NCT03497221

Brief Summary

The safety of the patient using a nasoenteral tube depends on the constant evaluation of the nursing team. The most implemented strategies for safe practice are education interventions, however, seem insufficient to change behavior. Active methodologies may be more promising alternatives for the development of these competencies. The objective is evaluate the effect of an isolated education intervention and combined with a visual identity campaign on the safe practice in the use of nursing care to the patient in use nasoenteral tubes. The clinical trial will be carried out in 2017, in a university hospital. Two profiles of participants will be included in the study: the first one refers to the nursing technicians of the hospital areas, part of them will receive a set of interventions, and the second one refers to the patients in use nasoenteral tube, considering that the effect of intervention will be measured by assessing compliance with care routines.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,084

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

3.9 years

First QC Date

April 6, 2018

Last Update Submit

February 9, 2021

Conditions

Keywords

Nursing Education

Outcome Measures

Primary Outcomes (1)

  • Absence of conformity of nursing care in enteral nutritional therapy (ENT) with recommendations of good practices according to institutional protocols.

    This outcome have been measured by means of a Nasoenteric Tube (NT) care checklist observed at the patient's bedside. The checklist contains 25 items that evaluate: Conference of labels and validity of the diets and water bottles and devices used for administration at NT; observation of head of bed routines during enteral infusions, correct NT fixation, hygiene of devices and infusion pumps used ENT.

    12 months

Secondary Outcomes (7)

  • The presence of adverse event related to obstruction NT

    12 months

  • The presence of adverse event related to displacement NT non-programmed

    12 months

  • The presence of adverse event related to withdrawal NT non-programmed

    12 months

  • The presence of adverse event related to administration of enteral diet by probe not positioned in the gastrointestinal tract

    12 months

  • The presence of adverse event related to non-administration of enteral diet (partial or full) when suspension was not planned

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Education intervention

OTHER

The educational intervention is based on a hospital institutional protocol for patient using enteral tubes. A clinical simulation will be performed using a low fidelity manikin, where nursing technicians will identify and correct erros, such as: inconsistency between the patient's identification and the diet label, the administration of the diet with a low headboard, fixation of tube not detached and dirty, delay of the diet and others. The simulation will be described through a guide.

Behavioral: Education intervention

Visual identity campaign

OTHER

The visual identity will be given by a set of actions, called "campaign". The campaign consists in the creation and implantation of different materials to be used at the bedside of the patients in use of diet by SNE, such as: (a) poster summarizing care, (b) colored adhesive label to identify devices (c) badge with safety care reminders.

Behavioral: Visual identity campaign

Interventions

The same description of arm Education intervention.

Education intervention

The same description of arm Visual identity campaign.

Visual identity campaign

Eligibility Criteria

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

You may qualify if:

  • Nursing technicians: All nursing technicians of the intervention units will be potentially eligible for the study.
  • Patients: with nasoenteral tube, adults (18 years of age or older) and who are hospitalized in the IG or CG units.

You may not qualify if:

  • Workers who are not working during data collection. The nursing technicians who are part of the IG will be that could be reassigned to one of the units of the CG and vice versa.
  • Patient: unaccompanied patients who are confused and / or disoriented.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035007, Brazil

Location

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Mariur G Beghetto, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2018

First Posted

April 13, 2018

Study Start

June 3, 2017

Primary Completion

May 1, 2021

Study Completion

July 1, 2021

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations