Using an Innovative Quality Improvement Process to Increase Delivery of Evidence-based Cardiovascular Risk Factor Care in Community Mental Health Organizations
Phase: NA
Conditions: Diabetes Mellitus, Hypertension, Dyslipidemias
Sponsor: Johns Hopkins University

A Quality Improvement Process to Support Delivery of Cardiovascular Care in Community 
Mental Health Organizations 
March 8, 2022    
NCT04696653 
 

Date: March 8, 2022    
Principal Investigator: Gail Daumit 
Application Number: IRB00269855 
 
 
Protocol 
 
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1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the 
research hypothesis, and the importance of the research. 
 
People with serious mental illness (SMI) such as schizophrenia, bipolar disorder and major 
depressive disorder, experience high burden and poor control of cardiovascular disease (CVD) 
risk factors, including hypertension, dyslipidemia, and diabetes mellitus.1-9,10,11-15 Low rates of 
guideline-concordant care contribute to poor control of CVD risk factors among individuals with 
SMI.10,16-18 This group’s complex co-morbidities and social challenges, e.g. housing instability 
and criminal justice involvement,19-23 and the historic separation between the general medical 
and specialty mental health systems24,25 – where people with SMI receive much of their 
care24,26,27 – can impede this group’s receipt of effective physical health care.27,28 
 
Maryland is among 19 states receiving funding under the Affordable Care Act Medicaid Health 
Home provision. Medicaid health homes programs were designed to improve physical health 
care and outcomes for persons with SMI through care coordination.29 In 2013, Maryland 
implemented health homes in psychiatric rehabilitation programs, which are affiliated with 
outpatient mental health clinics and provide skills training, case management, and social service 
coordination for persons with SMI.30 
 
A preliminary evaluation by the state of Maryland suggests that the program has not improved 
CVD risk factor control among participants with SMI. 31 Studies of other health home programs 
and other programs integrating physical health care into mental settings for persons with SMI 
have also shown limited or no improvements in CVD risk factor control.32,33 Our research shows 
that Maryland and other health home providers perceive lack of standard care coordination 
systems and processes to ensure delivery of evidence-based care, e.g. standard protocols for 
coordinating care for poorly controlled dyslipidemia, as a key barrier to achieving CVD risk 
factor control in health home participants.34,35 
 
This is a R34 pilot study funded by NIMH as part of the Johns Hopkins NIMH P50 Center to 
Accelerate Translation of Interventions to Decrease Premature Mortality in Serious Mental 
Illness. In this study, we will pilot test an adapted Comprehensive Unit Safety Program (CUSP) 
implementation strategy to improve mental health providers’ delivery of evidence-based CVD 
risk factor care for individuals with SMI in Maryland health homes. CUSP is a quality 
improvement strategy developed by the JHU Armstrong Institute for Patient Safety and Quality36 
and used to improve care delivery in other, primarily inpatient, contexts.37-45 CUSP is more 
recently being applied to outpatient quality improvement.42-45 Our study is the first to adapt 
CUSP for the community mental health setting. 

 
This study will result in an adapted set of CUSP tools and resources for community mental 
health programs, which other community mental health programs can use in the future. Study 
results will lay the foundation for development and evaluation of a scalable model for 
implementation of evidence-based physical health care in community mental health settings.  
 
2. 
Objectives (include all primary and secondary objectives) 
 
The project will pilot test a comprehensive unit-based safety program (CUSP) to implement 
evidenced-based practices to guide delivery of care for hypertension, dyslipidemia and diabetes 
for persons with serious mental illness in Maryland Medicaid health homes. The project will 
characterize implementation processes, organizational and provider-level factors, and 
cardiovascular disease risk factor care and control. 
 
