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临床试验/NCT03709277
NCT03709277已完成不适用

Patient-tailored Interventions to Improve Specialty Medication Adherence: Results From a Prospective Randomized Controlled Trial

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 438 人开始时间: 2019年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
438
试验地点
2
主要终点
Median Proportion of Days Covered (PDC) at 8-months Post-enrollment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Median Proportion of Days Covered (PDC) at 6-months Post-enrollment(6 months post-enrollment)
  • Reasons for Nonadherence in the Intervention Arm(35 months)
  • Median Proportion of Days Covered (PDC) at 12-months Post-enrollment(12 months post-enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amanda Kibbons

Clinical Pharmacist

Vanderbilt University Medical Center

研究点 (2)

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