Verbetering van de hypertensiecontrole in de instellingen voor veiligheidsnet: de Boston Hypertension Equity Alliance in behandeling (BHEAT)
Vergelijkende effectiviteit van interventies om hypertensie-controle te verbeteren in veiligheidsnetinstellingen: de Boston Hypertension Equity Alliance in behandeling
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Michael Fischer, MD MS
- Telefoonnummer: (617) 414-7288
- E-mail: Michael.Fischer@bmc.org
Studie Contact Back-up
- Naam: Justine Scott, MPH
- Telefoonnummer: (617) 414-7288
- E-mail: Justine.Scott@bmc.org
Studie Locaties
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02118
- Werving
- Boston Healthcare for the Homeless (BHCHP)
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Boston, Massachusetts, Verenigde Staten, 02118
- Werving
- Boston Medical Center Family Medicine
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Boston, Massachusetts, Verenigde Staten, 02118
- Werving
- Boston Medical Center, General Internal Medicine primary care
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Boston, Massachusetts, Verenigde Staten, 02118
- Werving
- Neighborhood Health
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Boston, Massachusetts, Verenigde Staten, 02126
- Werving
- Mattapan Community Health Center
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Quincy, Massachusetts, Verenigde Staten, 02169
- Werving
- Manet Community Health Center
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Roslindale, Massachusetts, Verenigde Staten, 02131
- Werving
- Greater Roslindale Medical and Dental Center (GRMDC)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Remote Blood Pressure Monitoring (RBPM)
Individual level interventions fo monitor blood pressure. |
Standardized blood pressure measurement and treatment protocols in clinical practice. |
|
Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Systolic blood pressure (SBP) improvement
Tijdsspanne: 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
Tijdsspanne: Baseline, 54 months
|
The number and proportion of individuals who receive each intervention. |
Baseline, 54 months
|
|
Patient activation
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Blood pressure control
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Michael Fischer, MD MS, Boston Medical Center, Internal Medicine
- Hoofdonderzoeker: Cheryl Clark, MD ScD, Institute for Health Equity Research, Evaluation & Policy, MA League of CHCs
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H-45398
- HMC-2023C2-33345 (Ander subsidie-/financieringsnummer: Patient-Centered Outcomes Research Institute (PCORI))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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