The specific aims are: 
 
Aim 1. Characterize implementation barriers, quality improvement culture, providers’ self-
efficacy, and CVD risk factor care and control in Maryland Medicaid SMI health home 
programs. Using observation, focus groups, surveys, and database abstraction, we will answer 4 
research questions: 
1. What are the barriers to delivery of evidence-based CVD risk factor care at health home sites, 
and what strategies could help to overcome those barriers? 
2. How supportive of quality improvement is the current health home culture? 
3. How do providers rate their self-efficacy to deliver/coordinate evidence-based CVD risk factor 
care? 
4. At the health home study sites, what are baseline rates of evidence-based care for and control 
of hypertension, dyslipidemia, and diabetes mellitus? 
 
Aim 2. Pilot test a comprehensive unit-based safety program (CUSP), designed to implement an 
evidence-based practice bundle, in Maryland Medicaid SMI health home programs. We 
hypothesize CUSP will: 
1. Improve the organizational culture surrounding delivery of evidence-based CVD risk factor 
care. 
2. Improve providers’ self-efficacy to deliver evidence-based CVD risk factor care. 
3. Yield preliminary data showing increased rates of evidence-based care for and control of 
hypertension, dyslipidemia, and diabetes among consumers with SMI. 
4. Be perceived as acceptable, appropriate, and feasible by health home providers. 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with 
procedures, drug or device, and any other relevant information to justify the research) 
 
Persons with serious mental illness (SMI) experience high prevalence and poor control of 
cardiovascular disease (CVD) risk factors including hypertension, dyslipidemia, and diabetes 
mellitus; 1-9 poor control is driven in part by low rates of guideline-concordant CVD risk factor 
care in this group. 10,16-18 Our team’s data from a trial46 of 269 adults with SMI in Maryland 

shows that 84% have hypertension, diabetes mellitus, or dyslipidemia and 45% meet clinical 
definitions of poor control for at least one of these conditions. 
 
The historic separation of the general medical and mental health systems contributes to deficits 
in care quality by impeding access, communication, and sharing of data and expertise across 
systems.27,47-52 In recent years, programs designed to integrate primary care services, like CVD 
risk factor management, into specialty mental health settings – where many people with SMI 
receive the majority of their care24,26,27 – have been implemented at the federal, state, and local 
levels.33,53,54 Maryland’s Medicaid health home program, implemented in October 2013, is one 
such model.55  
 
Health homes are currently implemented in 48 Maryland psychiatric rehabilitation programs, 
which receive a per-member-per-month payment to provide “health home services,” including 
primary care coordination and case management.55 All health homes have a director, primary 
care physician or nurse practitioner consultant, and one or more nurse care managers, but each 
site chooses their own service structure (ranging from co-location to facilitated referral to offsite 
primary care services).55 Nurse care managers provide basic services, like blood pressure 
monitoring, onsite.34 While 15% of sites have a primary care provider who provides onsite 
services 1+ days per week, most primary care physical health services are coordinated with 
offsite providers.34 Data suggests that health home implementation has not improved CVD risk 
factor control among health home participants with SMI.31  
 
Our research on health home implementation, including interviews and surveys with >80 health 
home leaders and >650 front-line providers and staff, suggests that lack of standardized systems 
and processes for tracking and coordinating evidence-based CVD risk factor care is a key barrier 
to achieving such care in health home programs.34 Systems for tracking and ensuring receipt of 
evidence-based guidelines, e.g. hemoglobin A1C (HBA1C) monitoring among consumers with 
diabetes, are lacking, as are standard protocols for delivering or coordinating appropriate care 
with primary care providers when consumers’ CVD risk factors are poorly controlled.34 Health 
homes received no formal guidance on how to set up such systems.  
 
In this pilot study guided by the Translating Evidence into Practice (TRIP) framework,56 we will 
partner with 5 health home programs to test an adapted Comprehensive Unit Safety Program 
(CUSP) implementation strategy designed to improve delivery of the evidence-based care 
delivery processes, e.g. population health management and care coordination, needed to 
implement evidence-based CVD risk factor care in SMI health homes. CUSP is a scalable 
implementation strategy that includes provider training and implementation of a team-based 
quality improvement process. CUSP is endorsed by AHRQ57 and leads to significant 
improvements in inpatient safety;37-41 CUSP is more recently being applied to outpatient quality 
improvement.42-45 Our study is the first to adapt CUSP for the community mental health setting. 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
b. Study duration and number of study visits required of research participants. 
 

