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

Study Overview
=================
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).

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

Conditions
-----------------
Chronic Illness, Adverse Effects, Medication Errors, Elderly Patients

Intervention / Treatment
-----------------
* Behavioral: Basic medication therapy management
* Behavioral: Enhanced medication therapy management


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Study subjects receive usual care, without the intervention. | |
| Experimental: Basic medication therapy management<br>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<br>* Subjects in this arm will receive medication reconciliation and drug related problem assessment by a medication therapy management clinician utilizing patient interview alone.<br>|
| Experimental: Enhanced medication therapy management<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Drug Events | ADEs will be assessed via patient telephone interview using a tool modified from Jarernsiripornkul et al | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Hospitalizations | The number of hospitalizations collected by a blinded study investigator 180 days via patient self report obtained during a telephone interview | 6 months | 
| Drug related problems | The number and types of DRPs will be collected from form completed by MTM clinician | 3 and 6 months | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medication therapy management, Pharmacist, Chronic care, Medicare, Medicaid, Medication reconciliation, Adverse drug events, Drug related problems