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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levels of Diagnostic and Therapeutic Intervention tool | Experimental | Medical doctors assigned to this group will incorporate a Levels of Diagnostic and Therapeutic Intervention tool into their clinical practice |
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| Usual clinical practice | Active Comparator | Medical doctors assigned to this group will continue their clinical practice as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col. | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| In-hospital Patient Mortality at 1 year from hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helena Camell | Contact | +34 938960025 | 46048 | hcamell@csapg.cat |
| Noemi Casaponsa | Contact | +34 938960025 | 43197 | recerca@csapg.cat |
| Name | Affiliation | Role |
|---|---|---|
| Helena Camell | CSAPG | Principal Investigator |
| César Gálvez | CSAPG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consorci Sanitari Alt Penedes i Garraf | Vilafranca del Penedès | Barcelona | 08720 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29475629 | Background | 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. |
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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).
After publication of main results of the study.
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.
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| ID | Term |
|---|---|
| D000208 | Acute Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000708228 | 2-cyclohexylidenhydrazo-4-phenyl-thiazole |
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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.
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| Usual clinical practice | Other | 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. |
|
Percentage of patients who die during hospitalization until 1 year from hospital discharge. |
| 1 year from hospital discharge |
| 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 |
| 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 |
| Hospital stay | Hospital stay in days | hospital discharge, assessed up to day 90 |
| Hospital readmission for any reason | Percentage of patients readmitted for any reason within 30 days of hospital discharge. | 30 days from hospital discharge |
| Hospital readmission for same reason | Percentage of patients readmitted for the same reason within 30 days of hospital discharge. | 30 days from hospital discharge |
| Patients admitted to the Intensive Care Unit (ICU) | Percentage of patients admitted to the ICU during hospitalization | hospital discharge, assessed up to day 90 |
| Calls to the "on-call doctor" | Number of calls to the "on-call doctor" during hospital admission | hospital discharge, assessed up to day 90 |
| 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 |
| Mortality at ICU | Percentage of patients admitted to the ICU | hospital discharge, assessed up to day 90 |