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Not yet recruitingNCT06315842NITUpdated Dec 5, 2025

Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients

An interventional study of Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col. and Usual clinical practice in Acute Disease, sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Consorci Sanitari de l'Alt Penedès i Garraf · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Disease

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Keywords

  • Patient Care Planning
  • Decision Making
  • Advance Care Planning
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Physician belonging to the Oncology-Hematology/Palliative Care Hospitalization Unit.
  • Refusal to participate in the study.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • 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.

  • Active comparator
    Usual clinical practice

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

    Other: Usual clinical practice

Interventions

  • OtherLevels 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.

  • OtherUsual 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.

05

What researchers measure

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.

    Time frame: 90 days from hospital discharge

Secondary outcomes

  1. In-hospital Patient Mortality at 6 months from hospital discharge

    Percentage of patients who die during hospitalization until 6 months from hospital discharge.

    Time frame: 6 months from hospital discharge

  2. In-hospital Patient Mortality at 1 year from hospital discharge

    Percentage of patients who die during hospitalization until 1 year from hospital discharge.

    Time frame: 1 year from hospital discharge

  3. 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)

    Time frame: hospital discharge, assessed up to day 90

  4. 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).

    Time frame: hospital discharge, assessed up to day 90

  5. Hospital stay

    Hospital stay in days

    Time frame: hospital discharge, assessed up to day 90

  6. Hospital readmission for any reason

    Percentage of patients readmitted for any reason within 30 days of hospital discharge.

    Time frame: 30 days from hospital discharge

  7. Hospital readmission for same reason

    Percentage of patients readmitted for the same reason within 30 days of hospital discharge.

    Time frame: 30 days from hospital discharge

  8. Patients admitted to the Intensive Care Unit (ICU)

    Percentage of patients admitted to the ICU during hospitalization

    Time frame: hospital discharge, assessed up to day 90

  9. Calls to the "on-call doctor"

    Number of calls to the "on-call doctor" during hospital admission

    Time frame: hospital discharge, assessed up to day 90

  10. Healthcare expenditure

    Descriptive analysis of healthcare expenditure associated with each intervention, using the billing data from the center.

    Time frame: through study completion, an average of 1.5 years

  11. Mortality at ICU

    Percentage of patients admitted to the ICU

    Time frame: hospital discharge, assessed up to day 90

06

Study locations

1 site
  • Consorci Sanitari Alt Penedes i Garraf
    Vilafranca del Penedès, Barcelona 08720, Spain
07

References and documents

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. PubMed 29475629 ↗

Individual participant data

Plan to share: Yes — 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).

Supporting information: Study protocol

08

Registry details

Key details

Study ID
NCT06315842
Lead sponsor
Consorci Sanitari de l'Alt Penedès i Garraf
Responsible party
Sponsor
First posted
Mar 18, 2024
Start date
Feb 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Dec 5, 2025

Study contacts

Helena Camell
Contact
hcamell@csapg.cat
+34 938960025 ext. 46048
Noemi Casaponsa
Contact
recerca@csapg.cat
+34 938960025 ext. 43197
Helena Camell
principal investigator · CSAPG
César Gálvez
study director · CSAPG

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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