The Effects of Nurse Led Transitional Care Model on Elderly Patients Undergoing Open Heart Surgery: A Randomized Controlled Trial
Phase: NA
Conditions: Nursing Care, Quality of Life, Transitional Care
Sponsor: Abant Izzet Baysal University

 
 
 
 
 
 
 
 
 
THE EFFECTS OF NURSE LED TRANSITIONAL CARE MODEL ON ELDERLY 
PATIENTS UNDERGOING OPEN HEART SURGERY: A RANDOMIZED 
CONTROLLED TRIAL 
 
 
 
 
 
 
 
Short running title: Nurse Led Transitional Care Model in Cardiac Surgery 
 
 
 
 
 
 
 
 
 
 
 
 
 
25.05.2017 

BACKGROUND  
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.  
We have not come across examples of a care model in literature that has actively been used on 
elderly patients undergoing open heart surgery in Turkey. However, in practice, patients 
undergoing open heart surgery are discharged from the hospital in an average of 4-5 days which 
is a period retaining patients and their families to experience a successful post-op transition 
process. Finally, all of these can provide a basis for the problems that patients undergoing open 
heart surgery and their relatives may experience throughout post discharge healthcare. In 
addition, problems due to increased health care expenses may arise in line with the repeated 
post discharge referrals to hospital and rehospitalization rates. 
In this study we have used a Transitional Care Model (TCM) developed by Mary Naylor 
basically for elderly patients undergoing open heart surgery, aiming to support 
defenseless/vulnerable elderly individuals with chronic diseases and their families and to 
prevent problems that cause an increase in repeated post discharge referrals to hospital and 
rehospitalization rates and aimed to evaluate the effect of the model on the quality of life, 
functional autonomy and repeated post discharge referrals to hospital and rehospitalization rates 
of elderly patients undergoing surgery. 
Aim of the study and hypotheses 
The purpose of this study is to evaluate the effectiveness of the Nurse Led Transitional Care 
Model. The hypotheses are as follows; 
H0: Nursing care carried out in collaboration with a multidisciplinary team in line with 
TCM for elderly patients who have undergone open heart surgery has no effect on 
decreasing the patients' functional autonomy, their quality of life levels and the rate of 
repeated post discharge referrals to hospital and rehospitalization. 
H1: Nursing care carried out in collaboration with a multidisciplinary team in line with 
TCM for elderly patients who have undergone open heart surgery may improve the 
patients' functional autonomy, their quality of life levels and decrease the rate of repeated 
post discharge referrals to hospital and rehospitalization. 
 
 
 

STUDY PROTOCOL 
1 | Study design 
The research was carried out between November 2017 and December 2018 in a pretest-posttest 
design structured in accordance with the CONSORT guidelines (Figure 1), as a randomized 
controlled intervention study with parallel groups (Schulz, Altman, & Moher, 2010).  
2 | Study participants and allocation  
The study was carried out in an 11-bed cardiovascular surgery clinic of a university hospital 
located in the Black Sea Region of Turkey with a total capacity of 320 beds. The group of 
patients aged 60 and over, who were hospitalized for open heart surgery, constituted the 
universe of the study. 
2.1 | Inclusion and exclusion criteria  
Inclusion criteria for participation in the study are as follows: The Patient should a) be 
hospitalized for the first time and for elective open heart surgery; b) have no other surgical 
intervention other than an open heart surgery, c) have no psychological and mental disorders, 
d) have no major chronic problems such as kidney problems, neurological problems or cancer, 
e) be able to speak Turkish, f) be available to be communicated by phone, g) provide consent 
to participate in the study, h) live at a maximum distance of 50 km from the hospital (for easy 
access during post-discharge follow-up visits). Exclusion criteria are as follows: The Patient 
should a) ask to leave the study, b) be exposed to a disease or trauma that may affect his/her 
functional autonomy during the study, c) die throughout the study.  
3.Data Collection  
3.1 | Enrollment 
A Ph.D. student and research assistant with clinical experience as a nurse for five years in the 
cardiovascular surgery clinic evaluated the participants who are decided to undergo an open 
heart surgery at their admission to the service and assigned those who met the application 
criteria to intervention and control groups respectively. 
3.2 | Allocation  
Patients were randomly assigned to the intervention and control groups respectively in line with 
the inclusion criteria of sampling through a computerized randomization system. Patients 
reached in the pre-application period (n = 6) were also included in the sample of the study, 
considering possible patient loss throughout the study. Ultimately, 66 patients were included in 
this study; the subjects were individually numbered and randomized by an individual outside 
of the investigation team using the website software program Research Randomizer 

