Clinical trial NCT06696521: An Analysis of Medication Adherence Using Televideo and Telephonic Monitoring and Utilization of an Education Protocol
Official title: A Prospective Analysis of Medication Adherence Comparing Televideo and Telephonic Modes of Longitudinal Monitoring and Utilization of a Standardized Educational Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Medication
Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients randomized to telephonic or televideo participation once enrolled in the study.
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate adherence to oral oncologic medication regimens utilizing a standardized education tool to explain the dosing, side effects and purpose of oral chemotherapy via televideo or telephonic interactions. Researchers aim to evaluate whether the modality of education and monitoring impact adherence.

Detailed description: The study will consist of eight total interactions. We will allow for a 72 hour window for each encounter to allow for patient flexibility and scheduling. The first encounter will include medication education using the standardized tool. The remaining seven interactions will include toxicity and adherence assessment through patient interviews, the OCAS, pill counts, and pharmacy fill data. All interactions will be completed via telephonic outreach or televideo platform by either CRNP, PA-C or PharmD. The patient will be approached when an OCA is prescribed to be given a copy of the OncoLink® patient education material and consent form for review. Patients will be randomized 1:1 to either televideo or telephonic interactions using a block size of 4. All study staff will be blinded to block size. Once a patient is randomized, s/he will be scheduled for the series of follow up encounters via the assigned modality. The first telemedicine interaction will occur within 72 hours of the patient receiving their prescribed OCA(s) at which time the standardized educational information regarding the agent(s), dosing of the medication and potential medication side effects will be reviewed with the patient and/or caregiver. The second encounter will occur approximately 2 weeks after the patient starts the medication to assess for adherence and toxicity. The third through eighth encounters will take place every 2 weeks thereafter through the study timeframe up to four months. At each visit, an adherence assessment including pill count, and Oral Chemotherapy Adherence Scale (OCAS) (Bagcivan and Akbayrak 2015) will be completed per standard of care in addition to patient interview to assess adherence and toxicity. Fill history will be obtained prior to each interaction to verify medication possession ratio and proportion of days covered.

Each patient in the study will participate for a duration of up to 4 months. All of the research will take place at the Abramson Cancer Center at Penn Presbyterian Medical Center.

Eligibility criteria: Inclusion Criteria:

1. Has a diagnosis of cancer
2. Receives cancer care at Abramson Cancer Center at Penn Presbyterian Medical Center
3. Physically and cognitively able to provide informed consent
4. Is 18 years or older
5. Is starting an oral cancer agent
6. Has access to the UPENN televideo platform
7. Lives in Pennsylvania

Exclusion Criteria:

1. Does not desire to participate in the study
2. Cannot consent for himself/herself
3. Does not have access to the UPENN televideo platform
4. Does not live in Pennsylvania
5. Chemoradiation patients

Primary outcomes:
measure: Will modality of outreach impact adherence based on medication possession ratio (MPR) or proportion of days covered (PDC)?
timeFrame: Through study completion, approximately 4 months
measure: Will modality of outreach impact adherence based on medication pill counts?
timeFrame: Through study completion, approximately 4 months
measure: Will modality of outreach impact adherence based on Oral Chemotherapy Adherence Scale (OCAS)?
timeFrame: Through study completion, approximately 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center at PPMC
state: Pennsylvania
Study officials:
References:
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