Effect of Pharmacists Treating Diabetes in a FQHC

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Pharmacist review of therapy

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

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Trenton, New Jersey, United States, 08618
      • Henry J Austin Health Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Other: Intervention group; 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.	Other: Pharmacist review of therapy; Patients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1C	Plasma glucose control	every 3 months for one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preventative care	How frequent does the patient see a dentist, podiatris, optomitrist,	Baseline 6 months and 12 months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Study Chair: Caitlin McCarthy, PharmD, Rutgers, Earnest Mario School of Pharmacy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 14, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: diabetes; Quality of Life; pharmacist; Preventative Care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 14-805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In addition, the pharacists at the clinic who are treating the have access to the patient data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No