Comparative Effectiveness of Health System vs. Multilevel Interventions to Reduce Hypertension Disparities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,820
- 试验地点
- 1
- 主要终点
- Number of Participants With Controlled Blood Pressure
研究概览
简要总结
The RICH LIFE Project is a two-armed, cluster-randomized trial, comparing the effectiveness of an enhanced standard of care arm, "Standard of Care Plus" (SCP), to a multi-level intervention, "Collaborative Care/Stepped Care" (CC/SC), in improving blood pressure control, patient activation and reducing disparities in blood pressure control among 1,890 adult patients with uncontrolled hypertension and cardiovascular disease risk factors at thirty primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized blood pressure measurement training, and audit and feedback of blood pressure control rates at the practice provider level. Fifteen practices in the CC/SC arm receive all the SCP interventions plus the implementation of the collaborative care model with additional stepped-care components of community health worker referrals and subspecialist curbside consults and an on-going virtual workshop for organizational leaders in quality improvement and disparities reduction. The primary clinical outcomes are the percent of patients with blood pressure <140/90 mm Hg and change from baseline in mean systolic blood pressure at 12 months. The primary patient reported outcome is change from baseline in self-reported patient activation at 12 months.
详细描述
The investigators refined research aim is to determine if a clinic-based collaborative care team, including a community health worker (CHW) to deliver community-based contextualized care, reduces disparities in blood pressure control rates, lowers cardiovascular disease (CVD) risk, and improves outcomes among patients with hypertension and other common comorbid conditions when compared to standard of care health system approaches to CVD risk management, including audit and feedback and staff and provider training.
Collaborative care includes care coordination and care management; regular and proactive monitoring and treatment to target specific patient needs using validated clinical tools and rating scales; and regular systematic caseload reviews by the care team and consultation with experts for patients who do not show clinical improvement. A typical collaborative care team includes the primary care provider, nurse care manager or coordinator, and other members of the clinic staff involved in patient care.
Intervention protocols are designed to address common comorbidities (diabetes, hyperlipidemia, depression and coronary heart disease), lifestyle factors (dietary intake, physical activity, and smoking) and medication adherence. The intensive intervention treats the "whole" patient, driven by individual patient goals and priorities, as opposed to the standard of care, which typically focuses on individual conditions. This proposed study responds directly to patient desires to feel more equipped to be involved in their care and manage multiple conditions that contribute to CVD. The investigators have worked successfully in the past with a broad range of stakeholders, including community members, patients, providers, and payors, and will continue to engage them through the research and dissemination process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (≥21 years of age) obtaining primary care from a provider at a participating practice
- •A diagnosis of hypertension or SBP≥140mmHg or DBP≥90mmHg twice in the past year or on antihypertensive medications plus at least one of the following CVD risk factors:
- •Diabetes mellitus (fasting blood sugar> 125mg/dl or hemoglobin A1c>6.5 or on a hypoglycemic medication);
- •Dyslipidemia (LDL >130 mg/dl, HDL<40 or total cholesterol >200 or on a lipid lowering agent);
- •Coronary heart disease
- •Current tobacco smokers
- •Depression by International Classification of Disease, 9th edition (ICD-9), codes or Patient Health Questionnaire (PHQ) score >9
排除标准
- •Cardiovascular event (unstable angina, myocardial infarction) within the past 6 months
- •Serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)
- •Condition which interferes with outcome measurement (e.g., dialysis)
- •Pregnant or planning a pregnancy during study period. Nursing mothers would need approval from physician.
- •Alcohol or substance use disorder if not sober/abstinent for ≥30 days
- •Planning to leave clinic within 6 months or move out of geographic area within 18 months
- •Individuals with cognitive impairment or other condition which makes them unable to participate in the intervention
- •Participating in another lifestyle modification, weight reduction, or treatment trial
研究组 & 干预措施
Standard of Care Plus
The standard of care plus arm will include audit and feedback of blood pressure control rates at the provider level along with web-based training about: 1) barriers to blood pressure and cardiovascular disease (CVD) risk factors management in at-risk patient populations; 2) strategies to address healthcare disparities in clinical settings; and 3) appropriate blood pressure (BP) measurement techniques for all clinical staff. The Hopkins research team will help clinics develop audit and feedback mechanisms if they are lacking and will provide all blood pressure measurement and web-based training.
