A Trial to De-prescribe Inappropriate Medications in the Community Dwelling Elderly (D-PRESCRIBE)
23. januar 2018 opdateret af: Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Developing Pharmacist-led Research to Educate and Sensitive Community Residents to the Inappropriate Prescription Burden in the Elderly
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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
600
Fase
- Fase 4
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
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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.
|
|
Ingen indgriben: Control
Participants in the control group will be wait-listed and observed for 6 months prior to receiving the intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Complete discontinuation of inappropriate prescriptions.
Tidsramme: 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.
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6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The frequency, timing and type of pharmaceutical opinions sent by the pharmacist to the patient's primary care physician.
Tidsramme: 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.
|
6 months
|
|
Effect of the pharmaceutical opinion on the prescriber's behaviour.
Tidsramme: 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.
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6 months
|
|
Patient-physician encounters to discuss inappropriate prescriptions.
Tidsramme: 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.
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6 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in risk perception around inappropriate prescriptions
Tidsramme: 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.
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Baseline, 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cara Tannenbaum, MD, MSc, Centre de recherche de l'institut Universitaire de Gériatrie de Montreal
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2014
Primær færdiggørelse (Faktiske)
1. oktober 2017
Studieafslutning (Faktiske)
1. december 2017
Datoer for studieregistrering
Først indsendt
31. januar 2014
Først indsendt, der opfyldte QC-kriterier
31. januar 2014
Først opslået (Skøn)
3. februar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- CIHR 201303MOP-299872-KTR
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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