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| ID | Type | Description | Link |
|---|---|---|---|
| HHSA290200500381 T02 | Other Grant/Funding Number | AHRQ |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
| Duke University | OTHER |
| Baylor Research Institute | OTHER |
| RTI International |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel R Touchette, PharmD, MA | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States | ||
| Duke University Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21249958 | Background | 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/ | |
| 23023840 |
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| OTHER |
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| 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. |
|
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 |
| Durham |
| North Carolina |
| 27705 |
| United States |
| Baylor Health Care System | Dallas | Texas | 75206 | United States |
| Derived |
| 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. |
| 22823552 | 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. |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
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