Evaluation of the Effectiveness of Delirium Preventive Care Protocol for Hip Fracture Patients
Phase: NA
Conditions: Delirium
Sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Evaluation of the Effectiveness Delirium Preventive Care Protocol For Hip Fracture Patients 
NCT 04188795 
Document Date: January 10, 2019 
 
STUDY PROTOCOL WITH ANALYSIS PLAN 
Hip fracture, which is defined as the most serious outcome of osteoporosis, affects patients' 
daily activities and quality of life (Ensrud, 2013). A high prevalence for the development of delirium 
after hip fracture is found in the group of geriatric patients (Tsang et al., 2012). Delirium prevention is 
essential rather than treatment (Strijbos et al., 2013). According to The National Institue for Health 
and Clinical Excellence (NICE), 30% of delirium cases can be prevented (NICE, 2010). The 
prevention of delirium, which is a multifactorial phenomenon, can be achieved through a 
multicomponent care protocol that targets at specific risk factors for delirium. 
The aim of this study was to investigate the effectiveness of delirium preventive care protocol 
on pain, functional status, sleep quality and delirium prevention in patients with hip fracture. 
This prospective, randomized controlled experimental study was conducted at a training and 
research hospital’s orthopedics and traumatology department in Turkey. Hip fracture patients aged 
≥65 years who were underwent surgery were included. The sample included 40 patients from the 
intervention group and 40 from the control group. A protocol with a nursing care plan referenced from 
international guideline and other litherature was developed to prevent delirium and apllied to 
intevention group (SIGN, 2008; NICE, 2010, Moon & Lee, 2010; Bjorkelund et al, 2010). Control 
group was applied to regular nursing care in line with the clinical procedure. Study data was collected 
by using Patient Information Form, Confusion Assessment Method, Visual Analogue Scale, Barthel 
Index, Mini Nutritional Assessment-Short Form and Richards Campbell Sleep Questionnaire. 
Delirium preventive care protocol applied to the intervention group includes; psycosocial care, 
monitor oxygen saturation to prevent hypoxemia, prevention dehydratation and nutritional support, 
normal elimination, adequate pain relief, sleep management, remove unnecessary catheter and early 
mobilization.  
The data obtained from the study were analyzed using the SPSS version 22.00 software 
package. Kolmogorov Smirnov and shapiro Wilk tests were used to evaluate the data with normal or 
non-normal distribution. Number, percentage, mean, standard deviation, median values and 
interquartile range were used in descriptive statistical evaluation of the data. In terms of the continuous 
variables of the intervention and control groups, the significance test of the difference between the two 
means, which is the parametric test for the normal distribution values (Student's t Test), and the Mann-
Whitney U Test for the values that do not fit the normal distribution were used. Pearson chi-square test 
was used to analyze categorical variables. Fisher's chi-square test was used when the expected value 
was less than five. ANOVA test was used for the evaluation of normal preoperative, postoperative 1st 
day and pre-discharge data. Two groups t-test (Paired Sample t test) was used for comparisons 

between groups. Friedman test and Wilcoxon test were used for the evaluation of preoperative, 
postoperative 1st day and pre-discharge data that do not conform to normal distribution. Cronbach α 
coefficient was used to evaluate the reliability of RCSQ sleep scale. p <0.05 was considered 
statistically significant and p <0.001 was considered statistically highly significant. 
 
References: 
1. 
Ensrud, K. E. (2013). Epidemiology of fracture risk with advancing age. J Gerontol A Biol Sci Med 
Sci.,68(10),1236-1242.  
2. 
Tsang, L. F., Yeung, C. H., Tse, C. C., Lam, K. B., Cheung, L. P., Chu, K. K., ... & Lau, P. Y. 
(2012). Developing a predictive tool for post-operative delirium in orthopaedic settings in Hong 
Kong. International Journal of Orthopaedic and Trauma Nursing, 16(3), 147-159. 
3. 
Strijbos, M. J., Steunenberg, B., van der Mast, R. C., Inouye, S. K., & Schuurmans, M. J. (2013). 
Design and methods of the Hospital Elder Life Program (HELP), a multicomponent targeted 
intervention to prevent delirium in hospitalized older patients: efficacy and cost-effectiveness in 
Dutch health care. BMC geriatrics, 13(1), 78. 
4. 
Scottish 
Standards 
of 
Care 
for 
Hip 
Fracture 
Patients 
2016. 
https://www.shfa.scot.nhs.uk/_docs/20161109_SSC_for_Hip_Fracture_Patients.pdf. 
Date: 
01.09.2018. 
5. 
The management of hip fracture in adults. Methods, Evidence & Guidance. (Updated 2017). 
https://www.nice.org.uk/guidance/cg124/evidence/full-guideline-pdf-183081997. 
Date: 
01.09.2018. 
6. 
Moon, K., & Lee, S. M. (2010). Development of an evidence-based protocol for preventing 
delirium in intensive care unit patients. J. Kor. Clin. Nurs. Res.,16(3),175–186. 
7. 
Bjorkelund, K. B., Hommel, A., Thorngren, K. G., Lundberg, D., & Larsson, S. (2009). Factors 
at admission associated with 4 months outcome in elderly patients with hip fracture. AANA 
Journal-American Association of Nurse Anesthetists, (1),49-58.