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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Nîmes Cedex 09、フランス、30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of patients with at least one medication error / total number of hospitalized patients included in the service
時間枠：5 days
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5 days
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For each medication error: the name of the drug
時間枠：5 days
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5 days
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For each medication error: the type of error
時間枠：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
時間枠：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
時間枠：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
時間枠：5 days
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5 days
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For each medication error: the criticality of the error
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：5 days
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5 days
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Nursing staff time dedicated to: the preparation of individual doses
時間枠：5 days
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5 days
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Nursing staff time dedicated to: ordering health products
時間枠：5 days
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5 days
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Nursing staff time dedicated to: stock management and exceptional orders
時間枠：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
時間枠：5 days
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5 days
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Nursing staff time dedicated to: cabinet inventories
時間枠：5 days
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5 days
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Nursing staff time dedicated to: the management of expired drugs
時間枠：5 days
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5 days
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The number of calls made to the central pharmacy
時間枠：5 days
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5 days
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Staff time dedicated to managing exceptional requests
時間枠：5 days
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5 days
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The number of drugs consumed
時間枠：5 days
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5 days
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The number of medical devices consumed
時間枠：5 days
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5 days
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The number of immobilized drugs
時間枠：5 days
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5 days
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The number of immobilized medical devices
時間枠：5 days
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5 days
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The cost of adverse drug events care
時間枠：5 days
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5 days
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Care staff satisfaction questionnaire
時間枠：5 days
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5 days
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Pharmacy technician satisfaction questionnaire
時間枠：5 days
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5 days
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協力者と研究者
捜査官
- スタディディレクター：Géraldine Leguelinel-Blache, PharmD, PhD、Centre Hospitalier Universitaire de Nīmes
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- LOCAL/2015/GL-01
- 2015-A01309-40 (その他の識別子：RCB number)
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