NCT04970147

Brief Summary

The concept of care bundle; It was developed by the American Institute for Healthcare Improvement (IHI) in 2001 to provide the best care safely in order to achieve desired results in patient care, increase compliance with standard procedures, improve patient safety and quality of care. Ensuring that nurses perform gastrostomy care correctly and according to the guidelines published in international standards will minimize the development of problems that may arise in gastrostomy care. The aim of this study was to development and implementation the gastrostomy care bundle for gastrostomy care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

December 28, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

July 16, 2021

Last Update Submit

October 5, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Compliance with the use of the care bundle

    Nurses' compliance with the use of the care bundle will be considered successful if the rate in the calculation is 95% or more

    6 months

  • Knowledge levels of nurses about gastrostomy care

    Data to be obtained from the Gastrostomy Care Questionnaire (pre-test) to be administered before the training to be given to nurses for the evidence-based nursing, gastrostomy, gastrostomy care bundle, and the Gastrostomy Care Questionnaire (post-test) to be administered after the training and use of the gastrostomy care bundle.

    6 months

  • Attitude Scale towards Evidence-Based Nursing

    Data to be obtained from the "Attitude Scale towards Evidence-Based Nursing" to be administered before the training to be given to the nurses for the evidence-based nursing, gastrostomy and gastrostomy care bundle, and the "Attitude Scale towards Evidence-Based Nursing" to be administered after the training and the use of the gastrostomy care bundle a survey using a 5-point Likert scale.

    6 months

Secondary Outcomes (1)

  • Nurses' views on the use of care bundle

    6 months

Study Arms (1)

there are not arm for this study.

OTHER

there is not a control group for this study.

Other: Gastrostomy care bundle

Interventions

Gastrostomy care bundle

there are not arm for this study.

Eligibility Criteria

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

You may qualify if:

  • For the patient;
  • Patients with gastrostomy over the age of 18 who receive treatment and care in the brain and neurosurgery intensive care unit, For the nurse;
  • Nurses working in the brain and neurosurgery intensive care unit,

You may not qualify if:

  • For the patient;
  • Patients who are treated in the brain and neurosurgery intensive care unit but do not have gastrostomy,
  • Patients under the age of 18,
  • Not giving consent to the study. For the nurse;
  • Leaving the brain and neurosurgery intensive care unit before the work process is completed,
  • Not filling out data collection forms at any stage of the study,
  • Not participating in the semi-structured in-depth individual interview,
  • Not giving consent to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

  • Rana Elcin SEZER CEREN

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2021

First Posted

July 21, 2021

Study Start

December 28, 2021

Primary Completion

October 5, 2022

Study Completion

October 5, 2022

Last Updated

October 6, 2022

Record last verified: 2022-10

Locations