Elderly Patients Clinical Trial
Official title:
Design & Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries
The purpose of this study is to determine if a medication therapy management program designed to reconcile a patient's medications and identify and resolve drug related problems can reduce adverse drug events and other measures of safety and improve patient satisfaction.
This study will be a multicenter, prospective, randomized study of usual care (Arm 1; control
group) compared with usual care plus medication reconciliation by patient interview and a
drug related problem assessment (Arm 2; Basic MTM) and usual care plus medication
reconciliation by patient interview with additional information obtained from the patient
chart and drug related problem assessment (Arm 3; Enhance MTM). Approximately 600 patients
will be enrolled in this study, 200 in each study arm. Two hundred potential subjects will be
recruited at each of the three participating sites: the UIC Medical Center, Baylor Health
Care System, and Duke Primary Care Research Consortium. For inclusion in the study, patients
must be at least 65 years old, primarily uses English for written and oral communication,
have 3 or more comorbid conditions from a list of conditions (see table 1 of protocol), have
two or more physician office visits at one or more affiliated clinics in the past year, have
received 8 or more different chronic prescription medications over the six months prior to
the enrollment period, have a telephone line and agree to maintain if for at least 6 months,
and have a situation placing him/her at risk for a drug related problem (see protocol for
list). Subjects unable to demonstrate comprehension of the informed consent, with a terminal
condition, or those enrolled in an MTM program where medication reconciliation and/or
assessment of drug related problems has occurred in the previous 12 months will be excluded
from enrolling in the study.
Patients in the control group will participate in the baseline study visit, will continue to
have access to the regular scheduled physician clinic visit and their prescription filled at
the UIC pharmacy, and will participate in the telephone survey after the sixth month of the
study. Patients in the Arms 2 and 3 intervention groups will participate in the baseline
visit, will be asked to participate in two clinic visits with an MTM clinician, and will be
asked to answer two telephone surveys (at 3 months and at 6 months after enrollment).
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