Video Consultation to Reduce Drug Interactions Among Patients Initiating Oral Anti-Cancer Drugs

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Video consultation

• Registration Number: NCT05299671
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2021-06-22
• Study First Submitted: 2022-01-25
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-29
• Primary Completion: 2023-05-05
• Study Completion: 2023-05-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Video consultation group	Video consultation	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.

Primary Outcome Measures

Name	Time	Method
Rate of absorption interaction	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Mean of medication list inaccuracies among study participants prior to the consultation	Baseline	Based on the pre-consultation medication reconciliation, we will assess the mean number of medication list inaccuracies identified by medication reconciliation among study participants.
Change in mean score on the Intervention Appropriateness Measure (IAM) before and after the consultation	Within 30 days of the consultation	Patient reported outcomes as measured by the Intervention Appropriateness Measure (IAM)
Change in mean score on the Feasibility of Intervention Measure (FIM) before and after the consultation	Within 30 days of the consultation	Patient reported outcomes as measured by the Feasibility of Intervention Measure (FIM)
Change in assess factors associated with OACD-related potential drug-drug interactions and medication inaccuracies	Within 30 days of the consultation	We will assess patient-level factors associated with OACD-related potential DDIs and medication inaccuracies, such as age, race/ethnicity, socioeconomic status, cancer diagnosis, number of medications, and number of comorbidities.
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	The change in patient confidence and competence regarding OACD administration using a modified version of the Medication Adherence Self-Efficacy Scale (MASES-R) before and after 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	Patient reported outcomes as measured by the Satisfaction with Information about Medications Scale (SIMS)
Number of medication changes recommended	Within 30 days of the consultation	The number of medication changes recommended to address polypharmacy and/or DDIs
Change in the proportion of patients with a mitigated DDI	Within 30 days of the consultation	The proportion of patients with a mitigated DDI, defined as a change in one involved medication 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	The 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	The change in medication list complexity using the Medication Regimen Complexity Index (MRCI) 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	Patient reported outcomes as measured by the Acceptability of Intervention Measure (AIM)

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States