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This study is a randomized controlled cross-over trial, in the form of a proof of concept study that is designed to evaluate the health outcomes resulting from incorporating a licensed clinical pharmacist in a health care team to provide case management for diabetic patients at the Henry J Austin Health Clinic. The study uses a control group design and will feature both an experimental group and a control group. The control group, of 80 patients, will receive the standard treatment at the clinic. The experimental group, of 80 patients, will receive the standard treatment as well as Medication Therapy Management and counseling from a pharmacist. After one year the patients in the control group can cross-over to the intervention group and receive care from the pharmacist.
We will put all patients into one of two groups by chance (like flipping a coin). One group of 80 patients will get the regular care at the clinic (control group). The other group of 80 patients will get their regular care at the clinic plus care by a pharmacist. The pharmacist and the regular provider will work as a team to manage the patient's drug therapy (Intervention group).
We will test the status of the patient's diabetes at each visit. Tests may include:
Patients will have appointments with their current provider and possibly with the pharmacist at least every 3 months. However, the total number of appointments is based on the patient's health needs. The first appointment with the pharmacist will take about one hour. Additional appointments will take about 30 minutes.
The group without the pharmacist will have regular appointment times. After 12 months in the study if the patients glucose is not well controlled they can be treated by the pharmacist for 6 months.
Final measures will be made after 12 mont
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | No Intervention | The no intervention group will serve as control group. This group will receive standard care and will be an active comparator. At the end of the study they may join the intervention group | |
| Intervention group | Other | The intervention group will be seen by a pharmacist iin addition to their normal provider. The pharmacist will provide medication therapy review of the patient's therapy. The pharmacist will make recommendations to make revisions in the patient's therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist review of therapy | Other | Patients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | Plasma glucose control | every 3 months for one year |
| Measure | Description | Time Frame |
|---|---|---|
| Preventative care | How frequent does the patient see a dentist, podiatris, optomitrist, | Baseline 6 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
HbA1C greater than 15% because the finger stick device can not accurately read values greater than this unless the HbA1C can be confirmed with a value drawn in the laboratory.
Age < 18 years old or age ≥ 75 years old
HbA1c < 8.5% PLUS presence of one or more of the following regardless of age:
HbA1c < 8.5% PLUS presence of one or more of the following if age ≥ 65 years old:
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| Name | Affiliation | Role |
|---|---|---|
| Caitlin McCarthy, PharmD | Rutgers, Earnest Mario School of Pharmacy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry J Austin Health Clinic | Trenton | New Jersey | 08618 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18363526 | Result | Wubben DP, Vivian EM. Effects of pharmacist outpatient interventions on adults with diabetes mellitus: a systematic review. Pharmacotherapy. 2008 Apr;28(4):421-36. doi: 10.1592/phco.28.4.421. | |
| 22864490 | Result | Wallack MC, Loafman M, Sorensen TD. The Patient Safety and Clinical Pharmacy Collaborative: improving medication use systems for the underserved. J Health Care Poor Underserved. 2012 Aug;23(3 Suppl):96-102. doi: 10.1353/hpu.2012.0143. |
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In addition, the pharacists at the clinic who are treating the have access to the patient data
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Patients are randomized to the control or intervention group. After 12 months patients in the control group who do not have well controlled diabetes may be crossed over to the interventiobn gorup
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