Blood Pressure Monitoring, Home, Hypertension
Conditions
Keywords
INSPIRED
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBP monitor use training and app training
Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings.
BEHAVIORALOnline patient portal enrollment and training
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.
BEHAVIORALSMS reminders to take blood pressure
Patients will receive reminders via SMS to take their blood pressure.
BEHAVIORALEducation about self-management of hypertension
One-time training with action planning, access to website with language concordant patient education, and educational text messages
BEHAVIORALEducational text messages that encourage seeking support from a support person
Educational text messages about behavioral changes that explicitly encourage seeking support from a support person
BEHAVIORALInvolvement of caregiver or support person
Patients will be asked to involve a caregiver or support person for all activities above, including patient portal proxy access.
BEHAVIORALGroup classes
Patients will be asked to attend in-person or online group education classes on hypertension management
Sponsors
University of California, San Francisco
University of California, Davis
Beth Israel Deaconess Medical Center
Agency for Healthcare Research and Quality (AHRQ)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old/order * Any sex or gender * Any race or ethnicity * Must be receiving primary care at any of the six enrolled clinics * Have uncontrolled hypertension (two clinic BP readings ≥140/90 mmHg within the previous 18 months) * Can read and write English, Spanish, or Cantonese * Be able to provide consent * Must own a cell phone that receives SMS or text messages
Exclusion criteria
* Those with conditions that might complicate remote BP monitoring: * Pregnancy (and 12 months postpartum) * Acute myocardial infarction or stroke in the last 12 months * End-stage renal disease on dialysis * Stage D heart failure * Active treatment for cancer (except for nonmelanoma skin cancers) * Pacemaker use * Those with dementia, in hospice care, or with serious behavioral health conditions impeding participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinic systolic BP | Baseline, 12 months, 18 months | — |
| BP Control | Monthly (-6 to 18 months) | Clinic patients with EHR recorded BP \< 140/90 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BP Control | Baseline, 12 months, 18 months | Enrolled participants with controlled BP based on (a) clinic BP values; (b) home BP values |
| Home Systolic BP (SBP) | Baseline, 12 months, 18 months | Home SBP for enrolled participants |
| Patient Adoption | 12 months | Number of SMBP values per participant |
| Clinic adoption | Monthly (-6 to 18 months) | Clinic patients with EHR documented patient reported BP |
| Reach | 12 months | Percent of participants who actively participate in SMBP monitoring |
| Costs | During trial; 12 months | Costs (including time, equipment, consumables) of SMBP monitoring + implementation strategies |
| Patient Activation | Baseline, 12 months | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElaine Khoong, MD, MS
University of California, San Francisco
Outcome results
None listed