MedStar Diabetes Pathway Chart Reviews (MedstarBC2)
Expanded MedStar Diabetes Pathway Ongoing Chart Review Protocol
調査の概要
詳細な説明
The MedStar Diabetes Pathway (MDP) early pilot program has generated evidence that an innovative technology-enabled "Boot Camp" approach to the delivery of diabetes survival skills education and medication management has a significant impact on glycemic control and healthcare utilization measures. The MDP is a 12 week Diabetes "Boot Camp" technology-enabled intervention which will offer learner-centered survival skills self-management education (DSSE) and algorithm-driven diabetes medications (DM) titration by Endocrinologist-supervised Certified Diabetes Educators (CDE), NPs and PharmDs. The program has been offered at 5 MedStar Medical Group (MMG) Primary Care Practices from November 2014 to February 2016 to high risk adults with uncontrolled type 2 diabetes who have a hemoglobin A1C (A1C) level -a marker of average blood glucose (BG) levels in the 2-3 months prior to the time the test is done- which is at or above 9% - considered to be poor control, and 1 or more additional risk factors for poor health outcomes. The program has been well received by MedStar Primary Care Providers and their diabetes patients. Patients that participated in the MDP achieved significantly higher A1C reduction and decreased risk risk for acute care utilization then matched controls that received standard of care. The pilot evidence demonstrated a significant impact on glycemic control and healthcare utilization measures as the result of a concise, focused DM education and medication management intervention. Building on the success of the MDP Phase 1.0 pilot, the next steps in expanding the program will be as follows:
- Transition of the Pathway from early feasibility pilot to the next phase as an expanded pilot program integrated within the MedStar Health System care delivery network and built upon a sustainable infrastructure across early adopter MMG practice sites.
- Expand recruitment to include high risk patients with uncontrolled type 2 diabetes, including those with a new diagnosis and A1C >9%, who have MedStar Emergency Department and/or Inpatient encounters
- Spread to additional targeted MedStar Primary Care Practices and/or to MedStar Managed Care Plan participants.
Chart reviews and data collection during the expansion phase will be essential to guide the process and allow rapid cycle adjustments to maximize the impact of the program and utilization of resources for the benefit of our patients.
研究の種類
入学 (実際)
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Diagnosis of Type 2 Diabetes, A1C equal or higher than 9%, active patient of medstar health provider, english speaking, willing and able to participate in the program
Exclusion Criteria:
- A1C less than 9%, severe illness that precludes participation such severe congestive heart failure or COPD, advanced kidney disease, recent acute illness such as heart attack or stroke in the past 30 days, active cancer, severe mental illness, high dose steroid, other types of diabetes, pregnant or lactating.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Cases
patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway
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Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.
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Matched controls
patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
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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 |
|---|---|---|
|
Percent Change in A1C
時間枠：12-16 weeks
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Change in Hemoglobin A1C from baseline to 12-16 weeks for both cases and controls
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12-16 weeks
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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 |
|---|---|---|
|
Risk for Emergency Room Visits at 30 Days From Baseline as Measured by Incidence Risk Ratio
時間枠：30 days
|
Comparison of risk of incurring an emergency room visits at 30 days from baseline for cases and controls.
This was done by calculating and comparing the incidence risk ratio for an ER visit for each group and comparing them.
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30 days
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Risk for Hospitalizations at 30 Days From Baseline
時間枠：30 days
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Comparison of risk for experiencing a hospital visit within 30 days from baseline in both group.
This was done by calculating the incidence risk ratio for hospitalizations for cases and controls at 30 days from baseline and comparing them.
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30 days
|
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Risk for Composite of Emergency Room Visits and Hospitalizations at 30 Days From Baseline
時間枠：30 days
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Comparison for risk of experiencing a visit to the emergency room and/or the hospital at 30 days from baseline.
This was measured by calculating the Incidence risk ratio for acute care utilization at 30 days from baseline for both cases and controls and comparing them.
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30 days
|
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Risk for Emergency Room Visits at 90 Days From Baseline
時間枠：90 days
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Comparison of the risk of experiencing an emergency room visit at 90 days from baseline in both groups.
This was done by calculating the Incidence risk ratio for an emergency room visit at 90 days for both cases and controls and comparing them
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90 days
|
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Risk for Hospitalizations at 90 Days From Baseline
時間枠：90 days
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Comparison of the risk for experiencing a hospitalization within 90 days from baseline in both groups.
This was done by calculating the Incidence Risk Ratio for hospitalizations for cases and controls within 90 days of baseline and comparing them.
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90 days
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Composite of Risk for Hospitalizations and Emergency Room Visits Within 90 Days From Baseline
時間枠：90 days
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Comparison of the risk for experiencing a hospitalization and/or emergency room visit within 90 days from baseline for both groups.
This was done by calculating then comparing the incidence risk ratio for acute care utilization within 90 days from baseline for cases and controls.
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90 days
|
協力者と研究者
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 (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 (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
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
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National Human Genome Research Institute (NHGRI)完了