Cancer
Conditions
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
Interventions
BEHAVIORALVideo 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.
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 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) |
| 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 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) |
| 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. |
| Number of medication changes recommended | Within 30 days of the consultation | The number of medication changes recommended to address polypharmacy and/or DDIs |
Countries
United States
Outcome results
None listed