Nurse Led Transitional Care Model in Cardiac Surgery

May 11, 2020 updated by: Abant Izzet Baysal University

The Effects of Nurse Led Transitional Care Model on Elderly Patients Undergoing Open Heart Surgery: A Randomized Controlled Trial

To evaluate the effectiveness of Nurse Led Transitional Care Model (TCM) on the functional autonomy, quality of life and rehospitalization rates of elderly patients undergoing open heart surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rate and number of successful cases in open heart surgery has been increasing due to the advances in medical technology and surgery. To improve patient convalescence results and reduce rate of post-discharge readmission to hospital and unplanned post-discharge rehospitalization, home-care and follow-up process of patients should be managed successfully.

A total of 66 elderly patients who agreed to participate in the study between November 2017 and December 2018 were randomly assigned to the intervention (n: 33) and control (n: 33) groups. Patients in intervention group were given care based on the TCM until the post discharge 9th week starting from date of hospitalization. Patients in control group were given standard care services. Functional autonomy and quality of life levels of patients were evaluated at admission to the clinic and at the post-discharge 9th week whereas their repeated admission rates to the clinic and re-hospitalization rates were evaluated at post discharge 2nd, 6th and 9th weeks and finally 6 months. The CONSORT checklist was used to check the procedure.

Study Type

Interventional

Enrollment (Actual)

66

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
    • Town Center
      • Bolu, Town Center, Turkey, 14030
        • Bolu Abant İzzet Baysal Üniversity

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • be hospitalized for the first time and for elective open heart surgery;
  • have no other surgical intervention other than an open heart surgery,
  • have no psychological and mental disorders,
  • have no major chronic problems such as kidney problems, neurological problems or cancer,
  • be able to speak Turkish,
  • be available to be communicated by phone,
  • provide consent to participate in the study,
  • live at a maximum distance of 50 km from the hospital (for easy access during post-discharge follow-up visits).

Exclusion Criteria:

  • ask to leave the study,
  • be exposed to a disease or trauma that may affect his/her functional autonomy during the study,
  • die throughout 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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: ''Standard Care''
''Standard Care'' group were given standard care services.
Experimental: "Transitional Care Model"
"Transitional Care Model" group were given care based on the Transitional Care Model until the post discharge 9th week starting from date of hospitalization.
Procedure: Nursing care based on the Transitonal Care Model
Nursing care carried out in collaboration with a multidisciplinary team in line with Transitonal Care Model for elderly patients who have undergone open heart surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline(up to 24 hours after the admission) in functional autonomy on the Functional Autonomy Measurement System (SMAF) at 9th week after discharge.
Time Frame: Baseline(up to 24 hours after the admission) and Week 9 after discharge
The Functional Autonomy Measurement System (SMAF) is a validated, self reported instrument assessing 25 functions of the individual including daily life activities, communication and mental functions. Possible scores range from 0 to -87. A total score below -5 obtained by the elderly person indicates that the patient is at the risk of losing his/her functional autonomy. Change = ( Week 9 after discharge score -Baseline score)
Baseline(up to 24 hours after the admission) and Week 9 after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline(up to 24 hours after the admission) inquality of life on the SF-36 Quality of Life Scale at 9th week after discharge.
Time Frame: Baseline(up to 24 hours after the admission) and Week 9 after discharge
The SF-36 Quality of Life Scale is a validated, self reported instrument consists of 36 items in total, assessing the health status in eight aspects namely; physical function (10 items), social function (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items) and overall health items (5 items). Each part of the scale is evaluated differently and hence does not have a total score that can be calculated. Change = ( Week 9 after discharge score -Baseline score).
Baseline(up to 24 hours after the admission) and Week 9 after discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeated admission and rehospitalization rates
Time Frame: Post discharge 2nd, 6th and 9th weeks and finally 6 months
The rate of repeated post discharge referrals to hospital and rehospitalization
Post discharge 2nd, 6th and 9th weeks and finally 6 months

Collaborators and Investigators

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

Sponsor

Abant Izzet Baysal University

Investigators

  • Study Director: SERGÜL DUYGULU, Assoc. Prof, the advisor of this doctoral thesis study

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

Helpful Links

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)

November 15, 2017

Primary Completion (Actual)

November 20, 2017

Study Completion (Actual)

December 15, 2018

Study Registration Dates

First Submitted

April 5, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 11, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AIBU-KDC-SC01

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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