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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
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Henry J Austin Health Clinic
Trenton, New Jersey, United States
Start Date
August 1, 2015
Primary Completion Date
November 1, 2018
Completion Date
December 31, 2019
Last Updated
November 16, 2018
239
ACTUAL participants
Pharmacist review of therapy
OTHER
Lead Sponsor
Rutgers, The State University of New Jersey
NCT06959901
NCT06574035
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06861062