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

Stress Clinical Trial

— HUMANCUIDA  

Official title:

Evaluation and Development of the HUMANisation of CARE in the Andalusian Public Health System in Complex User Units and Hospital Emergency Units: Attention to Frailty, Prevention of Adverse Events, and the Impact of the Nurse-patient Relationship on Health Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174844
• Other study ID #: PI22/00373
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Seville
• Contact: Regina Allande-Cussó, Dr.
• Phone: +34954551475
• Email: rallande[@]us.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Event
• Burnout, Professional
• Hospital Acquired Condition
• Iatrogenic Disease
• Nurse-Patient Relations
• PROM
• Satisfaction, Patient
• Satisfaction, Personal
• Stress

Intervention

Other:
• No intervention applied
No intervention applied: data will only be collected in the indicated sampling periods from patients admitted to the participating hospitals.

Locations

Country	Name	City	State
Spain	Hospital Virgen del Rocío	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
University of Seville	Andalusian Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health outcomes	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.	12 months
Primary	Adverse events	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).	12 months