Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients

Acute Disease Clinical Trial

— NIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315842
• Other study ID #: CSAPG-44
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Consorci Sanitari de l'Alt Penedès i Garraf
• Contact: Helena Camell
• Phone: +34 938960025
• Email: hcamell[@]csapg.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Consorci Sanitari Alt Penedes i Garraf	Vilafranca Del Penedès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital Patient Mortality at 90 days from hospital discharge	Percentage of patients who die during hospitalization until 90 days from hospital discharge.	90 days from hospital discharge
Secondary	In-hospital Patient Mortality at 6 months from hospital discharge	Percentage of patients who die during hospitalization until 6 months from hospital discharge.	6 months from hospital discharge
Secondary	In-hospital Patient Mortality at 1 year from hospital discharge	Percentage of patients who die during hospitalization until 1 year from hospital discharge.	1 year from hospital discharge
Secondary	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)	hospital discharge, assessed up to day 90
Secondary	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).	hospital discharge, assessed up to day 90
Secondary	Hospital stay	Hospital stay in days	hospital discharge, assessed up to day 90
Secondary	Hospital readmission for any reason	Percentage of patients readmitted for any reason within 30 days of hospital discharge.	30 days from hospital discharge
Secondary	Hospital readmission for same reason	Percentage of patients readmitted for the same reason within 30 days of hospital discharge.	30 days from hospital discharge
Secondary	Patients admitted to the Intensive Care Unit (ICU)	Percentage of patients admitted to the ICU during hospitalization	hospital discharge, assessed up to day 90
Secondary	Calls to the "on-call doctor"	Number of calls to the "on-call doctor" during hospital admission	hospital discharge, assessed up to day 90
Secondary	Healthcare expenditure	Descriptive analysis of healthcare expenditure associated with each intervention, using the billing data from the center.	through study completion, an average of 1.5 years
Secondary	Mortality at ICU	Percentage of patients admitted to the ICU	hospital discharge, assessed up to day 90