Uncontrolled HypertensionRICH LIFENCT02674464
Reducing Inequities in Care of Hypertension, Lifestyle Improvement for Everyone (RICH LIFE Project)
A study testing Provider Audit-Feedback, Stratified by Race and Ethnicity, Blood Pressure Measurement Standardization and System Level Leadership Intervention in people with Uncontrolled Hypertension, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Provider Audit-Feedback, Stratified by Race and Ethnicity, Blood Pressure Measurement Standardization and System Level Leadership Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,820 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- Cardiovascular event (unstable angina, myocardial infarction) within the past 6 months
- Serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)
- Condition which interferes with outcome measurement (e.g., dialysis)
- Pregnant or planning a pregnancy during study period. Nursing mothers would need approval from physician.
- Alcohol or substance use disorder if not sober/abstinent for ≥30 days
- Planning to leave clinic within 6 months or move out of geographic area within 18 months
- Individuals with cognitive impairment or other condition which makes them unable to participate in the intervention
- Participating in another lifestyle modification, weight reduction, or treatment trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
About this study
Official title: Comparative Effectiveness of Health System vs. Multilevel Interventions to Reduce Hypertension Disparities
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.
Read the 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.
- Conditions
- Uncontrolled Hypertension
- Being tested
- Provider Audit-Feedback, Stratified by Race and Ethnicity, Blood Pressure Measurement Standardization, System Level Leadership Intervention, Collaborative Care Team Intervention, Community Health Worker Referral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider Audit-Feedback, Stratified by Race and EthnicityBehavioural
Also called Stratified Hypertension Dashboard
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.
Blood Pressure Measurement StandardizationBehavioural
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 InterventionBehavioural
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 InterventionBehavioural
Also called Collaborative Care Model
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.
Community Health Worker ReferralBehavioural
As a "stepped up" component of the Collaborative Care Team Intervention for patients needing support in overcoming a variety of social determinants
Specialist Care ConsultationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Provider Audit-Feedback, Stratified by Race and Ethnicity; Behavioral: Blood Pressure Measurement Standardization |
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Controlled Blood Pressure
Number of participants with Controlled Blood Pressure (<140/90 mm Hg).
Measured: 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.
Measured: Baseline, 12 months
Secondary outcomes (25)
Mean Systolic Blood Pressure
Mean Systolic Blood Pressure in mm Hg at baseline and 12 months.
Measured: Baseline, 12 months
Mean Diastolic Blood Pressure
Mean Diastolic Blood Pressure in mm Hg at baseline and 12 months.
Measured: Baseline, 12 months
Change in Global Framingham Risk Score
Clinical Outcome
Measured: Baseline, 12, 24 months
Change in Mean Total Cholesterol (mg/dL)
Clinical Outcome
Measured: Baseline, 12, 24 months
Change in Mean LDL-C (mg/dL)
Clinical Outcome
Measured: Baseline, 12, 24 months
Change in Mean HDL (mg/dL)
Clinical Outcome
Measured: Baseline, 12, 24 months
% With Controlled Total Cholesterol
Clinical Outcome
Measured: Baseline
% With Controlled Total Cholesterol
Clinical Outcome
Measured: 12 months
% With Controlled Total Cholesterol
Clinical Outcome
Measured: 24 months
Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c)
Clinical Outcome
Measured: Baseline, 12, 24 months
% With Hemoglobin A1c< 7.0
Clinical Outcome
Measured: Baseline
% With Hemoglobin A1c< 7.0
Clinical Outcome
Measured: 12 months
% With Hemoglobin A1c< 7.0
Clinical Outcome
Measured: 24 months
Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus)
Patient Reported Outcome
Measured: Baseline, 12, 24 months
% With BP <140/90 mmHg
Clinical Outcome
Measured: 24 months
% With BP <130/80 mmHg
Clinical Outcome
Measured: 12 months
% With BP <130/80 mmHg
Clinical Outcome
Measured: 24 months
% With BP <120/80 mmHg
Clinical Outcome
Measured: 12 months
% With BP <120/80 mmHg
Clinical Outcome
Measured: 24 months
Change in Medication Adherence 4-Item Scale
Patient Reported Outcome
Measured: Baseline, 12, 24 months
Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score
Patient Reported Outcome
Measured: Baseline 12, 24 months
Change in Patient Ratings of Trust
Patient Reported Outcome
Measured: Baseline, 12, 24 months
Change in Hypertension Knowledge and Attitudes
Patient Reported Outcome
Measured: Baseline, 12, 24 months
Change in Health Related Quality of Life (PROMIS Global Scale)
Patient Reported Outcome
Measured: Baseline, 12, 24 months
Change in Patient Attainment of Self-Defined Goals
Patient Reported Outcome
Measured: Baseline, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study start1 Sep 2017
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Lisa Cooper, MD, MPH, Principal investigator, Johns Hopkins UniversityJill Marsteller, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674464
- Sponsor's protocol ID
- IRB00085630
- Other IDs
- UH3HL130688
- Acronym
- RICH LIFE
- Status last verified
- Jun 2022
- First submitted
- 4 Jan 2016
- Last updated
- 1 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36322608Alvarez 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.
