Uncontrolled Hypertension
Conditions
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
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.
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.
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.
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.
As a stepped up component of the Collaborative Care Team Intervention for patients needing support in overcoming a variety of social determinants
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
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Controlled Blood Pressure | 12 months | Number of participants with Controlled Blood Pressure (\<140/90 mm Hg). |
| Patient Activation Measure (PAM-13) | Baseline, 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % With BP <130/80 mmHg | 12 months | Clinical Outcome |
| % With BP <120/80 mmHg | 12 months | Clinical Outcome |
| Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c) | Baseline, 12, 24 months | Clinical Outcome |
| % With Hemoglobin A1c< 7.0 | Baseline | Clinical Outcome |
| Change in Medication Adherence 4-Item Scale | Baseline, 12, 24 months | Patient Reported Outcome |
| Mean Systolic Blood Pressure | Baseline, 12 months | Mean Systolic Blood Pressure in mm Hg at baseline and 12 months. |
| Mean Diastolic Blood Pressure | Baseline, 12 months | Mean Diastolic Blood Pressure in mm Hg at baseline and 12 months. |
| Change in Global Framingham Risk Score | Baseline, 12, 24 months | Clinical Outcome |
| Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus) | Baseline, 12, 24 months | Patient Reported Outcome |
| Change in Mean LDL-C (mg/dL) | Baseline, 12, 24 months | Clinical Outcome |
| Change in Mean HDL (mg/dL) | Baseline, 12, 24 months | Clinical Outcome |
| % With Controlled Total Cholesterol | Baseline | Clinical Outcome |
| Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score | Baseline 12, 24 months | Patient Reported Outcome |
| Change in Patient Ratings of Trust | Baseline, 12, 24 months | Patient Reported Outcome |
| Change in Hypertension Knowledge and Attitudes | Baseline, 12, 24 months | Patient Reported Outcome |
| Change in Health Related Quality of Life (PROMIS Global Scale) | Baseline, 12, 24 months | Patient Reported Outcome |
| Change in Patient Attainment of Self-Defined Goals | Baseline, 12, 24 months | Patient Reported Outcome |
| Change in Mean Total Cholesterol (mg/dL) | Baseline, 12, 24 months | Clinical Outcome |
| % With BP <140/90 mmHg | 24 months | Clinical 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
| Arm | Count |
|---|---|
| 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 |
| Total | 1,820 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 10 | 21 |
| Overall Study | Lost to Follow-up | 97 | 92 |
| Overall Study | Outside survey window | 6 | 3 |
| Overall Study | Withdrawal by Subject | 24 | 44 |
Baseline characteristics
| Characteristic | Collaborative Care/Stepped Care (CC/SC) | Standard of Care Plus (SCP) | Total |
|---|---|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 11.7 | 60.7 years STANDARD_DEVIATION 12.1 | 60.3 years STANDARD_DEVIATION 11.9 |
| Coronary heart disease | 110 Participants | 149 Participants | 259 Participants |
| Depression | 256 Participants | 263 Participants | 519 Participants |
| Diabetes | 392 Participants | 429 Participants | 821 Participants |
| Diastolic Blood Pressure | 86.6 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 Participants | 115 Participants | 218 Participants |
| Education, highest degree Graduate degree | 77 Participants | 105 Participants | 182 Participants |
| Education, highest degree High school diploma/GED | 428 Participants | 434 Participants | 862 Participants |
| Education, highest degree Less than high school diploma | 177 Participants | 156 Participants | 333 Participants |
| Education, highest degree Missing (refused) | 3 Participants | 4 Participants | 7 Participants |
| Education, highest degree Some college | 105 Participants | 113 Participants | 218 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 130 Participants | 172 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 851 Participants | 797 Participants | 1648 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hyperlipidemia | 646 Participants | 700 Participants | 1346 Participants |
| Medicaid Missing | 5 Participants | 6 Participants | 11 Participants |
| Medicaid No | 624 Participants | 703 Participants | 1327 Participants |
| Medicaid Yes | 264 Participants | 218 Participants | 482 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 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 566 Participants | 463 Participants | 1029 Participants |
