CompletedNot Applicable

Interventions to Improve Specialty Medication Adherence

United States438 participantsStarted 2019-05-10

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Median Proportion of Days Covered (PDC) at 8-months Post-enrollment

Timeframe: 8 months post-enrollment

Trial details

NCT IDNCT03709277

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-10

Results submitted2022-01-14

View on ClinicalTrials.gov More Adherence, Medication trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.