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

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1822

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Fadoi Foundation, Italy

Collaborators

ANìMO (Associazione Nazionale Infermieri Medicina)

Investigators

  • 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)

October 21, 2019

Primary Completion (Actual)

March 29, 2020

Study Completion (Actual)

March 29, 2020

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID 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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