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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04257422
Other study ID # FADOI.03.2018
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 21, 2019
Est. completion date March 29, 2020

Study information

Verified date February 2024
Source Fadoi Foundation, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1822
Est. completion date March 29, 2020
Est. primary completion date March 29, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Signature of informed consent - Patients who understand Italian Exclusion Criteria: - Patients who deny informed consent

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Fadoi Foundation, Italy ANìMO (Associazione Nazionale Infermieri Medicina)

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Falls and new bedsores 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 Call lights 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
Secondary Measurement of patient satisfaction with the nursing care received and hospitalization 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
Secondary Critical thinking of nurses 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
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