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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02674464
Recruitment Status : Active, not recruiting
First Posted : February 4, 2016
Last Update Posted : February 17, 2021
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Uncontrolled Hypertension 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1822 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Health System vs. Multilevel Interventions to Reduce Hypertension Disparities
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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.
Other Name: Stratified Hypertension Dashboard

Behavioral: 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.

Experimental: 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
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.
Other Name: Stratified Hypertension Dashboard

Behavioral: 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.

Behavioral: 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.

Behavioral: 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.
Other Name: Collaborative Care Model

Behavioral: 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

Behavioral: 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




Primary Outcome Measures :
  1. % with Controlled BP (<140/90) [ Time Frame: 12 months ]
    Clinical Outcome

  2. Change in Patient Activation Measure (PAM-13) [ Time Frame: Baseline, 12 months ]
    Patient Reported Outcome; The Patient Activation Measure is comprised of 13 items. Insignia Health scores the 13 items on a theoretical 0-100 scale. Higher scores indicate the patient is more activated.


Secondary Outcome Measures :
  1. Change in Global Framingham Risk Score [ Time Frame: Baseline, 12, 24 months ]
    Clinical Outcome

  2. Change in Mean Total Cholesterol (mg/dL) [ Time Frame: Baseline, 12, 24 months ]
    Clinical Outcome

  3. Change in Mean LDL-C (mg/dL) [ Time Frame: Baseline, 12, 24 months ]
    Clinical Outcome

  4. Change in Mean HDL (mg/dL) [ Time Frame: Baseline, 12, 24 months ]
    Clinical Outcome

  5. % with Controlled Total Cholesterol [ Time Frame: Baseline ]
    Clinical Outcome

  6. % with Controlled Total Cholesterol [ Time Frame: 12 months ]
    Clinical Outcome

  7. % with Controlled Total Cholesterol [ Time Frame: 24 months ]
    Clinical Outcome

  8. Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c) [ Time Frame: Baseline, 12, 24 months ]
    Clinical Outcome

  9. % with Hemoglobin A1c< 7.0 [ Time Frame: Baseline ]
    Clinical Outcome

  10. % with Hemoglobin A1c< 7.0 [ Time Frame: 12 months ]
    Clinical Outcome

  11. % with Hemoglobin A1c< 7.0 [ Time Frame: 24 months ]
    Clinical Outcome

  12. Change in Mean Systolic BP [ Time Frame: Baseline, 12, 24 months ]
    Clinical Outcome

  13. Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus) [ Time Frame: Baseline, 12, 24 months ]
    Patient Reported Outcome

  14. % with BP <140/90 mmHg [ Time Frame: Baseline ]
    Clinical Outcome

  15. % with BP <140/90 mmHg [ Time Frame: 12 months ]
    Clinical Outcome

  16. % with BP <140/90 mmHg [ Time Frame: 24 months ]
    Clinical Outcome

  17. % with BP <130/80 mmHg [ Time Frame: 12 months ]
    Clinical Outcome

  18. % with BP <130/80 mmHg [ Time Frame: 24 months ]
    Clinical Outcome

  19. % with BP <120/80 mmHg [ Time Frame: 12 months ]
    Clinical Outcome

  20. % with BP <120/80 mmHg [ Time Frame: 24 months ]
    Clinical Outcome

  21. Change in Medication Adherence 4-Item Scale [ Time Frame: Baseline, 12, 24 months ]
    Patient Reported Outcome

  22. Change in Depressive Symptoms PHQ-8 Score [ Time Frame: Baseline 12, 24 months ]
    Patient Reported Outcome

  23. Change in Patient Ratings of Trust [ Time Frame: Baseline, 12, 24 months ]
    Patient Reported Outcome

  24. Change in Hypertension Knowledge and Attitudes [ Time Frame: Baseline, 12, 24 months ]
    Patient Reported Outcome

  25. Change in Health Related Quality of Life (PROMIS Global Scale) [ Time Frame: Baseline, 12, 24 months ]
    Patient Reported Outcome

  26. Change in Patient Attainment of Self-Defined Goals [ Time Frame: Baseline, 12, 24 months ]
    Patient Reported Outcome

  27. Change in Mean Diastolic Blood Pressure (mm/Hg) [ Time Frame: Baseline, 12 months, 24 months ]
    Clinical Outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674464


Locations
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United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Lisa Cooper, MD, MPH Johns Hopkins University
Principal Investigator: Jill Marsteller, PhD Johns Hopkins Bloomberg School of Public Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02674464    
Other Study ID Numbers: IRB00085630
UH3HL130688 ( U.S. NIH Grant/Contract )
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases