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Completed

NCT Number: NCT05299671

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video consultation

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Mean of medication list inaccuracies among study participants prior to the consultation

    Time frame: 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.

  2. Change in assess factors associated with OACD-related potential drug-drug interactions and medication inaccuracies

    Time frame: 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.

  3. Number of medication changes recommended

    Time frame: Within 30 days of the consultation

    The number of medication changes recommended to address polypharmacy and/or DDIs

  4. Change in the proportion of patients with a mitigated DDI

    Time frame: 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

  5. Change in proportion of patients with a reduction in total number of medications and/or supplements

    Time frame: 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

  6. Change in Medication Regimen Complexity Index (MRCI) before and after the consultation

    Time frame: 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

  7. Mean Score to Medication Self-Efficacy Scale (MASES) to assess patient confidence and competence regarding OACD administration before and after the consultation

    Time frame: 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

  8. Change in mean score on the Satisfaction with Information about Medications Scale (SIMS) before and after the consultation

    Time frame: Within 30 days of the consultation

    Patient reported outcomes as measured by the Satisfaction with Information about Medications Scale (SIMS)

  9. Change in mean score on the Acceptability of Intervention Measure (AIM) before and after the consultation

    Time frame: Within 30 days of the consultation

    Patient reported outcomes as measured by the Acceptability of Intervention Measure (AIM)

  10. Change in mean score on the Intervention Appropriateness Measure (IAM) before and after the consultation

    Time frame: Within 30 days of the consultation

    Patient reported outcomes as measured by the Intervention Appropriateness Measure (IAM)

  11. Change in mean score on the Feasibility of Intervention Measure (FIM) before and after the consultation

    Time frame: Within 30 days of the consultation

    Patient reported outcomes as measured by the Feasibility of Intervention Measure (FIM)

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2022
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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