Intentional Rounding in Internal Medicine (INTENTO)

February 27, 2024 updated by: Fadoi Foundation, Italy

Intentional Rounding in Internal Medicine: a Multicenter, Randomized National Study Studio INTENTO - FADOI.03.2018

Each investigator will have to collect data for 50 hospitalized patients in the Internal Medicine wards. If the center is randomized to Intentional Rounding, the staff of nurses and OSS will have to implement the new care strategy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The centers participating in the study are randomized to the Intentional Roundig group and the Control group, in a 1: 1 ratio. In the randomized centers for experimental intervention, a training intervention lasting about 4 hours was conducted by a nurse expert in Intentional Rounding.

At the end of the study, training is also scheduled for the Control Centers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1822

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy
        • Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo
      • Arezzo, Italy
        • Ospedale San Donato
      • Biella, Italy
        • Ospedale Degli Infermi
      • Carpi, Italy
        • Ospedale "Bernardino Ramazzini"
      • Castelfranco Veneto, Italy
        • Ospedale di Castelfranco Veneto
      • Cuneo, Italy
        • Ospedale Poveri Infermi
      • Fano, Italy
        • Presidio Ospedaliero Pubblico " Santa Croce "
      • Firenze, Italy
        • AOU Careggi
      • Genova, Italy
        • Policlinico San Martino
      • Massa Marittima, Italy
        • Ospedale S. Andrea
      • Milano, Italy
        • Fondazione Don Gnocchi
      • Montebelluna, Italy
        • Ospedale Civile di Montebelluna
      • Napoli, Italy
        • Ospedale Buonconsiglio Fatebenfratelli
      • Noventa Vicentina, Italy
        • Ospedale di Noventa Vicentina
      • Palermo, Italy
        • Ospedali Riuniti Villa Sofia
      • Palermo, Italy
        • Ospedale Buccheri La Ferla FBF
      • Rho, Italy
        • Ospedale di Rho
      • Roma, Italy
        • Ospedale FBF Isola Tiberina
      • Savigliano, Italy
        • Ospedale Civile SS. Annunziata
      • Savona, Italy
        • Ospedale San Paolo
      • Siena, Italy
        • AOUS
      • Siena, Italy
        • Ospedale Dell'Alta Val D'Elsa
      • Vicenza, Italy
        • Ospedale San Bortolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Signature of informed consent
  • Patients who understand Italian

Exclusion Criteria:

  • Patients who deny informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intentional Rounding
In the centers randomized to Intentional Rounding the ward nurses will have to adopt a new proactive care method towards hospitalized patients
Other: Intentional Rounding
A new method of nursing care named Intentional Rounding. The "intentional roundings" are planned rounds, conducted at regular intervals by nursing staff to anticipate care, comfort, hospitality and psychological needs of hospitalized users.
No Intervention: Control
In randomized controlled centers, nurses guarantee the standard care provided by the ward

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Falls and new bedsores
Time Frame: 3 months
Cumulative assessment of the incidence of falls and the appearance of new pressure sores in hospitalized patients in the Internal Medicine wards
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Call lights
Time Frame: 3 months

Analysis of the impact of the implementation of Intentional Rounding on the call lights by hospitalized patients.

The total number of calls to the emergency bell is evaluated. A call light log will be used on which the nurses will report the reason for each call by the patient.
3 months
Measurement of patient satisfaction with the nursing care received and hospitalization
Time Frame: 3 months

Assessment of the relationship between implementation of the Intentional Rounding and level of patient satisfaction, defined on the basis of how patients consider the way care is provided useful, effective and advantageous (for patients able to perform this evaluation).

The information will be collected through a questionnaire consisting of two questions. The patient will have to evaluate the nursing care and hospitalization, assigning a score from 1 to 7 (where 1 = bad; 7 = excellent).
3 months
Critical thinking of nurses
Time Frame: 3 months

Evaluation of the critical thinking of nurses following the implementation of Intentional Rounding in clinical practice, defined as the process that is used by nurses when they have to make a clinical decision and manage daily problems (on a voluntary basis between the participating Centers).

Clinical decision making in nursing scale (CDMNS) will be used to evaluate the critical thinking of nurses.

For each of the 40 statements, the nurse must think about how she would behave during patient care.

There are no "right" or "wrong" answers. What matters is his evaluation of how he usually acts in making decisions in clinical reality.

The answers can be:

  • Always: what he constantly does every time.
  • Frequently: what he usually does in most cases.
  • Occasionally: what he does a few times.
  • Rarely: what he seldom does.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fadoi Foundation, Italy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ANìMO (Associazione Nazionale Infermieri Medicina)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dino Stefano Di Massimo, ANìMO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FADOI.03.2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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