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NCT03709277

Interventions to Improve Specialty Medication Adherence

Completed NA Results posted Last updated 1 December 2023
What this trial tests

NA trial testing Pharmacist-Driven Intervention in Adherence, Medication in 438 participants. Completed in 10 April 2022.

Timeline
10 May 2019
Primary endpoint
10 February 2021
10 April 2022

Quick facts

Lead sponsorVanderbilt University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment438
Start date10 May 2019
Primary completion10 February 2021
Estimated completion10 April 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vanderbilt University Medical Center

Who can join

Eligibility, any sex, with Adherence, Medication or Nonadherence, Medication. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Median Proportion of Days Covered (PDC) at 8-months Post-enrollment Primary · 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.

GroupValue95% CI
Patient-tailored Intervention0.940.84 – 1.0
Usual Care0.880.75 – 0.97
Median Proportion of Days Covered (PDC) at 6-months Post-enrollment Secondary · 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.

GroupValue95% CI
Patient-tailored Intervention0.950.84 – 1.00
Usual Care0.900.76 – 0.98
Reasons for Nonadherence in the Intervention Arm Secondary · 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).

Memory
GroupValue95% CI
Intervention Arm81
Unreachable for refill
GroupValue95% CI
Intervention Arm60
No known reason
GroupValue95% CI
Intervention Arm35
Unresponsive to refill requirements
GroupValue95% CI
Intervention Arm31
Clinical
GroupValue95% CI
Intervention Arm25
Social issues
GroupValue95% CI
Intervention Arm23
Health literacy
GroupValue95% CI
Intervention Arm19
Health system error
GroupValue95% CI
Intervention Arm15
Median Proportion of Days Covered (PDC) at 12-months Post-enrollment Secondary · 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.

GroupValue95% CI
Patient-tailored Intervention0.930.82 – 0.98
Usual Care0.870.72 – 0.95

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Patient-Tailored Interventions to Improve Specialty Medication Adherence: Results from a Prospective Randomized Controlled Trial.
    Kibbons AM, Moore R, Choi L, Zuckerman AD. · · 2023 · cited 4× · PMID 37028694 · DOI 10.1016/j.amjmed.2023.03.007
  2. Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial.
    Kibbons AM, Peter M, DeClercq J, Choi L, et al · · 2020 · cited 3× · PMID 32983839 · DOI 10.1007/s40801-020-00213-8
  3. Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial.
    Kibbons AM, Peter M, DeClercq J, Choi L, et al · · 2020 · cited 2× · PMID 32955714 · DOI 10.1007/s40801-020-00213-8

Verify or expand the search:

Other recruiting trials for Adherence, Medication

Currently open trials in the same condition.

Other Vanderbilt University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03709277.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing