Interventions to Improve Specialty Medication Adherence

Not Applicable

Completed

• Conditions: Nonadherence, Medication; Adherence, Medication
• Interventions: Behavioral: Pharmacist-Driven Intervention

• Registration Number: NCT03709277
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Study Start: 2019-05-10
• Primary Completion: 2021-02-10
• Results First Submitted: 2022-01-14
• Study Completion: 2022-04-10
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Results First Posted: 2023-12-01
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

• The same medication (at the Generic Product Identifier level 12) filled ≥4 times in the 12 months before date of import into the study database
• Prescription generated from one of the following Vanderbilt outpatient specialty clinics: Pediatric Rheumatology, Pediatric Gastroenterology/Inflammatory Bowel Disease, adult Vanderbilt Rheumatology clinics, Dermatology, Hematology, Adult Endocrinology, Neurology, Asthma Sinus & Allergy, Idiopathic Pulmonary Fibrosis, Pulmonary Arterial Hypertension, Cystic Fibrosis, Multiple Sclerosis, Neurology, or a Lipid clinic
• Proportion of Days Covered (PDC) < 90% over the previous 4 months and 12 months

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Exclusion Criteria

• Prescription issued by a non-VUMC provider
• Planned treatment discontinuation in the subsequent eight months
• More than one unique specialty medication from the same clinic in the previous four months
• Patients with > 30 gap days in the previous four months and whose last fill was > 30 days from importing into the study database.
• Any reason for misidentified nonadherence in the previous four months
• Deceased patients
• Incarcerated patients

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist-Driven Intervention	Pharmacist-Driven Intervention	The study group will receive a patient-tailored, 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.

Primary Outcome Measures

Name	Time	Method
Median Proportion of Days Covered (PDC) at 8-months Post-enrollment	8 months post-enrollment	Proportion of days covered (PDC) is a calculated value ranging from 0 to 1 where 1 indicates 100% adherence to medication and 0 indicates zero adherence to medication. It uses a patient's refill history to calculate the days' supply obtained over a time period (in days) divided by the time period (in days). It requires at least 2 refills.

Secondary Outcome Measures

Name	Time	Method
Median Proportion of Days Covered (PDC) at 6-months Post-enrollment	6 months post-enrollment	Proportion of days covered (PDC) is a calculated value ranging from 0 to 1 where 1 indicates 100% adherence to medication and 0 indicates zero adherence to medication. It uses a patient's refill history to calculate the days' supply obtained over a time period (in days) divided by the time period (in days). It requires at least 2 refills.
Reasons for Nonadherence in the Intervention Arm	35 months	Reasons for nonadherence were obtained from a combination of electronic health records and patient-reported reasons. Since only intervention patients were contacted during this study, only reasons from the intervention arm are reported. Reasons were collected for each patient starting on the date of enrollment until 8-months post-enrollment starting from the date the study began (May 2019) until the study was complete (April 2022).
Median Proportion of Days Covered (PDC) at 12-months Post-enrollment	12 months post-enrollment	Proportion of days covered (PDC) is a calculated value ranging from 0 to 1 where 1 indicates 100% adherence to medication and 0 indicates zero adherence to medication. It uses a patient's refill history to calculate the days' supply obtained over a time period (in days) divided by the time period (in days). It requires at least 2 refills.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States