Evaluation of the Effectiveness of Delirium Preventive Care Protocol

NCT ID: NCT04188795

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-25

Study Completion Date

2019-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention

Participants who met the criteria for inclusion in the study and volunteered to participate in the study were divided into experimental and control groups by block randomization method.

After obtaining written informed consent, the Patient Information Form, Mini Nutritional Assessment- Short Form, Confusion Assessment Method, Barthel Index and Visual Analog Scale were applied to patients. 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.

Group Type EXPERIMENTAL

Delirium Preventive Care Protocol

Intervention Type PROCEDURE

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.

Control Group

After obtaining written informed consent, the Patient Information Form, Mini Nutritional Assessment- Short Form, Confusion Assessment Method, Barthel Index and Visual Analog Scale were applied to patients. Routine nursing care was applied to hip fracture patients in the control group. Confusion Assessment Method, Barthel Index and Richards-Campbell Sleep Questionnaire were repeated to patients on the first postoperative day and on the third day.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gulten Guvenc, Proffessor

Role: STUDY_DIRECTOR

University of Health Sciences, Gulhane Faculty of Nursing

Locations

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University of Heath Sciences, Gulhane Faculty of Nursing

Ankara, , Turkey (Türkiye)

Site Status

University of Health Sciences, Faculty of Nursing

Ankara, , Turkey (Türkiye)

Site Status

University of Health Sciences, Gulhane Faculty of Nursing

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31521618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31343628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25662415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24885674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11380742 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34302312 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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50687469-2244

Identifier Type: -

Identifier Source: org_study_id

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