Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients

NCT06315842 | Not Yet Recruiting

• 1 other identifier: CSAPG-44
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Disease

Keywords

Patient Care Planning; Decision Making; Advance Care Planning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• In-hospital Patient Mortality at 6 months from hospital discharge

  6 months from hospital discharge

• In-hospital Patient Mortality at 1 year from hospital discharge

  1 year from hospital discharge

• Delirium Incidence

  hospital discharge, assessed up to day 90

• Pressure Ulcer Incidence

  hospital discharge, assessed up to day 90

• Hospital stay

  hospital discharge, assessed up to day 90

Study Arms (2)

Levels of Diagnostic and Therapeutic Intervention tool

EXPERIMENTAL

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.

Usual clinical practice

ACTIVE COMPARATOR

Medical doctors assigned to this group will continue their clinical practice as usual

Other: Usual clinical practice

Interventions

Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col. OTHER

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.

Levels of Diagnostic and Therapeutic Intervention tool

Usual clinical practice OTHER

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.

Usual clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Consorci Sanitari Alt Penedes i Garraf

Vilafranca del Penedès, Barcelona, 08720, Spain

Location

Related Publications (1)

• 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.

  PMID: 29475629 BACKGROUND

MeSH Terms

Conditions

Acute Disease

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helena Camell

  CSAPG

  PRINCIPAL INVESTIGATOR

• César Gálvez

  CSAPG

  STUDY DIRECTOR

Central Study Contacts

Helena Camell

CONTACT

+34 938960025; hcamell@csapg.cat

Noemi Casaponsa

CONTACT

+34 938960025; recerca@csapg.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participating physicians will be grouped into 4 clusters (5 physicians each). Each cluster will progressively (every 3 months) incorporate the use of a level of diagnostic and therapeutic intensity tool into their usual clinical practice.

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 18, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of main results of the study.
• 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.

Locations

ES (1)