Education Intervention as a Patient Safety Strategy in the Care of Nasoenteric Tube

February 9, 2021 updated by: Hospital de Clinicas de Porto Alegre

Simulation and Visual Identity as a Patient Safety Strategy in the Care of Nasoenteric Tube: Clinical Trial

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.

Study Overview

Status

Status

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

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 safety of the patient undergoing enteral nutritional therapy depends on the constant evaluation of the nursing team, which, through specific skills, allows the establishment of nutritional care and prevents incidents related to the diet administration process. The challenge is to adopt safe practices that contemplate all these specificities, knowing that only knowledge is insufficient for the development of these competences, but also depends on the ability and commitment of these professionals.

Training and capacity are predominant strategies in the health area to increase patient safety in the execution of nursing staff's care activities, however, this type of approach, when applied in isolation, is sometimes insufficient to change behavior end development of skills and attitudes among these professionals. Combined strategies such as alerts and reminders systems, educational visits, auditing systems, clinical simulations, feedbacks and workshops, on clinical practice safety are being deployed and evaluated as a more effective way of changing behavior.

In this sense, the research question of the present project is: The implementation of a strategy of safety in service through an educational intervention associated to the visual identity campaign is able to increase the adhesion of the nursing technicians to the fulfillment of routines in the use of nasoenteral tube? 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.

The study will be conducted according to the following steps, respectively: (1) Evaluation of the agreement between observers, (2) Pre-intervention evaluation (baseline), (3) Intervention (Educational Intervention and Visual Identity Campaign) and (4) Post-intervention evaluation. Both groups (IG and CG) will be submitted to the same research procedures in the evaluation stages (pre- and post-intervention); However, only the nursing technicians of the GI will be submitted to an intervention stage.

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 (Anticipated)

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.
1084

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 Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035007
        • Hospital De Clinicas De Porto Alegre

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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.
OTHER: Education intervention
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
The same description of arm Education intervention.
OTHER: Visual identity campaign
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
The same description of arm Visual identity campaign.

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
Absence of conformity of nursing care in enteral nutritional therapy (ENT) with recommendations of good practices according to institutional protocols.
Time Frame: 12 months
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 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
The presence of adverse event related to obstruction NT
Time Frame: 12 months
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
12 months
The presence of adverse event related to displacement NT non-programmed
Time Frame: 12 months
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
12 months
The presence of adverse event related to withdrawal NT non-programmed
Time Frame: 12 months
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
12 months
The presence of adverse event related to administration of enteral diet by probe not positioned in the gastrointestinal tract
Time Frame: 12 months
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
12 months
The presence of adverse event related to non-administration of enteral diet (partial or full) when suspension was not planned
Time Frame: 12 months
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
12 months
The presence of adverse event related to cases of diarrhea (three or more episodes of soft or liquid stools within 24 hours)
Time Frame: 12 months
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
12 months
The presence of adverse event related to cases of constipation (a disorder characterized by persistent difficulty of evacuation or a sensation of incomplete evacuation and / or infrequent bowel movements for at least 3 days)
Time Frame: 12 months
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
12 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.
Hospital de Clinicas de Porto Alegre

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.
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

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: Mariur G Beghetto, PhD, Federal University of Rio Grande do Sul

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.
June 3, 2017

Primary Completion (ANTICIPATED)

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.
May 1, 2021

Study Completion (ANTICIPATED)

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.
July 1, 2021

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).
April 6, 2018

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.
April 6, 2018

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.
April 13, 2018

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 11, 2021

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 9, 2021

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, 2021

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.
  • 63247916500005327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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