Pharmacy-led Intervention to Increase the Adoption of Fixed-dose Single Pill Blood Pressure Lowering Medications: Hybrid Effectiveness-Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Change in systolic blood pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Provider nudge only
Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the EHR.
干预措施: Provider nudge (Behavioral)
Provider nudge + Patient nudge
In addition to provider nudges (Provider nudge only arm), patients will receive pharmacist delivered nudges (e.g., text messages) 1-7 days before the visit to encourage fixed dose combination medications.
干预措施: Provider nudge (Behavioral)
Provider nudge + Patient nudge
In addition to provider nudges (Provider nudge only arm), patients will receive pharmacist delivered nudges (e.g., text messages) 1-7 days before the visit to encourage fixed dose combination medications.
干预措施: Patient nudge (Behavioral)
Provider nudge + Pharmacist Virtual Visit
In addition to provider nudges (Provider nudge only arm), patients will receive pharmacist counseling and prescribing delivered via virtual encounters after the visit.
干预措施: Provider nudge (Behavioral)
Provider nudge + Pharmacist Virtual Visit
In addition to provider nudges (Provider nudge only arm), patients will receive pharmacist counseling and prescribing delivered via virtual encounters after the visit.
干预措施: Pharmacist Virtual Visit (Behavioral)
结局指标
主要结局
Change in systolic blood pressure
时间窗: 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.
次要结局
- Change in diastolic blood pressure(6 months)
- Percentage of patients with well-controlled blood pressure(6 months)
- PCP level adoption: FDC prescribing; FDC discussion in EHR notes(6 months)
- Patient level adoption: FDC adherence (fill)(6 months)
研究者
Julie Lauffenburger
Associate Professor
Brigham and Women's Hospital