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临床试验/NCT04360746
NCT04360746已完成不适用

The Influence of Clinical Pharmacist on the Quality of Drug Prescribing and Rehabilitation Outcomes in Post-acute Hip Fractured Patients

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Summated Medication Appropriateness Index (MAI) score

研究概览

简要总结

The influence of clinical pharmacist on various drug related outcomes was reported in different healthcare setting including the community, long term care and during acute hospitalization. Nevertheless, data on the influence of clinical pharmacist intervention on the quality of drug prescribing and rehabilitation outcomes in post-acute hip fractured patients is scarce.

The aims of the current study are to evaluate the contribution of a clinical pharmacist on the appropriateness of drug prescribing among post-acute geriatric hip fractured patients and to investigate whether this involvement can improve rehabilitation outcomes.

The investigators hypothesis is that early review of geriatric hip fractured patients medical record by a clinical pharmacist will improve the appropriateness of drug treatment and the rehabilitation outcomes among this population.

详细描述

An Open label randomized prospective study of elderly patients (65 years old and above) admitted for rehabilitation after hip fracture. All study participants will be admitted in the same geriatric-rehabilitation department specialized in the rehabilitation of geriatric patients after hip fracture ("D" ward). This department is divided into 2 subunits (D1 and D2) with the same patient population but a different medical and nursing staff.

Randomization in this study will be based upon the admission subunit. The intervention group will include all hip fractured patients admitted to D1 subunit. This group will get a clinical pharmacist review of their medication and a pharmaceutical counseling to the medical staff in the first few days of admission (1-5 days post admission). The control group will include all hip fractured patients admitted to D2 subunit. This group will not receive any pharmacist intervention during their rehabilitation, unless the pharmacist will be asked directly to review a patient medical record by the medical or nursing staff. In this case the specific patient will be excluded from the study.

Pharmaceutical intervention will include a complete medication review by a clinical pharmacist with the following process: medication reconciliation, medication indication and dosage check, medication effectiveness and appropriateness assessment, drug-drug or drug-disease interactions check, medication duplications check, length and cost of treatment evaluation.

The pharmacist will use the following tools:

Medication appropriateness evaluation Medication appropriateness will be evaluated based upon the MAI (medication appropriateness index) score - an implicit (judgment-based) outcome measure. The MAI is a measure of prescribing appropriateness that assesses ten elements of prescribing: indication, effectiveness, dose, correct directions, practical directions, drug-drug interactions, drug-disease interactions, duplication, duration, and cost. Although based on implicit criteria, the index has operational definitions and explicit instructions, which standardize the rating process. Each medication can get a score between 0-18, with a higher score indicating inappropriateness of more drug elements. The ratings generate a weighted score that serves as a summary measure of prescribing appropriateness.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
65 Years 至 120 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly patient (65 years of older) who were admitted for rehabilitation after hip fracture at "D" ward in beit rivka post-acute geriatric center.

排除标准

  • Patient that did not complete the rehabilitation period due the following causes: death, acute care hospitalization or severe medical deterioration.
  • In the case of D2 sub unit hospitalized patient - any request by the sub unit medical or nursing staff for pharmacist consultation/intervention.

结局指标

主要结局

Summated Medication Appropriateness Index (MAI) score

时间窗: Admission (baseline value) and at discharge (approximately 5 weeks post admission)

The change from admission to discharge in the summated medication appropriateness index score. Each medication can get a score between 0-18, with a higher score indicating inappropriateness of more drug elements.

The change in medication discrepancy

时间窗: Admission (baseline value) and at discharge (approximately 5 weeks post admission)

The number of medication discrepancy and underuse of drugs

The change in Functional Independence measure (FIM) score

时间窗: Admission (baseline value) and at discharge (approximately 5 weeks post admission)

The change from admission to discharge in the Functional Independence measure score. the score is calculated for each patient and can be between 18-126, with a higher score indicating a better functional independence status.

The change in overused drugs

时间窗: Admission (baseline value) and at discharge (approximately 5 weeks post admission)

The number of overused or misused drugs

The change in motor functional independence measure (mFIM)

时间窗: Admission (baseline value) and at discharge (approximately 5 weeks post admission)

The change from admission to discharge in motor functional independence measure score. the score is calculated for each patient and can be between 18-91, with a higher score indicating a better motor functional independence status.

LOS (Length Of Stay)

时间窗: Through study completion, an average of 1 year

Length of rehabilitation center stay

Anticholinergic Cognitive Burden (ACB) score

时间窗: Admission (baseline value) and at discharge (approximately 5 weeks post admission)

The change from admission to discharge in the anticholinergic cognitive burden score. Each medication can get a score between 0-3, with a higher score indicating a higher anticholinergic burden.

The change in Montebello Rehabilitation Factor Score (MRFS)

时间窗: Admission (baseline value) and at discharge (approximately 5 weeks post admission)

The relative functional gain (motor functional independence measure effectiveness) achieved on the motor functional independence measure score. The Montebello Rehabilitation Factor Score (MRFS) is calculated as the motor functional independence measure score change (discharge score minus admission score) divided by the motor functional independence measure maximum score (a score of 91) minus the motor functional independence measure admission score. The Montebello Rehabilitation Factor Score can be between -80 to 100 with a higher score indicating a better motor functional independence measure effectiveness (a higher relative functional gain during rehabilitation).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AVITAL HERSHKOVITZ

Head of Rehabilitation Department D, 'Beit Rivka' Geriatric Rehabilitation Center

Rabin Medical Center

研究点 (1)

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