Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy (OPTI-PP)
Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy in the Hepato-Gastroenterology Department of the Nîmes University Hospital
The main objective of this study is to evaluate the impact of the presence of a pharmacy technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors.
This is a before-after study consisting of three sequential phases:
Month 1: one month of observation of what is happening in the department Month 2: one month wash out period Month 3: active participation of a pharmacy technician in the department
연구 개요
상태
정황
상세 설명
The secondary objectives of this study are:
A- To assess the impact of the presence of a pharmacy technician on the ratio of the number of patients with at least one medication error / number of included patients hospitalized in the service.
B- To characterize detected medication errors.
C- To identify and evaluate the potential causes of medication errors.
D- To evaluate whether the presence of a pharmacy technician reduces nursing time spent on medication management.
E- To evaluate the economic impact of the presence of a pharmacy technician.
F- To evaluate the acceptability of the intervention by the nursing staff and pharmacy technicians using questionnaires.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Nîmes Cedex 09, 프랑스, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- The patient must be insured or beneficiary of a health insurance plan
- The patient is hospitalized in the Hepato-Gastroenterology Department of the Nîmes University Hospital
Exclusion Criteria:
- The patient is under judicial protection
- The patient, or his/her legal guardian, expresses opposition to participation in the study
- It is impossible to correctly inform the patient
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 1st observational period (before experimental intervention)
Patients in this arm are included during a first month of observation before the intervention is implemented. Intervention: One month of department-wide observation |
A pharmacy technician will be present full time in the care unit from Monday to Friday between 8:30 and 17h for 1 month for observational purposes only.
During this phase, the pharmacy technician observes the current practices of preparation and administration of medication by nurses.
He / she will collect medication errors and other observational data.
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실험적: 2nd obs. period (during experimental intervention)
Following a one-month wash-out period, patients in this arm are included during a second month of observation during which the intervention is implemented. Intervention: Pharm Tech participates in department |
Following a 1 month wash-out period, a pharmacy technician will again be present full time (in practice, two technicians will relay each other) in the care unit from Monday to Friday between 8:30 and 17h for 1 month.
He/she will actively take part in drug care activities in the department: management of product pathways, verification of injectable preparation, advice, etc. Medication errors and other observational data will be collected.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The following ratio (relative units): Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission
기간: 5 days
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Primary Outcome Measure as given in protocol: Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission (during month 1 versus during month 3).
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5 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of patients with at least one medication error / total number of hospitalized patients included in the service
기간: 5 days
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5 days
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For each medication error: the name of the drug
기간: 5 days
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5 days
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For each medication error: the type of error
기간: 5 days
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Errors are classifies as one of the following types: Omission; Drug; Dosage form; Expired or damaged drug; Dose; Concentration; Frequency of administration; Administration technique; Route of Administration; Rate of administration; Duration of administration; Administration Time; Patient; Drug interaction. |
5 days
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For each medication error: the severity index
기간: 5 days
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5 days
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For each medication error: when (which step) the error occurred during the drug pathway
기간: 5 days
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The considered steps are: Writing the prescription Medical decision for the prescription Transcription Pharmaceutical analysis Deliverance Preparation / reconstitution Pillbox Administration Procurement Storage Compliance Therapeutic and clinical follow-up |
5 days
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For each medication error: the evolution of the adverse drug event, if occurred
기간: 5 days
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5 days
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For each medication error: the criticality of the error
기간: 5 days
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Criticality is graded according to the following classes:
3E: treatment or surgery with temporary harm 3F: longer duration of hospitalization with temporary harm 3G: permanent harm 3H: involving a life-threatening harm 3I: death Criticality is determined by the concordance of two, independent expert opinions; or, in case of discordance, the concordance of 2 out 3 expert opinions. |
5 days
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The potential causes of medication errors
기간: 5 days
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5 days
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The average number of interruptions per hour during preparation or administration of drug doses by nurses
기간: 5 days
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5 days
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The number of patients for whom personal treatments were managed by the nursing staff on admission / number of patients who brought their personal treatments to the care unit
기간: 5 days
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5 days
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The number of patients for whom personal treatments were returned by the nursing staff at hospital discharge / number of patients who brought their personal treatments to the care unit
기간: 5 days
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5 days
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Nursing staff time dedicated to: the preparation of individual doses
기간: 5 days
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5 days
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Nursing staff time dedicated to: ordering health products
기간: 5 days
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5 days
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Nursing staff time dedicated to: stock management and exceptional orders
기간: 5 days
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5 days
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Nursing staff time dedicated to: the delivery, receipt and storage of health products
기간: 5 days
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5 days
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Nursing staff time dedicated to: cabinet inventories
기간: 5 days
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5 days
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Nursing staff time dedicated to: the management of expired drugs
기간: 5 days
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5 days
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The number of calls made to the central pharmacy
기간: 5 days
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5 days
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Staff time dedicated to managing exceptional requests
기간: 5 days
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5 days
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The number of drugs consumed
기간: 5 days
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5 days
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The number of medical devices consumed
기간: 5 days
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5 days
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The number of immobilized drugs
기간: 5 days
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5 days
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The number of immobilized medical devices
기간: 5 days
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5 days
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The cost of adverse drug events care
기간: 5 days
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5 days
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Care staff satisfaction questionnaire
기간: 5 days
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5 days
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Pharmacy technician satisfaction questionnaire
기간: 5 days
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5 days
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공동 작업자 및 조사자
수사관
- 연구 책임자: Géraldine Leguelinel-Blache, PharmD, PhD, Centre Hospitalier Universitaire de Nîmes
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LOCAL/2015/GL-01
- 2015-A01309-40 (기타 식별자: RCB number)
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