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| ID | Type | Description | Link |
|---|---|---|---|
| UH3HL130688 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Systolic Blood Pressure | Mean Systolic Blood Pressure in mm Hg at baseline and 12 months. | Baseline, 12 months |
| Mean Diastolic Blood Pressure | Mean Diastolic Blood Pressure in mm Hg at baseline and 12 months. |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Cooper, MD, MPH | Johns Hopkins University | Principal Investigator |
| Jill Marsteller, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36322608 | Derived | 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. | |
| 35612394 | 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. |
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Participants were considered enrolled upon completing the baseline survey. Whenever possible, trained study staff administered the baseline survey immediately after obtaining consent to participate.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Plus | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2021 |
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| 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. |
|
| 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 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. |
|
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| 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 |
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| 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 |
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| Baseline, 12 months |
| Change in Global Framingham Risk Score | Clinical Outcome | Baseline, 12, 24 months |
| Change in Mean Total Cholesterol (mg/dL) | Clinical Outcome | Baseline, 12, 24 months |
| Change in Mean LDL-C (mg/dL) | Clinical Outcome | Baseline, 12, 24 months |
| Change in Mean HDL (mg/dL) | Clinical Outcome | Baseline, 12, 24 months |
| % With Controlled Total Cholesterol | Clinical Outcome | Baseline |
| % With Controlled Total Cholesterol | Clinical Outcome | 12 months |
| % With Controlled Total Cholesterol | Clinical Outcome | 24 months |
| Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c) | Clinical Outcome | Baseline, 12, 24 months |
| % With Hemoglobin A1c< 7.0 | Clinical Outcome | Baseline |
| % With Hemoglobin A1c< 7.0 | Clinical Outcome | 12 months |
| % With Hemoglobin A1c< 7.0 | Clinical Outcome | 24 months |
| Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus) | Patient Reported Outcome | Baseline, 12, 24 months |
| % With BP <140/90 mmHg | Clinical Outcome | 24 months |
| % With BP <130/80 mmHg | Clinical Outcome | 12 months |
| % With BP <130/80 mmHg | Clinical Outcome | 24 months |
| % With BP <120/80 mmHg | Clinical Outcome | 12 months |
| % With BP <120/80 mmHg | Clinical Outcome | 24 months |
| Change in Medication Adherence 4-Item Scale | Patient Reported Outcome | Baseline, 12, 24 months |
| Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score | Patient Reported Outcome | Baseline 12, 24 months |
| Change in Patient Ratings of Trust | Patient Reported Outcome | Baseline, 12, 24 months |
| Change in Hypertension Knowledge and Attitudes | Patient Reported Outcome | Baseline, 12, 24 months |
| Change in Health Related Quality of Life (PROMIS Global Scale) | Patient Reported Outcome | Baseline, 12, 24 months |
| Change in Patient Attainment of Self-Defined Goals | Patient Reported Outcome | Baseline, 12, 24 months |
| 32526534 | 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. |
| FG001 | 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. |
| 6 Month Follow-up | 6 month survey data collection of adverse events |
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| COMPLETED | 12 month follow-up (primary endpoint) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Education, highest degree | Count of Participants | Participants |
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| Medicaid | Count of Participants | Participants |
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| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| Diabetes | Electronic medical record diagnosis | Count of Participants | Participants |
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| Hyperlipidemia | Electronic medical record diagnosis | Count of Participants | Participants |
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| Coronary heart disease | Electronic medical record diagnosis | Count of Participants | Participants |
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| Depression | Electronic medical record diagnosis | Count of Participants | Participants |
| |||||||||||||||
| Smoker | Count of Participants | Participants |
| ||||||||||||||||
| Patient Activation Measure (PAM-13) | 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. | Mean | Standard Deviation | score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Controlled Blood Pressure | Number of participants with Controlled Blood Pressure (<140/90 mm Hg). | We received BP data on 750 patients in the SCP arm and on 754 patients in the CC/SC arm from EMR's. | Posted | Count of Participants | Participants | 12 months |
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| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, 12 months |
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| Secondary | Mean Systolic Blood Pressure | Mean Systolic Blood Pressure in mm Hg at baseline and 12 months. | We received BP data on 750 patients in the SCP arm and on 754 patients in the CC/SC arm from EMR's. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | Baseline, 12 months |
