A Trial to De-prescribe Inappropriate Medications in the Community Dwelling Elderly (D-PRESCRIBE)
2018년 1월 23일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
600
단계
- 4단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
65년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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간섭 없음: Control
Participants in the control group will be wait-listed and observed for 6 months prior to receiving the intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Complete discontinuation of inappropriate prescriptions.
기간: 6 months
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The frequency, timing and type of pharmaceutical opinions sent by the pharmacist to the patient's primary care physician.
기간: 6 months
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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.
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6 months
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Effect of the pharmaceutical opinion on the prescriber's behaviour.
기간: 6 months
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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
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Patient-physician encounters to discuss inappropriate prescriptions.
기간: 6 months
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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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in risk perception around inappropriate prescriptions
기간: Baseline, 6 months
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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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Cara Tannenbaum, MD, MSc, Centre de recherche de l'institut Universitaire de Gériatrie de Montreal
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 3월 1일
기본 완료 (실제)
2017년 10월 1일
연구 완료 (실제)
2017년 12월 1일
연구 등록 날짜
최초 제출
2014년 1월 31일
QC 기준을 충족하는 최초 제출
2014년 1월 31일
처음 게시됨 (추정)
2014년 2월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 1월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 1월 23일
마지막으로 확인됨
2018년 1월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CIHR 201303MOP-299872-KTR
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .