Proactive demonstrative project for care management

ISRCTN	ISRCTN17872657
DOI	https://doi.org/10.1186/ISRCTN17872657
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	PT-182023-UCH
Sponsor	Corporacio de Salut del Maresme i la Selva
Funder	CatSalut

Submission date: 04/08/2025
Registration date: 26/08/2025
Last edited: 26/08/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
There’s a global shortage of nurses, and by 2030, the World Health Organization expects a shortfall of 4.5 million nurses. This could affect the quality of healthcare. To help address this, researchers in Catalonia, Spain are testing a new digital tool that helps hospitals better match nursing care to each patient’s needs. The goal is to improve patient outcomes, reduce stress for nurses, and make hospital care more efficient.

Who can participate?
The study involves healthcare professionals and patients in selected hospital units. Participation is limited to those working or receiving care in the pilot hospitals involved in the study.

What does the study involve?
For patients, the study involves having their care needs assessed using a new digital tool when they are admitted to hospital. For nurses and other professionals, it means adjusting staffing levels based on these assessments and providing feedback through surveys. The study also includes tracking health outcomes and staff satisfaction.

What are the possible benefits and risks of participating?
Benefits may include better care for patients and improved working conditions for nurses. Risks are minimal, as the study mainly involves data collection and adjustments to staffing based on patient needs. No treatments are being tested, and patient safety remains a priority.

Where is the study run from?
The study is run by the Corporació de Salut del Maresme i la Selva, in collaboration with six hospitals in Girona and Barcelona (Spain)

When is the study starting and how long is it expected to run for?
May 2023 to May 2026.

Who is funding the study?
The study is funded by the Catalan Health Service (CatSalut) and is part of a wider initiative to improve healthcare in Catalonia (Spain)

Who is the main contact?
Eva Taravilla Suros, etaravilla@salutms.cat
Joana Blazquez Martinez, jblazquez@salutms.cat

Contact information

Mrs Joana Blazquez Martinez
Public, Scientific, Principal investigator

Sant Jaume 209-217
Calella
08370
Spain

Phone	+34 937 69 02 01
Email	jblazquez@salutms.cat

Mrs Eva Taravilla Suros
Scientific

Cala Sant Francesc 5
Blanes
17300
Spain

ORCID ID	0009-0006-8422-2058
Phone	+34 972353264
Email	etaravilla@salutms.cat

Study information

Primary study design	Observational
Study design	Multicentric observational phase I retrospective cohort
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Proactive demonstrative project for care management: adaptation and new roles for the needs of hospitalized patients
Study acronym	PT-CURAS
Study objectives	Evaluate whether the implementation of the digital tool or platform that calculates the patient's Care Intensity Index (CII) upon admission is effective in adjusting the use of nursing resources in the hospital care process, contributes to improving patient quality and safety, and enhances professional satisfaction.
Ethics approval(s)	Approved 26/02/2025, Maresme Healthcare Consortium (Research Unit (basement 2, door 5) Mataró Hospital, Carretera de Cirera, s/n 08304 Mataró – Barcelona, Barcelona, 08304, Spain; +34 937417730; assajosclinics@csdm.cat), ref: 87/24
Health condition(s) or problem(s) studied	Improve perception of professional satisfaction
Intervention	Phase I: Register the variables agreed upon to establish a Care Intensity Index (CII) and apply it to a sample of 10 patients per entity (in collaboration with six hospitals in Girona and Barcelona). Data extraction will be done through conventional statistical analysis to perform a pre-implementation study of the digital tool using an Excel document, where time and procedures will be manually recorded. Health indicators will be collected before the tool's implementation, and surveys will be conducted using the OMICE and NSS stress scales via URL. Phase II and III: 1. Create and implement the tool in a sample of patients, adjusting nursing staff by patient profiles and care load in a pilot unit at each center. 2. Evaluate the tool’s functionality using the SUS scale for usability. 3. Measure effectiveness during a two-month period using a manual checklist. The same Excel document from Phase I will be used to track the CII and verify its established variables Propose stress and neglect scales for healthcare professionals prior to the implementation phase of the digital application and subsequently in phase 3. Provide a Likert satisfaction scale for the management population. Pilot test in phase 3 of an internal medicine unit in the participating hospitals.
Intervention type	Other
Primary outcome measure(s)	1. Stress factors of healthcare professionals in hospitalization measured by the validated Spanish version of the NSS (Nursing Stress Scale) in phase I and phase III 2. Omission of nursing care measured by he Survey on OMISION OF NURSING CARE (OMICE) Spanish version (Spain) of the MISSCARE instrument in healthcare professionals in hospitalization during phase I and phase III 3. Management satisfaction measured with the satisfaction survey of management professionals who will use the digital tool in phase I prior to implementation and in phase III 4. Manual cures intensity index measured using the Barthel scale, medical order sheet, monitoring of vital signs and frequency according to medical indication and record of cures and PRN (project research nursing) in Phase II or validation 5. Cure intensity Index IIC measured using the digital tool or APP in phase III 6. The usability of the application or digital tool was measured using the Computer System Usability Questionnaire (CSUQ) for management professionals in Phase III
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	31/05/2026

Eligibility

Participant type(s)	Patient, Health professional
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	520
Key inclusion criteria	1. Care professional in the MI unit and patients over the age of 18 years admitted to that unit 2. Professional manager who uses the digital application
Key exclusion criteria	1. Patients not used Internal Medicine Unit 2. Under 18 years of age
Date of first enrolment	01/07/2025
Date of final enrolment	28/02/2026

Locations

Countries of recruitment

Spain

Study participating centre

Corporacion salud del Maresme y la Selva

Sant Jaume 209-217
Calella
08370
Spain

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/08/2025: Trial's existence confirmed by Maresme Healthcare Consortium.