Reducing Injuries From Medication-Related Falls Using Computerized Alerts for High Risk Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by McGill University
Sponsor:
Collaborator:
Canadian Patient Safety Institute
Information provided by (Responsible Party):
Robyn Tamblyn, McGill University
ClinicalTrials.gov Identifier:
NCT00818285
First received: January 5, 2009
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Fall Related Injury Risk
Device: CDS for psychotropic drug management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Reducing Injuries From Medication-Related Falls by Generating Targeted Computerized Alerts for High Risk Patients Within an Electronic Prescribing System

Further study details as provided by McGill University:

Primary Outcome Measures:
  • rate of potentially inappropriate psychotropic medication [ Time Frame: September 2008-July 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fall-related injury risk, fall related injuries, and hospitalizations. [ Time Frame: September 2008 - December 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 4800
Study Start Date: September 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Physicians in this arm will be using the standard electronic prescription interface.
Experimental: 2
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
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.

  Hide Detailed Description

Detailed Description:

Background: Fall-related injuries account for significant morbidity and mortality, particularly in the elderly where multiple comorbidities and age-related changes in bone density increase the risk of fall-related fractures Indeed use of psychotropic medications in elderly persons is associated with a 2 to 29 fold increase in the risk of falls and a 2 to 5 fold increase in the risk of hip fracture. At particular risk are individuals over the age of 70, those with a prior history of falls, cognitive impairment, stroke, Parkinson's disease, or other conditions that would impair balance or gait. In our particular study population, 67.5% of persons with a psychotropic drug prescribing problem had at least one additional risk factor for fall-related injuries. This was particularly true for women who not only were more likely to have a psychotropic drug prescribing alerts than men but were also more likely to have other risk factors. 70.3% of women who had a psychotropic prescribing alert had other risk factors in comparison to 62.1% of men, particularly as it related to older age and a history of a fall-related fracture or soft-tissue injury in the past 12 months. A recent in-hospital study showed that providing physicians with patient-specific recommendations for changes in high risk psychotropic therapy through a computerized order-entry system reduced the prescription of non-recommended drugs and doses by 10%, which in turn was associated with a significant two-fold reduction in the in-hospital fall rate{5007}. If even a 5% reduction (annual prevalence 16.1% to 11.1%) could be achieved in primary care through targeted recommendations for high risk patients with psychotropic drug prescribing alerts, we would expect that it could conservatively reduce the number of falls among Canadian elderly (assuming the lowest risk of RR=1.66) from 116,064 to 82,212 and the number of fall-related injuries from 11,606 to 8,221. Based on the average costs of treating fall-related injuries of $20,000/injury{5006}, a reduction in adverse events of this magnitude would be associated with an annual savings of $67,708,000 in direct care costs. The research question is the following: Can medication-related fall injuries be reduced 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?

Objective: To determine the extent to which a targeted psychotropic drug alert and recommendation system will reduce

a) the rate of potentially inappropriate psychotropic medication for patients at risk of fall-related injuries, and b) fall-related injury risk, fall-related injuries and hospitalizations.

Research Plan : A single blind, cluster randomized controlled trial will be conducted to test the hypothesized benefits of the targeted psychotropic drug alert and recommendation system versus the standard automated generic drug alert system within a fixed cohort of primary care physicians and an open cohort of patients seen by study physicians in the 16 month follow-up period for the assessment of reductions in potentially inappropriate psychotropic prescriptions and fall-related injuries. A single blind trial was planned because intervention status cannot be blinded for physicians in the study. However, study participants are blinded to the outcomes assessed, because the data required to assess these outcomes can be predominantly collected and assessed using data sources that are independent of the intervention status. Patients, clustered within physicians, is the unit of analysis because patient level information provides the most precise, non-ecological, method of the study outcomes as well as potential confounders, and because hierarchical multivariate analytic methods are now available to model clustering in the assessment of treatment effect{Chuang, 2000 4339 /id}. The benefit of the intervention will be assessed by comparing patients of physicians who received the psychotropic drug alert and recommendation system and patients of physicians who received automated drug decision support. This approach minimizes Hawthorne effects, arising from the intensive nature of practice intervention required to support computer-based systems in primary care that would likely result in over-estimation of benefit if computer-based decision support for drug management were compared to physicians with no computerized intervention. Further, it provides a means by which information on prescriptions, drug and disease profile can be assessed in an equivalent way between patients of physicians with automated control or targeted alert experimental decision-support, reducing biases related to differences in measurement sources.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physicians are eligible for inclusion if they are general practitioners or family physicians in full-time (≥ 4 days/week), fee-for-service practice in Quebec-patients where the study physician has written or dispensed psychotropic medications

Exclusion Criteria:

  • under 65 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818285

Contacts
Contact: Robyn Tamblyn, PhD 514-934-1934 ext 32999 robyn.tamblyn@mcgill.ca

Locations
Canada, Quebec
McGill University Recruiting
Montreal, Quebec, Canada
Contact: Robyn Tamblyn, PhD    514-934-1934 ext 32999    robyn.tamblyn@mcgill.ca   
Sponsors and Collaborators
McGill University
Canadian Patient Safety Institute
Investigators
Principal Investigator: Robyn M Tamblyn, PhD McGill University
  More Information

No publications provided by McGill University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robyn Tamblyn, Professor, McGill University
ClinicalTrials.gov Identifier: NCT00818285     History of Changes
Other Study ID Numbers: RFA06-1035-QC
Study First Received: January 5, 2009
Last Updated: April 25, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Psychotropic Drugs
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014