NCT03709277

Interventions to Improve Specialty Medication Adherence

Patient-tailored Interventions to Improve Specialty Medication Adherence: Results From a Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 438 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Patients deemed nonadherent to their specialty medications will be randomized to receive 8 months of patient-tailored adherence interventions and follow up from a specialty pharmacist as needed or the standard of care. Medication adherence will be measured using proportion of days covered (PDC) at 8-months post-randomization to determine if the intervention improved specialty medication adherence.

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% in the previous 4 and 12 months based on pharmacy claims. Patients who meet criteria will be randomized to receive an intervention corresponding to their specific reason for nonadherence and follow up from a specialty pharmacist or to receive usual care. For patients who are randomized to receive an intervention, the specialty pharmacist will review their medication fill history and electronic health record to identify potential reasons for nonadherence or to see if the pharmacy claims inappropriately categorized them as nonadherent (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 patient's pharmacy and medical history, if the pharmacist believes they are truly nonadherent (not taking medication as prescribed), the patient will be contacted to identify potential reasons for nonadherence and intervention(s) will be provided to combat the identified reasons for nonadherence. Adherence rates for those receiving the additional adherence interventions 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 pharmacist is not study staff, but a full-time employee of the health-system specialty pharmacy performing normal specialty pharmacist functions. The randomization to receive these services or not will allow for evaluation of their efficacy.

Conditions

• Adherence, Medication
• Nonadherence, Medication

Interventions

Type	Name	Description
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.)

Timeline

• Start date: 2019-05-10
• Primary completion: 2021-02-10
• Completion: 2022-04-10
• First posted: 2018-10-17
• Last updated: 2023-12-01
• Results posted: 2023-12-01

Locations

1 site across 1 country: United States