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Effect of Pharmacists Treating Diabetes in a FQHC

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacist review of therapy
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring pharmacist, diabetes, Preventative Care, Quality of Life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry J Austin Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

No intervention

Intervention group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Hemoglobin A1C
Plasma glucose control

Secondary Outcome Measures

Preventative care
How frequent does the patient see a dentist, podiatris, optomitrist,

Full Information

First Posted
April 26, 2017
Last Updated
November 14, 2018
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT03134170
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Measuring weight, heart rate, and blood pressure Finger stick with a small needle to check lipid (fat) concentrations, fasting blood sugar or HbA1c Examining feet, skin, and eyes Reviewing the patient's diary of blood sugars, diet, and exercise history Filling out a survey that measures quality of life and problems that make it hard to control your diabetes 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
pharmacist, diabetes, Preventative Care, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pharmacist review of therapy
Intervention Description
Patients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist
Primary Outcome Measure Information:
Title
Hemoglobin A1C
Description
Plasma glucose control
Time Frame
every 3 months for one year
Secondary Outcome Measure Information:
Title
Preventative care
Description
How frequent does the patient see a dentist, podiatris, optomitrist,
Time Frame
Baseline 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 and 74 Medicaid insurance HbA1c of 8% or greater Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caitlin McCarthy, PharmD
Organizational Affiliation
Rutgers, Earnest Mario School of Pharmacy
Official's Role
Study Chair
Facility Information:
Facility Name
Henry J Austin Health Clinic
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08618
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In addition, the pharacists at the clinic who are treating the have access to the patient data
Citations:
PubMed Identifier
18363526
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.
Results Reference
result
PubMed Identifier
22864490
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.
Results Reference
result

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Effect of Pharmacists Treating Diabetes in a FQHC

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