Clinical trial NCT03134170: Effect of Pharmacists Treating Diabetes in a FQHC
Official title: Impact of Adding a Pharmacist to the Health Care Team in a Federally Qualified Health Center
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: pharmacist
diabetes
Preventative Care
Quality of Life
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients are randomized to the control or intervention group. After 12 months patients in the control group who do not have well controlled diabetes may be crossed over to the interventiobn gorup
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: every 3 months for one year
Secondary outcomes:
measure: Preventative care
timeFrame: Baseline 6 months and 12 months
Other outcomes:
Locations:
city: Trenton
country: United States
facility: Henry J Austin Health Clinic
state: New Jersey
Study officials:
affiliation: Rutgers, Earnest Mario School of Pharmacy
name: Caitlin McCarthy, PharmD
role: STUDY_CHAIR
References:
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.
citation: 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.