Clinical trial NCT06315842: Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients
Official title: Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients. Cluster-Randomized and Stepped-Wedge Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Disease
Keywords: Patient Care Planning
Decision Making
Advance Care Planning
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: In-hospital Patient Mortality at 90 days from hospital discharge
timeFrame: 90 days from hospital discharge
Secondary outcomes:
measure: In-hospital Patient Mortality at 6 months from hospital discharge
timeFrame: 6 months from hospital discharge
measure: In-hospital Patient Mortality at 1 year from hospital discharge
timeFrame: 1 year from hospital discharge
measure: Delirium Incidence
timeFrame: hospital discharge, assessed up to day 90
measure: Pressure Ulcer Incidence
timeFrame: hospital discharge, assessed up to day 90
measure: Hospital stay
timeFrame: hospital discharge, assessed up to day 90
measure: Hospital readmission for any reason
timeFrame: 30 days from hospital discharge
measure: Hospital readmission for same reason
timeFrame: 30 days from hospital discharge
measure: Patients admitted to the Intensive Care Unit (ICU)
timeFrame: hospital discharge, assessed up to day 90
measure: Calls to the "on-call doctor"
timeFrame: hospital discharge, assessed up to day 90
measure: Healthcare expenditure
timeFrame: through study completion, an average of 1.5 years
measure: Mortality at ICU
timeFrame: hospital discharge, assessed up to day 90
Other outcomes:
Locations:
city: Vilafranca Del Penedès
country: Spain
facility: Consorci Sanitari Alt Penedes i Garraf
state: Barcelona
Study officials:
affiliation: CSAPG
name: Helena Camell
role: PRINCIPAL_INVESTIGATOR
affiliation: CSAPG
name: César Gálvez
role: STUDY_DIRECTOR
References:
citation: 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.