Heart Health NOW (Previously Known as FAST PACE NC) (HHN)
Heart Health NOW (Previously Known as Facilitation, Spread, and Translation of Patient-Centered Evidence in North Carolina Practices)
調査の概要
詳細な説明
The burden of cardiovascular disease in North Carolina remains large. The latest data available show an annual cardiovascular death rate of 263 per 100,000 explaining almost one-third of deaths in the state. Disease progression is largely determined by several risk factors including elevated blood pressure or cholesterol, not using aspirin for prevention, and tobacco use. Primary care practices as currently organized have been unable to get more than half these patients to achieve recommended targets for risk factor reduction. Small independent practices, in particular, lack resources for enhanced practice support to improve cardiovascular care.
This study will enroll 300 primary care practices to evaluate the effect of primary care support on evidence-based cardiovascular disease (CVD) prevention and organizational change process measures. Each practice will start the trial as a control, receive the intervention at a randomized time point, and then enter a maintenance period 12 months after starting the intervention. All practices will receive 12 months of the intense intervention including onsite quality improvement (QI) facilitation, academic detailing, electronic health record (EHR) support, and, through the North Carolina Health Information Exchange (HIE), a shared statewide utility providing whole population analytics, care gap identification, benchmarking, and an external reporting mechanism which otherwise would not be available to independent practices.
A successful intervention would prove that practice facilitation supported by effective informatics tools is an effective method of translating PCOR findings into practice. Discernible reductions in cardiovascular risk in 300 practices covering over an estimated 900,000 adult patients would likely lead to prevention of thousands of cardiovascular events within 10 years.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Primary care practice in North Carolina with 10 or fewer providers in a single location
- must have implemented an EHR and either be connected to or have agreed to connect to the HIE.
Exclusion Criteria:
- practices with more than 10 providers in a single location
- practices receiving practice facilitation services beyond the usual support provided by Area Health Education Centers (AHEC) or the Community Care of North Carolina (CCNC) program through their parent organization.
- practices without an EHR
- practices where the central practice organization either bars the practice from our program or provides onsite facilitation services equal to or greater than the 4-6 hour standard contact with a QI coach
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:ヘルスサービス研究
- 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 |
---|---|
実験的:Cluster A
50 practices randomly assigned to start intervention at month 9. Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
実験的:Cluster B
50 practices randomly assigned to start intervention at month 11.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
実験的:Cluster C
50 practices randomly assigned to start intervention at month 12. Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
実験的:Cluster D
50 practices randomly assigned to start intervention at month 14.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
実験的:Cluster E
50 practices randomly assigned to start intervention at month 16.
Assigned Intervention: Primary Care Practice Support.
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
|
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 |
---|---|---|
Measurable reduction in arteriosclerotic cardiovascular disease (ASCVD) risk
時間枠:18 months
|
By comparing EHR data at baseline and post-intervention, determine whether practice support resulted in discernible reduction in CVD risk.
|
18 months
|
協力者と研究者
捜査官
- 主任研究者:Sam Cykert, MD、UNC Chapel Hill
出版物と役立つリンク
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 (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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 15-0479
- 1R18HS023912-01 (米国 AHRQ グラント/契約)
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
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。
循環器疾患の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
Primary Care Practice Supportの臨床試験
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
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American Board of Internal MedicineThe Josiah Macy, Jr. Foundation完了