Purpose

Patients deemed non-adherent to their specialty medications will be randomized to receive a pharmacist-driven intervention or the standard of care. Medication adherence will be measured at 8-months post-randomization to determine if the intervention improved specialty medication adherence.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Truly (unexpectedle) non-adherent VSP patients
  • Patients with PDC < 90% over the last 4 months

Exclusion Criteria

  • Patients who have not attended a Vanderbilt University Medical Center (VUMC) clinic visit in 12 months from report date
  • non-VUMC patients
  • employees of VUMC not enrolled in a VUMC clinic
  • patients deceased since last fill
  • patient in the inflammatory bowel disease clinic

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pharmacist-Driven Intervention
The study group will receive a targeted, pharmacist-driven intervention(s) to overcome patient-specific barriers to adherence. Each patient in the study group will be intervened upon using a protocol that is based on their reason for non-adherence.
  • Behavioral: Pharmacist-Driven Intervention
    The pharmacist will investigate patient assistance options for patients who cannot afford their specialty medication, reach out to prescribers when needed to address intolerance/adverse effects, improve health literacy, recommend options for forgetfulness, make every effort to reach patient, address clinical and financial barriers to unresponsiveness (lack of lab completion, not returning to clinic, etc.)
No Intervention
Standard of Care
The Standard of Care Group will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37211
Contact:
Amanda M Kibbons, Pharm.D.
615-875-4745
amanda.m.kibbons@vumc.org

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Amanda M Kibbons, Pharm.D.
615-875-4745
amanda.m.kibbons@vumc.org

Detailed Description

This will be a single-center, prospective, randomized controlled trial. A report of patients who use the Vanderbilt Specialty Pharmacy (VSP) will be generated daily for patients with a Proportion of Days Covered (PDC) < 90% based on pharmacy claims. Patients who meet criteria will be randomized to receive an intervention by an adherence specialist (pharmacist) or to receive normal clinical care. For patients who are randomized to receive an intervention, the adherence specialist will review their medication fill history and electronic health record to identify potential reasons for nonadherence or to see if the pharmacy claims inappropriately categorize them as non-adherent (this could be due to holding treatment for a clinical reason, transferring the prescription outside of VSP or other reasons listed in Table 2). After reviewing the patients pharmacy and medical history, if the adherence specialist believes they should be taking treatment as prescribed, but are not (classified as truly nonadherent), she will contact the patient to identify potential reasons for nonadherence and intervene to improve adherence based on the identified reasons for nonadherence. Adherence rates for those receiving the additional adherence specialist and those receiving standard of care will be calculated 8 months after the date of randomization. The reasons for nonadherence and the intervention to improve adherence rates will be documented in a secured REDCap database. It is important to note that the adherence specialist is not study staff, but a full time employee of the Vanderbilt Specialty Pharmacy performing her normal functions. The randomization to receive these services or not will allow for evaluation of their efficacy.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.