Clinical trial NCT05299671: Video Consultation to Reduce Drug Interactions Among Patients Initiating Oral Anti-Cancer Drugs
Official title: Pilot Study to Assess Feasibility of a Pharmacist-Led Video Consultation to Reduce Drug Interactions Among Patients Initiating Oral Anti-Cancer Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects enrolled that complete the 30 minutes consultation and assessments
timeFrame: 30 minutes
measure: Rate of absorption interaction
timeFrame: Baseline
measure: Average of QTc prolongation
timeFrame: Baseline
Secondary outcomes:
measure: Mean of medication list inaccuracies among study participants prior to the consultation
timeFrame: Baseline
measure: Change in assess factors associated with OACD-related potential drug-drug interactions and medication inaccuracies
timeFrame: Within 30 days of the consultation
measure: Number of medication changes recommended
timeFrame: Within 30 days of the consultation
measure: Change in the proportion of patients with a mitigated DDI
timeFrame: Within 30 days of the consultation
measure: Change in proportion of patients with a reduction in total number of medications and/or supplements
timeFrame: Within 30 days of the consultation
measure: Change in Medication Regimen Complexity Index (MRCI) before and after the consultation
timeFrame: within 30 days of the consultation
measure: Mean Score to Medication Self-Efficacy Scale (MASES) to assess patient confidence and competence regarding OACD administration before and after the consultation
timeFrame: Within 30 days of the consultation
measure: Change in mean score on the Satisfaction with Information about Medications Scale (SIMS) before and after the consultation
timeFrame: Within 30 days of the consultation
measure: Change in mean score on the Acceptability of Intervention Measure (AIM) before and after the consultation
timeFrame: Within 30 days of the consultation
measure: Change in mean score on the Intervention Appropriateness Measure (IAM) before and after the consultation
timeFrame: Within 30 days of the consultation
measure: Change in mean score on the Feasibility of Intervention Measure (FIM) before and after the consultation
timeFrame: Within 30 days of the consultation
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Dawn Hershman, MD
role: PRINCIPAL_INVESTIGATOR
References: