Effect of Pharmacists Treating Diabetes in a FQHC

NCT03134170 | Unknown DMC

• 1 other identifier: 14-805
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

pharmacist; diabetes; Preventative Care; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  Plasma glucose control

  every 3 months for one year

Secondary Outcomes (1)

• Preventative care

  Baseline 6 months and 12 months

Study Arms (2)

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

Intervention group

OTHER

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

Interventions

Pharmacist review of therapy OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and 74
• Medicaid insurance
• HbA1c of 8% or greater

You may not qualify if:

• 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.
• Age \< 18 years old or age ≥ 75 years old
• HbA1c \< 8.5% PLUS presence of one or more of the following regardless of age:
• Limited life expectancy
• History of severe hypoglycemia
• HbA1c \< 8.5% PLUS presence of one or more of the following if age ≥ 65 years old:
• Residency in a long-term care facility (e.g. nursing home, adult family home, etc.)
• ≥ 3 co-existing chronic illnesses c
• Impairments in ability to perform two or more instrumental activities of daily living d
• Mild, moderate, or severe cognitive impairment as determined by the patient's provider and Mini-Cog test

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Henry J Austin Health Clinic

Trenton, New Jersey, 08618, United States

Location

Related Publications (2)

• 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.

  PMID: 18363526 RESULT

• 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.

  PMID: 22864490 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Caitlin McCarthy, PharmD

  Rutgers, Earnest Mario School of Pharmacy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: April 28, 2017
• Study Start: August 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: December 31, 2019
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)