Assessment of the Humanisation of Care in Hospitals in Andalusia-Spain (HUMANCUIDA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Burnout, Professional; Satisfaction, Patient; Nurse-Patient Relations; Adverse Event; Hospital Acquired Condition; PROM; Satisfaction, Personal
• Intervention / Treatment: Other: No intervention applied

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Regina Allande-Cussó, Dr.; Phone Number: +34954551475; Email: rallande@us.es
• Study Contact Backup: Name: Ana-María Porcel-Gálvez, Prof.; Phone Number: +34954551475; Email: aporcel@us.es

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocío
    • Contact: Regina Allande-Cussó, Dr.; Email: rallande@us.es
    • Contact: Ana-María Porcel-Gálvez, Prof.; Email: aporcel@us.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sample 1; Data collected from 1st January to 30th June of 2024	Other: No intervention applied; No intervention applied: data will only be collected in the indicated sampling periods from patients admitted to the participating hospitals.
Sample 2; Data collected from 1st January to 30th June of 2025	Other: No intervention applied; No intervention applied: data will only be collected in the indicated sampling periods from patients admitted to the participating hospitals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Seville
• Collaborators: Andalusian Health Service
• Investigators: Principal Investigator: Regina Allande-Cussó, Dr., Andalusian Health Service and University of Seville

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Health outcomes; Humanization of care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Stress, Psychological; Occupational Stress; Occupational Diseases; Burnout, Psychological; Burnout, Professional; Iatrogenic Disease
• Other Study ID Numbers: PI22/00373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The collected data is personal and will not be shared or publicized. These data will be stored by the research team for 10 years, following the specifications of the Ethics Committee that approved the Ethical opinion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No