Pilot Study to Assess Feasibility of a Pharmacist-Led Video Consultation to Reduce Drug Interactions Among Patients Initiating Oral Anti-Cancer Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Rate of absorption interaction
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Video consultation group
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.
Intervention: Video consultation (Behavioral)
Outcomes
Primary Outcomes
Rate of absorption interaction
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)