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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05299671
• Other study ID #: AAAT3167
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: December 15, 2024

Study information

• Verified date: June 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 15, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Video consultation
During the video visit, a pharmacist will speak with the patient about potential drug-drug interactions between the patient's cancer treatment and the other medications on the list, make recommendations about medication management (which will also be directly communicated to the oncologist), provide education about the patient's new OACD, and answer any questions. The virtual consultation will last about 30 minutes via an electronic device.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects enrolled that complete the 30 minutes consultation and assessments	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.	30 minutes
Primary	Rate of absorption interaction	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.	Baseline
Primary	Average of QTc prolongation	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.	Baseline
Secondary	Mean of medication list inaccuracies among study participants prior to the consultation	Based on the pre-consultation medication reconciliation, we will assess the mean number of medication list inaccuracies identified by medication reconciliation among study participants.	Baseline
Secondary	Change in assess factors associated with OACD-related potential drug-drug interactions and medication inaccuracies	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.	Within 30 days of the consultation
Secondary	Number of medication changes recommended	The number of medication changes recommended to address polypharmacy and/or DDIs	Within 30 days of the consultation
Secondary	Change in the proportion of patients with a mitigated DDI	The proportion of patients with a mitigated DDI, defined as a change in one involved medication within 30 days of the consultation	Within 30 days of the consultation
Secondary	Change in proportion of patients with a reduction in total number of medications and/or supplements	The proportion of patients with a reduction in total number of medications and/or supplements within 30 days of the consultation	Within 30 days of the consultation
Secondary	Change in Medication Regimen Complexity Index (MRCI) before and after the consultation	The change in medication list complexity using the Medication Regimen Complexity Index (MRCI) within 30 days of the consultation	within 30 days of the consultation
Secondary	Mean Score to Medication Self-Efficacy Scale (MASES) to assess patient confidence and competence regarding OACD administration before and after 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	Within 30 days of the consultation
Secondary	Change in mean score on the Satisfaction with Information about Medications Scale (SIMS) before and after the consultation	Patient reported outcomes as measured by the Satisfaction with Information about Medications Scale (SIMS)	Within 30 days of the consultation
Secondary	Change in mean score on the Acceptability of Intervention Measure (AIM) before and after the consultation	Patient reported outcomes as measured by the Acceptability of Intervention Measure (AIM)	Within 30 days of the consultation
Secondary	Change in mean score on the Intervention Appropriateness Measure (IAM) before and after the consultation	Patient reported outcomes as measured by the Intervention Appropriateness Measure (IAM)	Within 30 days of the consultation
Secondary	Change in mean score on the Feasibility of Intervention Measure (FIM) before and after the consultation	Patient reported outcomes as measured by the Feasibility of Intervention Measure (FIM)	Within 30 days of the consultation