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Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06315842
Acronym
NIT
Enrollment
20
Registered
2024-03-18
Start date
2026-02-28
Completion date
2027-08-31
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Disease

Keywords

Patient Care Planning, Decision Making, Advance Care Planning

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.

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.

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.

Sponsors

Consorci Sanitari de l'Alt Penedès i Garraf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
In-hospital Patient Mortality at 90 days from hospital discharge90 days from hospital dischargePercentage of patients who die during hospitalization until 90 days from hospital discharge.

Secondary

MeasureTime frameDescription
In-hospital Patient Mortality at 6 months from hospital discharge6 months from hospital dischargePercentage of patients who die during hospitalization until 6 months from hospital discharge.
In-hospital Patient Mortality at 1 year from hospital discharge1 year from hospital dischargePercentage of patients who die during hospitalization until 1 year from hospital discharge.
Delirium Incidencehospital discharge, assessed up to day 90Percentage 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)
Pressure Ulcer Incidencehospital discharge, assessed up to day 90Percentage of patients with pressure ulcer occurrence during hospital admission (pressure ulcers already present at the time of admission will not be considered).
Hospital stayhospital discharge, assessed up to day 90Hospital stay in days
Hospital readmission for any reason30 days from hospital dischargePercentage of patients readmitted for any reason within 30 days of hospital discharge.
Hospital readmission for same reason30 days from hospital dischargePercentage of patients readmitted for the same reason within 30 days of hospital discharge.
Patients admitted to the Intensive Care Unit (ICU)hospital discharge, assessed up to day 90Percentage of patients admitted to the ICU during hospitalization
Calls to the on-call doctorhospital discharge, assessed up to day 90Number of calls to the on-call doctor during hospital admission
Healthcare expenditurethrough study completion, an average of 1.5 yearsDescriptive analysis of healthcare expenditure associated with each intervention, using the billing data from the center.
Mortality at ICUhospital discharge, assessed up to day 90Percentage of patients admitted to the ICU

Countries

Spain

Contacts

Primary ContactHelena Camell
hcamell@csapg.cat+34 938960025
Backup ContactNoemi Casaponsa
recerca@csapg.cat+34 938960025

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026