Hypertension
Conditions
Keywords
hypertension, team-based, guidelines, implementation
Brief summary
This study is a prospective cluster randomized trial testing a systems-level strategy to implement current American Heart Association hypertension guidelines in African American communities at risk for cardiovascular related health disparities. The trial will take place within an integrated health system serving Detroit and will assess blood pressure control over one year's time.
Detailed description
The trial will randomize 12 clinics within the Henry Ford Health System to two arms. The first arm will be comparison clinics that continue to use existing team-based strategies for hypertension management. The second arm will be intervention clinics. These clinics will have enhancements to existing team-based hypertension management. The first enhancement is clinical decision support based in the electronic health record. The second enhancement is improved protocols to implement telehealth prescribing that is nurse-led. The trial will enroll participants through an urban emergency department. Participants will be assigned to one of these 12 clinics and continue study activities for 1 year. Clinicians at the clinics will manage blood pressure. Study specific visits will occur at 3, 6, 9, and 12 months. Primary outcome assessment is 12 months.
Interventions
OTHERIntervention
Enhancements to team-based care include clinical decision support and improved protocols for telehealth prescribing.
OTHERActive Comparator
Usual, team-based care
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (\>18 years) African Americans * Lacks established primary care for BP management * History of HTN * SBP ≥ 140 mmHg
Exclusion criteria
* Pregnancy * Need for hospitalization from ED * Serious comorbid conditions * Alcohol or drug dependence * Suspected resistant HTN * Anticipated poor-adherence to study designated primary care clinic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic blood pressure | 12 months | mean change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Intensity | 12 months | Calculated therapeutic intensity score |
| Change in systolic blood pressure | 6 months | mean change |
| Change in diastolic blood pressure | 12 months | mean change |
| Treatment Congruence | 12 months | Proportion of clinical encounters in which treatment is congruent with guidelines |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost effectiveness | 12 months | within trial cost and long-term projected costs compared to QALY |
Countries
United States
Outcome results
None listed