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| Secondary | Mean Diastolic Blood Pressure | Mean Diastolic Blood Pressure in mm Hg at baseline and 12 months. | We received BP data on 750 patients in the SCP arm and on 754 patients in the CC/SC arm from EMR's. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | Baseline, 12 months |
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| Secondary | Change in Global Framingham Risk Score | Clinical Outcome | Not Posted | Baseline, 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mean Total Cholesterol (mg/dL) | Clinical Outcome | Not Posted | Baseline, 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mean LDL-C (mg/dL) | Clinical Outcome | Not Posted | Baseline, 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mean HDL (mg/dL) | Clinical Outcome | Not Posted | Baseline, 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | % With Controlled Total Cholesterol | Clinical Outcome | Not Posted | Baseline | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | % With Controlled Total Cholesterol | Clinical Outcome | Not Posted | 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | % With Controlled Total Cholesterol | Clinical Outcome | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c) | Clinical Outcome | Not Posted | Baseline, 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | % With Hemoglobin A1c< 7.0 | Clinical Outcome | Not Posted | Baseline | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | % With Hemoglobin A1c< 7.0 | Clinical Outcome | Not Posted | 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | % With Hemoglobin A1c< 7.0 | Clinical Outcome | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus) | Patient Reported Outcome | Not Posted | Baseline, 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | % With BP <140/90 mmHg | Clinical Outcome | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | % With BP <130/80 mmHg | Clinical Outcome | Not Posted | 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | % With BP <130/80 mmHg | Clinical Outcome | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | % With BP <120/80 mmHg | Clinical Outcome | Not Posted | 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | % With BP <120/80 mmHg | Clinical Outcome | Not Posted | 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Medication Adherence 4-Item Scale | Patient Reported Outcome | Not Posted | Baseline, 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score | Patient Reported Outcome | Not Posted | Baseline 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Patient Ratings of Trust | Patient Reported Outcome | Not Posted | Baseline, 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Hypertension Knowledge and Attitudes | Patient Reported Outcome | Not Posted | Baseline, 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Health Related Quality of Life (PROMIS Global Scale) | Patient Reported Outcome | Not Posted | Baseline, 12, 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Patient Attainment of Self-Defined Goals | Patient Reported Outcome | Not Posted | Baseline, 12, 24 months | Participants |
Adverse events data were collected up to 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 21 | 927 | 0 | 927 | 515 | 927 |
| EG001 | 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. | 34 | 893 | 0 | 893 | 499 | 893 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self-reported stroke | Cardiac disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Fall precipitating medical treatment | General disorders | Systematic Assessment |
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| Hospitalizations | General disorders | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment | Systolic blood pressure less than 90 mm Hg or diastolic blood pressure less than 60 mm Hg |
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| Hypertension | Cardiac disorders | Systematic Assessment | Systolic blood pressure greater than or equal to 180 mm Hg or diastolic blood pressure greater than or equal to 110 mm Hg |
| |
| Bradycardia | Cardiac disorders | Systematic Assessment | Heart rate less than 40 beats/minute |
| |
| Hyponatremia | General disorders | Systematic Assessment | Serum sodium less than 130 mEq/L |
| |
| Hypernatremia | General disorders | Systematic Assessment | Serum sodium greater than 150 mEq/L |
| |
| Hypokalemia | General disorders | Systematic Assessment | Serum potassium less than 3.0 mEq/L |
| |
| Hyperkalemia | General disorders | Systematic Assessment | Serum potassium greater than 5.5 mEq/L |
| |
| Serum creatinine increase by at least 50% since previous measure | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Cooper, Principal Investigator | Johns Hopkins University School of Medicine | 4106143659 | lisa.cooper@jhmi.edu |
| May 2, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2018 | May 2, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D005006 | Ethnicity |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| High school diploma/GED |
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| Some college |
|
| Bachelor's degree |
|
| Graduate degree |
|
| Missing (refused) |
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| No |
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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. |
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