Hypertension
Conditions
Brief summary
The primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Finally, the investigators will estimate the economic impact of the intervention in terms of resource utilization.
Detailed description
The study design is a non-blinded pragmatic cluster-randomized controlled trial with a single intervention. Participants with uncontrolled hypertension will be identified from a randomly selected group of primary care clinics. Participants from half of the clinics will be enrolled in the intervention arm while the others will receive usual care. Participants in the intervention arm will undergo a series of software-driven medication initiation and titration steps until they reach a blood pressure target of systolic blood pressure \< 130 mmHg and diastolic blood pressure \< 80 mmHg. Participants will be subsequently monitored for up to 12 more months.
Interventions
OTHERTechnology-enabled blood pressure management
The intervention will consist of a technology-enabled remote hypertension management program.
Sponsors
Atman Health, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
non-blinded pragmatic cluster-randomized controlled trial with a single intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 18 years - 100 years * uncontrolled hypertension: as defined as SBP \> 140 or DBP \> 90 on 2 successive clinic visits
Exclusion criteria
* hearing impaired * visually impaired * cognitively impaired * hospice care * on hemodialysis at enrollment * New York Heart Association Class IV heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in SBP change | 6 months after enrollment | Difference in mean change in systolic blood pressure (SBP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HEDIS proportion | 6 months after enrollment | Difference in the proportion of patients meeting HEDIS definition of controlled hypertension (SBP \< 140 AND DBP \< 90) between intervention and usual care: overall and by patient group and by age, race, sex strata |
| Difference in DBP change | 6 months after enrollment | Difference in mean change in diastolic blood pressure (DBP) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean time required per patient for provider | 6 months | Cumulative time in minutes for all interactions, including documentation. |
| Mean time required per patient for navigator | 6 months | Cumulative time in minutes for all interactions, including documentation. |
| Home measured change in SBP and DBP | 6 months | Home measured change in blood pressure in intervention group - more accurately measured: overall and by patient group |
| Resource utilization | 18 months | Difference in resource utilization between intervention and usual care for different patient groups using claims data. |
| Proportion of patients measuring blood pressure at directed frequency | 6 months | Proportion of patients measuring blood pressure at least twice a day during active management period. |
| Patient satisfaction | 6 months | A patient satisfaction survey with questions similar to the Consumer Assessment of Healthcare Providers and Systems will be used. |
| Provider satisfaction | 6 months | A survey instrument will be developed and administered to assess provider satisfaction with having a remote team manage their patients. |
Contacts
Primary ContactRahul C Deo, MD PhD
Outcome results
None listed