Effect of Pharmacists Treating Diabetes in a FQHC

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03134170
• Other study ID #: 14-805
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2018
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 239
• Est. completion date: December 31, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 and 74

2. Medicaid insurance

3. HbA1c of 8% or greater

Exclusion Criteria:

1. 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.

2. Age < 18 years old or age = 75 years old

3. HbA1c < 8.5% PLUS presence of one or more of the following regardless of age:

1. Limited life expectancy

2. History of severe hypoglycemia

4. HbA1c < 8.5% PLUS presence of one or more of the following if age = 65 years old:

1. Residency in a long-term care facility (e.g. nursing home, adult family home, etc.)

2. = 3 co-existing chronic illnesses c

3. Impairments in ability to perform two or more instrumental activities of daily living d

4. Mild, moderate, or severe cognitive impairment as determined by the patient's provider and Mini-Cog test

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Pharmacist review of therapy
Patients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist

Locations

Country	Name	City	State
United States	Henry J Austin Health Clinic	Trenton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C	Plasma glucose control	every 3 months for one year
Secondary	Preventative care	How frequent does the patient see a dentist, podiatris, optomitrist,	Baseline 6 months and 12 months