Design & Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries

This study has been completed.
Sponsor:
Collaborators:
Duke University
Baylor Research Institute
RTI International
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00773942
First received: October 15, 2008
Last updated: October 30, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Chronic Illness
Adverse Effects
Medication Errors
Elderly Patients
Behavioral: Basic medication therapy management
Behavioral: Enhanced medication therapy management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Design & Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Adverse Drug Events [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Emergency department visits [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Hospitalizations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Drug related problems [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
  • Discrepancies in medication list, intervention arms compared with best possible medication history [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Patient satisfaction with care. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 637
Study Start Date: November 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773942

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27705
United States, Texas
Baylor Health Care System
Dallas, Texas, United States, 75206
Sponsors and Collaborators
University of Illinois at Chicago
Duke University
Baylor Research Institute
RTI International
Investigators
Principal Investigator: Daniel R Touchette, PharmD, MA University of Illinois at Chicago
  More Information

No publications provided by University of Illinois at Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel R. Touchette/ Assistant Professor of Pharmacy Practice, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00773942     History of Changes
Other Study ID Numbers: HHSA290200500381 T02, HHSA290200500381 T02
Study First Received: October 15, 2008
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
Medication therapy management
Pharmacist
Chronic care
Medicare
Medicaid
Medication reconciliation
Adverse drug events
Drug related problems

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014