Quality Improving Program on Agitation in the Surgical Intensive Care Unit

NCT02199262 | Completed

• 1 other identifier: CER:02-190
• Study Type: interventional
• Target: 1,107
• Locations: 1 country
• Sites: 1

Brief Summary

Agitation in the intensive care unit can have multiple consequences. The investigators hypothesize that agitation and its consequences can be reduced by the introduction of a reminder aiming at guiding the management of agitation. The investigators also hypothesize that they can prevent agitation and its consequences by acting on patients environment with reafferentation and relaxation methods. The investigators' objectives are to test within a quality improvement project by a prospective randomized study:

• If by reducing the number of agitation episodes we reduce the number of harmful consequences.
• If the introduction of reafferentation and relaxation methods (music therapy or reflexology) can prevent the occurrence of agitation.
• If the introduction of a reminder on management of agitation can reduce the number of agitation episodes. This study is conducted in an18 general surgical ICU beds receiving 1600 patients / year for a total of 6900 hospital /days /year, in a tertiary teaching hospital. The study is organized in 3 phases:
• First phase: Baseline phase (Prospective analysis of the present situation)
• Second phase: Learning phase (Implementation of a reminder about the management of agitation and delirium )
• Third phase: Randomized Intervention (reminder alone vs addition of music or reflexology)
• Implementation of a reminder of guidelines of agitation diagnosis and management.
• Music intervention( see description below) + reminder
• Reflexology (see description below)+ reminder

Conditions

Agitation

Keywords

Intensive care unit; Incidents; prevention; music; reflexology

Outcome Measures

Primary Outcomes (1)

• Diminution of agitation (SAS and CAM-ICU) trough a music intervention or reflexology

  Music intervention: The patient will listen to a variety of music for at least 20 minutes in the morning and in the afternoon (compact disc players with headphones with disposable ear pads). The preferred music will be freely available for the rest of the day. The choice of the music type will depend on the patients ability to communicate his desires. If the patient is not able to express his choice, the caregiver will ask his next of kin. If the information is not available, the caregiver will select a type of music he judges adapted to the patient's situation. Reflexology: This therapy will be applied 20 minutes per day to patients by a certified specialist in reflexologic massages. Measurements : Investigators analyze the presence or absence of agitation and delirium by SAS and CAM-ICU at each evaluation judged necessary by the nurse, at least once by shift (every 8 hours).

  lenght of patients' stay, 3.5 days on average

Secondary Outcomes (1)

• Correlation between the reduction of the number of agitation episodes (SAS and CAM-ICU) and the number of harmful consequences

  lenght of patients' stay, 3.5 days on average

Other Outcomes (1)

• Effect of reminder of guidelines of agitation diagnosis (by SAS and CAM-ICU ) and management

  lenght of patients' stay, 3.5 days on average

Study Arms (3)

control groupe

EXPERIMENTAL

agitation diagnosis and management according to implemented guidelines= reminder implementation

Other: reminder

music intervention + reminder

EXPERIMENTAL

agitation diagnosis and management according to implemented guidelines+ music intervention

Other: music intervention

reflexology + reminder

EXPERIMENTAL

agitation diagnosis and management according to implemented guidelines + reflexology

Other: reflexology

Interventions

music intervention OTHER

reminder+ 20 minutes in the morning and 20 minutes in the afternoon of music listening(classical or soft background music), delivered by compact disc players with headphones with disposable ear pads.

music intervention + reminder

reflexology OTHER

reminder + 20 minutes per day feet reflexology massage provided by certified specialist in reflexology massages

reflexology + reminder

reminder OTHER

Implementation of a reminder of guidelines of agitation diagnosis and management

control groupe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years
• admission in ICU \>24 hours

You may not qualify if:

• amputation
• paraplegia
• non french speaking
• consent refusal

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Surgical Intensive Care Unit

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 24, 2014
• Study Start: February 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

CH (1)