Clinical trial NCT02674464: Reducing Inequities in Care of Hypertension, Lifestyle Improvement for Everyone (RICH LIFE Project)
Official title: Comparative Effectiveness of Health System vs. Multilevel Interventions to Reduce Hypertension Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncontrolled Hypertension
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Patient-Centered Outcomes Research Institute
First posted: 2016-02-04
Enrollment: 1820
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients (≥21 years of age) obtaining primary care from a provider at a participating practice
2. 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

Exclusion Criteria:

1. Cardiovascular event (unstable angina, myocardial infarction) within the past 6 months
2. Serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)
3. Condition which interferes with outcome measurement (e.g., dialysis)
4. Pregnant or planning a pregnancy during study period. Nursing mothers would need approval from physician.
5. Alcohol or substance use disorder if not sober/abstinent for ≥30 days
6. Planning to leave clinic within 6 months or move out of geographic area within 18 months
7. Individuals with cognitive impairment or other condition which makes them unable to participate in the intervention
8. Participating in another lifestyle modification, weight reduction, or treatment trial

Primary outcomes:
measure: Number of Participants With Controlled Blood Pressure
timeFrame: 12 months
measure: Patient Activation Measure (PAM-13)
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Mean Systolic Blood Pressure
timeFrame: Baseline, 12 months
measure: Mean Diastolic Blood Pressure
timeFrame: Baseline, 12 months
measure: Change in Global Framingham Risk Score
timeFrame: Baseline, 12, 24 months
measure: Change in Mean Total Cholesterol (mg/dL)
timeFrame: Baseline, 12, 24 months
measure: Change in Mean LDL-C (mg/dL)
timeFrame: Baseline, 12, 24 months
measure: Change in Mean HDL (mg/dL)
timeFrame: Baseline, 12, 24 months
measure: % With Controlled Total Cholesterol
timeFrame: Baseline
measure: % With Controlled Total Cholesterol
timeFrame: 12 months
measure: % With Controlled Total Cholesterol
timeFrame: 24 months
measure: Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c)
timeFrame: Baseline, 12, 24 months
measure: % With Hemoglobin A1c< 7.0
timeFrame: Baseline
measure: % With Hemoglobin A1c< 7.0
timeFrame: 12 months
measure: % With Hemoglobin A1c< 7.0
timeFrame: 24 months
measure: Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus)
timeFrame: Baseline, 12, 24 months
measure: % With BP <140/90 mmHg
timeFrame: 24 months
measure: % With BP <130/80 mmHg
timeFrame: 12 months
measure: % With BP <130/80 mmHg
timeFrame: 24 months
measure: % With BP <120/80 mmHg
timeFrame: 12 months
measure: % With BP <120/80 mmHg
timeFrame: 24 months
measure: Change in Medication Adherence 4-Item Scale
timeFrame: Baseline, 12, 24 months
measure: Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score
timeFrame: Baseline 12, 24 months
measure: Change in Patient Ratings of Trust
timeFrame: Baseline, 12, 24 months
measure: Change in Hypertension Knowledge and Attitudes
timeFrame: Baseline, 12, 24 months
measure: Change in Health Related Quality of Life (PROMIS Global Scale)
timeFrame: Baseline, 12, 24 months
measure: Change in Patient Attainment of Self-Defined Goals
timeFrame: Baseline, 12, 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lisa Cooper, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Jill Marsteller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alvarez C, Ibe C, Dietz K, Carrero ND, Avornu G, Turkson-Ocran RA, Bhattarai J, Crews D, Lipman PD, Cooper LA; RICH LIFE Project Investigators. Development and Implementation of a Combined Nurse Care Manager and Community Health Worker Training Curriculum to Address Hypertension Disparities. J Ambul Care Manage. 2022 Jul-Sep 01;45(3):230-241. doi: 10.1097/JAC.0000000000000422.
citation: Cooper LA, Marsteller JA, Carson KA, Dietz KB, Boonyasai RT, Alvarez C, Ibe CA, Crews DC, Yeh HC, Miller ER 3rd, Dennison-Himmelfarb CR, Lubomski LH, Purnell TS, Hill-Briggs F, Wang NY; RICH LIFE Project Investigators. The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities. Am Heart J. 2020 Aug;226:94-113. doi: 10.1016/j.ahj.2020.05.001. Epub 2020 May 8.