Clinical trial NCT03709277: Interventions to Improve Specialty Medication Adherence
Official title: Patient-tailored Interventions to Improve Specialty Medication Adherence: Results From a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence, Medication
Nonadherence, Medication
Keywords: Specialty
Pharmacist Intervention
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 438
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Median Proportion of Days Covered (PDC) at 8-months Post-enrollment
timeFrame: 8 months post-enrollment
Secondary outcomes:
measure: Median Proportion of Days Covered (PDC) at 6-months Post-enrollment
timeFrame: 6 months post-enrollment
measure: Reasons for Nonadherence in the Intervention Arm
timeFrame: 35 months
measure: Median Proportion of Days Covered (PDC) at 12-months Post-enrollment
timeFrame: 12 months post-enrollment
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Autumn D Zuckerman, Pharm.D.
role: STUDY_DIRECTOR
References:
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citation: Andrade SE, Kahler KH, Frech F, Chan KA. Methods for evaluation of medication adherence and persistence using automated databases. Pharmacoepidemiol Drug Saf. 2006 Aug;15(8):565-74; discussion 575-7. doi: 10.1002/pds.1230.
citation: Kibbons AM, Peter M, DeClercq J, Choi L, Bell J, Jolly J, Cherry E, Alhashemi B, Shah NB, Zuckerman AD. Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial. Drugs Real World Outcomes. 2020 Sep 21:1-11. doi: 10.1007/s40801-020-00213-8. Online ahead of print.
citation: Kibbons AM, Peter M, DeClercq J, Choi L, Bell J, Jolly J, Cherry E, Alhashemi B, Shah NB, Zuckerman AD. Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial. Drugs Real World Outcomes. 2020 Dec;7(4):295-305. doi: 10.1007/s40801-020-00213-8.