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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00773942
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Agency for Healthcare Research and Quality (AHRQ)
Duke University
Baylor Research Institute
RTI International
Information provided by (Responsible Party):
Daniel R. Touchette, University of Illinois at Chicago

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Illness Adverse Effects Medication Errors Elderly Patients Behavioral: Basic medication therapy management Behavioral: Enhanced medication therapy management Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 637 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Design & Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries
Study Start Date : November 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Adverse Drug Events [ Time Frame: 3 and 6 months ]
    ADEs will be assessed via patient telephone interview using a tool modified from Jarernsiripornkul et al


Secondary Outcome Measures :
  1. Emergency department visits [ Time Frame: 6 months ]
    The number of ED visits collected by a blinded study investigator 180 days via patient self report obtained during a telephone interview

  2. Hospitalizations [ Time Frame: 6 months ]
    The number of hospitalizations collected by a blinded study investigator 180 days via patient self report obtained during a telephone interview

  3. Drug related problems [ Time Frame: 3 and 6 months ]
    The number and types of DRPs will be collected from form completed by MTM clinician

  4. Discrepancies in medication list, intervention arms compared with best possible medication history [ Time Frame: 6 months ]
    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.

  5. Patient satisfaction with care. [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773942


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel R. Touchette, Professor of Pharmacy, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00773942    
Other Study ID Numbers: 2007-0305
HHSA290200500381 T02 ( Other Grant/Funding Number: AHRQ )
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Keywords provided by Daniel R. Touchette, 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:
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Chronic Disease
Disease Attributes
Pathologic Processes