Clinical trial NCT03104114: Pharmacist-led Intervention on Adherence in Patients Undergoing Treatment With an Oral Oncology Medication
Official title: Evaluating Adherence and Persistence in Patients Receiving Oral Oncolytic Therapy in a Safety Net Hospital's Pharmacist-driven Medication Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Medication
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2017-04-07
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pharmacist-led intervention group vs historical-control group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Boston Medical Center provides care to cancer patients on oral cancer medications through the use of Boston Medical Center Specialty Pharmacy (BMC SP). The use of oral medications in cancer treatments is relatively new and unfortunately, very little is known about adherence in cancer patients. This study will evaluate the influence of a pharmacist-driven medication management program on adherence and persistence rates. Boston Medical Center's Specialty Pharmacy Adherence Program (B-SPAP), will utilize a high-touch counseling model involving clinical pharmacist that will focus on educating patients about their oral cancer treatments. The program will require face-to-face counseling with a pharmacist, through the use of a proven patient teaching tool, prior to initiating treatment with oral oncolytic treatments and, periodically thereafter, based on protocol. This study will help improve our understanding of the role of the pharmacist in cancer patients. In addition, the study will help identify independent factors that may contribute or impact adherence. The outcomes of this program will be compared to a historical control group of patients that have already received treatment for their cancer through the BMC Specialty Pharmacy.

Detailed description: Boston Medical Center's Specialty Pharmacy Adherence Program (B-SPAP) will focus on improving adherence and persistence through the implementation of a high-touch program. In order to be eligible for the program, patients must be initiated on oral chemotherapy or targeted therapy with a life expectancy \>6 months. All patients will be administered a Patient Activation Measure (PAM) 13 survey prior to consultation. Patients eligible for our program will receive a 30-60 minute pharmacist consultation prior to initiation of treatment. The pharmacy consultation includes, but is not limited to the dissemination of medical information utilizing a standardized counseling checklist, supplying of patient education materials, pharmacist-led interventions, and/or the use of other materials or devices that may improve patient adherence. All counseling checklists and monitoring will be standardized and approved by a multidisciplinary oncology team. At week 1, 2, and 4, patients will be contacted by the pharmacist for an assessment of treatment goals; monthly contacts will continue thereafter by either a specialty pharmacist or certified pharmacy technician. Scheduled follow up visits with the consulting pharmacist will be made at months 3, 6 and 12. Prior to the scheduled pharmacist consultation, patients will be administered the PAM 13 survey. Patients with a treatment gap \>37 days will be referred to the consulting pharmacist for follow up. The consulting pharmacist will attempt to contact the patient via telephone for an assessment of adherence and adverse drug-related events. If patients experience a treatment gap \>45, then the patient will be contacted and scheduled for a pharmacist consultation, additionally, the prescribing provider will be notified. All consultations and interventions will be documented in the hospital's electronic medical record system, EPIC®.

Eligibility criteria: Pharmacist-intervention group

Inclusion Criteria:

1. Treatment with 1 or more oral oncology agents. Oral oncology agent defined as medication taken mouth with the purpose to treat a patient's cancer
2. Treatment dispensed through the BMC Specialty Pharmacy
3. Age\>18 years
4. Life expectancy \>6 months
5. Patients must have ability to give written consent, or, must have a legally authorized representative

Exclusion Criteria:

1. Treatment indicated for neoadjuvant, adjuvant, peri-operative treatment
2. Concurrent radiation treatment
3. Patients that are unable to have oral oncology agents dispense through BMC Specialty Pharmacy

Historical Control:

1. 2 controls:1 intervention match
2. Matched to a patient in intervention group based on drug type

Primary outcomes:
measure: Medication Possession Ratio
timeFrame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
measure: Persistence rate
timeFrame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Secondary outcomes:
measure: Health-belief model
timeFrame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
measure: Provider-patient relationship
timeFrame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
measure: Pharmacist-patient relationship
timeFrame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: scott gould, PharmD
role: PRINCIPAL_INVESTIGATOR
References: