Förbättra hypertensionskontroll i säkerhetsnätinställningar: Boston Hypertension Equity Alliance in Treatment (BHEAT)
Jämförande effektivitet av interventioner för att förbättra hypertoni-kontrollen i säkerhetsnätinställningar: Boston Hypertension Equity Alliance in Treatment
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Michael Fischer, MD MS
- Telefonnummer: (617) 414-7288
- E-post: Michael.Fischer@bmc.org
Studera Kontakt Backup
- Namn: Justine Scott, MPH
- Telefonnummer: (617) 414-7288
- E-post: Justine.Scott@bmc.org
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02118
- Rekrytering
- Boston Healthcare for the Homeless (BHCHP)
-
Boston, Massachusetts, Förenta staterna, 02118
- Rekrytering
- Boston Medical Center Family Medicine
-
Boston, Massachusetts, Förenta staterna, 02118
- Rekrytering
- Boston Medical Center, General Internal Medicine primary care
-
Boston, Massachusetts, Förenta staterna, 02118
- Rekrytering
- Neighborhood Health
-
Boston, Massachusetts, Förenta staterna, 02126
- Rekrytering
- Mattapan Community Health Center
-
Quincy, Massachusetts, Förenta staterna, 02169
- Rekrytering
- Manet Community Health Center
-
Roslindale, Massachusetts, Förenta staterna, 02131
- Rekrytering
- Greater Roslindale Medical and Dental Center (GRMDC)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Remote Blood Pressure Monitoring (RBPM)
Individual level interventions fo monitor blood pressure. |
Standardized blood pressure measurement and treatment protocols in clinical practice. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Systolic blood pressure (SBP) improvement
Tidsram: 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
Tidsram: Baseline, 54 months
|
The number and proportion of individuals who receive each intervention. |
Baseline, 54 months
|
|
Patient activation
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Blood pressure control
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Michael Fischer, MD MS, Boston Medical Center, Internal Medicine
- Huvudutredare: Cheryl Clark, MD ScD, Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-45398
- HMC-2023C2-33345 (Annat bidrag/finansieringsnummer: Patient-Centered Outcomes Research Institute (PCORI))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .