セーフティネット設定での高血圧制御の改善：ボストン高血圧エクイティアライアンスの治療 (BHEAT)
セーフティネット設定での高血圧制御を改善するための介入の比較有効性：ボストン高血圧エクイティアライアンス治療における
High blood pressure (BP) or hypertension (HTN) affects over 100 million individuals in the US, increasing the risk of adverse outcomes, including stroke, myocardial infarction (MI), and chronic kidney disease (CKD). Effective therapies include non-pharmacologic approaches and multiple medication classes. Successful HTN management requires ongoing patient engagement for BP monitoring and treatment intensification. Reaching this goal is challenging, and many patients with HTN do not have controlled BP.
Using a collaborative partnership between patients, clinicians, health system and public health stakeholders, and the research team the investigators plan to overcome barriers to widespread implementation of evidence-based health system strategies to improve BP control in a large, urban, primary care-based safety-net setting for diverse populations experiencing disparities in HTN-related outcomes.
調査の概要
詳細な説明
A hybrid type 1 effectiveness-implementation study will be implemented to evaluate the comparative impact of each intervention on clinical outcomes while also assessing implementation at each site. The multi-site cluster randomized stepped-wedge design allows for feasible resource allocation and sequential roll out of the interventions for comparison, ensuring each site has the opportunity to benefit from both approaches. Data will be collected for multiple patient reported outcomes (PROs) to understand the range of impacts of the interventions from the patient perspective.
The specific aims are to:
- Assess comparative effectiveness of remote BP monitoring (RBPM) versus RBPM + multilevel intensification intervention (MII) on HTN control and quality of care. Prior research has demonstrated the effectiveness of each of these interventions yet the optimal approach to achieve equity in HTN control in safety net practices remains unknown.
- Use mixed methods, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, to assess implementation of the two comparators as measured by reach, adoption, implementation (fidelity) and maintenance. Using a convergent parallel design, the investigators will use concurrent quantitative and qualitative data to obtain perspectives across multiple levels to understand the reasons for success or failure of implementation of each comparator. By merging these data, integration can be achieved by using qualitative themes related to implementation to support or refute quantitative findings of reach and fidelity.
- Evaluate the comparative impacts of each intervention on PROs assessed with validated measures of patient activation, medication adherence, and trust in medical settings. The study intervention approaches were informed by direct feedback from the targeted diverse patients and clinical providers to address patient-reported barriers to HTN control: lack of activation, adherence to medications, and trust in their care providers.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Michael Fischer, MD MS
- 電話番号：(617) 414-7288
- メール：Michael.Fischer@bmc.org
研究連絡先のバックアップ
- 名前：Justine Scott, MPH
- 電話番号：(617) 414-7288
- メール：Justine.Scott@bmc.org
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02118
- 募集
- Boston Healthcare for the Homeless (BHCHP)
-
Boston、Massachusetts、アメリカ、02118
- 募集
- Boston Medical Center Family Medicine
-
Boston、Massachusetts、アメリカ、02118
- 募集
- Boston Medical Center, General Internal Medicine primary care
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Boston、Massachusetts、アメリカ、02118
- 募集
- Neighborhood Health
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Boston、Massachusetts、アメリカ、02126
- 募集
- Mattapan Community Health Center
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Quincy、Massachusetts、アメリカ、02169
- 募集
- Manet Community Health Center
-
Roslindale、Massachusetts、アメリカ、02131
- 募集
- Greater Roslindale Medical and Dental Center (GRMDC)
-
-
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:
- Adult (age>18) patients receiving primary care at one of the 9 participating sites, with primary care provider (PCP) visit in the preceding year
- Presence of HTN defined by one or more of: 1) diagnosis included on active problem list, 2) active HTN medications in prior year, 3) 3 separate elevated BP measurements
- Uncontrolled HTN defined as systolic blood pressure (SBP)>140
Exclusion Criteria:
- Not meeting the inclusion criteria
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：順次割り当て
- 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：Remote Blood Pressure Monitoring (RBPM)
Individual level interventions fo monitor blood pressure. |
Standardized blood pressure measurement and treatment protocols in clinical practice. |
|
実験的：Multilevel Intensification interventions (MII)
Team-based interventions to mitigate clinical inertia which is the lack of intensification of treatment despite inadequate disease control such as for HTN. |
Standardized blood pressure measurement and treatment protocols in clinical practice. Team-based interventions including multiple evidence-proven interventions such as clinician decision support, monitoring medication non-adherence, use of combination pills, and formulary modifications. |
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 |
|---|---|---|
|
Systolic blood pressure (SBP) improvement
時間枠：Baseline, every 3 months up to 54 months
|
Change in BP abstracted from the electronic health record (EHR). |
Baseline, every 3 months up to 54 months
|
|
Interventions received
時間枠：Baseline, 54 months
|
The number and proportion of individuals who receive each intervention. |
Baseline, 54 months
|
|
Patient activation
時間枠：Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
Patient activation will be assessed with the Consumer Health Activation index (CHAI), a 10 item validated instrument that generates a score of 0-100, with ≥80 indicating moderate/high activation. |
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood pressure control
時間枠：Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
Assessed as Yes/No from EHR records for Systolic BP<140 mmHg and Systolic BP<130 mmHg. |
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
|
Medication intensification
時間枠：Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
Assessed from EHR and claims data. |
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
|
BP monitoring
時間枠：Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
Assessed by EHR data on the frequency of BP monitoring. |
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
|
Fidelity of interventions
時間枠：Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
The number and proportion of individuals who receive all key elements of the interventions based on EHR data. |
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
|
Medication adherence
時間枠：Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
the 3-item self-report scale by Wilson will be used to assess this outcome. It queries patients about how many days they missed medications and overall consistency over the last 30 days. This measure has been standardized to a 0-100 scale, with good adherence defined as ≥80. |
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
|
Trust in primary care
時間枠：Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
Assessed with the 10 item Wake Forest Physician Trust Scale. The scale uses a 5-point Likert scale [1=strongly disagree to 5=strongly agree]. Total scores can range from 10 to 50, and higher scores represent greater trust. |
Baseline, 18 months, 30 months, 36 months, 42 months, 54 months
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Michael Fischer, MD MS、Boston Medical Center, Internal Medicine
- 主任研究者：Cheryl Clark, MD ScD、Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
その他の研究ID番号
- H-45398
- HMC-2023C2-33345 (その他の助成金/資金番号：Patient-Centered Outcomes Research Institute (PCORI))
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?
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