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| ID | Type | Description | Link |
|---|---|---|---|
| R18HS029817 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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This clinical trial aims to assess the impact of patient-focused and clinical-focused implementation strategies on blood pressure control. The investigators will assess the costs of these strategies and how effective they were at safely and equitably increasing home blood pressure monitoring.
This study will focus on assessing implementation strategies to increase adoption of self-monitored blood pressure (SMBP) monitoring among low-income, culturally and linguistically diverse patients with hypertension in an urban safety net. The investigators propose a hybrid type 1 effectiveness-implementation trial of implementation strategies to increase use of SMBP monitoring with clinical support in an urban safety net system. 330 patients will be randomized to a low-intensity vs high-intensity implementation strategy for SMBP monitoring. The low-intensity strategy will replicate frequently used implementation efforts (provision of BP monitor with training on using a monitor) while the high-intensity strategy will address additional factors identified in prior work (e.g., digital literacy, social support). In six adult primary clinics, the investigators will concurrently provide a stepped-wedge clinic-level implementation strategy (clinical champions, electronic health record [EHR] tools) to increase provision of clinical support for SMBP data. To guide dissemination in other under-resourced settings, an economic evaluation will also be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Intensity (Usual Care) | Active Comparator | Patient level: training on how to use a blood pressure (BP) monitor and online patient portal (ex. MyChart), receive reminders to take their BP at home, receive educational messages, and access to language-concordant educational materials. Clinic level: training on standardized workflows and EHR tools, audit and feedback |
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| High-Intensity | Experimental | Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person. Clinic level: training on standardized workflows and EHR tools, audit and feedback |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BP monitor use training and app training | Behavioral | Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in clinic systolic BP | Baseline, 12 months, 18 months | |
| BP Control | Clinic patients with EHR recorded BP < 140/90 | Monthly (-6 to 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| BP Control | Enrolled participants with controlled BP based on (a) clinic BP values; (b) home BP values | Baseline, 12 months, 18 months |
| Home Systolic BP (SBP) | Home SBP for enrolled participants |
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Inclusion Criteria:
Exclusion Criteria:
Those with conditions that might complicate remote BP monitoring:
Those with dementia, in hospice care, or with serious behavioral health conditions impeding participation
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| Name | Affiliation | Role |
|---|---|---|
| Elaine Khoong, MD, MS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital | San Francisco | California | 94110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41057081 | Derived | Khoong EC, Kim HC, Li J, Larreynaga J, Luna I, Yang A, Kazi DS, Lyles CR, McCulloch C, Rahman SB, Sarkar U, Curtis N. Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations (InSPIRED): A study protocol. Contemp Clin Trials. 2025 Nov;158:108101. doi: 10.1016/j.cct.2025.108101. Epub 2025 Oct 6. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 22, 2025 | Jan 30, 2026 |
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| Online patient portal enrollment and training | Behavioral | Patients will receive training on how to use an online patient portal. If they are not yet enrolled in an online patient portal and would like to be, they will also be enrolled into one. |
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| SMS reminders to take blood pressure | Behavioral | Patients will receive reminders via SMS to take their blood pressure. |
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| Education about self-management of hypertension | Behavioral | One-time training with action planning, access to website with language concordant patient education, and educational text messages |
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| Educational text messages that encourage seeking support from a support person | Behavioral | Educational text messages about behavioral changes that explicitly encourage seeking support from a support person |
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| Involvement of caregiver or support person | Behavioral | Patients will be asked to involve a caregiver or support person for all activities above, including patient portal proxy access. |
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| Group classes | Behavioral | Patients will be asked to attend in-person or online group education classes on hypertension management |
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| Baseline, 12 months, 18 months |
| Patient Adoption | Number of SMBP values per participant | 12 months |
| Clinic adoption | Clinic patients with EHR documented patient reported BP | Monthly (-6 to 18 months) |
| Reach | Percent of participants who actively participate in SMBP monitoring | 12 months |
| Costs | Costs (including time, equipment, consumables) of SMBP monitoring + implementation strategies | During trial; 12 months |
| Patient Activation | Patient Assessment of Chronic Illness Care (PACIC) - Minimum score: 1, Maximum score: 5. The PACIC is scored by summing participants' responses across all 20 items then dividing by 20, the number of items in the scale. Thus, scores on the PACIC range from 1 to 5 with higher scores indicating a better outcome (patient's perception of greater involvement in self-management and receipt of chronic care counseling). | Baseline, 12 months |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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