Elderly Patients Clinical Trial
Official title:
Design & Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries
Verified date | July 2019 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 637 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Chicago | Chicago | Illinois |
United States | Baylor Health Care System | Dallas | Texas |
United States | Duke University Health System | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | Agency for Healthcare Research and Quality (AHRQ), Baylor Research Institute, Duke University, RTI International |
United States,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Drug Events | ADEs will be assessed via patient telephone interview using a tool modified from Jarernsiripornkul et al | 3 and 6 months | |
Secondary | Emergency department visits | The number of ED visits collected by a blinded study investigator 180 days via patient self report obtained during a telephone interview | 6 months | |
Secondary | Hospitalizations | The number of hospitalizations collected by a blinded study investigator 180 days via patient self report obtained during a telephone interview | 6 months | |
Secondary | Drug related problems | The number and types of DRPs will be collected from form completed by MTM clinician | 3 and 6 months | |
Secondary | Discrepancies in medication list, intervention arms compared with best possible medication history | 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. | 6 months | |
Secondary | Patient satisfaction with care. | 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. | 6 months |
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