Number: NCT06174844
• Lead Sponsor: University of Seville

Brief Summary

Observational assessment through patient interviews of relational, structural and organisational aspects related to the humanisation of health care. These data will be related to health outcomes such as pain, sleep quality, anxiety levels, adverse events (pressure injuries, falls, and mortality), satisfaction with the care received, and experience in communication processes with health professionals.

Data will also be collected on work ergonomics variables (stress, burnout, working conditions, ratios) of nurses and health technicians, which will also be related to the health outcomes collected.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-18
• Study Start: 2024-01-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• All patients admitted to the internal medicine and emergency units of the participating hospitals during the sampling time.

Exclusion Criteria

• Patients presenting with haemodynamic instability or emergencies at the time of sampling
• Patients with cognitive impairment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events	12 months	Design of a predictive model based on regression models of the occurrence of adverse events (falls, mortality, venous catheter infection pressure injuries, which will be asked with items created ad-hoc) and their relationship with the rest of the study variables (assessed with the scales used for outcome 1).
Health outcomes	12 months	Levels obtained in the health outcomes identified as study variables: anxiety, measured with the Golberg scale; sleep quality, measured with the Athens Sleep Scale; frailty status, measured with the Tilburg Index; level of pain, measured with the Visual Analogue Pain Scale; level of care dependency, measured with the INICIARE scale; and the variables of mortality, falls, venous catheter infection and pressure injuries, which will be asked with items created ad-hoc. We will also study the association between the results obtained with the aforementioned scales and the variables of organisational context and structure of the centre: management leadership, measured with the Leadership Scale; nurse-patient relationship, measured with the NIC_CA Scale; work stress, measured with the Nursing Stress Scale; work conditions, measured with the PES-NWI Scale; and the variables of turnover intention and nurse-patient ratio, measured with questions designed ad hoc.

Trial Locations

Locations (1)

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain