Discovering Healthcare Innovations to Address Disparities in Stroke (DIADS)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2013 |
| End Date: | June 2016 |
Discovering Healthcare Innovations to Address Disparities in Stroke
The goal of this pragmatic study is to improve hypertension (HTN) control rate in blacks and
to reduce racial disparity in HTN control. To accomplish this, the investigators propose to
perform a cluster randomized controlled trial at the primary care provider (PCP) level and
including 191 PCPs within KPNC East Bay Service Area with more than 45,000 patients in the
HTN registry of which approximately 15,000 are black. The investigators will randomize all
PCP patient panels to a three-arm trial to receiving either 1) usual care; or 2) culturally
tailored diet and lifestyle coaching; or 3) an intensified BP management protocol with
pharmacotherapy. The "Shake, Rattle and Roll" trial is named for: 1) "shake" the salt habit;
2) "rattle" the intensity of current BP management; and 3) design the interventions with the
goal of being able to adapt and "roll" them out to community clinics outside of a managed
care system. Primary research question: whether a primary prevention intervention of either
diet and lifestyle coaching or an intensive pharmacotherapy protocol is more effective than
usual care in improving rates of HTN control in blacks and thereby reducing disparities
between black and white. Primary aim: By implementing either intervention, the investigators
will reduce the disparity in hypertension control rates between blacks and whites by 4% at 1
year post-study enrollment. Hypothesis: Among blacks with HTN, a diet/lifestyle coaching
intervention or an intensified BP management protocol will result in an increase in HTN
control rate compared to usual care. Primary outcome: the proportion of patients with
sustained BP control at 1 year post-study enrollment.
to reduce racial disparity in HTN control. To accomplish this, the investigators propose to
perform a cluster randomized controlled trial at the primary care provider (PCP) level and
including 191 PCPs within KPNC East Bay Service Area with more than 45,000 patients in the
HTN registry of which approximately 15,000 are black. The investigators will randomize all
PCP patient panels to a three-arm trial to receiving either 1) usual care; or 2) culturally
tailored diet and lifestyle coaching; or 3) an intensified BP management protocol with
pharmacotherapy. The "Shake, Rattle and Roll" trial is named for: 1) "shake" the salt habit;
2) "rattle" the intensity of current BP management; and 3) design the interventions with the
goal of being able to adapt and "roll" them out to community clinics outside of a managed
care system. Primary research question: whether a primary prevention intervention of either
diet and lifestyle coaching or an intensive pharmacotherapy protocol is more effective than
usual care in improving rates of HTN control in blacks and thereby reducing disparities
between black and white. Primary aim: By implementing either intervention, the investigators
will reduce the disparity in hypertension control rates between blacks and whites by 4% at 1
year post-study enrollment. Hypothesis: Among blacks with HTN, a diet/lifestyle coaching
intervention or an intensified BP management protocol will result in an increase in HTN
control rate compared to usual care. Primary outcome: the proportion of patients with
sustained BP control at 1 year post-study enrollment.
Kaiser Permanente Northern California (KPNC) serves a population of over 3 million
enrollees, representative of the socio-demographic characteristics of the San Francisco Bay
Area, Santa Rosa, and Sacramento except for under-representation of the very rich and very
poor.78 KPNC is the largest nonprofit integrated health care organization in the country,
with 22 hospitals and 44 outpatient facilities, and cares for 30% of the population in the
region. The majority of Californians are managed in four large hospital networks, so the
KPNC system is a model for the 167 Program Director/Principal Investigator (Last, First,
Middle): Sidney, Stephen, MD, MPH PHS 398/2590 (Rev. 06/09) Page Continuation Format Page
prevalent system of care in the state. An effective system-wide intervention in KPNC would
likely be generalizable and feasible in the other healthcare networks in the State and,
thus, could benefit the population more broadly. The project focuses on the East Bay Service
Area (EBSA) because approximately one-third of African American KPNC members with HTN
receive care within this geographical area. The East Bay area, home of the flagship Oakland
Medical Center and Richmond Medical Center, comprises 12 cities and municipalities within
the Alameda County and the western section of Contra Costa County. From Kaiser Permanente's
inception in 1945, the nonprofit organization has led with innovation, beginning with its
prepaid health care services offered to Richmond shipyard workers during World War II.
Today, the Richmond and Oakland Medical Centers are home to about 700 physicians and 5,600
employees who serve over a quarter of a million members yearly.
Kaiser Permanente East Bay has expanded its services for West Contra Costa members. The
brand new Pinole Medical Office Building, just eight miles from the Richmond Medical Center
offers convenient access to members in the East Bay Area, which includes Pinole, El
Sobrante, Hercules, Rodeo and Crockett.
The Pinole center provides adult medicine, family practice, pediatrics,
obstetrics/gynecology, radiology, a lab, a pharmacy, and health education. For emergency
services, members go to the Richmond Medical Center, and for labor and delivery services,
the Oakland Medical Center. The fourth member of the EBSA is the Alameda Medical Center
which offers services for internal medicine, gynecology, pediatrics, pharmacy, and members
outreach. Using KPNC as a model offers several major advantages. Members generally remain in
the plan for many years, with 94% retention at 1 year and 84% retention at 5 years among
enrollees 65-74 years old.
Sources of electronic medical data are extensive and easy to manipulate. They will be
combined to produce an electronic registry of patients with uncontrolled HTN (Figure -
Electronic Registry; source of data provided in brackets). The following information is
available from electronic medical record (EMR) system:
- Inpatient discharge abstracts with primary and secondary diagnoses and procedures coded
by a trained medical records analyst.
- Inpatient discharge abstracts for all out-of-plan hospital admissions.
- Emergency-department and outpatient diagnoses coded by the treating physician.
- All outpatient records including BP measurements.
- All radiology reports generated by reviewing radiologists.
- Listing of all major health problems generated and frequently updated by all treating
physicians.
- Cardiologist interpretations of all ECGs.
- Reports from all clinical laboratory studies.
- Listing of all outpatient filled prescriptions and completed inpatient medication
orders.
The EMR databases have been validated extensively and, in combination, have been shown to
accurately reflect a number of disease diagnosis, comorbidities, and outcomes.79-81 The KPNC
Division of Research maintains a mortality database for all KPNC members dating back to
1971. The primary sources of mortality data are the California Department of Health
Services, which maintains a registry of deaths and their causes, and Social Security
mortality files for more recent deaths. With the recent loss of the utility of the Social
Security mortality files, we have made arrangements to have more frequent updates (quarterly
or semi-annually) from the California Department of Health Services so that our mortality
file will be current until the approximately past 6 months. Mortality will also be assessed
from the KPNC EMR if they occur during a hospitalization. The "Shake, Rattle and Roll" trial
is named for: 1) "shake" the salt habit; 2) "rattle" the intensity of the current clinical
BP protocol; and 3) design the interventions with the ultimate goal of being able to adapt
and "roll" out the interventions to community clinics outside of the managed care system.
Randomization There are 194 PCPs in the EBSA with 191 providers having African Americans in
their patient panels.
The unit of randomization will be the primary care providers in the EBSA (N=191) who have
black patients in their panels. The other 3 PCPs can be randomized into the study at a later
date if and when they add African American patients to their panels. All PCPs will be
randomized to one of the 3 arms. To the extent possible, we will strive to have an
approximately equal number of African Americans with HTN in each arm of the trial
(approximately 1896 with uncontrolled HTN expected per group). This will be accomplished by
using stratified black patients with hypertension in each clinician's panel.
With the intensified BP protocol intervention, because it is a quality improvement effort,
randomizing at the provider level will allow all African American patients with HTN to be
targeted for the intervention should their BP ever become uncontrolled. We will not need to
ask patients if they are willing to participate given the intervention is an extension of
the usual care model with more intensive focus on aggressive HTN management for African
Americans. We will seek a waiver of informed consent for the intervention from our local
Institutional Review Board (IRB) and have been advised by the IRB administrator that the
waiver will likely be approved by the IRB.
Being able to include all African Americans in this intervention will increase the
generalizability of the study findings. With the diet and lifestyle coaching intervention,
randomizing at the provider level will also allow us to invite all African American patients
with uncontrolled HTN to participate in this intervention. Even though the materials used in
developing this intervention are available within KPNC, a formal coaching program for diet
and lifestyle effects on HTN is currently non-existent. We will send out letters to inform
eligible patients of this on-going improvement project. The patients will have the option of
opting out of the study by returning a stamped envelope to us. If the patients choose not to
opt out, then a research staff will contact them to discuss enrollment as scheduled (Figure
- study diagram, above). As detailed in the Statistical Analysis Section we anticipate
enrollment of approximately 1896 blacks with uncontrolled HTN to each arm of the study
spread out over a 2-year period. The randomization process of all PCPs will be carried out
by a programmer at the KPNC DOR offices (Oakland, CA).
enrollees, representative of the socio-demographic characteristics of the San Francisco Bay
Area, Santa Rosa, and Sacramento except for under-representation of the very rich and very
poor.78 KPNC is the largest nonprofit integrated health care organization in the country,
with 22 hospitals and 44 outpatient facilities, and cares for 30% of the population in the
region. The majority of Californians are managed in four large hospital networks, so the
KPNC system is a model for the 167 Program Director/Principal Investigator (Last, First,
Middle): Sidney, Stephen, MD, MPH PHS 398/2590 (Rev. 06/09) Page Continuation Format Page
prevalent system of care in the state. An effective system-wide intervention in KPNC would
likely be generalizable and feasible in the other healthcare networks in the State and,
thus, could benefit the population more broadly. The project focuses on the East Bay Service
Area (EBSA) because approximately one-third of African American KPNC members with HTN
receive care within this geographical area. The East Bay area, home of the flagship Oakland
Medical Center and Richmond Medical Center, comprises 12 cities and municipalities within
the Alameda County and the western section of Contra Costa County. From Kaiser Permanente's
inception in 1945, the nonprofit organization has led with innovation, beginning with its
prepaid health care services offered to Richmond shipyard workers during World War II.
