- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03709277
Interventions to Improve Specialty Medication Adherence
November 29, 2023 updated by: Amanda Kibbons, Vanderbilt University Medical Center
Patient-tailored Interventions to Improve Specialty Medication Adherence: Results From a Prospective Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
438
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37211
- Vanderbilt University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pharmacist-Driven Intervention
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.
|
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.)
|
No Intervention: Standard of Care
The usual care group will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Proportion of Days Covered (PDC) at 8-months Post-enrollment
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Proportion of Days Covered (PDC) at 6-months Post-enrollment
Time Frame: 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
|
Reasons for Nonadherence in the Intervention Arm
Time Frame: 35 months
|
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
|
Median Proportion of Days Covered (PDC) at 12-months Post-enrollment
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Autumn D Zuckerman, Pharm.D., Vanderbilt University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2019
Primary Completion (Actual)
February 10, 2021
Study Completion (Actual)
April 10, 2022
Study Registration Dates
First Submitted
October 11, 2018
First Submitted That Met QC Criteria
October 15, 2018
First Posted (Actual)
October 17, 2018
Study Record Updates
Last Update Posted (Actual)
December 1, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 181452
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will not be shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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