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Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients

No phase Interventional Acute Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col., Usual clinical practice.
Who it may be relevant to
Registry conditions: Acute Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • In-hospital Patient Mortality at 90 days from hospital discharge [Time frame: 90 days from hospital discharge]
Secondary outcome measures (11)
  • In-hospital Patient Mortality at 6 months from hospital discharge [Time frame: 6 months from hospital discharge]
  • In-hospital Patient Mortality at 1 year from hospital discharge [Time frame: 1 year from hospital discharge]
  • Delirium Incidence [Time frame: hospital discharge, assessed up to day 90]
  • Pressure Ulcer Incidence [Time frame: hospital discharge, assessed up to day 90]
  • Hospital stay [Time frame: hospital discharge, assessed up to day 90]
  • Hospital readmission for any reason [Time frame: 30 days from hospital discharge]
  • Hospital readmission for same reason [Time frame: 30 days from hospital discharge]
  • Patients admitted to the Intensive Care Unit (ICU) [Time frame: hospital discharge, assessed up to day 90]
  • Calls to the "on-call doctor" [Time frame: hospital discharge, assessed up to day 90]
  • Healthcare expenditure [Time frame: through study completion, an average of 1.5 years]
  • Mortality at ICU [Time frame: hospital discharge, assessed up to day 90]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Supportive care

Study locations

Spain · 1 center
  • Consorci Sanitari Alt Penedes i Garraf — Vilafranca del Penedès

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.re PMID 29475629

Identifiers

NCT: NCT06315842 · CSAPG-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