Today, the Richmond and Oakland Medical Centers are home to about 700 physicians and 5,600
employees who serve over a quarter of a million members yearly.
Kaiser Permanente East Bay has expanded its services for West Contra Costa members. The
brand new Pinole Medical Office Building, just eight miles from the Richmond Medical Center
offers convenient access to members in the East Bay Area, which includes Pinole, El
Sobrante, Hercules, Rodeo and Crockett.
The Pinole center provides adult medicine, family practice, pediatrics,
obstetrics/gynecology, radiology, a lab, a pharmacy, and health education. For emergency
services, members go to the Richmond Medical Center, and for labor and delivery services,
the Oakland Medical Center. The fourth member of the EBSA is the Alameda Medical Center
which offers services for internal medicine, gynecology, pediatrics, pharmacy, and members
outreach. Using KPNC as a model offers several major advantages. Members generally remain in
the plan for many years, with 94% retention at 1 year and 84% retention at 5 years among
enrollees 65-74 years old.
Sources of electronic medical data are extensive and easy to manipulate. They will be
combined to produce an electronic registry of patients with uncontrolled HTN (Figure -
Electronic Registry; source of data provided in brackets). The following information is
available from electronic medical record (EMR) system:
- Inpatient discharge abstracts with primary and secondary diagnoses and procedures coded
by a trained medical records analyst.
- Inpatient discharge abstracts for all out-of-plan hospital admissions.
- Emergency-department and outpatient diagnoses coded by the treating physician.
- All outpatient records including BP measurements.
- All radiology reports generated by reviewing radiologists.
- Listing of all major health problems generated and frequently updated by all treating
physicians.
- Cardiologist interpretations of all ECGs.
- Reports from all clinical laboratory studies.
- Listing of all outpatient filled prescriptions and completed inpatient medication
orders.
The EMR databases have been validated extensively and, in combination, have been shown to
accurately reflect a number of disease diagnosis, comorbidities, and outcomes.79-81 The KPNC
Division of Research maintains a mortality database for all KPNC members dating back to
1971. The primary sources of mortality data are the California Department of Health
Services, which maintains a registry of deaths and their causes, and Social Security
mortality files for more recent deaths. With the recent loss of the utility of the Social
Security mortality files, we have made arrangements to have more frequent updates (quarterly
or semi-annually) from the California Department of Health Services so that our mortality
file will be current until the approximately past 6 months. Mortality will also be assessed
from the KPNC EMR if they occur during a hospitalization. The "Shake, Rattle and Roll" trial
is named for: 1) "shake" the salt habit; 2) "rattle" the intensity of the current clinical
BP protocol; and 3) design the interventions with the ultimate goal of being able to adapt
and "roll" out the interventions to community clinics outside of the managed care system.
Randomization There are 194 PCPs in the EBSA with 191 providers having African Americans in
their patient panels.
The unit of randomization will be the primary care providers in the EBSA (N=191) who have
black patients in their panels. The other 3 PCPs can be randomized into the study at a later
date if and when they add African American patients to their panels. All PCPs will be
randomized to one of the 3 arms. To the extent possible, we will strive to have an
approximately equal number of African Americans with HTN in each arm of the trial
(approximately 1896 with uncontrolled HTN expected per group). This will be accomplished by
using stratified black patients with hypertension in each clinician's panel.
With the intensified BP protocol intervention, because it is a quality improvement effort,
randomizing at the provider level will allow all African American patients with HTN to be
targeted for the intervention should their BP ever become uncontrolled. We will not need to
ask patients if they are willing to participate given the intervention is an extension of
the usual care model with more intensive focus on aggressive HTN management for African
Americans. We will seek a waiver of informed consent for the intervention from our local
Institutional Review Board (IRB) and have been advised by the IRB administrator that the
waiver will likely be approved by the IRB.
Being able to include all African Americans in this intervention will increase the
generalizability of the study findings. With the diet and lifestyle coaching intervention,
randomizing at the provider level will also allow us to invite all African American patients
with uncontrolled HTN to participate in this intervention. Even though the materials used in
developing this intervention are available within KPNC, a formal coaching program for diet
and lifestyle effects on HTN is currently non-existent. We will send out letters to inform
eligible patients of this on-going improvement project. The patients will have the option of
opting out of the study by returning a stamped envelope to us. If the patients choose not to
opt out, then a research staff will contact them to discuss enrollment as scheduled (Figure
- study diagram, above). As detailed in the Statistical Analysis Section we anticipate
enrollment of approximately 1896 blacks with uncontrolled HTN to each arm of the study
spread out over a 2-year period. The randomization process of all PCPs will be carried out
by a programmer at the KPNC DOR offices (Oakland, CA).
Inclusion Criteria:
- African American
- > age 18
- Blood Pressure >140/90
Exclusion Criteria:
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