PubMed 35612394Cooper 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.
PubMed 32526534
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Health System vs. Multilevel Interventions to Reduce Hypertension Disparities
- ClinicalTrials.gov ID
- NCT02674464
- Acronym / sponsor ID
- RICH LIFE / IRB00085630
- Conditions
- Uncontrolled Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,820 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Patient-Centered Outcomes Research Institute
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Posted 1 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Plus | Active comparator | Behavioral: Provider Audit-Feedback, Stratified by Race and Ethnicity, Behavioral: Blood Pressure Measurement StandardizationThe 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 | 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 ConsultationThe 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 |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (8 listed)
- Cardiovascular event (unstable angina, myocardial infarction) within the past 6 months
- Serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)
- Condition which interferes with outcome measurement (e.g., dialysis)
- Pregnant or planning a pregnancy during study period. Nursing mothers would need approval from physician.
- Alcohol or substance use disorder if not sober/abstinent for ≥30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provider Audit-Feedback, Stratified by Race and EthnicityAlso: Stratified Hypertension DashboardTransparent 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. | Behavioural | Collaborative Care/Stepped Care (CC/SC), Standard of Care Plus |
| Blood Pressure Measurement StandardizationAll 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. | Behavioural | Collaborative Care/Stepped Care (CC/SC), Standard of Care Plus |
| System Level Leadership InterventionThis 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. | Behavioural | Collaborative Care/Stepped Care (CC/SC) |
| Collaborative Care Team InterventionAlso: Collaborative Care ModelThe 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. | Behavioural | Collaborative Care/Stepped Care (CC/SC) |
| Community Health Worker ReferralAs a "stepped up" component of the Collaborative Care Team Intervention for patients needing support in overcoming a variety of social determinants | Behavioural | Collaborative Care/Stepped Care (CC/SC) |
| Specialist Care ConsultationAs 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 | Behavioural | Collaborative Care/Stepped Care (CC/SC) |
Primary outcome
Number of Participants With Controlled Blood Pressure
Time frame: 12 months
Number of participants with Controlled Blood Pressure (<140/90 mm Hg).
Patient Activation Measure (PAM-13)
Time frame: 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.
25 secondary outcomes
Mean Systolic Blood Pressure
Time frame: Baseline, 12 months
Mean Diastolic Blood Pressure
Time frame: Baseline, 12 months
Change in Global Framingham Risk Score
Time frame: Baseline, 12, 24 months
Change in Mean Total Cholesterol (mg/dL)
Time frame: Baseline, 12, 24 months
Change in Mean LDL-C (mg/dL)
Time frame: Baseline, 12, 24 months
Change in Mean HDL (mg/dL)
Time frame: Baseline, 12, 24 months
% With Controlled Total Cholesterol
Time frame: Baseline
% With Controlled Total Cholesterol
Time frame: 12 months
% With Controlled Total Cholesterol
Time frame: 24 months
Change in Mean Glycosylated Hemoglobin (Hemoglobin A1c)
Time frame: Baseline, 12, 24 months
% With Hemoglobin A1c< 7.0
Time frame: Baseline
% With Hemoglobin A1c< 7.0
Time frame: 12 months
% With Hemoglobin A1c< 7.0
Time frame: 24 months
Change in Patient Assessment of Care for Chronic Conditions (PACIC-Plus)
Time frame: Baseline, 12, 24 months
% With BP <140/90 mmHg
Time frame: 24 months
% With BP <130/80 mmHg
Time frame: 12 months
% With BP <130/80 mmHg
Time frame: 24 months
% With BP <120/80 mmHg
Time frame: 12 months
% With BP <120/80 mmHg
Time frame: 24 months
Change in Medication Adherence 4-Item Scale
Time frame: Baseline, 12, 24 months
Change in Depressive Symptoms Patient Health Questionnaire (PHQ) 8 Score
Time frame: Baseline 12, 24 months
Change in Patient Ratings of Trust
Time frame: Baseline, 12, 24 months
Change in Hypertension Knowledge and Attitudes
Time frame: Baseline, 12, 24 months
Change in Health Related Quality of Life (PROMIS Global Scale)
Time frame: Baseline, 12, 24 months
Change in Patient Attainment of Self-Defined Goals
Time frame: Baseline, 12, 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36322608Alvarez 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.
- Derived from this study: PubMed 35612394Alvarez 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.
- Derived from this study: PubMed 32526534Cooper 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Cooper, MD, MPH principal investigator
Johns Hopkins University
Jill Marsteller, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Audit-Feedback, Stratified by Race and Ethnicity, Blood Pressure Measurement Standardization and System Level Leadership Intervention in people with Uncontrolled Hypertension, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Controlled Blood Pressure (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02674464, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.