Clinical trial NCT04188795: Evaluation of the Effectiveness of Delirium Preventive Care Protocol
Official title: Evaluation of the Effectiveness of Delirium Preventive Care Protocol for Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: Care protocol
Delirium
Nursing care
Hip fracture
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized controlled trial conducted at Gulhane Training and Research Hospital , Orthopedic and Traumatologic clinic between May 2018 and January 2019.The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomized controlled trials (RCTs) has been used to describe the methods.
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Richards-Campbell Sleep Questionnaire (RCSQ)
timeFrame: 4 minutes.
measure: Barthel Index (BI)
timeFrame: 5 minutes.
measure: Visual Analog Scale (VAS)
timeFrame: 1 minute.
measure: Mini Nutritional Assesment- Short Form (MNA-SF)
timeFrame: 2 minutes.
Secondary outcomes:
Other outcomes:
measure: Confusion Assessment Method- Intensive Care Unit (CAM-ICU)
timeFrame: 5 minutes.
Locations:
city: Ankara
country: Turkey
facility: University of Heath Sciences, Gulhane Faculty of Nursing
city: Ankara
country: Turkey
facility: University of Health Sciences, Faculty of Nursing
city: Ankara
country: Turkey
facility: University of Health Sciences, Gulhane Faculty of Nursing
Study officials:
affiliation: University of Health Sciences, Gulhane Faculty of Nursing
name: Gulten Guvenc, Proffessor
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.
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. doi: 10.1046/j.1532-5415.2001.49108.x.
citation: Unal N, Guvenc G, Naharci M. Evaluation of the effectiveness of delirium prevention care protocol for the patients with hip fracture: A randomised controlled study. J Clin Nurs. 2022 Apr;31(7-8):1082-1094. doi: 10.1111/jocn.15973. Epub 2021 Jul 23.