Zuckerberg San Francisco General Hospital
San Francisco, California, 94110, United States
NCT Number: NCT06871462
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94110, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings.
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.
Patients will receive reminders via SMS to take their blood pressure.
One-time training with action planning, access to website with language concordant patient education, and educational text messages
Educational text messages about behavioral changes that explicitly encourage seeking support from a support person
Patients will be asked to involve a caregiver or support person for all activities above, including patient portal proxy access.
Patients will be asked to attend in-person or online group education classes on hypertension management
Time frame: Baseline, 12 months, 18 months
Time frame: Monthly (-6 to 18 months)
Clinic patients with EHR recorded BP < 140/90
Time frame: Baseline, 12 months, 18 months
Enrolled participants with controlled BP based on (a) clinic BP values; (b) home BP values
Time frame: Baseline, 12 months, 18 months
Home SBP for enrolled participants
Time frame: 12 months
Number of SMBP values per participant
Time frame: Monthly (-6 to 18 months)
Clinic patients with EHR documented patient reported BP
Time frame: 12 months
Percent of participants who actively participate in SMBP monitoring
Time frame: During trial; 12 months
Costs (including time, equipment, consumables) of SMBP monitoring + implementation strategies
Time frame: 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).
University of California, San Francisco
Other
Acronym: INSPIRED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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