(http://www.random.org）to divide the subjects into the intervention group (33 patients) and 
control group (33 patients). The patients were not blinded. If someone declined, the next patient 
from the list was invited instead. 
3.3 | Sample size 
The sample of the study was determined by power analysis with the help of NCSS-PASS 2014 
software. The study findings of Naylor et al. (2004)  determine the standard deviation rate (±1,3) 
with a 90% confidence level and a tolerance rate of 0.1%; each group consisting of 30 people, 
n=60 (Julious, 2009; Zar, 1984). The study began with a pre-application process for the first six 
patients. Since there is no difference between the forms used during the pre-application process 
and no problem was encountered in the maintenance process, the pre-application group was 
included in the study. 
3.4 | Ethical considerations  
A permission dated 25.05.2017 and No: 2017/42 was obtained from the University Clinical 
Research Ethics Committee for the implementation of the study. Furthermore, in order for the 
study to be carried out in the university hospital, necessary written permits were obtained from 
General Directorate of Turkish Public Hospitals, General Secretariat of the Provincial Public 
Hospitals Association, Head Physician and Nursing Services Department of the University 
Hospital in question. Written permission was obtained from the authors via e-mail for the scales 
used in the research. Verbal and written consent was obtained from the patients included in the 
study. 
3.5 | Intervention  
Patients in intervention group were given care based on the 'Nurse Led Transitional Care Model 
Protocol' (Figure 2) until the post discharge 9th week starting from date of hospitalization. 
Patients in control group were given standard care services. 
The patients in both groups were interviewed face-to-face by the Researcher (Coordinator 
Nurse) in the first twenty-four hours following their admission to the hospital and administered 
"Introductory Information Form", " The Functional Autonomy Measurement System " and "SF-
36 Quality of Life Scale". In addition, the Researcher (Coordinator Nurse) reached the patients 
in both groups after nine weeks following their discharge and reapplied the " The Functional 
Autonomy Measurement System" and "SF-36 Quality of Life Scale". Six months following 
their discharge these patients were called by phone and checked up on their repeated referrals 
to hospital and/or rehospitalization. 
 
  

3.6 | Statistical methods 
The data obtained throughout the study were evaluated by statistical analyzes (using IBM SPSS 
Statistics 23 software). Parametric tests were leveraged while evaluating research data based on 
the argument of Law of Large Numbers stating that (İnal & Günay, 2002) ‘‘The average of the 
results obtained from a large number of trials n→∞ will tend to become closer to the expected 
value’’. The evaluation of the research data provides frequency distribution (number, 
percentage) for categorical variables and descriptive statistics (mean, standard deviation) for 
numerical variables. Difference between categorical variables with two groups was tested using 
Independent t-Test whereas the difference between the categorical variables with more than 
two groups was tested with "One Way Variance Analysis" (ANOVA). Following the analysis; 
initially, the homogeneity of the variance was controlled by Levene Test and then the group or 
groups causing the difference were controlled by "Multiple Comparison Test". The difference 
between the groups regarding the variables that provide variance homogeneity was evaluated 
via Bonferonni while Tamhane’s T2 test was used to examine the difference between groups in 
variables that do not comply with variance homogeneity. In addition, the difference between 
the two numerical variables over time was evaluated with Dependent Sample t Test while the 
relationship between the two categorical variables was examined with the Chi-Square test. 
Statistical significance was considered as p <0.05. 
4 | Study Limitations And Recommendations For Future Research  
This study has some limitatons. Firstly, the sample size is quite small and the research was 
carried out in a single center with patients who lived within a 50 km. distance from the hospital 
where the study was carried out due to transportation limitations. No conclusions have been 
derived for patients residing at a greater distance. Secondly, WHO currently defines the elderly 
as individuals 65 years old and above. However, based on the cultural values of our country, 
average life expectancy and mean retirement age foreseen in our society, the population of 
elderly patients included in our study consisted of patients at 60 years of age and older. 
5 | Acknowledgements  
Authors declared no financial support while investigating and writing this paper. 
6 | Results point of contact  
Abant Izzet Baysal Unıversity, Abant Izzet Baysal University Clinical Research Ethics 
Committee, Phone: 0374 253 46 56   Ext: 3072 ,   Email: boluetik@ibu.edu.tr 
 