Currently this protocol is being submitted as a study where all study procedures are delivered 
remotely. If and when COVID-19 restrictions are lifted, we may submit a petition to have some 
of the study activities (e.g., training) in-person as appropriate. 
 
Overview: We will work with 5 behavioral health home programs in Maryland.  Health homes 
are responsible for coordinating physical health care for persons with serious mental illness and 
are based in community mental health programs. The project will pilot test a comprehensive 
unit-based safety program (CUSP) to implement evidenced-based practices to guide delivery of 
care for hypertension, dyslipidemia and diabetes for persons with serious mental illness in the 
behavioral health homes. The project will also characterize implementation processes, 
organizational and provider-level factors, and cardiovascular disease risk factor care and control. 
The health home programs are already providing care in these domains for these individuals with 
serious mental illness. They will not be expanding their scope of practice with this project. The 
evidenced-based practices (“evidence bundle”) the study team is providing training for as part of 
the CUSP model are based on current practice guidelines.58-63 CUSP is a quality improvement 
implementation strategy.  
 
Study sites and participants:  We plan for five community psychiatric rehabilitation programs 
that have health home programs to participate in the study. Participants will be health home team 
staff including a nurse care manager, a primary care consultant (primary care physician or nurse 
practitioner), and psychiatric rehabilitation program staff who work with the health home 
program. Other study participants will include the broader psychiatric rehabilitation program 
staff and primary care physicians outside the community mental health organization with whom 
the health home coordinates care. Persons with serious mental illness enrolled in the health home 
are also study participants as their data will be analyzed. 
 
Study implementation intervention: CUSP 
CUSP is a scalable quality improvement strategy developed by the JHU Armstrong Institute for 
Patient Safety and Quality used to improve collaboration and improve patient safety and quality 
of care. A foundation of CUSP is the CUSP “team” that implements the patient safety and 
quality processes, in order to increase delivery of care as defined in the evidence-bundle. Each 
health home program will form a CUSP team that will participate in advanced CUSP training 
and implement the CUSP process over the course of the project. The CUSP team will have 
approximately five to ten members including health home program staff and an organizational 
leader. The CUSP process and trainings will follow standard formats used and evaluated in prior 
CUSPs. 37-45,64  
 
Timeline for CUSP 
 
Before CUSP: 1 month. The CUSP team will participate in trainings outlined below (Table 1) as 
part of the pre-implementation period.  
 
CUSP Implementation: 12-months, monthly meetings. During the implementation period the 
CUSP team will meet monthly for one hour for a meeting guided by study team expert CUSP 
facilitators focused on problem-solving through a team-based quality improvement process. At 
these meetings the CUSP team will review issues, problems or events regarding the 

cardiovascular care of health home clients/patients. Health homes already measure CVD risk 
factor care but without using standard processes. As part of implementing the evidence-bundle 
on management of CVD risk factors, care coordination and population health, CUSP team 
members will use a standard population health spreadsheet template that the study team provides 
to track CVD risk factors and care processes during regular health home program care. Using the 
spreadsheet, CUSP team members can aggregate patient-level data and identify trends in CVD 
risk factor prevalence and quality of care metrics for persons enrolled in the health home. Team 
members will identify problems in the care delivery process and use worksheets and guides to 
brainstorm processes and procedures as a team to improve care. They will then implement and 
develop how the process or procedure will be evaluated.  
 
CUSP Sustainment: 3-months. CUSP implementation will be followed by a 3-month sustainment 
period in which the CUSP team will continue to use evidence-based care practices and follow the 
CUSP process without our team’s expert facilitators. 
 
CUSP Training Overview  
Study team members will conduct trainings (Table 1) by Zoom while the study is remote.  
 
