Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technology-enabled blood pressure management | Experimental | The intervention will consist of a technology-enabled remote hypertension management program. Participants will be given a cellular blood pressure (BP) cuff and patients with heart failure and chronic kidney disease stage 3b-5 will be given a scale also. Patients will undergo a series of protocolized 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. Patients will be subsequently monitored for up to 12 more months. If their blood pressure increases, they can re-enter active management. |
|
| No intervention | No Intervention | Patients meeting inclusion care undergoing usual care in control clinics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology-enabled blood pressure management | Other | The intervention will consist of a technology-enabled remote hypertension management program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in SBP change | Difference in mean change in systolic blood pressure (SBP) | 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| HEDIS proportion | 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 | 6 months after enrollment |
| Difference in DBP change |
| Measure | Description | Time Frame |
|---|---|---|
| Home measured change in SBP and DBP | Home measured change in blood pressure in intervention group - more accurately measured: overall and by patient group | 6 months |
| Patient satisfaction | A patient satisfaction survey with questions similar to the Consumer Assessment of Healthcare Providers and Systems will be used. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rahul C Deo, MD PhD | Contact | 339-204-5454 | rahul@atmanhealth.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
non-blinded pragmatic cluster-randomized controlled trial with a single intervention
Not provided
Not provided
Not provided
Not provided
Difference in mean change in diastolic blood pressure (DBP) |
| 6 months after enrollment |
| 6 months |
| Provider satisfaction | A survey instrument will be developed and administered to assess provider satisfaction with having a remote team manage their patients. | 6 months |
| Mean time required per patient for provider | Cumulative time in minutes for all interactions, including documentation. | 6 months |
| Mean time required per patient for navigator | Cumulative time in minutes for all interactions, including documentation. | 6 months |
| Proportion of patients measuring blood pressure at directed frequency | Proportion of patients measuring blood pressure at least twice a day during active management period. | 6 months |
| Resource utilization | Difference in resource utilization between intervention and usual care for different patient groups using claims data. | 18 months |