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

NCT02674464 | Completed Results DMC

• 2 other identifiers: IRB00085630UH3HL130688
• Study Type: interventional
• Target: 1,820
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncontrolled Hypertension

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Controlled Blood Pressure

  Number of participants with Controlled Blood Pressure (\<140/90 mm Hg).

  12 months

• 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 Outcomes (25)

• Mean Systolic Blood Pressure

  Baseline, 12 months

• Mean Diastolic Blood Pressure

  Baseline, 12 months

• Change in Global Framingham Risk Score

  Baseline, 12, 24 months

• Change in Mean Total Cholesterol (mg/dL)

  Baseline, 12, 24 months

• Change in Mean LDL-C (mg/dL)

  Baseline, 12, 24 months

Study Arms (2)

Standard of Care Plus

ACTIVE COMPARATOR

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.

Behavioral: Provider Audit-Feedback, Stratified by Race and Ethnicity; Behavioral: Blood Pressure Measurement Standardization

Collaborative Care/Stepped Care (CC/SC)

EXPERIMENTAL

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

Behavioral: Provider Audit-Feedback, Stratified by Race and Ethnicity; Behavioral: Blood Pressure Measurement Standardization; Behavioral: System Level Leadership Intervention; Behavioral: Collaborative Care Team Intervention; Behavioral: Community Health Worker Referral; Behavioral: Specialist Care Consultation

Interventions

Provider Audit-Feedback, Stratified by Race and Ethnicity BEHAVIORAL

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.

Also known as: Stratified Hypertension Dashboard

Collaborative Care/Stepped Care (CC/SC); Standard of Care Plus

Blood Pressure Measurement Standardization BEHAVIORAL

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.

Collaborative Care/Stepped Care (CC/SC); Standard of Care Plus

System Level Leadership Intervention BEHAVIORAL

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/Stepped Care (CC/SC)

Collaborative Care Team Intervention BEHAVIORAL

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.

Also known as: Collaborative Care Model

Collaborative Care/Stepped Care (CC/SC)

Community Health Worker Referral BEHAVIORAL

As a "stepped up" component of the Collaborative Care Team Intervention for patients needing support in overcoming a variety of social determinants

Collaborative Care/Stepped Care (CC/SC)

Specialist Care Consultation BEHAVIORAL

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

Collaborative Care/Stepped Care (CC/SC)

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

• Alvarez C, Perrin N, Carson KA, Marsteller JA, Cooper LA; RICH LIFE Project Investigators. Adverse Childhood Experiences, Depression, Patient Activation, and Medication Adherence Among Patients With Uncontrolled Hypertension. Am J Hypertens. 2023 Mar 15;36(4):209-216. doi: 10.1093/ajh/hpac123.

  PMID: 36322608 DERIVED

• 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.

  PMID: 35612394 DERIVED

• 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.

  PMID: 32526534 DERIVED

MeSH Terms

Interventions

Ethnicity

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Results Point of Contact

• Title: Dr. Lisa Cooper, Principal Investigator
• Organization: Johns Hopkins University School of Medicine

lisa.cooper@jhmi.edu

4106143659

Study Officials

• Lisa Cooper, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Jill Marsteller, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: February 4, 2016
• Study Start: September 1, 2017
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: July 1, 2022
• Results First Posted: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)