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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02674464
Acronym
RICH LIFE
Enrollment
1820
Registered
2016-02-04
Start date
2017-09-01
Completion date
2022-02-28
Last updated
2022-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncontrolled Hypertension

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.

Interventions

BEHAVIORALProvider 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.

BEHAVIORALBlood 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.

BEHAVIORALSystem 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.

BEHAVIORALCollaborative 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.

BEHAVIORALCommunity 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

BEHAVIORALSpecialist 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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Controlled Blood Pressure12 monthsNumber of participants with Controlled Blood Pressure (\<140/90 mm Hg).
Patient Activation Measure (PAM-13)Baseline, 12 monthsThe 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.

Secondary

MeasureTime frameDescription
% With BP <130/80 mmHg12 monthsClinical Outcome
% With BP <120/80 mmHg12 monthsClinical Outcome
Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c)Baseline, 12, 24 monthsClinical Outcome
% With Hemoglobin A1c< 7.0BaselineClinical Outcome
Change in Medication Adherence 4-Item ScaleBaseline, 12, 24 monthsPatient Reported Outcome
Mean Systolic Blood PressureBaseline, 12 monthsMean Systolic Blood Pressure in mm Hg at baseline and 12 months.
Mean Diastolic Blood PressureBaseline, 12 monthsMean Diastolic Blood Pressure in mm Hg at baseline and 12 months.
Change in Global Framingham Risk ScoreBaseline, 12, 24 monthsClinical Outcome
Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus)Baseline, 12, 24 monthsPatient Reported Outcome
Change in Mean LDL-C (mg/dL)Baseline, 12, 24 monthsClinical Outcome
Change in Mean HDL (mg/dL)Baseline, 12, 24 monthsClinical Outcome
% With Controlled Total CholesterolBaselineClinical Outcome
Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 ScoreBaseline 12, 24 monthsPatient Reported Outcome
Change in Patient Ratings of TrustBaseline, 12, 24 monthsPatient Reported Outcome
Change in Hypertension Knowledge and AttitudesBaseline, 12, 24 monthsPatient Reported Outcome
Change in Health Related Quality of Life (PROMIS Global Scale)Baseline, 12, 24 monthsPatient Reported Outcome
Change in Patient Attainment of Self-Defined GoalsBaseline, 12, 24 monthsPatient Reported Outcome
Change in Mean Total Cholesterol (mg/dL)Baseline, 12, 24 monthsClinical Outcome
% With BP <140/90 mmHg24 monthsClinical Outcome

Countries

United States

Participant flow

Recruitment details

Using eligibility criteria, the study biostatistician screened participating health systems' electronic medical record (EMR) data to identify potentially eligible patients. Only patients seen within 6 months prior to the recruitment data pull were assessed for eligibility. Trained study staff recruited participants between August 1, 2017, and October 31, 2019. The baseline blood pressure measurement was included in the recruitment data.

Pre-assignment details

Participants were considered enrolled upon completing the baseline survey. Whenever possible, trained study staff administered the baseline survey immediately after obtaining consent to participate.

Participants by arm

ArmCount
Standard of Care Plus (SCP)
Practices in the Standard of Care Plus (SCP) comparator group received interventions designed to reinforce and standardize evidence-based hypertension care best practices across both intervention and comparator practices. The plus in the standard care arm included integration of proper BP measurement techniques, hypertension care best practices, and audit and feedback of hypertension control performance, as usual care at each practice. Additionally, health-system- and practice-level leaders at SCP practices participated in a system-level leadership engagement intervention consisting of quarterly, one-hour calls.
927
Collaborative Care/Stepped Care (CC/SC)
The intensive Collaborative Care/Stepped Care (CC/SC) arm includes all components of the SCP arm and plus the establishment of a practice-based collaborative care team with a stepped-care approach; quarterly hypertension dashboard education and training; and twice quarterly coaching calls for system- and practice-level leaders, care managers (CM), and community health workers (CHWs) the CC/SC arm to discuss the interventions during their active intervention phase. In the CC/SC approach, treatment for patients with prolonged uncontrolled hypertension is enhanced by adding a care manager and a community health worker (CHW) to deliver community-based contextualized care, or consultation with a panel of sub-specialists, or both, as necessary, to improve patient-centered outcomes and reduce disparities in hypertension control.
893
Total1,820

