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

Sponsors and Collaborators:	University of Illinois Agency for Healthcare Research and Quality (AHRQ) Duke University Baylor Research Institute RTI International
Information provided by:	University of Illinois
ClinicalTrials.gov Identifier:	NCT00773942

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

MedlinePlus related topics: Coping with Chronic Illness Medicare

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:	Design & Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries

Further study details as provided by University of Illinois:

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 ]

Estimated Enrollment:	600
Study Start Date:	November 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Usual care: No Intervention Study subjects receive usual care, without the intervention.
Basic medication therapy management: Experimental 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.
Enhanced medication therapy management: Experimental 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

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

Contacts

Contact: Daniel R. Touchette, PharmD, MA

312-355-3204

drtouche@uic.edu

Locations

United States, Illinois
University of Illinois at Chicago	Recruiting
Chicago, Illinois, United States, 60612
Contact: Daniel R Touchette, PharmD, MA 312-355-3204 drtouche@uic.edu
Principal Investigator: Daniel R Touchette, PharmD, MA
United States, North Carolina
Duke University Health System	Recruiting
Durham, North Carolina, United States, 27705
Contact: Rowena Dolor, M.D. 919-668-8627 rowena.dolor@duke.edu
Principal Investigator: Rowena Dolor, M.D.
United States, Texas
Baylor Health Care System	Recruiting
Dallas, Texas, United States, 75206
Contact: Andrew Masica, M.D., MSCI 214-265-3624 AndrewMa@BaylorHealth.edu
Principal Investigator: Andrew Masica, M.D., MSCI

Sponsors and Collaborators

University of Illinois

Agency for Healthcare Research and Quality (AHRQ)

Duke University

Baylor Research Institute

RTI International

Investigators

Principal Investigator:

Daniel R Touchette, PharmD, MA

University of Illinois

More Information

Responsible Party:	University of Illinois at Chicago ( Daniel R. Touchette/ Assistant Professor of Pharmacy Practice )
Study ID Numbers:	HHSA290200500381 T02, HHSA290200500381 T02
Study First Received:	October 15, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00773942
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Illinois:

Medication therapy management
Pharmacist
Chronic care
Medicare

Medicaid
Medication reconciliation
Adverse drug events
Drug related problems

Study placed in the following topic categories:

Chronic Disease

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009