| Race (NIH/OMB) More than one race | 25 Participants | 30 Participants | 55 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 74 Participants | 93 Participants |
| Race (NIH/OMB) White | 279 Participants | 359 Participants | 638 Participants |
| Region of Enrollment United States | 893 Participants | 927 Participants | 1820 Participants |
| Sex: Female, Male Female | 547 Participants | 534 Participants | 1081 Participants |
| Sex: Female, Male Male | 346 Participants | 393 Participants | 739 Participants |
| Smoker | 280 Participants | 267 Participants | 547 Participants |
| Systolic Blood Pressure | 152.7 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 type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 21 / 927 | 34 / 893 |
| other Total, other adverse events | 515 / 927 | 499 / 893 |
| serious Total, serious adverse events | 0 / 927 | 0 / 893 |
Outcome results
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Plus (SCP) | Number of Participants With Controlled Blood Pressure | 462 Participants |
| Collaborative Care/Stepped Care (CC/SC) | Number of Participants With Controlled Blood Pressure | 442 Participants |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard of Care Plus (SCP) | Patient Activation Measure (PAM-13) | Baseline | 65.4 score on a scale |
| Standard of Care Plus (SCP) | Patient Activation Measure (PAM-13) | 12 months | 66.7 score on a scale |
| Collaborative Care/Stepped Care (CC/SC) | Patient Activation Measure (PAM-13) | Baseline | 66.1 score on a scale |
| Collaborative Care/Stepped Care (CC/SC) | Patient Activation Measure (PAM-13) | 12 months | 67.9 score on a scale |
Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score
Patient Reported Outcome
Time frame: Baseline 12, 24 months
Change in Global Framingham Risk Score
Clinical Outcome
Time frame: Baseline, 12, 24 months
Change in Health Related Quality of Life (PROMIS Global Scale)
Patient Reported Outcome
Time frame: Baseline, 12, 24 months
Change in Hypertension Knowledge and Attitudes
Patient Reported Outcome
Time frame: Baseline, 12, 24 months
Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c)
Clinical Outcome
Time frame: Baseline, 12, 24 months
Change in Mean HDL (mg/dL)
Clinical Outcome
Time frame: Baseline, 12, 24 months
Change in Mean LDL-C (mg/dL)
Clinical Outcome
Time frame: Baseline, 12, 24 months
Change in Mean Total Cholesterol (mg/dL)
Clinical Outcome
Time frame: Baseline, 12, 24 months
Change in Medication Adherence 4-Item Scale
Patient Reported Outcome
Time frame: Baseline, 12, 24 months
Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus)
Patient Reported Outcome
Time frame: Baseline, 12, 24 months
Change in Patient Attainment of Self-Defined Goals
Patient Reported Outcome
Time frame: Baseline, 12, 24 months
Change in Patient Ratings of Trust
Patient Reported Outcome
Time frame: Baseline, 12, 24 months
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard of Care Plus (SCP) | Mean Diastolic Blood Pressure | Baseline | 84.7 mm Hg |
| Standard of Care Plus (SCP) | Mean Diastolic Blood Pressure | 12 months | 78.9 mm Hg |
| Collaborative Care/Stepped Care (CC/SC) | Mean Diastolic Blood Pressure | Baseline | 86.7 mm Hg |
| Collaborative Care/Stepped Care (CC/SC) | Mean Diastolic Blood Pressure | 12 months | 79.8 mm Hg |
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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Standard of Care Plus (SCP) | Mean Systolic Blood Pressure | Baseline | 151.8 mm Hg |
| Standard of Care Plus (SCP) | Mean Systolic Blood Pressure | 12 months | 137.1 mm Hg |
| Collaborative Care/Stepped Care (CC/SC) | Mean Systolic Blood Pressure | Baseline | 152.5 mm Hg |
| Collaborative Care/Stepped Care (CC/SC) | Mean Systolic Blood Pressure | 12 months | 138.7 mm Hg |
% With BP <120/80 mmHg
Clinical Outcome
Time frame: 24 months
% With BP <120/80 mmHg
Clinical Outcome
Time frame: 12 months
% With BP <130/80 mmHg
Clinical Outcome
Time frame: 24 months
% With BP <130/80 mmHg
Clinical Outcome
Time frame: 12 months
% With BP <140/90 mmHg
Clinical Outcome
Time frame: 24 months
% With Controlled Total Cholesterol
Clinical Outcome
Time frame: 24 months
% With Controlled Total Cholesterol
Clinical Outcome
Time frame: 12 months
% With Controlled Total Cholesterol
Clinical Outcome
Time frame: Baseline
% With Hemoglobin A1c< 7.0
Clinical Outcome
Time frame: 12 months
% With Hemoglobin A1c< 7.0
Clinical Outcome
Time frame: Baseline
% With Hemoglobin A1c< 7.0
Clinical Outcome
Time frame: 24 months