Study to Test Use of a Decision Aid in a Clinical Visit to Help Patients Choose a Diabetes Medication (TRICEP)
Translating Information on Comparative Effectiveness Into Practice (TRICEP)
調査の概要
詳細な説明
To conduct a cluster-randomized practical trial to evaluate the impact of our decision aid (Diabetes Medication Choice Cards) versus usual care as strategies to translate CER into practice among patients with poorly controlled diabetes in need of drug intensification (Hemoglobin Alc (HbA1c) > 7.3%). Patient outcomes including reaching glycemic control target (HbA1c less than or equal to 7.3%), medication choice and adherence, satisfaction and knowledge. From the physician perspective, we will be measuring physician adoption and satisfaction with the decision aid.
To identify, describe, and explain factors that promote or inhibit the uptake of complex interventions such as decision aids in practices participating in the trial.
To conduct an exploratory analysis of the ability of patients to adhere to the medications chosen while exploring the factors that enable or hinder the patients' ability to incorporate these medications into their routine.
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
-
-
Minnesota
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Albert Lea、Minnesota、アメリカ、56007
- Albert Lea Medical Center
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Kasson、Minnesota、アメリカ、55944
- Mayo Clinic Kasson
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Mankato、Minnesota、アメリカ、56002
- Mayo Clinic Health System- Immanual St. Joseph's
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Minneapolis、Minnesota、アメリカ、55415
- Hennepin County Medical Center
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Saint Louis Park、Minnesota、アメリカ、55416
- Park Nicollet Institute
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Wisconsin
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La Crosse、Wisconsin、アメリカ、54601
- Mayo Clinic Health System-Franciscan Healthcare
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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:
- 18 years of age and older
- Have a diagnosis of Type 2 diabetes mellitus and on diabetes medication
- Have a diagnosis of Type 2 diabetes mellitus for 1 year or more if not currently on diabetes medication
- Recognize their primary care provider as their main diabetes care provider
- Use 0, 1, 2, or 3 oral hypoglycemic agents
- Have a recent HbA1c measure (within 12 months) of greater than 7.3, with priority to patients with rising HbA1c levels.
Exclusion Criteria:
- Not available for follow-up for 12 months after study visit.
- Unable to read and speak English.
- Has major barriers to providing written informed consent.
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Usual Care
Clinicians will present diabetes medication options to patients, in their usual way.
|
|
|
実験的：Diabetes Medication Decision Aid
In the decision aid arm, clinicians will use the diabetes medication decision aid cards (if they choose) when discussing diabetes medication options with their patients.
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Clinician uses the Diabetes Medication Choice Cards to inform and engage patient in discussing the issues they find relevant in choosing a new diabetes medication.
|
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 |
|---|---|---|
|
Patient Satisfaction and knowledge
時間枠：baseline to 12 months
|
Primary outcome is to evaluate the impact of our decision aid (Diabetes Medication Choice Cards) versus usual care as strategies to translate CER into practice among patients with poorly controlled diabetes in need of drug intensification (Hemoglobin A1c (HbA1c) > 7.3%).
Patient outcomes include satisfaction with use of the decision aid and knowledge, compared to the control, usual care group (by written survey at point of care and follow-up).
|
baseline to 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physician adoption and satisfaction with the decision aid.
時間枠：baseline to 12 months
|
Brief post-visit surveys will be completed by the clinicians, directly following clinical visit.
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baseline to 12 months
|
協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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。