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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02674464
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 1,820
• Location: 1
• Arms: 2
• Actual Duration (Months): 53.9
• Patients Per Site Per Month: 33.8

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1820 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: Sep 1, 2017
• Actual Primary Completion Date: Feb 28, 2022
• Actual Study Completion Date: Feb 28, 2022

Arms and Interventions

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 Names: 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 Names: 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 Names: 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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Controlled Blood Pressure [12 months]

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

2. 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 Outcome Measures

1. Mean Systolic Blood Pressure [Baseline, 12 months]

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

2. Mean Diastolic Blood Pressure [Baseline, 12 months]

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

3. Change in Global Framingham Risk Score [Baseline, 12, 24 months]

   Clinical Outcome

4. Change in Mean Total Cholesterol (mg/dL) [Baseline, 12, 24 months]

   Clinical Outcome

5. Change in Mean LDL-C (mg/dL) [Baseline, 12, 24 months]

   Clinical Outcome

6. Change in Mean HDL (mg/dL) [Baseline, 12, 24 months]

   Clinical Outcome

7. % With Controlled Total Cholesterol [Baseline]

   Clinical Outcome

8. % With Controlled Total Cholesterol [12 months]

   Clinical Outcome

9. % With Controlled Total Cholesterol [24 months]

   Clinical Outcome

10. Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c) [Baseline, 12, 24 months]

    Clinical Outcome

11. % With Hemoglobin A1c< 7.0 [Baseline]

    Clinical Outcome

12. % With Hemoglobin A1c< 7.0 [12 months]

    Clinical Outcome

13. % With Hemoglobin A1c< 7.0 [24 months]

    Clinical Outcome

14. Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus) [Baseline, 12, 24 months]

    Patient Reported Outcome

15. % With BP <140/90 mmHg [24 months]

    Clinical Outcome

16. % With BP <130/80 mmHg [12 months]

    Clinical Outcome

17. % With BP <130/80 mmHg [24 months]

    Clinical Outcome

18. % With BP <120/80 mmHg [12 months]

    Clinical Outcome

19. % With BP <120/80 mmHg [24 months]

    Clinical Outcome

20. Change in Medication Adherence 4-Item Scale [Baseline, 12, 24 months]

    Patient Reported Outcome

21. Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score [Baseline 12, 24 months]

    Patient Reported Outcome

22. Change in Patient Ratings of Trust [Baseline, 12, 24 months]

    Patient Reported Outcome

23. Change in Hypertension Knowledge and Attitudes [Baseline, 12, 24 months]

    Patient Reported Outcome

24. Change in Health Related Quality of Life (PROMIS Global Scale) [Baseline, 12, 24 months]

    Patient Reported Outcome

25. Change in Patient Attainment of Self-Defined Goals [Baseline, 12, 24 months]

    Patient Reported Outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Lisa Cooper, MD, MPH, Johns Hopkins University
• Principal Investigator: Jill Marsteller, PhD, Johns Hopkins Bloomberg School of Public Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 15, 2021
• Informed Consent Form - Jul 2, 2018

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02674464
• Other Study ID Numbers: IRB00085630; UH3HL130688
• First Posted: Feb 4, 2016
• Last Update Posted: Jul 1, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

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 Detail

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

Arm/Group Title	Standard of Care Plus	Collaborative Care/Stepped Care (CC/SC)
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	927	893
6 Month Follow-up	771	806
COMPLETED	790	733
NOT COMPLETED	137	160

Baseline Characteristics

Arm/Group Title	Standard of Care Plus (SCP)	Collaborative Care/Stepped Care (CC/SC)	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	927	893	1820
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.7 (12.1)	59.9 (11.7)	60.3 (11.9)
Sex: Female, Male (Count of Participants)
Female	534 57.6%	547 61.3%	1081 59.4%
Male	393 42.4%	346 38.7%	739 40.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	130 14%	42 4.7%	172 9.5%
Not Hispanic or Latino	797 86%	851 95.3%	1648 90.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	4 0.4%	4 0.2%
Asian	1 0.1%	0 0%	1 0.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	463 49.9%	566 63.4%	1029 56.5%
White	359 38.7%	279 31.2%	638 35.1%
More than one race	30 3.2%	25 2.8%	55 3%
Unknown or Not Reported	74 8%	19 2.1%	93 5.1%
Region of Enrollment (Count of Participants)
United States	927 100%	893 100%	1820 100%
Education, highest degree (Count of Participants)
Less than high school diploma	156 16.8%	177 19.8%	333 18.3%
High school diploma/GED	434 46.8%	428 47.9%	862 47.4%
Some college	113 12.2%	105 11.8%	218 12%
Bachelor's degree	115 12.4%	103 11.5%	218 12%
Graduate degree	105 11.3%	77 8.6%	182 10%
Missing (refused)	4 0.4%	3 0.3%	7 0.4%
Medicaid (Count of Participants)
Yes	218 23.5%	264 29.6%	482 26.5%
No	703 75.8%	624 69.9%	1327 72.9%
Missing	6 0.6%	5 0.6%	11 0.6%
Systolic Blood Pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	151.9 (11.7)	152.7 (12.9)	152.3 (12.1)
Diastolic Blood Pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	84.4 (11.7)	86.6 (12.9)	85.5 (12.3)
Diabetes (Count of Participants)
Count of Participants [Participants]	429 46.3%	392 43.9%	821 45.1%
Hyperlipidemia (Count of Participants)
Count of Participants [Participants]	700 75.5%	646 72.3%	1346 74%
Coronary heart disease (Count of Participants)
Count of Participants [Participants]	149 16.1%	110 12.3%	259 14.2%
Depression (Count of Participants)
Count of Participants [Participants]	263 28.4%	256 28.7%	519 28.5%
Smoker (Count of Participants)
Count of Participants [Participants]	267 28.8%	280 31.4%	547 30.1%
Patient Activation Measure (PAM-13) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	65.4 (16.2)	66.7 (15.9)	66.0 (16.1)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Controlled Blood Pressure
Description	Number of participants with Controlled Blood Pressure (<140/90 mm Hg).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Standard of Care Plus (SCP)	Collaborative Care/Stepped Care (CC/SC)
Arm/Group Description	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.	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.
Measure Participants	750	754
Count of Participants [Participants]	462 49.8%	442 49.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care Plus (SCP), Collaborative Care/Stepped Care (CC/SC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments	The a priori threshold for statistical significance was <0.05.
	Method	Generalized Estimating Equations (GEE)
	Comments	Assuming an exchangeable correlation structure
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.90
	Confidence Interval	(2-Sided) 95%; 0.62 to 1.30
	Parameter Dispersion	Type: Value:
	Estimation Comments	CC/SC arm compared to the SCP arm.

2. Primary Outcome

Title	Patient Activation Measure (PAM-13)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Standard of Care Plus (SCP)	Collaborative Care/Stepped Care (CC/SC)
Arm/Group Description	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.	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.
Measure Participants	789	731
Baseline	65.4	66.1
12 months	66.7	67.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care Plus (SCP), Collaborative Care/Stepped Care (CC/SC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.60
	Comments	The a priori threshold for statistical significance was <0.05.
	Method	Mixed Effects Regression
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.49
	Confidence Interval	(2-Sided) 95%; -1.32 to 2.30
	Parameter Dispersion	Type: Value:
	Estimation Comments	CC/SC arm was compared to the SCP arm.

3. Secondary Outcome

Title	Mean Systolic Blood Pressure
Description	Mean Systolic Blood Pressure in mm Hg at baseline and 12 months.
Time Frame	Baseline, 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Standard of Care Plus (SCP)	Collaborative Care/Stepped Care (CC/SC)
Arm/Group Description	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.	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.
Measure Participants	750	754
Baseline	151.8	152.5
12 months	137.1	138.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care Plus (SCP), Collaborative Care/Stepped Care (CC/SC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments	The a priori threshold for statistical significance was <0.05.
	Method	Mixed Effects Regression
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; -1.04 to 2.71
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Mean Diastolic Blood Pressure
Description	Mean Diastolic Blood Pressure in mm Hg at baseline and 12 months.
Time Frame	Baseline, 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Standard of Care Plus (SCP)	Collaborative Care/Stepped Care (CC/SC)
Arm/Group Description	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.	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.
Measure Participants	750	754
Baseline	84.7	86.7
12 months	78.9	79.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care Plus (SCP), Collaborative Care/Stepped Care (CC/SC)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments	The a priori threshold for statistical significance was <0.05.
	Method	Mixed Effects Regression
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.2
	Confidence Interval	(2-Sided) 95%; -2.43 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	CC/SC arm compared to SCP arm.

5. Secondary Outcome

Title	Change in Global Framingham Risk Score
Description	Clinical Outcome
Time Frame	Baseline, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Change in Mean Total Cholesterol (mg/dL)
Description	Clinical Outcome
Time Frame	Baseline, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Change in Mean LDL-C (mg/dL)
Description	Clinical Outcome
Time Frame	Baseline, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Change in Mean HDL (mg/dL)
Description	Clinical Outcome
Time Frame	Baseline, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	% With Controlled Total Cholesterol
Description	Clinical Outcome
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	% With Controlled Total Cholesterol
Description	Clinical Outcome
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	% With Controlled Total Cholesterol
Description	Clinical Outcome
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c)
Description	Clinical Outcome
Time Frame	Baseline, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Secondary Outcome

Title	% With Hemoglobin A1c< 7.0
Description	Clinical Outcome
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Secondary Outcome

Title	% With Hemoglobin A1c< 7.0
Description	Clinical Outcome
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Secondary Outcome

Title	% With Hemoglobin A1c< 7.0
Description	Clinical Outcome
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Secondary Outcome

Title	Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus)
Description	Patient Reported Outcome
Time Frame	Baseline, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

17. Secondary Outcome

Title	% With BP <140/90 mmHg
Description	Clinical Outcome
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

18. Secondary Outcome

Title	% With BP <130/80 mmHg
Description	Clinical Outcome
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

19. Secondary Outcome

Title	% With BP <130/80 mmHg
Description	Clinical Outcome
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

20. Secondary Outcome

Title	% With BP <120/80 mmHg
Description	Clinical Outcome
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

21. Secondary Outcome

Title	% With BP <120/80 mmHg
Description	Clinical Outcome
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

22. Secondary Outcome

Title	Change in Medication Adherence 4-Item Scale
Description	Patient Reported Outcome
Time Frame	Baseline, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

23. Secondary Outcome

Title	Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score
Description	Patient Reported Outcome
Time Frame	Baseline 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

24. Secondary Outcome

Title	Change in Patient Ratings of Trust
Description	Patient Reported Outcome
Time Frame	Baseline, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

25. Secondary Outcome

Title	Change in Hypertension Knowledge and Attitudes
Description	Patient Reported Outcome
Time Frame	Baseline, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

26. Secondary Outcome

Title	Change in Health Related Quality of Life (PROMIS Global Scale)
Description	Patient Reported Outcome
Time Frame	Baseline, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

27. Secondary Outcome

Title	Change in Patient Attainment of Self-Defined Goals
Description	Patient Reported Outcome
Time Frame	Baseline, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse events data were collected up to 1 year.
Arm/Group Title	Standard of Care Plus (SCP)		Collaborative Care/Stepped Care (CC/SC)
Arm/Group Description	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.		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.
All Cause Mortality
	Standard of Care Plus (SCP)		Collaborative Care/Stepped Care (CC/SC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/927 (2.3%)		34/893 (3.8%)
Serious Adverse Events
	Standard of Care Plus (SCP)		Collaborative Care/Stepped Care (CC/SC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/927 (0%)		0/893 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care Plus (SCP)		Collaborative Care/Stepped Care (CC/SC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	515/927 (55.6%)		499/893 (55.9%)
Cardiac disorders
Self-reported stroke	22/875 (2.5%)		24/835 (2.9%)
Myocardial infarction	9/875 (1%)		19/835 (2.3%)
Hypotension	197/873 (22.6%)		186/842 (22.1%)
Hypertension	147/873 (16.8%)		150/842 (17.8%)
Bradycardia	3/873 (0.3%)		0/842 (0%)
General disorders
Fall precipitating medical treatment	84/875 (9.6%)		82/835 (9.8%)
Hospitalizations	227/875 (25.9%)		212/835 (25.4%)
Hyponatremia	6/927 (0.6%)		12/893 (1.3%)
Hypernatremia	1/927 (0.1%)		2/893 (0.2%)
Hypokalemia	6/927 (0.6%)		8/893 (0.9%)
Hyperkalemia	21/927 (2.3%)		29/893 (3.2%)
Renal and urinary disorders
Serum creatinine increase by at least 50% since previous measure	9/927 (1%)		15/893 (1.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.