 
 

Assessed for eligibility (n= 73) 
 
 
Excluded (n=7) 
Not meet inclusion criteria (n=7) 
• Refused to anticipate (n=3) 
• Lack of phone equipment 
(n=2) 
• Loss of life before surgery 
(n=2) 
 
 
Randomized (n= 66) 
 
 
Intervention group (n=33)  
Received care services under The 
Nurse Led Transitional Care Model 
 
 
Control group (n=33) 
Received standard care services 
 
Intervention group (n=33) 
 
Control group (n=32) 
Lost to follow up (n=1) 
• Lost contact (n=1) 
 
 
Intervention group (n=32) 
Lost to follow up (n=1) 
• Exitus 
 
 
Control group (n=32) 
 
 
 
Intervention group (n=32) 
 
 
Control group (n=32) 
 
 
Intervention group (n=32) 
 
 
Control group (n=32) 
 
 
Data analyzed (n=32) 
 
 
Data analyzed (n=32) 
 
Figüre 1. CONSORT diagram of the trial flow 
Follow up at 2nd week 
Follow up at 6th week 
Follow up at 9th week 
Follow up at 6th months 

Patients at 60 years of age and older who are decided to  
have open heart surgery 
Coordinator Nurse: 
✓ Taking the Patient's Medical History 
✓ Hospital and Clinic Promotion 
✓ Providing Training Guide 
✓ Daily Regular Patient Visits 
✓ Coordinating the Healthcare Services 
Case analysis (pre-operative period) 
Team members: physician, nurse, coordinator nurse, physiotherapist, dietician, evaluation of caregiving 
family member  
Coordinator Nurse: 
Post-operation training 
for patients  
Daily Patient Visits 
 
Clinic Nurses: 
To execute healthcare 
services in line with 
designated healthcare 
plan 
Completion of the 
practices in the Clinical 
Pathway (post-op 1st, 
2nd, 3rd, 4th, 5… days) 
Dietician: 
To plan a nutrition 
program for the patient 
and train the patient 
accordingly  
 
Physiotherapist: 
To plan the physical 
activity and exercise 
program for the patient 
and train the patient 
accordingly 
 
Case analysis (post-operative period) 
Team members: physician, nurse, coordinator nurse, physiotherapist, dietician, evaluation of caregiving 
family member  
Coordinator Nurse: 
Post-operation training 
for patients  
Daily Patient Visits 
 
Clinic Nurses: 
To execute healthcare 
services in line with 
designated healthcare 
plan 
Completion of the 
practices in the Clinical 
Pathway (post-op 1st, 
2nd, 3rd, 4th, 5… days) 
Dietician: 
To plan a nutrition 
program for the patient 
and train the patient 
accordingly  
 
Physiotherapist: 
To plan the physical 
activity and exercise 
program for the patient 
and train the patient 
accordingly 
 
Coordinator Nurse: 
✓ Home visit within 24 hours after hospital discharge;  
• The patient's living conditions,  
• Understanding and executing the proposed treatment and drug regimen, 
• Assessment of the performance on executing practices to accelerate the recovery of the patient 
• To continue planning and executing healthcare services 
✓ Providing consultancy service via telephone to the patient and family members within post discharge first 
week  
Coordinator Nurse: 
✓ Home visits at post discharge 2nd and 6th weeks; 
• "Post-Discharge Home Follow-Up Form of Elderly Person Undergoing Open Heart Surgery" 
• "Post-Discharge Recurrent Hospital Admission Follow-Up Form" 
• Providing training and consultancy in cooperation with the team members for the detected problems  
• Follow-Up for the detected problems 
Coordinator Nurse: 
✓ Home visits at post discharge 9th week; 
• "Post-Discharge Home Follow-Up Form of Elderly Person Undergoing Open Heart Surgery" 
• "Post-Discharge Recurrent Hospital Admission Follow-Up Form" 
• Providing training and consultancy in cooperation with the team members for the detected problems  
• Follow-Up for the detected problems 
• ‘The Functional Autonomy Measurement System’,  
• ‘SF-36 Quality of Life Scale’ 
Coordinator Nurse: 
✓ Telephone Communication at post discharge 6th month 
• “Post-Discharge Recurrent Hospital Admission Follow-Up Form" 
Figure 2.'Nurse Led Transitional Care Model Protocol'