A Software to Prevent Delirium (PREVEDEL) in Hospitalized Older Adults

Summary

Background

Delirium, is a clinical condition characterized by acute and fluctuating deterioration of the cognitive state, generally secondary to an acute pathology. It is a common condition in hospitalized older adults and it develops in 20-30% of patients hospitalized in a general ward and up to 80% of those hospitalized in critical care units. Delirium is associated with negative outcomes in older adults, such as longer hospitalizations, higher mortality, and short and medium-term institutionalization. Randomized clinical trials have shown that delirium is preventable through non-pharmacological prevention measures, decreasing its incidence by 30 to 50%. These interventions include promoting physical activity, facilitating the use of glasses and hearing aids, cognitive stimulation, and providing frequent reorientation of time and space, among others.

These measures are currently seldom applied in hospitals in Chile and around the world for various reasons some of which include the heavy workload of clinical staff, the lack of trained personnel, and, in general, the absence of systematic implementation processes.

The main objective is to evaluate whether cognitive stimulation guided by PREVEDEL software prevents delirium status(full/subsyncromal delirium) in hospitalized older adults.

Method/Design: randomized controlled trial, parallel groups, multicenter.

Participants: patients 65 years or older who have been hospitalized for less than 48 hours in the general ward or in the intermediate care unit of 4 hospitals in Santiago, Chile.

Intervention: participants in the intervention group will use a tablet with cognitive stimulation software for delirium prevention for 5 continuous days versus the control group who will use the tablet without the software.

Evaluations: The incidence of delirium and subsyndromal delirium, duration, density of delirium, cognitive and functional status at discharge, adherence to prevention measures, as well as demographic variables of interest will be evaluated.

Conditions

• Delirium
• Confusion
• Neurobehavioral Manifestations
• Neurologic Manifestations

Interventions

OTHER

Prevention software

The software is installed on an Alcatel OneTouch Pixi-3 10 tablet and is delivered every day to each patient between 9:00 am and 8:00 pm, with nighttime pickup (8:00 pm to 09:00 am), so the patient can rest and to charge the device. The first day, a previously trained health professional delivers the tablet and trains the older adults in its use, taking 10 to 15 minutes. The day after the tablet is delivered, the same person goes to the patient's room to check if he or she has any doubts or problems with its use. Both groups are advised to use the tablet 3 times a day, at least 10 minutes each time.

OTHER

Placebo

All patients will have a tablet without the software PREVEDEL between 09:00-19:00 hrs.

OTHER

Implement a program of non-pharmacological interventions to prevent delirium

Three months before the start of the clinical trial, an intervention is carried out in the Internal Medicine, Geriatrics and Intermediate Care Unit services of the 4 participating centers in order to establish a homogeneous plan of nPPD and assess adherence. The implementation methodology in the first stage will be according to the Consolidated Framework for Advancing Implementation Science (CFIR) model, used in a local pilot study.

Sponsors & Collaborators

• University of Chile

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-01

Primary Completion

2022-08-31

Completion

2023-01-15

Countries

• Chile

Study Locations