Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Impact of Adding a Pharmacist to the Health Care Team in a Federally Qualified Health Center
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:
1. Measuring weight, heart rate, and blood pressure
2. Finger stick with a small needle to check lipid (fat) concentrations, fasting blood
sugar or HbA1c
3. Examining feet, skin, and eyes
4. Reviewing the patient's diary of blood sugars, diet, and exercise history
5. Filling out a survey that measures quality of life and problems that make it hard to
control your diabetes
6. Referral to other specialists such as a podiatrist (foot doctor), optometrist (eye
doctor), nutritionist, and dentist
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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