干预措施: Provider Audit-Feedback, Stratified by Race and Ethnicity (Behavioral)
Standard of Care Plus
The standard of care plus arm will include audit and feedback of blood pressure control rates at the provider level along with web-based training about: 1) barriers to blood pressure and cardiovascular disease (CVD) risk factors management in at-risk patient populations; 2) strategies to address healthcare disparities in clinical settings; and 3) appropriate blood pressure (BP) measurement techniques for all clinical staff. The Hopkins research team will help clinics develop audit and feedback mechanisms if they are lacking and will provide all blood pressure measurement and web-based training.
干预措施: Blood Pressure Measurement Standardization (Behavioral)
Collaborative Care/Stepped Care (CC/SC)
The CC/SC arm includes: -BP training -Audit and feedback dashboard, data stratified by race, ethnicity, payor status -A 4 hour workshop for organizational leaders in quality improvement and disparities reduction, with follow up meetings for problem-solving and support, and web-based, patient-centered communication skills training program for providers and staff -Support and guidance in establishing collaborative care model (CCM): team-based care targeting health behaviors and medication adherence. The primary care provider (PCP), care manager, CHW, and specialists in: medication management, psychosocial/behavioral, and self-management will make up the CCM team -Community health workers (CHW) working on contextualized patient interactions focused on problem-solving skills and patient self-management. CHWs will visit their patients in their homes and communities -Provider access to on-call specialists for help with patients who do not achieve BP control under the CC/SC
干预措施: Provider Audit-Feedback, Stratified by Race and Ethnicity (Behavioral)
Collaborative Care/Stepped Care (CC/SC)
The CC/SC arm includes: -BP training -Audit and feedback dashboard, data stratified by race, ethnicity, payor status -A 4 hour workshop for organizational leaders in quality improvement and disparities reduction, with follow up meetings for problem-solving and support, and web-based, patient-centered communication skills training program for providers and staff -Support and guidance in establishing collaborative care model (CCM): team-based care targeting health behaviors and medication adherence. The primary care provider (PCP), care manager, CHW, and specialists in: medication management, psychosocial/behavioral, and self-management will make up the CCM team -Community health workers (CHW) working on contextualized patient interactions focused on problem-solving skills and patient self-management. CHWs will visit their patients in their homes and communities -Provider access to on-call specialists for help with patients who do not achieve BP control under the CC/SC
干预措施: Blood Pressure Measurement Standardization (Behavioral)
Collaborative Care/Stepped Care (CC/SC)
The CC/SC arm includes: -BP training -Audit and feedback dashboard, data stratified by race, ethnicity, payor status -A 4 hour workshop for organizational leaders in quality improvement and disparities reduction, with follow up meetings for problem-solving and support, and web-based, patient-centered communication skills training program for providers and staff -Support and guidance in establishing collaborative care model (CCM): team-based care targeting health behaviors and medication adherence. The primary care provider (PCP), care manager, CHW, and specialists in: medication management, psychosocial/behavioral, and self-management will make up the CCM team -Community health workers (CHW) working on contextualized patient interactions focused on problem-solving skills and patient self-management. CHWs will visit their patients in their homes and communities -Provider access to on-call specialists for help with patients who do not achieve BP control under the CC/SC
干预措施: System Level Leadership Intervention (Behavioral)
Collaborative Care/Stepped Care (CC/SC)
The CC/SC arm includes: -BP training -Audit and feedback dashboard, data stratified by race, ethnicity, payor status -A 4 hour workshop for organizational leaders in quality improvement and disparities reduction, with follow up meetings for problem-solving and support, and web-based, patient-centered communication skills training program for providers and staff -Support and guidance in establishing collaborative care model (CCM): team-based care targeting health behaviors and medication adherence. The primary care provider (PCP), care manager, CHW, and specialists in: medication management, psychosocial/behavioral, and self-management will make up the CCM team -Community health workers (CHW) working on contextualized patient interactions focused on problem-solving skills and patient self-management. CHWs will visit their patients in their homes and communities -Provider access to on-call specialists for help with patients who do not achieve BP control under the CC/SC
