NCT00818285

Brief Summary

Drug-related illness accounts for 5% to 23% of hospital admissions, and is now claimed to be the sixth leading cause of mortality. Older adults are at higher risk of adverse drug-related events, and medication-related fall injuries are the most common adverse event that could be potentially prevented. There are 1.2 million falls per year among Canadian elderly, at a cost of $2.4 billion in health care services, and substantial risk of loss of independence. The overall purpose of this research program is to reduce medication-related fall injuries by using computerized electronic prescribing and drug management systems to identify high risk patients and provide physicians with patient-specific recommendations for modifying psychotropic medication use to reduce this risk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,628

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

January 5, 2009

Last Update Submit

August 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • rate of potentially inappropriate psychotropic medication

    September 2008-July 2010

Secondary Outcomes (1)

  • Fall-related injury risk, fall related injuries, and hospitalizations.

    September 2008 - December 2011

Study Arms (2)

1

NO INTERVENTION

Physicians in this arm will be using the standard electronic prescription interface.

2

EXPERIMENTAL

In addition to the standard electronic prescription module, physicians in this arm will receive targeted drugs alert and decision support for psychotropic drug management

Device: CDS for psychotropic drug management

Interventions

Computerized decision support (CDS) for patients with available supplies of psychotropic medications. The decision support will consist of a screen displaying to the physician the patient's current risk of falling as well as what their risk could be lowered to with modifications to medications.

2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may not qualify if:

  • under 65 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, Canada

Location

Related Publications (1)

  • Tamblyn R, Eguale T, Buckeridge DL, Huang A, Hanley J, Reidel K, Shi S, Winslade N. The effectiveness of a new generation of computerized drug alerts in reducing the risk of injury from drug side effects: a cluster randomized trial. J Am Med Inform Assoc. 2012 Jul-Aug;19(4):635-43. doi: 10.1136/amiajnl-2011-000609. Epub 2012 Jan 12.

Study Officials

  • Robyn M Tamblyn, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 7, 2009

Study Start

September 1, 2008

Primary Completion

July 1, 2010

Study Completion

August 1, 2012

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations