Effect of Pharmacists Treating Diabetes in a FQHC
Impact of Adding a Pharmacist to the Health Care Team in a Federally Qualified Health Center
調査の概要
詳細な説明
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
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New Jersey
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Trenton、New Jersey、アメリカ、08618
- Henry J Austin Health Clinic
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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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他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hemoglobin A1C
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Preventative care
時間枠：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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協力者と研究者
捜査官
- スタディチェア：Caitlin McCarthy, PharmD、Rutgers, Earnest Mario School of Pharmacy
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
2型糖尿病の臨床試験
Pharmacist review of therapyの臨床試験
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