A Trial to De-prescribe Inappropriate Medications in the Community Dwelling Elderly (D-PRESCRIBE)
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|ClinicalTrials.gov Identifier: NCT02053194|
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Inappropriate Dose of Drug Administered Health Behavior||Behavioral: Pharmacist-led educational intervention||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Developing Pharmacist-led Research to Educate and Sensitive Community Residents to the Inappropriate Prescription Burden in the Elderly|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Pharmacist-led educational intervention
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
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.
No Intervention: Control
Participants in the control group will be wait-listed and observed for 6 months prior to receiving the intervention.
- Complete discontinuation of inappropriate prescriptions. [ Time Frame: 6 months ]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.
- The frequency, timing and type of pharmaceutical opinions sent by the pharmacist to the patient's primary care physician. [ Time Frame: 6 months ]The occurrence and delivery date of any pharmaceutical opinion sent to the patient's physician will be ascertained by the presence of a pharmacist billing claim recorded within 6 months after randomization of pharmacies to the intervention group. The type of opinion (evidence-based example provided by the research team vs customized by the pharmacist) will be ascertained by obtaining a photocopied paper copy of the pharmaceutical opinion from the patient's pharmacy record at the end of the trial (by law, the pharmacist must keep a copy in the patient's dossier). The dates of the paper copy will be matched to the date of the billing registered in the billing database to validate that the latter relates to the drug under study.
- Effect of the pharmaceutical opinion on the prescriber's behaviour. [ Time Frame: 6 months ]Pharmacists will be provided with a "study response card" to accompany any pharmaceutical opinion sent to a physician for study patients with inappropriate prescriptions. The "response card" will ask the physician to endorse one of the following three options: 1) I agree with the proposed recommendation and have signed the prescription recommendation you have provided to discontinue or substitute the inappropriate prescription 2) I will discuss with the patient at the next visit; or 3) no change required. The physician will be asked to fax back the response card to the pharmacist. A copy of all response cards received by the pharmacist will be collected by the research team at the end of the trial. The pharmacist will also be asked whether the physician acknowledged the pharmaceutical opinion in any other way. Lack of acknowledgment of the pharmaceutical opinion by the physician will be coded as a non-response.
- Patient-physician encounters to discuss inappropriate prescriptions. [ Time Frame: 6 months ]Patient visits to their primary care provider within the 6-months post-intervention will be ascertained by physician billing claims. Visits to physicians where discussions about inappropriate prescriptions occurred will be determined by patient self-report during the 6-month semi-structured telephone follow-up interview by asking whether patients met with their physician to discuss their prescriptions and what happened during these encounters. We will also query any phone call discussions with physician on this subject and conversations with pharmacists to discuss prescription changes.
- Change in risk perception around inappropriate prescriptions [ Time Frame: Baseline, 6 months ]Baseline and post-intervention evaluation of participant's, pharmacist's and physician's beliefs about the risks associated with certain inappropriate prescriptions, as listed on the Beers Criteria of inappropriate medication in the elderly.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053194
|Principal Investigator:||Cara Tannenbaum, MD, MSc||Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal|