Prospective Randomised Controlled Trial of Delirium Management by Geriatric Medicine Versus General Medicine

NCT01650896 | Unknown DMC

• 1 other identifier: CADIS-2012
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The typical delirium study between 1989 and 2005 compared delirium management in a specialty unit such as geriatric medicine with delirium management in general medicine (in most cases the research diagnosis of delirium was not communicated to the general medicine group). This study will provide open diagnosis of delirium by the CAM to both the geriatric medicine and general medicine groups (medical staff, patients, families) plus daily monitoring of delirium using digit span and delirium index which is reported to both patient groups. It will also compare confusion assessment method (CAM)to a novel diagnostic system of Paul Regal with respect to hard endpoints (survival and return home). Hypotheses: 1) General medicine can manage delirium as well as geriatric medicine when delirium is openly diagnosed and monitored daily (even in speciality units it is rare to find daily measurement of tools such as delirium index); 2) The Regal diagnostic system will be superior to the CAM in predicting hard endpoints (survival and return home rate for patients living in the community).

Conditions

Delirium

Keywords

Delirium; Dementia; Instrumental activities of daily living

Outcome Measures

Primary Outcomes (4)

• Return home rate

  The percentage of subjects returning home divided by the number living at home prior to admission and surviving until discharge

  10-50 days

• Survival

  Surivors divided by subjects reaching that milestone

  30, 90, 180 days, 12 and 24 month

• Percentage residing at home

  Number of subjects at home divided by number surviving to that milesone

  30, 90 and 180 days, 12 and 24 months

• Hospital complications of delirium

  Absconding from ward, physical violence, pulling out intravenous lines and indwelling catheters, refusing medications, falls and injurious falls

  7-50 days from admission

Study Arms (2)

General Medicine

NO INTERVENTION

Geriatric Medicine

ACTIVE COMPARATOR

Daily medical review, adjust medications, treat infection, occupational therapy

Other: Geriatric assessment review

Interventions

Geriatric assessment review OTHER

Adjust medications, treat precipitants of delirium, one-on-one supervision of agitated violent patients

Geriatric Medicine

Eligibility Criteria

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

Sponsors & Collaborators

• Central Coast Local Health District: lead

Study Sites (1)

Wyong Hospital

Kanwal, New South Wales, 2263, Australia

RECRUITING

MeSH Terms

Conditions

Delirium; Dementia

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Aileen Carter, BSc

CONTACT

612 43948000; AECarter@nsccahs.health.nsw.gov.au

Paul J Regal, MD FRACP

CONTACT

61 0448 675 93; pregal@nsccahs.health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Geriatric Medicine

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 26, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2016
• Last Updated: July 26, 2012

Record last verified: 2012-07

Locations

AU (1)