Reducing Inequities in Care of Hypertension, Lifestyle Improvement for Everyone (RICH LIFE Project)

Uncontrolled Hypertension Clinical Trial

— RICH LIFE  

Official title:

Comparative Effectiveness of Health System vs. Multilevel Interventions to Reduce Hypertension Disparities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674464
• Other study ID #: IRB00085630
• Secondary ID: UH3HL130688
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: February 28, 2022

Study information

• Verified date: June 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1820
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

Behavioral:
• Provider Audit-Feedback, Stratified by Race and Ethnicity
Transparent and timely access to and review of clinical performance data are among the key elements of successful improvement activities. The RICH LIFE Project provides the health systems with the logic to build practice and provider level hypertension (HTN) dashboards, support in building the dashboard, and education in utilizing the dashboard. The practice dashboard provides a display of the percentage of patients achieving BP control, defined as <140/90 mm Hg for the overall practice, while the provider dashboard provides a display of the percentage of patients achieving BP control for each provider's patient panel. Both the practice and provider Dashboards stratify hypertension performance data by race (White, non-Hispanic; Black, non-Hispanic; and All Hispanic) to help practice administration and clinicians evaluate differences between races and ethnicities in BP control rates. New reports are generated at least quarterly and will display data from the previous 3 months.
• Blood Pressure Measurement Standardization
All adult medicine staff at participating study practices receive standardized, evidence-based, best practices BP measurement training. Aspects of the training include proper patient preparation and positioning, how use of an automated BP measurement device, and executing a "screen and confirm" protocol when measuring patients' blood pressures.
• System Level Leadership Intervention
This System-Level Leadership intervention aims to create a learning network through an inter-organizational approach to promote health equity and reduce CVD disparities. Elements of the system-level leadership intervention, then, include: 1) an introductory session during the kick-off event (baseline); 2) a quarterly 1 hour "content call" with a presentation on leading for equity and discussion among system-level leaders, community organization leaders, and interested practice champions in the CC/Stepped care arm conducted via conference call/webinar; and 3) monthly "coaching calls" for the system and practice level leaders, CMs, and CHWs in the CC/stepped care arm to discuss the interventions, while they are actively engaged in the intervention phase.
• Collaborative Care Team Intervention
The collaborative care intervention creates a collaborative care team that, at a minimum, consists of PCP, nurse, or social worker care manager, and community health worker. The collaborative care team develops the medical management plan in partnership with patients; 2) uses care coordination to maximize interaction of the patients' PCPs with other care providers addressing medication management, patient self-management, and psychosocial support on a regular, consistent basis; and 3) determines patient access to CHW support and subspecialty consultations.
• Community Health Worker Referral
As a "stepped up" component of the Collaborative Care Team Intervention for patients needing support in overcoming a variety of social determinants
• Specialist Care Consultation
As a "stepped up" component of the Collaborative Care Team Intervention for patients with complex medical conditions and/or patients that may not typically have access to specialist care

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI), Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Controlled Blood Pressure	Number of participants with Controlled Blood Pressure (<140/90 mm Hg).	12 months
Primary	Patient Activation Measure (PAM-13)	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.	Baseline, 12 months
Secondary	Mean Systolic Blood Pressure	Mean Systolic Blood Pressure in mm Hg at baseline and 12 months.	Baseline, 12 months
Secondary	Mean Diastolic Blood Pressure	Mean Diastolic Blood Pressure in mm Hg at baseline and 12 months.	Baseline, 12 months
Secondary	Change in Global Framingham Risk Score	Clinical Outcome	Baseline, 12, 24 months
Secondary	Change in Mean Total Cholesterol (mg/dL)	Clinical Outcome	Baseline, 12, 24 months
Secondary	Change in Mean LDL-C (mg/dL)	Clinical Outcome	Baseline, 12, 24 months
Secondary	Change in Mean HDL (mg/dL)	Clinical Outcome	Baseline, 12, 24 months
Secondary	% With Controlled Total Cholesterol	Clinical Outcome	Baseline
Secondary	% With Controlled Total Cholesterol	Clinical Outcome	12 months
Secondary	% With Controlled Total Cholesterol	Clinical Outcome	24 months
Secondary	Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c)	Clinical Outcome	Baseline, 12, 24 months
Secondary	% With Hemoglobin A1c< 7.0	Clinical Outcome	Baseline
Secondary	% With Hemoglobin A1c< 7.0	Clinical Outcome	12 months
Secondary	% With Hemoglobin A1c< 7.0	Clinical Outcome	24 months
Secondary	Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus)	Patient Reported Outcome	Baseline, 12, 24 months
Secondary	% With BP <140/90 mmHg	Clinical Outcome	24 months
Secondary	% With BP <130/80 mmHg	Clinical Outcome	12 months
Secondary	% With BP <130/80 mmHg	Clinical Outcome	24 months
Secondary	% With BP <120/80 mmHg	Clinical Outcome	12 months
Secondary	% With BP <120/80 mmHg	Clinical Outcome	24 months
Secondary	Change in Medication Adherence 4-Item Scale	Patient Reported Outcome	Baseline, 12, 24 months
Secondary	Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score	Patient Reported Outcome	Baseline 12, 24 months
Secondary	Change in Patient Ratings of Trust	Patient Reported Outcome	Baseline, 12, 24 months
Secondary	Change in Hypertension Knowledge and Attitudes	Patient Reported Outcome	Baseline, 12, 24 months
Secondary	Change in Health Related Quality of Life (PROMIS Global Scale)	Patient Reported Outcome	Baseline, 12, 24 months
Secondary	Change in Patient Attainment of Self-Defined Goals	Patient Reported Outcome	Baseline, 12, 24 months