Clinical trial NCT00773942: Design & Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries
Official title: Design & Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Duke University
name: Baylor Research Institute
name: RTI International
First posted: 2008-10-16
Enrollment: 637
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Adverse Drug Events
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Emergency department visits
timeFrame: 6 months
measure: Hospitalizations
timeFrame: 6 months
measure: Drug related problems
timeFrame: 3 and 6 months
measure: Discrepancies in medication list, intervention arms compared with best possible medication history
timeFrame: 6 months
measure: Patient satisfaction with care.
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Dallas
country: United States
facility: Baylor Health Care System
state: Texas
Study officials:
affiliation: University of Illinois at Chicago
name: Daniel R Touchette, PharmD, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/
citation: 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.
citation: 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.