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.

Study Overview

• Status: Completed
• Conditions: Elderly Patients; Chronic Illness; Adverse Effects; Medication Errors
• Intervention / Treatment: Behavioral: Basic medication therapy management; Behavioral: Enhanced medication therapy management

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 637
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Health System
  • Texas
    • Dallas, Texas, United States, 75206
      • Baylor Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be at least 65 years old at enrollment
• Primarily uses English language for written and oral communication
• Have three or more comorbid conditions associated with increased healthcare utilization (Diabetes Mellitus, Congestive Heart Failure, Asthma, Hypertension, Dyslipidemia, COPD, Coronary Artery Disease, Chronic Renal Failure, Arthritis, Depression, Dementia, Chronic Pain, Conditions requiring anticoagulation with warfarin)
• Have visited a physician at one or more of the clinics on a regular basis (defined as two or more clinic visits over one year prior to the study start) for these conditions
• Have received 6 or more different chronic prescription medications over the six months prior to the enrollment period
• Have a telephone line and agree to maintain it for at least six months
• Have one of the following situations placing him/her at risk for a DRP (Any ER visit in past 30 days or Urgent Care visit in past 30 days leading to a change in medication or change in medication dose; New physician visit in past 30 days; Hospitalization in past 30 days; Invasive procedure (a procedure requiring substantive changes to medication taking practices or which requires informed consent) in past 30 days; Change in medication in past 30 days; Three or more providers seen in the past year

Exclusion Criteria:

• Terminal condition, where life expectancy is less than 6 months
• Patients already enrolled in an MTM program where medication reconciliation and/or assessment of DRPs has occurred in the previous 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Study subjects receive usual care, without the intervention.
Experimental: Basic medication therapy management; Subjects in this arm will receive medication reconciliation and drug related problem assessment by a medication therapy management clinician utilizing patient interview alone.	Behavioral: Basic medication therapy management; Subjects in this arm will receive medication reconciliation and drug related problem assessment by a medication therapy management clinician utilizing patient interview alone.
Experimental: Enhanced medication therapy management; Subjects in this arm will receive medication reconciliation and drug related problem assessment by a medication therapy management clinician utilizing patient interview and a brief chart synopsis including patient medical history, medication history, and relevant laboratory information.	Behavioral: Enhanced medication therapy management; Subjects in this arm will receive medication reconciliation and drug related problem assessment by a medication therapy management clinician utilizing patient interview and chart information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Drug Events	ADEs will be assessed via patient telephone interview using a tool modified from Jarernsiripornkul et al	3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency department visits	The number of ED visits collected by a blinded study investigator 180 days via patient self report obtained during a telephone interview	6 months
Hospitalizations	The number of hospitalizations collected by a blinded study investigator 180 days via patient self report obtained during a telephone interview	6 months
Drug related problems	The number and types of DRPs will be collected from form completed by MTM clinician	3 and 6 months
Discrepancies in medication list, intervention arms compared with best possible medication history	Differences observed in MTM intervention medication list and a "Best Possible Medication History," as developed by a formal process and conducted by a study investigator.	6 months
Patient satisfaction with care.	Patient self-reported satisfaction with care, obtained using the Pharmacutical Care Questionnaire administered via telephone interview. Overall satisfaction of care assessed using a 3-item questionnaire administered during telephone interview.	6 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Duke University; Baylor Research Institute; RTI International; Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Daniel R Touchette, PharmD, MA, University of Illinois at Chicago

Publications and helpful links

General Publications

• Masica AL, Touchette DR, Dolor RJ, Schumock GT, Kliethermes MA, Rodgers PT, Craft JL, Choi Y-K, Lux LJ, Smith SR. Evaluation of a medication therapy management program in Medicare beneficiaries at high risk of adverse drug events: study methods. Advances in Patient Safety. Volume 4 / Technology and Medication Safety (AHRQ 08-0034-4) http://www.ahrq.gov/qual/advances2/#v1
• Touchette DR, Masica AL, Dolor RJ, Schumock GT, Choi YK, Kim Y, Smith SR. Safety-focused medication therapy management: a randomized controlled trial. J Am Pharm Assoc (2003). 2012 Sep-Oct;52(5):603-12. doi: 10.1331/JAPhA.2012.12036.
• Dolor RJ, Masica AL, Touchette DR, Smith SR, Schumock GT. Patient safety-focused medication therapy management: challenges affecting future implementation. Am J Manag Care. 2012 Jul 1;18(7):e238-44.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: October 15, 2008
• First Submitted That Met QC Criteria: October 15, 2008
• First Posted (Estimate): October 16, 2008

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Pharmacist; Medicare; Medicaid; Medication therapy management; Adverse drug events; Drug related problems; Medication reconciliation; Chronic care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 2007-0305; HHSA290200500381 T02 (Other Grant/Funding Number: AHRQ)