Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients (NIT)

Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients. Cluster-Randomized and Stepped-Wedge Clinical Trial

The objective of this clinical trial is to investigate the impact of implementing a tool for adjusting the level of diagnostic and therapeutic intensity in the clinical practice of physicians attending hospitalized patients.

The goal of this clinical trial is to investigate the impact of a tool for adjusting diagnostic and therapeutic intensity in hospitalized patients. The main question it aims to answer is: Is there a difference in patient mortality when using the aforementioned tool? The participating physicians will be grouped into 4 groups (5 physicians each). Each group will progressively (every 3 months) incorporate the use of the aforementioned tool into their usual clinical practice.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Disease
• Intervention / Treatment: Other: Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col.; Other: Usual clinical practice

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noemí Casaponsa; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat
• Study Contact Backup: Name: Helena Camell; Phone Number: 46048 +34 938960025; Email: hcamell@csapg.cat

Study Locations

• Spain
  • Barcelona
    • Vilafranca del Penedès, Barcelona, Spain, 08720
      • Consorci Sanitari Alt Penedes i Garraf
      • Contact: Noemí Casaponsa; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat
      • Contact: Helena Camell; Phone Number: 46048 +34 938960025; Email: hcamell@csapg.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Physician belonging to the non-surgical medical area.
• Routine clinical activity on a hospital ward caring for hospitalized patients.

Exclusion Criteria:

• Physician belonging to the Oncology-Hematology/Palliative Care Hospitalization Unit.
• Refusal to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levels of Diagnostic and Therapeutic Intervention tool; Medical doctors assigned to this group will incorporate a Levels of Diagnostic and Therapeutic Intervention tool into their clinical practice	Other: Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col.; During the intervention periods, participating physicians will integrate into their usual clinical practice a tool for adjusting diagnostic and therapeutic intensity designed by Fontecha-Gómez and colleagues. The tool for adjusting the level of diagnostic and therapeutic intensity classifies patients' profiles into 5 groups based on the recommended level of adjustment.
Active Comparator: Usual clinical practice; Medical doctors assigned to this group will continue their clinical practice as usual	Other: Usual clinical practice; The participating physicians will carry out the standard clinical practice currently performed in the study centers. This means that during this period, the diagnostic and therapeutic adjustment tool or any similar tool will not be introduced into routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital Patient Mortality at 90 days from hospital discharge	Percentage of patients who die during hospitalization until 90 days from hospital discharge.	90 days from hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital Patient Mortality at 6 months from hospital discharge	Percentage of patients who die during hospitalization until 6 months from hospital discharge.	6 months from hospital discharge
In-hospital Patient Mortality at 1 year from hospital discharge	Percentage of patients who die during hospitalization until 1 year from hospital discharge.	1 year from hospital discharge
Delirium Incidence	Percentage of patients with delirium occurrence during hospital admission (delirium already present at the time of admission will not be considered). Delirium will be evaluated through Confusion Assessment Method (CAM)	hospital discharge, assessed up to day 90
Pressure Ulcer Incidence	Percentage of patients with pressure ulcer occurrence during hospital admission (pressure ulcers already present at the time of admission will not be considered).	hospital discharge, assessed up to day 90
Hospital stay	Hospital stay in days	hospital discharge, assessed up to day 90
Hospital readmission for any reason	Percentage of patients readmitted for any reason within 30 days of hospital discharge.	30 days from hospital discharge
Hospital readmission for same reason	Percentage of patients readmitted for the same reason within 30 days of hospital discharge.	30 days from hospital discharge
Patients admitted to the Intensive Care Unit (ICU)	Percentage of patients admitted to the ICU during hospitalization	hospital discharge, assessed up to day 90
Calls to the "on-call doctor"	Number of calls to the "on-call doctor" during hospital admission	hospital discharge, assessed up to day 90
Healthcare expenditure	Descriptive analysis of healthcare expenditure associated with each intervention, using the billing data from the center.	through study completion, an average of 1.5 years
Mortality at ICU	Percentage of patients admitted to the ICU	hospital discharge, assessed up to day 90

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Investigators: Principal Investigator: Helena Camell, CSAPG; Study Director: César Gálvez, CSAPG

Publications and helpful links

General Publications

• Fontecha-Gomez BJ, Amblas-Novellas J, Betancor-Santana E, Rexach-Cano L, Ugarte MI, Lopez-Perez A, Planas K, Gutierrez Jimenez N, Casas Floriano R, Garcia-Fortea C, Serrano Bermudez G, Rotllan-Terradellas M, Fernandez-Ponce D. [Regional protocol for adjusting the therapeutic intensity. Southern Metropolitan Area of Barcelona]. Rev Esp Geriatr Gerontol. 2018 Jul-Aug;53(4):217-222. doi: 10.1016/j.regg.2018.01.003. Epub 2018 Feb 21. Spanish.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Decision Making; Advance Care Planning; Patient Care Planning
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Acute Disease; 2-cyclohexylidenhydrazo-4-phenyl-thiazole
• Other Study ID Numbers: CSAPG-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
• IPD Sharing Time Frame: After publication of main results of the study.
• IPD Sharing Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No