Acute DiseaseNITNCT06315842

Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients

A study testing Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col. and Usual clinical practice in people with Acute Disease, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Disease
What is being tested?: Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col. and Usual clinical practice
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteSpain
Study dates: Feb 2026to Aug 2027
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Physician belonging to the non-surgical medical area.
Routine clinical activity on a hospital ward caring for hospitalized patients.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Consorci Sanitari Alt Penedes i Garraf
Vilafranca del Penedès, Barcelona, 08720

Other trials in Spain

About this study

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

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.

Conditions: Acute Disease
Being tested: Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col., Usual clinical practice
Keywords: Patient Care Planning, Decision Making, Advance Care Planning
Medical subject headings: Acute Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
Usual clinical practiceOther
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.

Study groups in NCT06315842
Study group	Role	What they receive
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 Receives: Other: Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col.
Usual clinical practice	Active comparator	Medical doctors assigned to this group will continue their clinical practice as usual Receives: Other: Usual clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

In-hospital Patient Mortality at 90 days from hospital discharge
Percentage of patients who die during hospitalization until 90 days from hospital discharge.
Measured: 90 days from hospital discharge

Secondary outcomes (11)

In-hospital Patient Mortality at 6 months from hospital discharge
Percentage of patients who die during hospitalization until 6 months from hospital discharge.
Measured: 6 months from hospital discharge
In-hospital Patient Mortality at 1 year from hospital discharge
Percentage of patients who die during hospitalization until 1 year from hospital discharge.
Measured: 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)
Measured: 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).
Measured: hospital discharge, assessed up to day 90
Hospital stay
Hospital stay in days
Measured: 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.
Measured: 30 days from hospital discharge
Hospital readmission for same reason
Percentage of patients readmitted for the same reason within 30 days of hospital discharge.
Measured: 30 days from hospital discharge
Patients admitted to the Intensive Care Unit (ICU)
Percentage of patients admitted to the ICU during hospitalization
Measured: hospital discharge, assessed up to day 90
Calls to the "on-call doctor"
Number of calls to the "on-call doctor" during hospital admission
Measured: 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.
Measured: through study completion, an average of 1.5 years
Mortality at ICU
Percentage of patients admitted to the ICU
Measured: hospital discharge, assessed up to day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2026Aug 2027

First posted18 Mar 2024
Study startFeb 2026 (estimated)
Primary completionAug 2027 (estimated)
Study completionAug 2027 (estimated)

Why it stopped: Feasibility issues (organizational changes required to perform the trial are not feasible)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06315842
Sponsor's protocol ID: CSAPG-44
Acronym: NIT
Status last verified: Oct 2026
First submitted: 5 Mar 2024
Last updated: 28 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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).

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.regg.2018.01.003. Epub 2018 Feb 21. Spanish.
PubMed 29475629

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Levels of Diagnostic and Therapeutic Intervention in Hospitalized Patients. Cluster-Randomized and Stepped-Wedge Clinical Trial
ClinicalTrials.gov ID: NCT06315842
Acronym / sponsor ID: NIT / CSAPG-44
Conditions: Acute Disease
Keywords: Patient Care Planning, Decision Making, Advance Care Planning
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Feasibility issues (organizational changes required to perform the trial are not feasible)
Enrolment: 0 participants (actual)
Lead sponsor: Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
Study start: Feb 2026 (estimated)
Primary completion: Aug 2027 (estimated)
Study completion: Aug 2027 (estimated)
First posted: 18 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Levels of Diagnostic and Therapeutic Intervention tool	Experimental	Other: Levels of Diagnostic and Therapeutic Intervention tool by Fontecha and col.Medical doctors assigned to this group will incorporate a Levels of Diagnostic and Therapeutic Intervention tool into their clinical practice
Usual clinical practice	Active comparator	Other: Usual clinical practiceMedical doctors assigned to this group will continue their clinical practice as usual

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Physician belonging to the non-surgical medical area.
Routine clinical activity on a hospital ward caring for hospitalized patients.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Levels of Diagnostic and Therapeutic Intervention tool
Usual clinical practiceThe 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.	Other	Usual clinical practice

Primary outcome

In-hospital Patient Mortality at 90 days from hospital discharge
Time frame: 90 days from hospital discharge
Percentage of patients who die during hospitalization until 90 days from hospital discharge.

11 secondary outcomes

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

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Background: PubMed 29475629Fontecha-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.
Individual participant dataSharing planned: Yes. 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).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Helena Camell principal investigator

CSAPG

César Gálvez study director

CSAPG

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital Patient Mortality at 90 days from hospital discharge (time frame: 90 days from hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06315842, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.