NCT03626272

Brief Summary

Introduction: In situ simulation is a methodology that meets the concept of permanent education, since it allows learning from the context of practice and in the work environment itself. Objective: to compare the development of skills (knowledge and skills) for CPR between groups submitted to different in situ simulation periodicities, and to identify the level of confidence to participate in a CPR. Method: A randomized controlled, non-blind study comparing 3 periodicities of educational intervention performed by in situ simulation. This study will include nursing professionals from the nephrology department of a university hospital. The sample will be composed of 24 randomized participants in the groups, using opaque envelopes for each periodicity of training and professional category, being subdivided into 3 groups of periodicities with intervals of 2, 4 and 8 months. The instruments will evaluate the knowledge and skills in cardiopulmonary resuscitation and the perception of preparation for performing the maneuvers.

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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

March 8, 2018

Last Update Submit

August 9, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Average number of hits in the test of knowledge on cardiopulmonary resuscitation

    Measurement of the average/median/standard deviation of hits in the questions of the knowledge test, in each group (A, B, C,). This measurement was performed in two moments: * Pre and post initial intervention: measure performed to evaluate the impact of the initial intervention on the participants' knowledge about the issue. * After simulation intervention: measurement performed to evaluate the impact of the simulation intervention on the maintenance of knowledge, according to the periodicity group of intervention where the participant was allocated. The measurement was applied to all groups at the same moments. The following tests were used to make comparisons among groups: Wilcoxon Test; Estimate of the size of the Cohen's d effect (paired data); Kruskal-Wallis Test - Dunn's Post Hoc; Cohen's d: Effect size measures by the " Cohen's d" method complemented by the Confidence Interval 95%.

    up to eight months

  • Average number of hits in the accomplishment of a set of skills.

    To compare, among groups exposed to the periodicity of different interventions, the average/median/standard deviation of hits in the accomplishment of a set of skills that matches the CPR procedures. Group A was evaluated when receiving the intervention every eight months, group B every four months, and group C every two months. The Kruskal-Wallis Test was applied to compare the significance of the average outcomes among groups.

    Group A was evaluated when receiving the intervention every eight months, group B every four months, and group C every two months.

  • Average agreement in the preparation for CPR

    To Measure the average/median/standard deviation, referring to the agreement level of preparation for the accomplishment of CPR, in order to check the impact of the intervention performed according to the periodicity of application. The following tests were used to make comparisons among groups: Wilcoxon Test; Estimate of the size of the Cohen's d effect (paired data); Kruskal-Wallis Test - Dunn's Post Hoc; Cohen's d: Effect size measures by the "Cohen's d" method complemented by the Confidence Interval 95%.

    up to eight months

Study Arms (3)

8-month intervals

ACTIVE COMPARATOR

Participants will be submitted to the educational intervention with in situ simulation every 8 months.

Other: educational intervention

4-month intervals

ACTIVE COMPARATOR

Participants will be submitted to the educational intervention with in situ simulation every 4 months.

Other: educational intervention

2-month intervals

ACTIVE COMPARATOR

Participants will be submitted to the educational intervention with in situ simulation every 2 months.

Other: educational intervention

Interventions

The simulation scenarios were constructed using the service environment, with real equipment and materials and a low fidelity mannequin. The interventions were not filmed, and the clinical cases elaborated were fictitious, with clear objectives and developed according to the context of the unit. The simulations took place during the working hours of the participants, with the expected duration of the 10 minutes (average) for the scenario, and the average duration of the debriefing was 10 minutes, which took place immediately after the simulation and in the same location of the scenario.

2-month intervals4-month intervals8-month intervals

Eligibility Criteria

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

You may qualify if:

  • They must be nurses and nursing technicians.

You may not qualify if:

  • not complete the evaluations
  • be under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleidilene Ramos Magalhaes

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Learning Disabilities

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This is a randomized, non-blind controlled trial that will compare three periodicities of an educational intervention to be performed through in situ simulation. Group A will be submitted to intervention at 8-month intervals, group B every four months and group C every two months; each group will be divided into two subgroups, totaling six subgroups consisting of one nurse and three nursing technicians. The research was approved by the Research Ethics Committees of the Federal University of Health Sciences of Porto Alegre, under approval certificate no. 56516216.9.0000.5345, and of the Universidade Católica do Rio Grande do Sul/PUCRS, under approval certificate no. 56516216.9.3001.5336.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2018

First Posted

August 13, 2018

Study Start

January 1, 2018

Primary Completion

November 1, 2018

Study Completion

August 1, 2019

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations