Hypertension, Primary Care
Conditions
Brief summary
The proposed study is an effectiveness-implementation hybrid type II trial designed to evaluate the impact of provider- and patient-directed interventions on FDC use. The trial will test the effectiveness of theory-driven nudges tailored to address provider and patient barriers. All interventions will be pharmacist-driven, with pharmacists delivering information via nudges to providers and via nudges or more intensive interventions (i.e., CPA) to patients. Data to evaluate outcomes will be extracted from electronic health records.
Interventions
BEHAVIORALProvider nudge
Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR)
BEHAVIORALPatient nudge
Patients will receive pharmacist-delivered nudges (e.g., text messages) 1-7 days before their visit to encourage fixed-dosed combinations
BEHAVIORALPharmacist Virtual Visit
Patients will receive pharmacist counseling and prescribing delivered via virtual encounters after their visit
Sponsors
Brigham and Women's Hospital
National Institute on Aging (NIA)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with documented hypertension diagnosis * had an elevated ambulatory blood pressure reading during the qualifying visit (systolic \>140 mmHg or diastolic \>90 mmHg * have an upcoming scheduled visit * have an active prescription for 1 blood pressure lowering medication with a fixed-dose combination (FDC) alternative
Exclusion criteria
* have received a prescription for a FDC in the preceding two years * reside in a nursing home * have a documented allergy to any FDC components * are pregnant * preferred language is not English or Spanish, defined as documentation in the EHR indicating a primary language other than English or Spanish, or a documented request for an interpreter in a language other than Spanish * have a diagnosis of heart failure or renal failure, given that antihypertensive management in these populations typically requires disease-specific regimens and more frequent treatment adjustments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic blood pressure | 6 months | Data for this outcome will be extracted from electronic health records. The primary effectiveness outcome will be a change in ambulatory systolic blood pressure at 3 months. For patients who do not return within 3 months, their index visit reading will be carried forward. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in diastolic blood pressure | 6 months | Change in diastolic blood pressure from qualifying visit blood pressure reading to the end of the 6-month follow-up, using EHR data |
| Percentage of patients with well-controlled blood pressure | 6 months | Percentage of patients who reach blood pressure control defined as \<140/90mmHg |
| PCP level adoption: FDC prescribing; FDC discussion in EHR notes | 6 months | Percentage of patients whose PCPs prescribe FDC within 6 months; any intensification at 6 months will also be explored; any FDC documentation in the notes |
| Patient level adoption: FDC adherence (fill) | 6 months | Percentage of patients who fill their first FDC prescription within 6 months; filling any intensified prescription within 6 months will also be explored. |
Countries
United States
Outcome results
None listed