Clinical trial NCT03497221: Education Intervention as a Patient Safety Strategy in the Care of Nasoenteric Tube
Official title: Simulation and Visual Identity as a Patient Safety Strategy in the Care of Nasoenteric Tube: Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Safety
Enteral Nutrition
Keywords: Nursing Education
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2018-04-13
Enrollment: 1084
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Absence of conformity of nursing care in enteral nutritional therapy (ENT) with recommendations of good practices according to institutional protocols.
timeFrame: 12 months
Secondary outcomes:
measure: The presence of adverse event related to obstruction NT
timeFrame: 12 months
measure: The presence of adverse event related to displacement NT non-programmed
timeFrame: 12 months
measure: The presence of adverse event related to withdrawal NT non-programmed
timeFrame: 12 months
measure: The presence of adverse event related to administration of enteral diet by probe not positioned in the gastrointestinal tract
timeFrame: 12 months
measure: The presence of adverse event related to non-administration of enteral diet (partial or full) when suspension was not planned
timeFrame: 12 months
measure: The presence of adverse event related to cases of diarrhea (three or more episodes of soft or liquid stools within 24 hours)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Mariur G Beghetto, PhD
role: PRINCIPAL_INVESTIGATOR
References: