Effect of Pharmacists Treating Diabetes in a FQHC
Impact of Adding a Pharmacist to the Health Care Team in a Federally Qualified Health Center
研究概览
详细说明
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
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New Jersey
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Trenton、New Jersey、美国、08618
- Henry J Austin Health Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预: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
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其他: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.
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Patients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Hemoglobin A1C
大体时间:every 3 months for one year
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Plasma glucose control
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every 3 months for one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Preventative care
大体时间:Baseline 6 months and 12 months
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How frequent does the patient see a dentist, podiatris, optomitrist,
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Baseline 6 months and 12 months
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合作者和调查者
调查人员
- 学习椅:Caitlin McCarthy, PharmD、Rutgers, Earnest Mario School of Pharmacy
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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