Interventions to Improve Specialty Medication Adherence
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| ClinicalTrials.gov Identifier: NCT03709277 |
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Recruitment Status :
Completed
First Posted : October 17, 2018
Results First Posted : December 1, 2023
Last Update Posted : December 1, 2023
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Sponsor:
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Amanda Kibbons, Vanderbilt University Medical Center
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adherence, Medication Nonadherence, Medication | Behavioral: Pharmacist-Driven Intervention | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 438 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Patient-tailored Interventions to Improve Specialty Medication Adherence: Results From a Prospective Randomized Controlled Trial |
| Actual Study Start Date : | May 10, 2019 |
| Actual Primary Completion Date : | February 10, 2021 |
| Actual Study Completion Date : | April 10, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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.) |
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No Intervention: Standard of Care
The usual care group will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy.
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Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
- 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).
- 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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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) < 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709277
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37211 | |
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
| Study Director: | Autumn D Zuckerman, Pharm.D. | Vanderbilt University Medical Center |
Study Documents (Full-Text)
Documents provided by Amanda Kibbons, Vanderbilt University Medical Center:
Documents provided by Amanda Kibbons, Vanderbilt University Medical Center:
Study Protocol [PDF] September 14, 2022
Statistical Analysis Plan [PDF] August 17, 2022
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amanda Kibbons, Clinical Pharmacist, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT03709277 |
| Other Study ID Numbers: |
181452 |
| First Posted: | October 17, 2018 Key Record Dates |
| Results First Posted: | December 1, 2023 |
| Last Update Posted: | December 1, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | IPD will not be shared |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Amanda Kibbons, Vanderbilt University Medical Center:
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Specialty Pharmacist Intervention |