Pharmacist-led Intervention on Adherence in Patients Undergoing Treatment With an Oral Oncology Medication
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/18/2019 |
| Start Date: | May 2, 2017 |
| End Date: | October 2019 |
| Contact: | Scott Gould, PharmD |
| Email: | scott.gould@bmc.org |
| Phone: | 617-638-5952 |
Evaluating Adherence and Persistence in Patients Receiving Oral Oncolytic Therapy in a Safety Net Hospital's Pharmacist-driven Medication Management Program
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.
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.
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®.
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®.
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
We found this trial at
1
site
Click here to add this to my saved trials
