Using a randomized controlled trial design to compare clinical outcomes of patients receiving a hybrid community-based practice model with other practice models

Abstract

Objective: The objective of this study is to compare clinical outcomes and knowledge scores for patients who receive medication therapy management (MTM), adherence packaging, and refill synchronization with those who do not receive these services. Method(s): This is a prospective, randomized controlled trial design conducted through an integrated delivery network. Four hundred twenty-four patients were initially identified and invited to participate. Enrollment began in August 2014 and is ongoing. Patients are required to have Paramount insurance, type 2 diabetes, hypertension, hyperlipidemia, prescriptions of at least five oral medications, and prescription of an oral medication for each disease state. Patients were randomly assigned to one of four groups receiving different types of care. The first group receives standard pill bottles. The second group receives adherence packaging and refill synchronization. The third group receives pill bottles and MTM using an appointmentbased model. The fourth group receives a hybrid practice model including adherence packaging, refill synchronization, and MTM using an appointment-based model. Clinical indicators include hemoglobin, A1C levels, systolic and diastolic blood pressure values, low-density lipoprotein cholesterol measurements, height, weight, and body mass index. Associated with clinical indicators is patients' social history with respect to lifestyle measures such as caffeine and alcohol consumption, diet, smoking status, and level of physical activity. Clinical outcomes will be collected every 6 months using data from eClinicalWorks and lab values. Patients' disease state knowledge will be evaluated using a 10-item knowledge test for each disease state at 6-month intervals. Descriptive statistics will be used to compare the outcomes of the fourth group (i.e., the hybrid practice model) with the other three groups. Result(s): Research in progress. Currently, 99 patients responded to invitation letters and 32 are enrolled. Results will be available and presented at APhA2015.