NCT04257422

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,822

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

23 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2020

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

January 31, 2020

Last Update Submit

February 27, 2024

Conditions

Hospitalization

Keywords

Nursing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Call lights

    3 months

  • Measurement of patient satisfaction with the nursing care received and hospitalization

    3 months

  • Critical thinking of nurses

    3 months

Study Arms (2)

Intentional Rounding

EXPERIMENTAL

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

Control

NO INTERVENTION

In randomized controlled centers, nurses guarantee the standard care provided by the ward

Interventions

Intentional RoundingOTHER

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.

Intentional Rounding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who deny informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Location

Ospedale San Donato

Arezzo, Italy

Location

Ospedale degli Infermi

Biella, Italy

Location

Ospedale "Bernardino Ramazzini"

Carpi, Italy

Location

Ospedale di Castelfranco Veneto

Castelfranco Veneto, Italy

Location

Ospedale Poveri Infermi

Cuneo, Italy

Location

Presidio Ospedaliero Pubblico " Santa Croce "

Fano, Italy

Location

AOU Careggi

Florence, Italy

Location

Policlinico San Martino

Genova, Italy

Location

Ospedale S. Andrea

Massa Marittima, Italy

Location

Fondazione Don Gnocchi

Milan, Italy

Location

Ospedale Civile di Montebelluna

Montebelluna, Italy

Location

Ospedale Buonconsiglio Fatebenfratelli

Napoli, Italy

Location

Ospedale di Noventa Vicentina

Noventa Vicentina, Italy

Location

Ospedale Buccheri La Ferla FBF

Palermo, Italy

Location

Ospedali Riuniti Villa Sofia

Palermo, Italy

Location

Ospedale di Rho

Rho, Italy

Location

Ospedale FBF Isola Tiberina

Roma, Italy

Location

Ospedale Civile SS. Annunziata

Savigliano, Italy

Location

Ospedale San Paolo

Savona, Italy

Location

AOUS

Siena, Italy

Location

Ospedale Dell'Alta Val D'Elsa

Siena, Italy

Location

Ospedale San Bortolo

Vicenza, Italy

Location

Study Officials

  • Dino Stefano Di Massimo

    ANìMO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Cluster randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 6, 2020

Study Start

October 21, 2019

Primary Completion

March 29, 2020

Study Completion

March 29, 2020

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(23)