Adherence, Medication, Nonadherence, Medication
Conditions
Keywords
Specialty, Pharmacist Intervention
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.
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.
Interventions
BEHAVIORALPharmacist-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.)
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Proportion of Days Covered (PDC) at 8-months Post-enrollment | 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
| Measure | Time frame | Description |
|---|---|---|
| Median Proportion of Days Covered (PDC) at 6-months Post-enrollment | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient-tailored Intervention The study group will receive a patient-tailored intervention(s) to overcome their specific barrier(s) to adherence. Each patient in the study group will be intervened upon using a protocol that is based on their reason for non-adherence and follow up will continue until 8 months post-enrollment.
Pharmacist-Driven Intervention: The pharmacist will provide instructions for setting up phone reminders, investigate patient assistance options, reach out to prescribers to address intolerance/adverse effects, provide medication counseling and/or written materials, make every effort to reach patients for refills, address clinical and financial barriers to unresponsiveness (lack of lab completion, not returning to clinic, etc.) | 218 |
| Standard of Care The Standard of Care Group will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy. | 220 |
| Total | 438 |
Baseline characteristics
| Characteristic | Patient-tailored Intervention | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 54 years | 54 years | 54 years |
| Median 12-month baseline proportion of days covered (PDC) | 0.88 proportion of days covered (PDC) | 0.86 proportion of days covered (PDC) | 0.87 proportion of days covered (PDC) |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 34 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 12 Participants | 19 Participants |
| Race (NIH/OMB) White | 186 Participants | 174 Participants | 360 Participants |
| Region of Enrollment United States | 218 participants | 220 participants | 438 participants |
| Sex: Female, Male Female | 155 Participants | 143 Participants | 298 Participants |
| Sex: Female, Male Male | 63 Participants | 77 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 8 months post-enrollment
Population: Only patients with at least 2 fills after their enrollment date were analyzed due to PDC calculations requiring at least 2 fills. Of the 218 patients in the intervention arm, 201 were analyzed. Of the 220 usual care patients, 199 were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient-tailored Intervention | Median Proportion of Days Covered (PDC) at 8-months Post-enrollment | 0.94 proportion of days covered (PDC) |
| Usual Care | Median Proportion of Days Covered (PDC) at 8-months Post-enrollment | 0.88 proportion of days covered (PDC) |
p-value: 0.001Wilcoxon (Mann-Whitney)
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.
Time frame: 12 months post-enrollment
Population: Only patients with at least 2 fills after their enrollment date were analyzed due to PDC calculations requiring at least 2 fills. Of the 218 patients in the intervention arm, 201 were analyzed. Of the 220 usual care patients, 200 were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient-tailored Intervention | Median Proportion of Days Covered (PDC) at 12-months Post-enrollment | 0.93 Proportion of days covered (PDC) |
| Usual Care | Median Proportion of Days Covered (PDC) at 12-months Post-enrollment | 0.87 Proportion of days covered (PDC) |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: 6 months post-enrollment
Population: Only patients with at least 2 fills after their enrollment date were analyzed due to PDC calculations requiring at least 2 fills. Of the 218 patients in the intervention arm, 201 were analyzed. Of the 220 usual care patients, 195 were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patient-tailored Intervention | Median Proportion of Days Covered (PDC) at 6-months Post-enrollment | 0.95 Proportion of days covered (PDC) |
| Usual Care | Median Proportion of Days Covered (PDC) at 6-months Post-enrollment | 0.90 Proportion of days covered (PDC) |
p-value: 0.003Wilcoxon (Mann-Whitney)
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).
Time frame: 35 months
Population: Reasons for nonadherence were provided for all 218 patients randomized to the intervention arm (not just for the patients included in the analysis). Patients may have had more than one reason. Reasons for nonadherence were not collected for the usual care arm as the specialty pharmacist had no contact with the usual care patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient-tailored Intervention | Reasons for Nonadherence in the Intervention Arm | Unresponsive to refill requirements | 31 Reasons |
| Patient-tailored Intervention | Reasons for Nonadherence in the Intervention Arm | Clinical | 25 Reasons |
| Patient-tailored Intervention | Reasons for Nonadherence in the Intervention Arm | Health system error | 15 Reasons |
| Patient-tailored Intervention | Reasons for Nonadherence in the Intervention Arm | Financial | 8 Reasons |
| Patient-tailored Intervention | Reasons for Nonadherence in the Intervention Arm | Memory | 81 Reasons |
| Patient-tailored Intervention | Reasons for Nonadherence in the Intervention Arm | Unreachable for refill | 60 Reasons |
| Patient-tailored Intervention | Reasons for Nonadherence in the Intervention Arm | No known reason | 35 Reasons |
| Patient-tailored Intervention | Reasons for Nonadherence in the Intervention Arm | Social issues | 23 Reasons |
| Patient-tailored Intervention | Reasons for Nonadherence in the Intervention Arm | Health literacy | 19 Reasons |