Evaluation of the Effectiveness of Delirium Preventive Care Protocol

Delirium Clinical Trial

Official title:

Evaluation of the Effectiveness of Delirium Preventive Care Protocol for Hip Fracture Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188795
• Other study ID #: 50687469-2244
• Status: Completed
• Phase: N/A
• Start date: May 25, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: November 2019
• Source: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The prospective, randomized controlled experimental trial investigates the effectiveness of delirium preventive care protocol for hip fracture patients.

Description:

The aim of this prospective, randomized controlled experimental trial is to evaluate the effectiveness of delirium preventive care protocol on pain, functional status, sleep quality and delirium prevention in patients with hip fracture.

This research was conducted at a training and research hospital's orthopedics and traumatology department. The study sample was compromised of 80 patients with hip fracture. Intervention and control groups were applied after block randomization. Study data was collected by using Patient Information Form, Mini-Cog Test, Confusion Assessment Method, Visual Analogue Scale, Barthel Index, Mini Nutritional Assessment-Short Form and Richards Campbell Sleep Questionnaire. The patients in the intervention group were provided with nursing care in accordance with the delirium preventive care protocol developed with the support of literature. In the control group, routine nursing care was provided in line with the clinical procedure. The data was analyzed by using number, percentage, mean, standard deviation, median, Interquartile Range, Student's t test, Mann-Whitney U test, Pearson's chi square test, Fisher corrected chi-square test, ANOVA test, Paired Sample t test, Friedman test, Wilcoxon test and Cronbach α coefficient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 1, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Planned surgery for hip fracture,

• 65 years and older,

• No communication problems in Turkish,

• Without cognitive impairment,

• Patients who volunteered to participate in the study

Exclusion Criteria:

• Patients who could not be evaluated by the investigator before the operation

• Patients with dementia and Mini-Cog test less than 3 points

• Patients with a history of cerebrovascular accident

• Patients with severe comorbidity

Related Conditions & MeSH terms

• Delirium

Intervention

Procedure:
• Delirium Preventive Care Protocol
Nursing care was applied to hip fracture patients in the experimental group in accordance with the care protocol developed to prevent delirium. Delirium preventive care protocol was consist of; psychosocial care, monitoring of oxygen saturation, prevention of dehydration, nutritional support, normal elimination, pain control, sleep regulation, avoidance of bladder catheterization and early mobilization. Confusion Assessment Method, Barthel Index and Richards-Campbell Sleep Questionnaire were repeated to patients on the first postoperative day and on the third day.

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Faculty of Nursing	Ankara
Turkey	University of Health Sciences, Gulhane Faculty of Nursing	Ankara
Turkey	University of Heath Sciences, Gulhane Faculty of Nursing	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Durst J, Wilson D. Effects of protocol on prevention of delirium in hospitalized hip fracture patients: A quality improvement project. Int J Orthop Trauma Nurs. 2020 Feb;36:100710. doi: 10.1016/j.ijotn.2019.100710. Epub 2019 Aug 1. — View Citation

Flikweert ER, Izaks GJ, Knobben BA, Stevens M, Wendt K. The development of a comprehensive multidisciplinary care pathway for patients with a hip fracture: design and results of a clinical trial. BMC Musculoskelet Disord. 2014 May 30;15:188. doi: 10.1186/1471-2474-15-188. — View Citation

Holly C. Primary Prevention to Maintain Cognition and Prevent Acute Delirium Following Orthopaedic Surgery. Orthop Nurs. 2019 Jul/Aug;38(4):244-250. doi: 10.1097/NOR.0000000000000569. — View Citation

Marcantonio ER, Flacker JM, Wright RJ, Resnick NM. Reducing delirium after hip fracture: a randomized trial. J Am Geriatr Soc. 2001 May;49(5):516-22. — View Citation

Prestmo A, Hagen G, Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Lydersen S, Halsteinli V, Saltnes T, Lamb SE, Johnsen LG, Saltvedt I. Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial. Lancet. 2015 Apr 25;385(9978):1623-33. doi: 10.1016/S0140-6736(14)62409-0. Epub 2015 Feb 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Confusion Assessment Method- Intensive Care Unit (CAM-ICU)	It was applied to patients at first admission to the clinic, on the first and third postoperative day and in cases of change of consciousness. The scale was developed by Ely et al in 2001. The scale consists of four items. In the first item, sudden changes in consciousness or fluctuation; In the second article, squeezing the hand with letter A in less than 12 in the attention assessment test tests the two most important signs of delirium, fluctuations in the level of consciousness and distortion of attention. In the third article, it is evaluated whether the thought organization is disrupted or not by four questions and a simple command. The fourth item is related to the assessment of consciousness level. According to this scale, the first two items and one of the third or fourth items must be positive for the diagnosis of delirium. CAM-ICU, which is the most widely used scale that best complies with Diagnostic and Statistical Manual of Mental Disorders.	5 minutes.
Primary	Richards-Campbell Sleep Questionnaire (RCSQ)	It was applied to patients at first admission to the clinic, on the first and third postoperative day. The scale developed by Richards in 1987; It consists of six items that assess the depth of night's sleep, the time to fall asleep, the frequency of waking up, the time to wake up, the quality of sleep and the noise level in the environment. Each item is evaluated on the chart from 0 to 100. A score of 0-25 indicates a very poor sleep and a score of '76 -100 indicates a very good sleep. The higher the scale score, the better the sleep quality of the patients.; The total sleep score is calculated by taking the average of the depth of sleep, the time to fall asleep, the frequency of waking up, the time to stay awake and the quality of sleep.	4 minutes.
Primary	Barthel Index (BI)	Patients filled at frst admission to the clinic, on the first and third postoperative day was developed in 1965 by Mahoney and Barthel. It is used to determine the level of independence of individuals in their activities. The Barthel Index measures the social and physical function of daily life and consists of 10 items that assess the individual's ability to meet daily functions (nutrition, bathing, personal care, dressing, toileting, mobility on flat surfaces, transfer, climbing stairs, bowel and bladder function) without assistance. Each item is scored between 0-15 (varies according to the question). Barthel Index total scores vary between 0-100; 0-20 points completely addiction; 21-61 points severe addiction; Moderate dependence of 62-90 points; 91-99 points mild addiction; 100 points explain independence. In the studies using the Barthel Index, 60 points were taken as the limit and scores above 60 explain the ability to function independently.	5 minutes.
Primary	Visual Analog Scale (VAS)	It was applied to patients at first admission to the clinic, on the first and third postoperative day. It is used to measure the severity of pain. It is easy to use and the same in every language. At the two ends of a ten-centimeter line, two end definitions of the parameter to be evaluated are written and the patient is asked to indicate where his or her condition is appropriate by drawing a line or by pointing or pointing (0: I have no pain, 10: I have unbearable pain). The length of the distance from the absence of pain to the location of the patient indicates the pain of the patient. Less than three of this numerical expression indicates mild pain, three to seven indicates moderate pain, and more than seven indicates severe pain.	1 minute.
Primary	Mini Nutritional Assesment- Short Form (MNA-SF)	It was applied to patients at first admission to the clinic for evaluating of malnutrition. Its use in the elderly is recommended by the European Society for Clinical Nutrition and Metabolism (ESPEN). According to the screening score; 0-7 points indicate malnutrition, 8-11 points indicate malnutrition risk, 12-14 points indicate normal nutritional status.	2 minutes.