Patient SafetyNCT03497221
Education Intervention as a Patient Safety Strategy in the Care of Nasoenteric Tube
A study testing Education intervention and Visual identity campaign in people with Patient Safety and Enteral Nutrition, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Safety, Enteral Nutrition
- What is being tested?
- Education intervention and Visual identity campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,084 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Jun 2017to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035007
About this study
Official title: 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.
Read the 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.
- Conditions
- Patient Safety, Enteral Nutrition
- Being tested
- Education intervention, Visual identity campaign
- Keywords
- Nursing Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education interventionBehavioural
The same description of arm Education intervention.
Visual identity campaignBehavioural
The same description of arm Visual identity campaign.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Visual identity campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
The presence of adverse event related to obstruction NT
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
Measured: 12 months
The presence of adverse event related to displacement NT non-programmed
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
Measured: 12 months
The presence of adverse event related to withdrawal NT non-programmed
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
Measured: 12 months
The presence of adverse event related to administration of enteral diet by probe not positioned in the gastrointestinal tract
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
Measured: 12 months
The presence of adverse event related to non-administration of enteral diet (partial or full) when suspension was not planned
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
Measured: 12 months
The presence of adverse event related to cases of diarrhea (three or more episodes of soft or liquid stools within 24 hours)
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
Measured: 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)
This outcome have been measured through the evaluation of the records of the professional health team (nurses, doctors, nutritionists and nursing technicians).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start3 Jun 2017
- Primary completionMay 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,084 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Sponsor
- Investigators
- Mariur G Beghetto, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497221
- Sponsor's protocol ID
- 63247916500005327
- Status last verified
- Feb 2021
- First submitted
- 6 Apr 2018
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation and Visual Identity as a Patient Safety Strategy in the Care of Nasoenteric Tube: Clinical Trial
- ClinicalTrials.gov ID
- NCT03497221
- Acronym / sponsor ID
- 63247916500005327
- Conditions
- Patient Safety, Enteral Nutrition
- Keywords
- Nursing Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,084 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 3 Jun 2017 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education intervention | Other | Behavioral: Education interventionThe 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. |
| Visual identity campaign | Other | Behavioral: Visual identity campaignThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education interventionThe same description of arm Education intervention. | Behavioural | Education intervention |
| Visual identity campaignThe same description of arm Visual identity campaign. | Behavioural | Visual identity campaign |
Primary outcome
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.
7 secondary outcomes
The presence of adverse event related to obstruction NT
Time frame: 12 months
The presence of adverse event related to displacement NT non-programmed
Time frame: 12 months
The presence of adverse event related to withdrawal NT non-programmed
Time frame: 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
The presence of adverse event related to non-administration of enteral diet (partial or full) when suspension was not planned
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariur G Beghetto, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education intervention and Visual identity campaign in people with Patient Safety and Enteral Nutrition, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of conformity of nursing care in enteral nutritional therapy (ENT) with recommendations of good practices according to institutional protocols. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.