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Fall Related Injury RiskNCT00818285

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

A study testing CDS for psychotropic drug management in people with Fall Related Injury Risk, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Fall Related Injury Risk
What is being tested?
CDS for psychotropic drug management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,628 participants
Where
1 siteCanada
Study dates
Sep 2008to Aug 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • under 65 years old

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McGill University

    Montreal, Quebec

Other trials in Canada

About this study

Official title: Reducing Injuries From Medication-Related Falls by Generating Targeted Computerized Alerts for High Risk Patients Within an Electronic Prescribing System

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.

Read the 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

  1. 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.

Being tested
CDS for psychotropic drug management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CDS for psychotropic drug managementDevice

    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.

Study groups in NCT00818285
Study groupRoleWhat they receive
1No interventionPhysicians in this arm will be using the standard electronic prescription interface.
2ExperimentalIn addition to the standard electronic prescription module, physicians in this arm will receive targeted drugs alert and decision support for psychotropic drug management
Receives: Device: CDS for psychotropic drug management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of potentially inappropriate psychotropic medication

    Measured: September 2008-July 2010

Secondary outcomes (1)
  1. Fall-related injury risk, fall related injuries, and hospitalizations.

    Measured: September 2008 - December 2011

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2009 (estimated)
  2. Study startSep 2008
  3. Primary completionJul 2010
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
5,628 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00818285
Sponsor's protocol ID
RFA06-1035-QC
Status last verified
Aug 2019
First submitted
5 Jan 2009
Last updated
20 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22246963

Questions about this trial

What is this clinical trial studying?

A study testing CDS for psychotropic drug management in people with Fall Related Injury Risk, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of potentially inappropriate psychotropic medication (time frame: September 2008-July 2010). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00818285, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.

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