Effect of Pharmacists Treating Diabetes in a FQHC

NCT ID: NCT03134170

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2019-12-31

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: OTHER

Pharmacist review of therapy

Intervention Type: OTHER

Patients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist

Interventions

Pharmacist review of therapy

Patients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Mary Louise Wagner

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caitlin McCarthy, PharmD

Role: STUDY_CHAIR

Rutgers, Earnest Mario School of Pharmacy

Locations

Henry J Austin Health Clinic

Trenton, New Jersey, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18363526 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22864490 (View on PubMed)

Other Identifiers

14-805

Identifier Type: -

Identifier Source: org_study_id