Implementation of Intensive Hypertension Management Approaches: Cleveland Clinic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,520
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure Change
研究概览
简要总结
The primary objective of the Implementation of Effective Hypertension Management Approaches: Cleveland Clinic program is to improve blood pressure control for patients diagnosed with hypertension (HTN) and uncontrolled blood pressure, specifically defined as a blood pressure greater than 150/95, across all Cleveland Clinic Northeast Ohio primary care practices. The project will scale up the availability of resources for treating hypertension in 56 primary care practices within the Cleveland Clinic Health System in Northern Ohio, reaching up to approximately 3800 patients. This project will utilize evidence from a randomized controlled trial by Margolis et al.(1) to build upon Cleveland Clinic's existing team-based primary care provider (PCP) collaboration with pharmacists and advanced practice providers (APP) and will use a mechanism that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.
详细描述
Primary care providers will offer the program to patients in Northeast Ohio with a hypertension diagnosis and aged 18-85, except those who are pregnant, have stage 5 chronic kidney disease or end stage renal disease, or enrolled in hospice care. The project time frame is 48 months. Quantitative and qualitative methods will be used to evaluate implementation and effectiveness outcomes associated with the program. Electronic medical records and surveys will be the key data sources for the quantitative evaluation. Qualitative data collection methods will include semi-structured interviews, field observations, and periodic reflections.
Specific Aims Aim 1. To prepare for implementation of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Pre-Implementation) Pre-Implementation Phase (12 months)
- Quantitative assessment of practice variation in HTN control.
- Qualitative assessment of practice barriers and facilitators to HTN management.
- Creation of a clinical decision support tool for program referral.
- Creation of project-specific patient and employee Advisory Panel.
- Pharmacist and advanced practice provider (APP) training for delivery of the program.
- Practice facilitation training with the Cleveland Clinic continuous improvement team.
- Community Health Worker/Primary Care Navigator Training for Patient Outreach.
- Creation of presentations for primary care staff meetings. Aim 2. To implement the intensive HTN management program across all Northeast Ohio Primary Care Practices (Rollout and Active Implementation) Implementation Phase (24 months)
- Stepped wedge rollout of intensive HTN management program.
- Implementation of the clinical decision support tool at implementation sites.
- Community Health Worker/Primary Care Navigator outreach to patients.
- Delivery of Presentations at primary care staff meetings.
- Practice Facilitation at Implementation Sites.
- Qualitative data collection regarding patient and provider implementation outcomes of acceptability and feasibility.
- Quantitative data collection of implementation outcomes of adoption, fidelity, effectiveness, implementation cost; provider surveys re: acceptability, appropriateness, feasibility.
- Patient and employee advisory panel input into implementation evaluation. Aim 3. To monitor and evaluate the maintenance of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Maintenance) Maintenance Phase (9 months)
- Quantitative data collection of implementation outcomes-reach, adoption, fidelity, effectiveness, cost-compared to the active implementation phase.
- Capture practice-level adaptations with comparison to the active implementation phase.
- Complete final data collection and analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertension diagnosis, aged 18-85 years old
- •Uncontrolled blood pressure, defined as a blood pressure reading of > 150/95
排除标准
- •pregnant, stage 5 chronic kidney disease, End Stage Renal Disease, enrolled in hospice care
结局指标
主要结局
Systolic Blood Pressure Change
时间窗: Patients will be followed for up to 33 months: 24-month implementation/intervention period and 9-month maintenance period.
The main effectiveness finding the investigators expect to report at the end of the proposed implementation project is the change in patient systolic blood pressure from baseline to 12 months post-implementation. The expected change in systolic blood pressure based upon Margolis et al.(1) is -18mmHg. The period of evaluation will be from the time of program enrollment, with home BP measurements assessed every 2-3 weeks until the blood pressure is less than 135/85 and at 12 months. The blood pressure will continue to be measured every 6 months through the full the 24-month implementation/intervention period (allowing all sites to roll out the intervention) and a 9-month maintenance period.
次要结局
- Diastolic Blood Pressure Change(The patient's blood pressure will be measured for up to 33 months (24-month implementation/intervention period and 9-month maintenance period). Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance.)
- Reach (Actual): Patients Offered, Initiated, Completed(Measured every 3 months for up to 33 months.)
- Effectiveness: Equity in Outcomes (Race)(Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.)
- Effectiveness: Equity in Outcomes (Ethnicity)(Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.)
- Effectiveness: Equity in Outcomes (Gender)(Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.)
- Effectiveness: Equity in Outcomes (Age)(Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.)
- Effectiveness: Equity in Outcomes (Insurance)(Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months.)
- Effectiveness: Medication change(Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.)
- Effectiveness: Medication Adherence(Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.)
- Effectiveness: Cardiovascular outcomes(Baseline, and every 6 months through maintenance: for up to 33 months.)
- Effectiveness: Acute Renal Failure - Change in glomerular filtration rate (GFR).(Every 6 months through maintenance: for up to 33 months.)
- Effectiveness: PROMIS-10 Survey(Baseline at intake visit then at 12 months: up to 24-months.)
- Effectiveness: Adverse Effects(Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months.)
- Implementation: Provider views of the Acceptability, Appropriateness, and Feasibility survey(Every 6 months starting throughout active implementation and maintenance: for up to 33 months.)
- Primary Care Provider Adoption(Every 3 months during intervention period: for up to 24 months)
- Pharmacist Adoption(Every 3 months during intervention period: for up to 24 months.)
- Advanced Practice Provider Adoption(Every 3 months during intervention period: for up to 24 months.)
- Formal Qualitative Assessment of context of high proportion of HTN control and low proportion of HTN control practices: Pre-Implementation(Pre-Implementation: up to 12 months.)
- Formal Qualitative Assessment: Observations of Employee and Patient Advisory Panels(Quarterly meetings throughout pre- and active implementation: up to 36 months.)
- Formal Qualitative Assessment: Semi-structured Interviews with Patients at High/Low proportion of HTN Control(Baseline, 6 months, 12 months during active implementation: up to 24 months.)
- Formal Qualitative Assessment: Periodic Reflections with agents of implementation(Monthly or bimonthly throughout active implementation and maintenance: for up to 33 months.)
- Outcome measure type: Effectiveness (Hospitalizations / Emergency Department Visits)(Every 6 months: up to 33 months.)
- Outcome Measure Type: Effectiveness (Outpatient Visits)(Every 6 months: up to 33 months.)
研究者
Anita Misra-Hebert
Professor of Medicine, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Staff, Department of Internal Medicine, Director, Healthcare Delivery and Implementation Science Center
The Cleveland Clinic