N/A
N=438
Interventions to Improve Specialty Medication Adherence
Adherence, Medication · Nonadherence, Medication
Bottom Line
View on ClinicalTrials.gov: NCT03709277 ↗Enrolled (actual)
438
Serious AEs
—
Results posted
Dec 2023
Primary outcome: Primary: Median Proportion of Days Covered (PDC) at 8-months Post-enrollment — 0.94; 0.88 proportion of days covered (PDC) — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacist-Driven Intervention (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Proportion of Days Covered (PDC) at 8-months Post-enrollment |
0.94; 0.88 | 0.001 sig |
| SECONDARY Median Proportion of Days Covered (PDC) at 6-months Post-enrollment |
0.95; 0.90 | 0.003 sig |
| SECONDARY Reasons for Nonadherence in the Intervention Arm |
81; 60; 35; 31; 25; 23 | — |
| SECONDARY Median Proportion of Days Covered (PDC) at 12-months Post-enrollment |
0.93; 0.87 | <0.001 sig |
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.
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) 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
Data sourced from ClinicalTrials.gov (NCT03709277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.