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临床试验/NCT05299671
NCT05299671已完成不适用

Pilot Study to Assess Feasibility of a Pharmacist-Led Video Consultation to Reduce Drug Interactions Among Patients Initiating Oral Anti-Cancer Drugs

Columbia University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年6月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Rate of absorption interaction

研究概览

简要总结

This is a non-randomized prospective pilot intervention study to assess the feasibility of a onetime pharmacist-led video consultation for medication review and patient education among patients initiating an oral anti-cancer drug. In addition, investigator will evaluate reductions in polypharmacy, potential DDIs, and patient self-efficacy by comparing these variables for each patient before and after the video consultation.

详细描述

In this study, the investigator will be evaluating a 30-minute pharmacist-led video consultation to provide education about patients new oral anti-cancer drug (OACD) and help identify and manage potential drug-drug interactions alongside your oncologist. While OACDs offer both clinical benefits and added convenience when compared to traditional intravenous chemotherapy, they also present a number of potential challenges. One critical challenge involves the increased risk of taking multiple oral medications daily. Patients taking multiple medications can result in harmful effects due to unexpected drug interactions, as well as patient confusion regarding when to take specific medications. Given the relatively recent rise in available OACDs, little is known about the extent of this issue

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults age ≥18 years
  • •Patients must have access to a smartphone, tablet, or computer to facilitate a video visit, or be willing to come into the hospital to borrow a tablet for the visit
  • •Patients must have received a prescription for a new oral anti-cancer drug within 4 weeks of enrollment, not administered as part of a clinical trial
  • •Patients must take at least three prescribed, standing oral medications in addition to their newly prescribed anti-cancer drug

排除标准

  • •Patients who do not speak English or Spanish
  • •Patients without cognitive capacity to give informed consent for participation
  • •Patients uncomfortable with using video-based technology

研究组 & 干预措施

Video consultation group

Experimental

Patients starting a new oral anti-cancer drug (OACD) will receive help to identify and manage potential drug-drug interactions alongside patient's oncologist through a one-time video consultation.

干预措施: Video consultation (Behavioral)

结局指标

主要结局

Rate of absorption interaction

时间窗: Baseline

Based on the pre-consultation medication reconciliation, we will assess the characteristics (absorption interaction) of medication list inaccuracies identified by medication reconciliation among study participants.

Proportion of subjects enrolled that complete the 30 minutes consultation and assessments

时间窗: 30 minutes

To determine feasibility of a one-time pharmacist-led video consultation among advanced cancer patients initiating oral anti-cancer drugs. Feasibility will be defined as significant evidence that 50% of enrolled patients will complete all components of the study.

Average of QTc prolongation

时间窗: Baseline

Based on the pre-consultation medication reconciliation, we will assess the characteristics ( QTc prolongation) of medication list inaccuracies identified by medication reconciliation among study participants.

次要结局

  • Change in mean score on the Intervention Appropriateness Measure (IAM) before and after the consultation(Within 30 days of the consultation)
  • Mean of medication list inaccuracies among study participants prior to the consultation(Baseline)
  • Change in mean score on the Feasibility of Intervention Measure (FIM) before and after the consultation(Within 30 days of the consultation)
  • Change in assess factors associated with OACD-related potential drug-drug interactions and medication inaccuracies(Within 30 days of the consultation)
  • Mean Score to Medication Self-Efficacy Scale (MASES) to assess patient confidence and competence regarding OACD administration before and after the consultation(Within 30 days of the consultation)
  • Change in mean score on the Satisfaction with Information about Medications Scale (SIMS) before and after the consultation(Within 30 days of the consultation)
  • Number of medication changes recommended(Within 30 days of the consultation)
  • Change in the proportion of patients with a mitigated DDI(Within 30 days of the consultation)
  • Change in mean score on the Acceptability of Intervention Measure (AIM) before and after the consultation(Within 30 days of the consultation)
  • Change in proportion of patients with a reduction in total number of medications and/or supplements(Within 30 days of the consultation)
  • Change in Medication Regimen Complexity Index (MRCI) before and after the consultation(within 30 days of the consultation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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