Clinical Trials Directory

Trials / Unknown

UnknownNCT03134170

Effect of Pharmacists Treating Diabetes in a FQHC

Impact of Adding a Pharmacist to the Health Care Team in a Federally Qualified Health Center

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
239 (actual)
Sponsor
Rutgers, The State University of New Jersey · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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

Conditions

Interventions

TypeNameDescription
OTHERPharmacist review of therapyPatients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist

Timeline

Start date
2015-08-01
Primary completion
2018-11-01
Completion
2019-12-31
First posted
2017-04-28
Last updated
2018-11-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03134170. Inclusion in this directory is not an endorsement.