Interventions to Improve Specialty Medication Adherence

NCT03709277 | Completed Results

• 1 other identifier: 181452
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Medication; Nonadherence, Medication

Keywords

Specialty; Pharmacist Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Median Proportion of Days Covered (PDC) at 6-months Post-enrollment

  6 months post-enrollment

• Reasons for Nonadherence in the Intervention Arm

  35 months

• Median Proportion of Days Covered (PDC) at 12-months Post-enrollment

  12 months post-enrollment

Study Arms (2)

Pharmacist-Driven Intervention

EXPERIMENTAL

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.

Behavioral: Pharmacist-Driven Intervention

Standard of Care

NO INTERVENTION

The usual care group will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy.

Interventions

Pharmacist-Driven Intervention BEHAVIORAL

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.)

Pharmacist-Driven Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37211, United States

Location

Related Publications (9)

• 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.

  PMID: 24591853 BACKGROUND

• 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.

  PMID: 21389250 BACKGROUND

• 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.

  PMID: 21153000 BACKGROUND

• 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.

  PMID: 22473898 BACKGROUND

• 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.

  PMID: 20681888 BACKGROUND

• 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.

  PMID: 26928927 BACKGROUND

• 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.

  PMID: 16514590 BACKGROUND

• 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.

  PMID: 32983839 DERIVED

• 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.

  PMID: 32955714 DERIVED

Related Links

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

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Amanda Kibbons
• Organization: Vanderbilt University Medical Center

amanda.m.kibbons@vumc.org

615-875-4745

Study Officials

• Autumn D Zuckerman, Pharm.D.

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 17, 2018
• Study Start: May 10, 2019
• Primary Completion: February 10, 2021
• Study Completion: April 10, 2022
• Last Updated: December 1, 2023
• Results First Posted: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)