Forbedring av hypertensjonskontroll i sikkerhetsnettinnstillinger: Boston Hypertensjon Equity Alliance i behandlingen (BHEAT)
Sammenlignende effektivitet av intervensjoner for å forbedre hypertensjonskontroll i sikkerhetsnettinnstillinger: Boston Hypertensjon Equity Alliance i behandlingen
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Michael Fischer, MD MS
- Telefonnummer: (617) 414-7288
- E-post: Michael.Fischer@bmc.org
Studer Kontakt Backup
- Navn: Justine Scott, MPH
- Telefonnummer: (617) 414-7288
- E-post: Justine.Scott@bmc.org
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02118
- Rekruttering
- Boston Healthcare for the Homeless (BHCHP)
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Boston, Massachusetts, Forente stater, 02118
- Rekruttering
- Boston Medical Center Family Medicine
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Boston, Massachusetts, Forente stater, 02118
- Rekruttering
- Boston Medical Center, General Internal Medicine primary care
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Boston, Massachusetts, Forente stater, 02118
- Rekruttering
- Neighborhood Health
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Boston, Massachusetts, Forente stater, 02126
- Rekruttering
- Mattapan Community Health Center
-
Quincy, Massachusetts, Forente stater, 02169
- Rekruttering
- Manet Community Health Center
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Roslindale, Massachusetts, Forente stater, 02131
- Rekruttering
- Greater Roslindale Medical and Dental Center (GRMDC)
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Remote Blood Pressure Monitoring (RBPM)
Individual level interventions fo monitor blood pressure. |
Standardized blood pressure measurement and treatment protocols in clinical practice. |
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Systolic blood pressure (SBP) improvement
Tidsramme: 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
Tidsramme: Baseline, 54 months
|
The number and proportion of individuals who receive each intervention. |
Baseline, 54 months
|
|
Patient activation
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood pressure control
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Michael Fischer, MD MS, Boston Medical Center, Internal Medicine
- Hovedetterforsker: Cheryl Clark, MD ScD, Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-45398
- HMC-2023C2-33345 (Annet stipend/finansieringsnummer: Patient-Centered Outcomes Research Institute (PCORI))
Plan for individuelle deltakerdata (IPD)
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