The Effect of Care Bundle in Heart Surgery

December 19, 2022 updated by: Yasemin Yılmaz, Harran University

Investigation of the Effect of Care Bundle Implementation on Recovery Process in Open Heart Surgery Patients

This study is a quasi-experimental (non-randomized) design study with control and study group patients undergoing open heart surgery. The main purpose of the research to examine the effect of the care bundle application on the quality of recovery and respiratory patterns (respiratory rate, presence of dyspnea, oxygen saturation, etc.) in patients with open heart surgery. The other purpose is examine the compliance rates of nurses in the implementation of the cardiac surgery care bundle on patients. In the study, nurses working in the cardiovascular surgery clinic and surgical intensive care unit in a training and research hospital in southeast Turkey voluntarily applied the care bundle created by the researcher to the patients in the study group. When the data of the study were examined, it was seen that the respiratory patterns and recovery status of the patients who received the care bundle were better. However, it was determined that the compliance rate of the nurses to the care bundle was not at the desired level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: There are several ways to transfer evidence-based practice to the clinic. One of them is "care bundle" implementation.

Purpose: To examine the effect of applying the "Cardiac Surgery Care Bundle" which consists of evidence-based applications, on patients with open heart surgery (AKC) on the quality of recovery and respiratory patterns (respiratory rate, presence of dyspnea, oxygen saturation, etc.). In the study, the compliance status of nurses in the implementation of the care bundle was also examined.

Method:This research is a quasi-experimental, non-randomized study with AKC applied control and study groups. In the study, volunteer nurses working in the surgical intensive care and cardiovascular surgery clinics applied the care bundle created by the researcher to the patients in the study group. care bundle; It includes "Informing the Patients and Their Relatives", "Respiratory Management" and "Early Mobilization" implementations. A total of 103 patients, 69 of whom were control and 34 were study, were included in the study. First, the data of the control group and then the study group were collected. Patients in the control group received standard care, while the study group received a care bundle in addition to the standard care. Data were obtained using the "Descriptive Characteristics Data Form", "Patient Outcomes for Complications Form" and the "Quality of Recovery-40-QoR-40".

Statistical analyses were performed using the IBM SPSS for Windows 22.0 software. The variables were analyzed for normality of distribution using skewness and kurtosis coefficients. Normally distributed variables were presented using mean ± standard deviation values and non-normally distributed variables were presented using median (minimum-maximum) values. Differences between two samples were analyzed using the "Independent Samples t test" when the assumption of normality was met, and using the "Mann-Whitney U" test when the assumption of normality was not met. Categorical variables were analyzed using Chi-square or Fisher's exact tests. Statistical significance was set at p < 0.05.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • 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

  • Turkey
    • Haliliye
      • Şanlıurfa, Haliliye, Turkey
        • Yasemin Yılmaz

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion Criteria for Patients

    • 18 years and older,
    • Elective AKC planned
    • Those who will undergo cardiac surgery for the first time
    • Extubated after cardiac surgery and not given sedating drugs
    • No communication barrier (including hearing and vision problems),
    • Does not have a musculoskeletal disease or neurological problem that will prevent walking after surgery,
    • Does not have any respiratory disease,
    • Psychiatric, not diagnosed with mental illness,
    • Those who volunteered to participate in the research
    • Patients who are 18 years of age or older who volunteer to participate in the research.

  • Inclusion Criteria for Nurses

    • Working as a nurse in cardiovascular surgery clinic or surgical intensive care clinic,
    • It is the nurses who volunteer to participate in the research.

Exclusion Criteria:

  • Exclusion Criteria for Patients

    • Patients with active bleeding after surgery
    • Developing neurological complications
    • Complications that prevent the patient from standing up after surgery
    • Those with respiratory problems that will delay weaning from the mechanical ventilator
    • Re-operated due to the development of any complication
    • Those who want to leave the research during the pre- or post-surgical research process
    • These are the patients who develop a situation where they cannot continue to accompany the patient while they are accompanying the patient, or who are the relatives of the patients who want to leave the research during the research process.

  • Exclusion Criteria for Nurses

    • Assigned to another clinic during the research process,
    • Resigned from his job during the research process,
    • Nurses who want to leave the study during any phase of the study.

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CONTROL GROUP
Procedure: Care Bundle Implementation
In this study, the control group received standard care. The nurse group was given training on the implementation of the care bundle. A "cardiac surgery care bundle" was applied to the study group by clinical nurses.
Experimental: NURSE GROUP
Procedure: Care Bundle Implementation
In this study, the control group received standard care. The nurse group was given training on the implementation of the care bundle. A "cardiac surgery care bundle" was applied to the study group by clinical nurses.
Experimental: STUDY GROUP
Procedure: Care Bundle Implementation
In this study, the control group received standard care. The nurse group was given training on the implementation of the care bundle. A "cardiac surgery care bundle" was applied to the study group by clinical nurses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of the care bundle on the recovery status of the patients
Time Frame: One week after surgery
In the study, the recovery status of patients after surgery was measured with the "Recovery Quality-40 Questionnaire". The contribution of the cardiac surgery care bundle applied to the study group by the clinical nurses to the recovery status was examined.
One week after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examination of nurses' compliance with the care bundle
Time Frame: One week after the data collection process of the study group patients was completed.
In this study, nurses' compliance rates to the care bundle (application rates to patients) were examined. According to the literature, compliance should be at least 95% in order to have a high level of compliance with the care bundle.
One week after the data collection process of the study group patients was completed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harran University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 11, 2021

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

June 24, 2022

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Estimate)

December 28, 2022

Study Record Updates

Last Update Posted (Estimate)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Harran University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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