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WithdrawnNCT06315842NITUpdated Oct 28, 2026

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. Withdrawn at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

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

Why this study was withdrawn
Feasibility issues (organizational changes required to perform the trial are not feasible)
Updated Oct 28, 2026Now WithdrawnEnrollment updatedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
0
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

In context

Acute Disease

57 studies on the registry are indexed under Acute Disease; 12 are open to participants now.

Browse Acute Disease studies →

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf is the lead sponsor of 41 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
05

Study design

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

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.

06

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

07

Study locations

1 site
  • Consorci Sanitari Alt Penedes i Garraf
    Vilafranca del Penedès, Barcelona 08720, Spain
08

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

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.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Withdrawn Feasibility issues (organizational changes required to perform the trial are not feasible)
changed Oct 28, 2026
Enrollment
20 (estimated)→0 (actual)
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    Not yet recruiting→Withdrawn
    Why stopped Feasibility issues (organizational changes required to perform the trial are not feasible)
    Enrollment 20 (estimated)→0 (actual)
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

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
Oct 28, 2026

Study contacts

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 withdrawn, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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