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

NCT06174844 | Recruiting

• 1 other identifier: PI22/00373
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Humanization of care; Health outcomes

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Sample 1

Data collected from 1st January to 30th June of 2024

Other: No intervention applied

Sample 2

Data collected from 1st January to 30th June of 2025

Other: No intervention applied

Interventions

No intervention applied OTHER

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

Sample 1; Sample 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Seville: lead
• Andalusian Health Service: collaborator

Study Sites (1)

Hospital Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Related Publications (1)

• Allande-Cusso R, Mejias-Martin YA, Quinoz-Gallardo MD, Porcel-Galvez AM. The impact of humanising hospital care on health outcomes: an observational study protocol. BMC Nurs. 2025 Apr 28;24(1):463. doi: 10.1186/s12912-025-03105-w.

  PMID: 40296139 DERIVED

MeSH Terms

Conditions

Patient Satisfaction; Personal Satisfaction; Burnout, Professional; Iatrogenic Disease

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Regina Allande-Cussó, Dr.

  Andalusian Health Service and University of Seville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Allande-Cussó, Dr.

CONTACT

+34954551475; rallande@us.es

Ana-María Porcel-Gálvez, Prof.

CONTACT

+34954551475; aporcel@us.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 18, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)