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

NCT00773942 | Completed

• 2 other identifiers: 2007-0305HHSA290200500381 T02
• Study Type: interventional
• Target: 637
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Illness; Adverse Effects; Medication Errors; Elderly Patients

Keywords

Medication therapy management; Pharmacist; Chronic care; Medicare; Medicaid; Medication reconciliation; Adverse drug events; Drug related problems

Outcome Measures

Primary Outcomes (1)

• Adverse Drug Events

  ADEs will be assessed via patient telephone interview using a tool modified from Jarernsiripornkul et al

  3 and 6 months

Secondary Outcomes (5)

• Emergency department visits

  6 months

• Hospitalizations

  6 months

• Drug related problems

  3 and 6 months

• Discrepancies in medication list, intervention arms compared with best possible medication history

  6 months

• Patient satisfaction with care.

  6 months

Study Arms (3)

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

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

Interventions

Basic medication therapy management BEHAVIORAL

Subjects in this arm will receive medication reconciliation and drug related problem assessment by a medication therapy management clinician utilizing patient interview alone.

Basic medication therapy management

Enhanced medication therapy management BEHAVIORAL

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.

Enhanced medication therapy management

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Duke University: collaborator
• Baylor Research Institute: collaborator
• RTI International: collaborator

Study Sites (3)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Duke University Health System

Durham, North Carolina, 27705, United States

Location

Baylor Health Care System

Dallas, Texas, 75206, United States

Location

Related Publications (3)

• Masica AL, Touchette DR, Dolor RJ, Schumock GT, Kliethermes MA, Rodgers PT, Craft JL, Choi YK, Lux LJ, Smith SR. Evaluation of a Medication Therapy Management Program in Medicare Beneficiaries at High Risk of Adverse Drug Events: Study Methods. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 4: Technology and Medication Safety). Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK43763/

  PMID: 21249958 BACKGROUND

• 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.

  PMID: 23023840 DERIVED

• 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.

  PMID: 22823552 DERIVED

MeSH Terms

Conditions

Chronic Disease; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Study Officials

• Daniel R Touchette, PharmD, MA

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacy

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

US (3)