干预措施: Collaborative Care Team Intervention (Behavioral)
Collaborative Care/Stepped Care (CC/SC)
The CC/SC arm includes: -BP training -Audit and feedback dashboard, data stratified by race, ethnicity, payor status -A 4 hour workshop for organizational leaders in quality improvement and disparities reduction, with follow up meetings for problem-solving and support, and web-based, patient-centered communication skills training program for providers and staff -Support and guidance in establishing collaborative care model (CCM): team-based care targeting health behaviors and medication adherence. The primary care provider (PCP), care manager, CHW, and specialists in: medication management, psychosocial/behavioral, and self-management will make up the CCM team -Community health workers (CHW) working on contextualized patient interactions focused on problem-solving skills and patient self-management. CHWs will visit their patients in their homes and communities -Provider access to on-call specialists for help with patients who do not achieve BP control under the CC/SC
干预措施: Community Health Worker Referral (Behavioral)
Collaborative Care/Stepped Care (CC/SC)
The CC/SC arm includes: -BP training -Audit and feedback dashboard, data stratified by race, ethnicity, payor status -A 4 hour workshop for organizational leaders in quality improvement and disparities reduction, with follow up meetings for problem-solving and support, and web-based, patient-centered communication skills training program for providers and staff -Support and guidance in establishing collaborative care model (CCM): team-based care targeting health behaviors and medication adherence. The primary care provider (PCP), care manager, CHW, and specialists in: medication management, psychosocial/behavioral, and self-management will make up the CCM team -Community health workers (CHW) working on contextualized patient interactions focused on problem-solving skills and patient self-management. CHWs will visit their patients in their homes and communities -Provider access to on-call specialists for help with patients who do not achieve BP control under the CC/SC
干预措施: Specialist Care Consultation (Behavioral)
结局指标
主要结局
Number of Participants With Controlled Blood Pressure
时间窗: 12 months
Number of participants with Controlled Blood Pressure (\<140/90 mm Hg).
Patient Activation Measure (PAM-13)
时间窗: Baseline, 12 months
The Patient Activation Measure assesses knowledge, skills, and confidence in the management of one's health. It is comprised of 13 items and each item is on a 1-5 scale. Insignia health scores on a standardized overall score of 0-100 where higher scores indicate a better outcome.
次要结局
- % With BP <120/80 mmHg(24 months)
- Change in Medication Adherence 4-Item Scale(Baseline, 12, 24 months)
- Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score(Baseline 12, 24 months)
- % With Controlled Total Cholesterol(24 months)
- Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c)(Baseline, 12, 24 months)
- Mean Systolic Blood Pressure(Baseline, 12 months)
- Mean Diastolic Blood Pressure(Baseline, 12 months)
- Change in Mean Total Cholesterol (mg/dL)(Baseline, 12, 24 months)
- Change in Mean HDL (mg/dL)(Baseline, 12, 24 months)
- Change in Global Framingham Risk Score(Baseline, 12, 24 months)
- Change in Mean LDL-C (mg/dL)(Baseline, 12, 24 months)
- Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus)(Baseline, 12, 24 months)
- % With Hemoglobin A1c< 7.0(24 months)
- % With BP <140/90 mmHg(24 months)
- % With BP <130/80 mmHg(24 months)
- Change in Patient Ratings of Trust(Baseline, 12, 24 months)
- Change in Hypertension Knowledge and Attitudes(Baseline, 12, 24 months)
- Change in Health Related Quality of Life (PROMIS Global Scale)(Baseline, 12, 24 months)
- Change in Patient Attainment of Self-Defined Goals(Baseline, 12, 24 months)
- % With Controlled Total Cholesterol(Baseline)
- % With Controlled Total Cholesterol(12 months)
- % With Hemoglobin A1c< 7.0(Baseline)
- % With Hemoglobin A1c< 7.0(12 months)
- % With BP <130/80 mmHg(12 months)
- % With BP <120/80 mmHg(12 months)