Interventions to Improve Specialty Medication Adherence

Adherence, Medication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709277
• Other study ID #: 181452
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: April 10, 2022

Study information

• Verified date: November 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: April 10, 2022
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Medication
• Nonadherence, Medication

Intervention

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.)

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011 Apr;86(4):304-14. doi: 10.4065/mcp.2010.0575. Epub 2011 Mar 9. — View Citation

Butt AA, Yan P, Shaikh OS, Chung RT, Sherman KE; ERCHIVES study. Treatment adherence and virological response rates in hepatitis C virus infected persons treated with sofosbuvir-based regimens: results from ERCHIVES. Liver Int. 2016 Sep;36(9):1275-83. doi: 10.1111/liv.13103. Epub 2016 Mar 24. — View Citation

Iuga AO, McGuire MJ. Adherence and health care costs. Risk Manag Healthc Policy. 2014 Feb 20;7:35-44. doi: 10.2147/RMHP.S19801. eCollection 2014. — View Citation

Jabbour EJ, Kantarjian H, Eliasson L, Cornelison AM, Marin D. Patient adherence to tyrosine kinase inhibitor therapy in chronic myeloid leukemia. Am J Hematol. 2012 Jul;87(7):687-91. doi: 10.1002/ajh.23180. Epub 2012 Mar 31. — View Citation

Koncz T, Pentek M, Brodszky V, Ersek K, Orlewska E, Gulacsi L. Adherence to biologic DMARD therapies in rheumatoid arthritis. Expert Opin Biol Ther. 2010 Sep;10(9):1367-78. doi: 10.1517/14712598.2010.510508. — View Citation

Tan H, Cai Q, Agarwal S, Stephenson JJ, Kamat S. Impact of adherence to disease-modifying therapies on clinical and economic outcomes among patients with multiple sclerosis. Adv Ther. 2011 Jan;28(1):51-61. doi: 10.1007/s12325-010-0093-7. Epub 2010 Dec 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Proportion of Days Covered (PDC) at 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.	8 months post-enrollment
Secondary	Median Proportion of Days Covered (PDC) at 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.	6 months post-enrollment
Secondary	Reasons for Nonadherence in the Intervention Arm	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).	35 months
Secondary	Median Proportion of Days Covered (PDC) at 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.	12 months post-enrollment

External Links

•   Update on Medication Quality Measures in Medicare Part D Plan Star Ratings-2018