All psychiatric rehabilitation program and health home leaders/providers/staff participate in a 
brief CUSP Process Training that introduces the principles of CUSP, and at the end of the 12-
month implementation phase, in a training about sustaining CUSP.64 
 
The CUSP team participates in advanced CUSP training including training in the evidence-
bundle. The evidence-bundle focuses on evidence-based CVD risk factor guidelines and care 
coordination/ population health management for CVD risk factors in persons with SMI. The 
evidence-bundle training also includes content in motivational interviewing as a key-component 
of helping clients with SMI make healthy behavioral change.  
 
The real-time motivational interviewing training will be supplemented with an online avatar 
practice module.65,66 The avatar practice module includes a 15-minute didactic component where 
providers learn about motivational interviewing and techniques that can be used to guide patients 
with SMI toward health changes, and 15-minute practice conversations where providers take on 
the role of virtual provider avatar and practice the use of motivational interviewing techniques in 
simulated conversations about managing cholesterol in persons with serious mental illness using 
patient avatars on the Kognito platform. We will recommend CUSP team members practice 
weekly for the first three months. An online dashboard will give CUSP team members an 
individualized report on their performance each time they practice.  
 
 

 
Data Collection: 
Study data collection is outlined in Table 2 and in more detail below. Study team involvement in 
data collection is all virtual/remote.   
 
Table 1. CUSP Training  
Topic 
Who receives training 
Estimated Length  
CUSP Process Training - Introductory 
Introduces the Principles of CUSP 
CUSP team and all 
psychiatric rehabilitation 
program staff  
60 minutes 
CUSP Process Training- Advanced 
1. Introduction to CUSP and Science of 
Quality 
2. Creating Engagement and Ownership of 
CUSP 
3. Identifying and Learning from 
Challenges 
4. Kicking off CUSP 
CUSP team 
Four one-hour sessions 
Evidence Bundle (evidenced-based practices) for 
CVD risk factors and care 
coordination/population health management  
CUSP team 
Two two-hour sessions 
Evidence Bundle Motivational Interviewing for 
CVD risk factor management  
CUSP team 
Two two-hour sessions  
Motivational Interviewing for CVD risk factor 
management – using Avatar 
CUSP team 
Recommended weekly 15-
minute practice sessions for 
three months and then as 
needed/desired 
Sustaining a CUSP Team 
CUSP team and all 
psychiatric rehabilitation 
program staff  
60 minutes 
Table 2. Study Data Collection 
Qualitative Data Collection 
Who 
Estimated 
time 
When 
CUSP Team Focus Groups  
Selected CUSP team 
members (~5 per site) 
60 minutes 
Baseline, 15 
months 
Primary Care Provider Interviews  
Primary care providers 
caring for health home 
program patients but 
who are not health 
home team members 
(~5 per site) 
30 minutes 
Baseline  
Survey Measures 
 
 
 
Demographic Characteristics:  age, sex, race, 
ethnicity, length of time at program, role in 
program, previous Motivational Interviewing 
training, comfort with technology  
Health home team and 
psychiatric 
rehabilitation program 
staff (~30 per site) 
~5 minutes 
Baseline 
Implementation Climate: This is a measure of 
the degree to which an organization supports 
evidence-based practice implementation 
Health home team and 
psychiatric 
rehabilitation program 
staff (~30 per site) 
~3 minutes 
Baseline 
Quality Improvement Culture: Measured using 
a modified version of the validated 42-item 
Survey on Patient safety used in inpatient CUSPs 
Health home team and 
psychiatric 
rehabilitation program 
staff (~30 per site) 
~5 minutes 
Baseline, 12 
months 

 
Qualitative Data Collection 
Pre-Implementation Health Homes Survey: 
The nurse care manager will assess the behavioral 
health home’s database and what is currently 
tracked. 
CUSP team member 
(health home 
nurse/nurse care 
manager) (1 per site) 
~10 minutes 
Baseline 
Self-Efficacy: Self-efficacy to deliver evidence-
based CVD risk factor  
CUSP team (~10 per 
site) 
~5 minutes 
Baseline, 12 
months 
Acceptability, Appropriateness, and Feasibility 
of the Intervention Implementation Strategies:  
Measured with a brief 4-item practice instrument 
(AIM, IAM, FIM)67 
CUSP team (~10 per 
site) 
~5 minutes 
Baseline, 12 
months 
Acceptability, Appropriateness, and Feasibility 
of the Evidence-Based Practice Bundle: 
Measured with a brief 4-item practice instrument 
(AIM, IAM, FIM)67 
CUSP team (~10 per 
site) 
~5 minutes 
Baseline, 12 
months 
Motivation: Degree to which providers and staff 
agree or disagree with statements that deal with 
aspects of the health homes intervention to 
improve cardiovascular risk factor care  
CUSP team (~10 per 
site) 
~3 minutes 
Baseline, 12 
months 
Beliefs about Motivational Interviewing 
Questionnaire  
CUSP team (~10 per 
site) 
~2 minutes 
Baseline, 3, 6, 12 
months 
Importance and Confidence of Using 
Motivational Interviewing 
CUSP team (~10 per 
site) 
~2 minutes 
Baseline, 3, 6, 12 
months 
Perceived Usefulness 
CUSP team (~10 per 
site) 
~2 minutes 
12 months 
Fidelity Measures 
Avatar Motivational Interviewing Performance 
Measurements: from use of motivational 
interviewing techniques in simulated online 
conversations  
CUSP team (~10 per 
site) 
15 minutes 
Baseline to 3 
months (weekly 
requested), 6, 12 
months 
Fidelity to Motivational Interviewing: 
Standardized Actor Interviews will be conducted 
to assess fidelity to motivational interviewing.  
CUSP team (~10 per 
site) 
30 minutes 
Baseline, 3, 6, 12 
months 
Health Home Enrollee Measures 
Sociodemographic and Mental Health: age, 
gender, race, ethnicity, living arrangement, 
disability status, any issues with transportation, 
scheduling or obtaining medications, primary 
diagnosis, categories of psychotropic medications 
used 
 
All health home 
enrollees (patients) 
(~200 per site) 
Collected by CUSP 
team/ health home 
staff during regular 
health home program 
care 
 
 
Baseline, 6, 12 
months 
CVD risk factors: weight, BMI, tobacco smoking 
status, blood pressure, diabetes, HgbA1c, lipids, 
diagnoses of hypertension, diabetes, dyslipidemia, 
CVD risk scores 
Evidence-Based CVD Risk Factor Care: % of 
consumers eligible to receive each care process in 
the evidence bundle who receive that process 
(e.g., statin prescription, diabetes foot exam, 
follow-up visits) 
CVD Risk Factor Control: % of consumers 
meeting clinical criteria for having controlled 
hypertension (eg BP< 130/80) dyslipidemia, and 
diabetes (HgbAc1<7.0)  

CUSP Team Focus Groups: ~ 5 selected CUSP team members per site will be asked to 
participate in focus group interviews by Zoom. These focus groups will be 60-minutes and 
conducted by our research team using a semi-structured guide. Focus groups will be audio or 
video-recorded, and recordings will be transcribed using Production Transcripts, Inc. 
 
Primary Care Provider Interviews: ~5 primary care providers per site who provide care for health 
home enrollees and coordinate care with but are not formally part of the health home team will 
participate in a ~30-minute interview by phone or Zoom. Interviews will be audio or video-
recorded, and recordings will be transcribed using Production Transcripts, Inc. 
 
Surveys 
Surveys will be administered via email with instructions and a link to the surveys in REDCap. 
Surveys may also be delivered in hard copy if needed and mailed back to the study team.  
 
Demographic Characteristics: Health home team and psychiatric rehabilitation program staff 
(~30 per site) will provide demographic characteristics such as age, sex, race, ethnicity. We will 
also ask about their current role in the program and length of time at program. We will ask about 
any prior Motivational Interviewing training and comfort with using technology for online 
trainings. This survey is 13 questions.  
 
Implementation Climate: Health home team and psychiatric rehabilitation program staff (~30 per 
site) will take this survey. Ehrhart’s implementation climate scale;68 overall score of 4 = 
excellent implementation climate. This is a measure of the degree to which an organization 
supports evidence-based practice implementation. 
 
Quality Improvement Culture: Health home team and psychiatric rehabilitation program staff 
(~30 per site). Measured using a modified version of the validated 42-item Survey on Patient 
safety used in inpatient CUSPs. Score ≥4 indicates good quality improvement culture. 
 
Pre-Implementation Health Homes Survey: The nurse care manager who is part of the CUSP 
team (~1 per site) will assess the behavioral health home’s current methods of collecting and 
tracking information on cardiovascular risk factors.   
 
Self-Efficacy: The CUSP team (~10 per site) will take this survey. Measures self-efficacy to 
deliver evidence-based CVD risk factor measured as a numeric score created by averaging 10 
items adapted from Compeau & Higgins’ task-focused self-efficacy scale69 
 
Acceptability, Appropriateness, and Feasibility of the Intervention Implementation Strategies: 
The CUSP team (~10 per site) will take this survey. Acceptability, feasibility and 
appropriateness of the implementation strategies (cardiovascular risk factor reduction 
intervention and CUSP quality of care process) will be measured with validated 4-item 
measures67 
 
Acceptability, Appropriateness, and Feasibility of the Evidence-Based Practice Bundle: The 
CUSP team (~10 per site) will take this survey. Acceptability, feasibility and appropriateness of 
the evidence-based bundle will be measured with validated 4-item measures67  

 
Motivation: The CUSP team (~10 per site) will take this survey. Measured by assessing the 
degree to which providers and staff agree or disagree with statements that deal with aspects of 
the health homes intervention to improve cardiovascular risk factor care. Categories include 
expectancy, instrumentality, and valence regarding the evidence-based CVD risk factor care 
bundle and the CUSP quality of care process. 
 
Beliefs about Motivational Interviewing Questionnaire: The CUSP team (~10 per site) will take 
this survey. A 7-question survey assessing the extent to which each person agrees with 
statements about motivational interviewing. 
 
Importance and Confidence of Using Motivational Interviewing: The CUSP team (~10 per site) 
will take this survey.  A 6-question survey assessing the importance and confidence each person 
has with motivational interviewing. 
 
Perceived Usefulness: The CUSP team (~10 per site) will take this survey. A 6-question survey 
assessing the perceived usefulness of the motivational interviewing avatar platform during the 
course of the project.  
 
Fidelity Measures 
Avatar Motivational Interviewing Performance Measurements: Members of the CUSP team (~10 
per site) will use the avatar platform and have 15-minute practice “conversations” where they 
practice use of motivational interviewing techniques in simulated conversations about managing 
cholesterol with patient avatars. An online dashboard will give CUSP team members an 
individualized report on their performance each time they practice. 
 
Fidelity to Motivational Interviewing: Standardized Actor Interviews: Members of the CUSP 
team (~10 per site) will participate in 30-minute audio-recorded phone interviews with 
standardized patient actors. These standardized patient actors are trained actors playing roles of 
patients with SMI and CVD risk factors.  
 
Health Home Enrollee Measures 
As part of implementing the evidence-bundle on management of CVD risk factors, care 
coordination and population health, CUSP team members will be using a standard population 
health spreadsheet template that the study team provides to track CVD risk factors and care 
processes during regular health home program care. Using the spreadsheet, CUSP team members 
can aggregate patient-level data and identify trends in CVD risk factor prevalence and quality of 
care metrics for persons enrolled in the health home. This data (in a limited dataset) will also be 
used for study evaluation purposes. Health home enrollee data will include sociodemographic 
and basic mental health diagnosis/medication categories, CVD risk factors, evidence-based CVD 
risk factor care processes and CVD risk factor control.  
 
 
Data Management:  
Qualitative data. Interview and focus group data will be audio or video-recorded and  

recordings will be transcribed using Production Transcripts, Inc or another approved Johns 
Hopkins vendor. Names will be removed from transcripts. Recordings will be stored in a Johns 
Hopkins secure network drive and will be destroyed when analyses are complete. Standardized 
actor interview recordings will be reviewed by experts in motivational interviewing for fidelity 
to motivational interviewing practices and stored in a Johns Hopkins secure network drive or 
OneDrive. 
Quantitative data. Each participant will be assigned a unique study ID number for data 
collection. We will store data in a Johns Hopkins REDCap database. Study team members are 
trained to protect integrity and confidentiality of the data. Kognito, a health simulation company,  
developed the avatar simulations for this project and hosts the avatar training platform and 
dashboard. Avatar performance measurement data for motivational interviewing practice 
conversations is accessible only by the individual study participant (CUSP team member) and 
the study team, not shared outside Kognito. Kognito stores data securely behind two firewalls. 
For health home enrollee measures, the CUSP team will use participant initials and a study ID 
number in the Excel population health tracking spreadsheet. Participant names, used for 
implementing the evidence-bundle, will be removed by the CUSP team. They will use Johns 
Hopkins OneDrive, available to non-Johns Hopkins collaborators, to deposit the spreadsheet at 
baseline, 6 and 12 months. The data will contain no names or birthdates but will have dates of 
process measures (e.g., lab values) thus it will be a limited dataset. Each study site will only be 
able to access a folder specific to their site, and spreadsheets will have password protection.  
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
N/A 
d. Justification of why participants will not receive routine care or will have current 
therapy stopped. N/A 
e. Justification for inclusion of a placebo or non-treatment group N/A 
f. Definition of treatment failure or participant removal criteria. N/A 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. N/A 
 
5. 
Inclusion/Exclusion Criteria 
Psychiatric rehabilitation program and health home team staff, including providers and 
leadership are those employed by the psychiatric rehabilitation program or health home program. 
All are adults and English-speaking.  
 
Primary care providers are those who provide primary care to health home enrollees.  
 
Health home enrollees are by definition persons with serious mental illness who are members of 
a behavioral health home. All are 18 years and older.  
 
 
6. 
Drugs/ Substances/ Devices-N/A 
a. The rationale for choosing the drug and dose or for choosing the device to be used.  
b. Justification and safety information if FDA approved drugs will be administered for 
non-FDA approved indications or if doses or routes of administration or participant 
populations are changed.  

c. Justification and safety information if non-FDA approved drugs without an IND will 
be administered.  
 
7. 
Study Statistics 
a. Primary outcome variable and analytic plans 
 
We will conduct three main analyses. First, we will compare pre/post (baseline, 12 mo.) quality 
improvement culture and provider self-efficacy, the mechanisms through which CUSP is 
designed to improve delivery of evidence-based care, using a generalized linear mixed effects 
modeling approach. We will evaluate the effects of CUSP (baseline, 6 mo, 12 mo) on consumer-
level evidence-based care and CVD risk factor control outcomes using a multi-level modeling 
approach. We will assess mediator and moderator by testing whether sites’ quality improvement 
culture and provider self-efficacy mediate CUSP’s effects on health home enrollee outcomes by 
adding these variables to the multi-level models of health home enrollee outcomes. We will also 
assess potential moderating effects of implementation climate by adding appropriate interaction 
terms to the main models. We will use descriptive statistics to analyze survey measures of staff 
perceptions of the acceptability, feasibility and appropriateness of CUSP and the evidence-
bundle. Interview and focus group transcripts will be analyzed in NVivo V.11, using inductive 
coding to identify key themes. Survey analysis will be done using Stata 14 or SAS software.  
 
8. 
Risks 
 
We expect any risk to be minimal in this study. 
 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency.  
 
For the CUSP implementation of the evidence-based bundle for CVD risk factor care, 
coordination and population health, the health home programs are already providing care in these 
domains for their enrollees with serious mental illness. Health home staff will be working within 
their current scope of practice with this project. The evidenced-based practices the study team is 
providing training for as part of the CUSP model are based on current practice guidelines. CUSP 
is a quality improvement implementation strategy. Thus, we do not expect there to be increased 
risk for health home enrollees.  
 
