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Completed

NCT Number: NCT03104114

Pharmacist-led Intervention on Adherence in Patients Undergoing Treatment With an Oral Oncology Medication

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.

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Key information

Conditions

Adherence, Medication Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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®.

Who can participate

Healthy volunteers accepted: Yes

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

Pharmacist-intervention group

Inclusion criteria

  • 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
  • Treatment dispensed through the BMC Specialty Pharmacy
  • Age>18 years
  • Life expectancy >6 months
  • Patients must have ability to give written consent, or, must have a legally authorized representative

Exclusion criteria

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

Historical Control:

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

Treatment and study plan

pharmacist-intervention

Behavioral

A clinical pharmacist provides patients with motivational counseling regarding their cancer treatments. Patients will be asked to complete three different surveys throughout the study; surveys focus on social support systems and both provider- and pharmacist-patient relationships

Historical control

Behavioral

Patients that did not receive in-person motivational counseling support from a clinical pharmacist prior and during treatment

Primary outcomes

  1. Medication Possession Ratio

    Time frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first

    MPR >80%

  2. Persistence rate

    Time frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first

    allowance of 45 day time gap

Secondary outcomes

  1. Health-belief model

    Time frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first

    PAM-13 surveys

  2. Provider-patient relationship

    Time frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first

    Trust-in-physician survey

  3. Pharmacist-patient relationship

    Time frame: Month 0(time of first dispense) to month 12 or discontinuation of medication, whichever occurs first

    Pharmacist satisfaction survey

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

Evaluating Adherence and Persistence in Patients Receiving Oral Oncolytic Therapy in a Safety Net Hospital's Pharmacist-driven Medication Management Program

Acronym: BSPAP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 7, 2017
Registry last updated
Aug 1, 2019

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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