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath1021
Overall StudyLost to Follow-up9792
Overall StudyOutside survey window63
Overall StudyWithdrawal by Subject2444

Baseline characteristics

CharacteristicCollaborative Care/Stepped Care (CC/SC)Standard of Care Plus (SCP)Total
Age, Continuous59.9 years
STANDARD_DEVIATION 11.7
60.7 years
STANDARD_DEVIATION 12.1
60.3 years
STANDARD_DEVIATION 11.9
Coronary heart disease110 Participants149 Participants259 Participants
Depression256 Participants263 Participants519 Participants
Diabetes392 Participants429 Participants821 Participants
Diastolic Blood Pressure86.6 mm Hg
STANDARD_DEVIATION 12.9
84.4 mm Hg
STANDARD_DEVIATION 11.7
85.5 mm Hg
STANDARD_DEVIATION 12.3
Education, highest degree
Bachelor's degree
103 Participants115 Participants218 Participants
Education, highest degree
Graduate degree
77 Participants105 Participants182 Participants
Education, highest degree
High school diploma/GED
428 Participants434 Participants862 Participants
Education, highest degree
Less than high school diploma
177 Participants156 Participants333 Participants
Education, highest degree
Missing (refused)
3 Participants4 Participants7 Participants
Education, highest degree
Some college
105 Participants113 Participants218 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
42 Participants130 Participants172 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
851 Participants797 Participants1648 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Hyperlipidemia646 Participants700 Participants1346 Participants
Medicaid
Missing
5 Participants6 Participants11 Participants
Medicaid
No
624 Participants703 Participants1327 Participants
Medicaid
Yes
264 Participants218 Participants482 Participants
Patient Activation Measure (PAM-13)66.7 score on a scale
STANDARD_DEVIATION 15.9
65.4 score on a scale
STANDARD_DEVIATION 16.2
66.0 score on a scale
STANDARD_DEVIATION 16.1
Race (NIH/OMB)
American Indian or Alaska Native
4 Participants0 Participants4 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
566 Participants463 Participants1029 Participants
Race (NIH/OMB)
More than one race
25 Participants30 Participants55 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
19 Participants74 Participants93 Participants
Race (NIH/OMB)
White
279 Participants359 Participants638 Participants
Region of Enrollment
United States
893 Participants927 Participants1820 Participants
Sex: Female, Male
Female
547 Participants534 Participants1081 Participants
Sex: Female, Male
Male
346 Participants393 Participants739 Participants
Smoker280 Participants267 Participants547 Participants
Systolic Blood Pressure152.7 mm Hg
STANDARD_DEVIATION 12.9
151.9 mm Hg
STANDARD_DEVIATION 11.7
152.3 mm Hg
STANDARD_DEVIATION 12.1

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
21 / 92734 / 893
other
Total, other adverse events
515 / 927499 / 893
serious
Total, serious adverse events
0 / 9270 / 893

Outcome results

Primary

Number of Participants With Controlled Blood Pressure

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

Time frame: 12 months

Population: We received BP data on 750 patients in the SCP arm and on 754 patients in the CC/SC arm from EMR's.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard of Care Plus (SCP)Number of Participants With Controlled Blood Pressure462 Participants
Collaborative Care/Stepped Care (CC/SC)Number of Participants With Controlled Blood Pressure442 Participants
p-value: 0.6895% CI: [0.62, 1.3]Generalized Estimating Equations (GEE)
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.

Time frame: Baseline, 12 months

Population: 790 patients in the SCP arm completed the follow-up survey at 12-months, but 1 patient did not complete the PAM-13 (primary patient-reported outcome) questions in the survey resulting in 789 patients in the sample. 733 patients in the CC/SC arm competed the follow-up survey at 12-months, but 2 patients did not complete the PAM-13 (primary patient-reported outcome) questions in the survey resulting in 731 patients in the sample.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Standard of Care Plus (SCP)Patient Activation Measure (PAM-13)Baseline65.4 score on a scale
Standard of Care Plus (SCP)Patient Activation Measure (PAM-13)12 months66.7 score on a scale
Collaborative Care/Stepped Care (CC/SC)Patient Activation Measure (PAM-13)Baseline66.1 score on a scale
Collaborative Care/Stepped Care (CC/SC)Patient Activation Measure (PAM-13)12 months67.9 score on a scale
p-value: 0.695% CI: [-1.32, 2.3]Mixed Effects Regression
Secondary

Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score

Patient Reported Outcome

Time frame: Baseline 12, 24 months

Secondary

Change in Global Framingham Risk Score

Clinical Outcome

Time frame: Baseline, 12, 24 months

Secondary

Change in Health Related Quality of Life (PROMIS Global Scale)

Patient Reported Outcome

Time frame: Baseline, 12, 24 months

Secondary

Change in Hypertension Knowledge and Attitudes

Patient Reported Outcome

Time frame: Baseline, 12, 24 months

Secondary

Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c)

Clinical Outcome

Time frame: Baseline, 12, 24 months

Secondary

Change in Mean HDL (mg/dL)

Clinical Outcome

Time frame: Baseline, 12, 24 months

Secondary

Change in Mean LDL-C (mg/dL)

Clinical Outcome

Time frame: Baseline, 12, 24 months

Secondary

Change in Mean Total Cholesterol (mg/dL)

Clinical Outcome

Time frame: Baseline, 12, 24 months

Secondary

Change in Medication Adherence 4-Item Scale

Patient Reported Outcome

Time frame: Baseline, 12, 24 months

Secondary

Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus)

Patient Reported Outcome

Time frame: Baseline, 12, 24 months

Secondary

Change in Patient Attainment of Self-Defined Goals

Patient Reported Outcome

Time frame: Baseline, 12, 24 months

Secondary

Change in Patient Ratings of Trust

Patient Reported Outcome

Time frame: Baseline, 12, 24 months

Secondary

Mean Diastolic Blood Pressure

Mean Diastolic Blood Pressure in mm Hg at baseline and 12 months.

Time frame: Baseline, 12 months

Population: We received BP data on 750 patients in the SCP arm and on 754 patients in the CC/SC arm from EMR's.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Standard of Care Plus (SCP)Mean Diastolic Blood PressureBaseline84.7 mm Hg
Standard of Care Plus (SCP)Mean Diastolic Blood Pressure12 months78.9 mm Hg
Collaborative Care/Stepped Care (CC/SC)Mean Diastolic Blood PressureBaseline86.7 mm Hg
Collaborative Care/Stepped Care (CC/SC)Mean Diastolic Blood Pressure12 months79.8 mm Hg
p-value: 0.0595% CI: [-2.43, 0.01]Mixed Effects Regression
Secondary

Mean Systolic Blood Pressure

Mean Systolic Blood Pressure in mm Hg at baseline and 12 months.

Time frame: Baseline, 12 months

Population: We received BP data on 750 patients in the SCP arm and on 754 patients in the CC/SC arm from EMR's.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)
Standard of Care Plus (SCP)Mean Systolic Blood PressureBaseline151.8 mm Hg
Standard of Care Plus (SCP)Mean Systolic Blood Pressure12 months137.1 mm Hg
Collaborative Care/Stepped Care (CC/SC)Mean Systolic Blood PressureBaseline152.5 mm Hg
Collaborative Care/Stepped Care (CC/SC)Mean Systolic Blood Pressure12 months138.7 mm Hg
p-value: 0.3895% CI: [-1.04, 2.71]Mixed Effects Regression
Secondary

% With BP <120/80 mmHg

Clinical Outcome

Time frame: 24 months

Secondary

% With BP <120/80 mmHg

Clinical Outcome

Time frame: 12 months

Secondary

% With BP <130/80 mmHg

Clinical Outcome

Time frame: 24 months

Secondary

% With BP <130/80 mmHg

Clinical Outcome

Time frame: 12 months

Secondary

% With BP <140/90 mmHg

Clinical Outcome

Time frame: 24 months

Secondary

% With Controlled Total Cholesterol

Clinical Outcome

Time frame: 24 months

Secondary

% With Controlled Total Cholesterol

Clinical Outcome

Time frame: 12 months

Secondary

% With Controlled Total Cholesterol

Clinical Outcome

Time frame: Baseline

Secondary

% With Hemoglobin A1c< 7.0

Clinical Outcome

Time frame: 12 months

Secondary

% With Hemoglobin A1c< 7.0

Clinical Outcome

Time frame: Baseline

Secondary

% With Hemoglobin A1c< 7.0

Clinical Outcome

Time frame: 24 months

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026