NCT02053194

Brief Summary

The objective of this trial is to test the beneficial effect of a pharmacist-initiated knowledge transfer intervention to both patients and prescribers on the discontinuation of inappropriate prescriptions, compared to usual care. The investigators hypothesize that the pharmacist-led intervention will reduce inappropriate prescriptions by at least 20% over 6-months compared to usual care. The intervention consists of simultaneously educating consumers and providing physicians with an evidence-based pharmaceutical opinion on inappropriate prescriptions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

January 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

3.6 years

First QC Date

January 31, 2014

Last Update Submit

January 23, 2018

Conditions

Inappropriate Dose of Drug AdministeredHealth Behavior

Keywords

Inappropriate prescribingHealth EducationCommunity Pharmacy ServicesMedication Therapy ManagementPreventive Health ServicesPolypharmacyInappropriate prescriptionsAged

Outcome Measures

Primary Outcomes (1)

  • Complete discontinuation of inappropriate prescriptions.

    Provincial prescription insurance claims will be used to measure whether the inappropriate prescription has been discontinued in the intervention and control group at 6-months. Prescription data contain information on all dispensed prescriptions including drug name, dispensation date, dosage, drug form, duration and quantity of the drug dispensed, as well as the license number of the physician who wrote the prescription. Discontinuation of an inappropriate prescription will be defined as the lack of a claims renewal for that medication during a minimum of three or more consecutive months (with no subsequent renewals) during the nine months following receipt of the intervention.

    6 months

Secondary Outcomes (3)

  • The frequency, timing and type of pharmaceutical opinions sent by the pharmacist to the patient's primary care physician.

    6 months

  • Effect of the pharmaceutical opinion on the prescriber's behaviour.

    6 months

  • Patient-physician encounters to discuss inappropriate prescriptions.

    6 months

Other Outcomes (1)

  • Change in risk perception around inappropriate prescriptions

    Baseline, 6 months

Study Arms (2)

Pharmacist-led educational intervention

EXPERIMENTAL

Participants will receive an educational brochure on an inappropriate prescription they are currently taking from their pharmacists. Participants' physicians will receive an evidence-based pharmaceutical opinion for the same medication.

Behavioral: Pharmacist-led educational intervention

Control

NO INTERVENTION

Participants in the control group will be wait-listed and observed for 6 months prior to receiving the intervention.

Interventions

Pharmacist-led educational interventionBEHAVIORAL

1\) Educational material to participants in the form of a written educational brochure on inappropriate prescriptions that was developed and tested during the EMPOWER study. 2) Evidence-based pharmaceutical opinions sent to the treating physicians.

Pharmacist-led educational intervention

Eligibility Criteria

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

You may qualify if:

  • Men and women 65 years of age and older (no upper age limit)
  • Individuals for whom prescription claims derive from only one pharmacy identifier
  • Chronic consumption (\> 3 month claims) of one of the target inappropriate prescriptions. (benzodiazepine/non benzodiazepine hypnotic, long-acting sulfonylurea oral hypoglycemic agents, anticholinergic agents (in the form of first-generation antihistamines) or Nonsteroidal anti-inflammatory drugs \[NSAIDs\] )
  • Patients who are willing to participate in the study.

You may not qualify if:

  • A probable diagnosis of dementia (persons without the capacity to provide informed consent), as determined by a) a prescription for memantine or a cholinesterase inhibitor; b) report from a caregiver or family-member; or c) a baseline screening score on the Folstein Mini-Mental State Exam \< 24
  • Inability to understand and or communicate in English and/or French
  • Patients living in a long-term care facility
  • Concomitant use of any antipsychotic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Turner JP, Martin P, Zhang YZ, Tannenbaum C. Patients beliefs and attitudes towards deprescribing: Can deprescribing success be predicted? Res Social Adm Pharm. 2020 Apr;16(4):599-604. doi: 10.1016/j.sapharm.2019.07.007. Epub 2019 Jul 10.

    PMID: 31303479DERIVED

  • Martin P, Tamblyn R, Benedetti A, Ahmed S, Tannenbaum C. Effect of a Pharmacist-Led Educational Intervention on Inappropriate Medication Prescriptions in Older Adults: The D-PRESCRIBE Randomized Clinical Trial. JAMA. 2018 Nov 13;320(18):1889-1898. doi: 10.1001/jama.2018.16131.

    PMID: 30422193DERIVED

  • Martin P, Tamblyn R, Ahmed S, Benedetti A, Tannenbaum C. A consumer-targeted, pharmacist-led, educational intervention to reduce inappropriate medication use in community older adults (D-PRESCRIBE trial): study protocol for a cluster randomized controlled trial. Trials. 2015 Jun 10;16:266. doi: 10.1186/s13063-015-0791-1.

    PMID: 26058676DERIVED

MeSH Terms

Conditions

Health BehaviorHealth Education

Condition Hierarchy (Ancestors)

BehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Study Officials

  • Cara Tannenbaum, MD, MSc

    Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Cara Tannenbaum

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 3, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

January 25, 2018

Record last verified: 2018-01