Trial Outcomes & Findings for Interventions to Improve Specialty Medication Adherence (NCT NCT03709277)

Last Updated: 2023-12-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

438 participants

Primary outcome timeframe

8 months post-enrollment

Results posted on

2023-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	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.)	Standard of Care The Standard of Care Group will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy.
Overall Study STARTED	218	220
Overall Study COMPLETED	218	220
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interventions to Improve Specialty Medication Adherence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient-tailored Intervention n=218 Participants 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.)	Standard of Care n=220 Participants The Standard of Care Group will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy.	Total n=438 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	218 participants n=5 Participants	220 participants n=7 Participants	438 participants n=5 Participants
Median 12-month baseline proportion of days covered (PDC)	0.88 proportion of days covered (PDC) n=5 Participants	0.86 proportion of days covered (PDC) n=7 Participants	0.87 proportion of days covered (PDC) n=5 Participants
Age, Continuous	54 years n=5 Participants	54 years n=7 Participants	54 years n=5 Participants
Sex: Female, Male Female	155 Participants n=5 Participants	143 Participants n=7 Participants	298 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	77 Participants n=7 Participants	140 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	34 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) White	186 Participants n=5 Participants	174 Participants n=7 Participants	360 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patient-tailored Intervention n=201 Participants The Intervention arm 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.)	Usual Care n=199 Participants The Usual care arm will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy.
Median Proportion of Days Covered (PDC) at 8-months Post-enrollment	0.94 proportion of days covered (PDC) Interval 0.84 to 1.0	0.88 proportion of days covered (PDC) Interval 0.75 to 0.97

SECONDARY outcome

Timeframe: 6 months post-enrollment

Outcome measures

Outcome measures
Measure	Patient-tailored Intervention n=201 Participants The Intervention arm 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.)	Usual Care n=195 Participants The Usual care arm will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy.
Median Proportion of Days Covered (PDC) at 6-months Post-enrollment	0.95 Proportion of days covered (PDC) Interval 0.84 to 1.0	0.90 Proportion of days covered (PDC) Interval 0.76 to 0.98

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Patient-tailored Intervention n=218 Participants The Intervention arm 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.)	Usual Care The Usual care arm will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy.
Reasons for Nonadherence in the Intervention Arm Memory	81 Reasons	—
Reasons for Nonadherence in the Intervention Arm Unreachable for refill	60 Reasons	—
Reasons for Nonadherence in the Intervention Arm No known reason	35 Reasons	—
Reasons for Nonadherence in the Intervention Arm Unresponsive to refill requirements	31 Reasons	—
Reasons for Nonadherence in the Intervention Arm Clinical	25 Reasons	—
Reasons for Nonadherence in the Intervention Arm Social issues	23 Reasons	—
Reasons for Nonadherence in the Intervention Arm Health literacy	19 Reasons	—
Reasons for Nonadherence in the Intervention Arm Health system error	15 Reasons	—
Reasons for Nonadherence in the Intervention Arm Financial	8 Reasons	—

SECONDARY outcome

Timeframe: 12 months post-enrollment

Outcome measures

Outcome measures
Measure	Patient-tailored Intervention n=201 Participants The Intervention arm 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.)	Usual Care n=200 Participants The Usual care arm will receive the standard of care provided to all patients that utilize Vanderbilt Specialty Pharmacy.
Median Proportion of Days Covered (PDC) at 12-months Post-enrollment	0.93 Proportion of days covered (PDC) Interval 0.82 to 0.98	0.87 Proportion of days covered (PDC) Interval 0.72 to 0.95

Adverse Events

Patient-tailored Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amanda Kibbons

Vanderbilt University Medical Center

Phone: 615-875-4745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place