Psychiatric rehabilitation program and health home team staff and primary care providers may be 
come tired or bored during surveys, interviews or focus groups.  
  
b. Steps taken to minimize the risks. 
 
Psychiatric rehabilitation program and health home team staff, and primary care providers will 
be appropriately recruited and informed of the study by the study team with waiver of 
documentation of informed consent. The study team will inform them that they do not have to 
answer any questions they do not want to, and that their employment or evaluations will not be 
affected by their responses.  
 
c. Plan for reporting unanticipated problems or study deviations  

 
Dr. Daumit, internist with experience in working with persons with SMI and staff in community 
mental health settings, will be responsible for data safety and monitoring. If new guidelines for 
treatment of hypertension, dyslipidemia, or diabetes mellitus were to be released during the study 
period, we will make any appropriate modifications in the evidence bundle/protocol and 
communicate with the study sites. If safety issues about management of cardiovascular risk 
factors in individual health home enrollees care are raised, Dr. Daumit will communicate with 
the health home nurse director as appropriate. Any unanticipated problems will also be reported 
to the IRB. We expect any issues to be rare.  
 
d. Legal risks such as the risks that would be associated with breach of confidentiality  
 
Risk of loss of confidentiality is the main risk. We expect this risk to be extremely low, as we 
will be taking multiple safeguards to protect the data.  To protect against breach of 
confidentiality, all information will be considered confidential.  This confidentiality will be 
assured through several mechanisms.   
 
As per above, psychiatric rehabilitation program and health home team staff, and primary care 
providers will be appropriately recruited and informed of the study by the study team with 
waiver of documentation of informed consent. The study team will inform them that they do not 
have to answer any questions they do not want to, and that their employment or evaluations will 
not be affected by their responses.  
 
For qualitative data, no focus group participants will be individually identified; a site identifier 
will be used.  The link to the site ID will be held in a locked file. Focus group transcripts will 
have names (if mentioned during the group) removed, and no participants will be identified by 
name in any publications.  Furthermore, data will not be presented in such a way that their 
identity can be inferred.  Similar procedures will be used for interviews. Psychiatric 
rehabilitation program/health home directors will give assurance to providers/staff that their 
participation and information shared will not affect their employment or their evaluation.  Data 
will not be presented in such a way that identity can be inferred.  As described in Data 
Management, data will be stored in Johns Hopkins secure drives.  
 
For quantitative data, as in Data Management above, each staff participant will be assigned a 
unique study ID number for data collection and data will be stored in REDCap. For health home 
enrollee measures from the population health spreadsheet, we will request a waiver of informed 
consent. The study team will receive limited datasets from health home program sites in Johns 
Hopkins OneDrive with study IDs. The data will have dates of process measures (e.g., lab 
values) but no names or birthdates. Folders and spreadsheets will have password protection.  
 
9. 
Benefits 
a. Description of the probable benefits for the participant and for society. 
 
There is no benefit to individual participants. This research will help stakeholders have a greater 
understanding of the organizational and staff-level barriers to delivery of evidence-based 
cardiovascular risk factor care in community mental health settings.  

 
10. 
Payment and Remuneration 
a. Detail compensation for participants including possible total compensation, 
proposed bonus, and any proposed reductions or penalties for not completing the 
protocol. 
 
Primary care providers will be paid $50 for completing an interview. CUSP team members will 
be paid $50 for participating in a focus group and will be paid $25 for each standardized actor 
interview. CUSP team members will be compensated $25 for completion of surveys 
administered at baseline and 12-month data collection and $10 for completion of surveys at all 
other time points. Psychiatric rehabilitation program staff, who are not part of the CUSP team 
will receive $10 for completion of surveys at baseline and 12 months.  
 
11. 
Costs – N/A 
a. Detail costs of study procedure(s) or drug (s) or substance(s) to participants and 
identify who will pay for them.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
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