Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women Project
Phase: NA
Conditions: Depression, Breast Cancer Screening, Cervical Cancer Screening, Colorectal Cancer Screening
Sponsor: Clinical Directors Network

 
 
 
 
 
 
 
 
 
 
 
 
 
Study Protocol 
 
 
Collaborative Care to Reduce Depression and Increase 
Cancer Screening among Low-Income Urban Women 
 
 
 
NCT Number: 02273206 
 
 
 
Document Date: July 30, 2017 

                                                                                                                                                                               
1
CLINICAL DIRECTORS NETWORK, INC. 
 
Collaborative Care to Reduce Depression and Increase Cancer 
Screening among Low-Income Urban Women – Prevention Care Manager 3 Project 
 
PROJECT PROTOCOL FOR THE RANDOMIZED CONTROLLED TRIAL (RCT) 
 
A. STUDY PURPOSE AND RATIONALE 
The Bronx, a borough of New York City, is home to 1.39 million people and is the poorest urban 
county in the U.S. Twenty-nine percent of the population lives below the poverty line, and 30% of 
individuals have not completed high school or received their GED.1 Forty-three percent of the population 
is black and 54% of residents are Hispanic; 45% of the population speaks Spanish at home, and one-third 
of residents self-identify as foreign born.1 Forty-two percent of individuals are enrolled in Medicaid;2 at 
the same time, 18% of the population remains uninsured.3 Almost one-third (28%) of individuals in the 
Bronx consider themselves to be in fair or poor health, and the Bronx was ranked the worst county in 
New York State with respect to population health outcomes.4 Yet despite the numerous socio-economic 
and health challenges faced by its residents, the Bronx is a resilient community with a long history of 
community engagement.5 In the past 25 years, non-profit housing development corporations, settlement 
houses, and social service agencies have come together with residents to rebuild the Bronx and to meet 
the social service needs of individuals and families. A number of federally qualified health centers now 
exist to address the healthcare needs of the community, regardless of an individual’s ability to pay or 
immigration status. While these efforts have accomplished a great deal, more work is still needed to 
improve health outcomes and patients’ experiences in care.  
Two health-specific areas that have been identified by Bronx social and medical service providers 
as being of significant importance for the improvement of patient health outcomes and well-being are 
mental health care and cancer screening.6 Cancer is the leading cause of premature death in the Bronx, 
with lung, prostate, and colorectal cancers accounting for the highest mortality among men, and lung, 
breast, and colorectal cancers accounting for the highest mortality among women.7,3 The death rate due to 
cancer is 15% higher in the Bronx than in New York City as a whole,3 and the cervical cancer rate in the 
Bronx is about 35% higher than the U.S. rate overall,8 Each year, 30 women in the Bronx die of cervical 
cancer, a completely preventable disease through screening.7 Low-income populations are significantly 
more likely to be diagnosed with preventable and late-stage cancers than the general population, a 
disparity that may be partially explained by lower rates of cancer screening and delayed follow-ups of 
abnormal results.9-12,13-17 Low-income women of all ethnicities, but particularly among racial and ethnic 
minorities, have lower rates of cervical, breast, and colon cancer screening in the U.S,18-23,24-26 and in New 
York City.27 In fact, socioeconomic status has consistently been found to be one of the greatest predictors 
of screening 25,17,26 and stage of cancer detection.17,28,29 Absence of screening is not only a primary 
predictor of late-stage cancer diagnosis and accompanying morbidity, but also of significantly lower 
survival rates for breast, cervical, and colon cancer.25,30,31 Thus, despite improvements in cancer screening 
rates in the past 20 years, pervasive disparities persist.32 24 33  
The reasons for the screening disadvantage associated with low SES as well as race and ethnicity 
include inadequate insurance coverage and concerns about cost; uncertainty about how to access 
screening; lack of a physician recommendation; language and literacy barriers, including difficulty 
communicating with a provider; lack of knowledge about cancer prevention; transportation and time 
barriers; medical mistrust; embarrassment associated with procedures; fear of cancer, the procedures, 
and/or deportation; perceived susceptibility to the disease; self-efficacy; fatalism, and perceived social 
norms.34,35,36,37,24,38,39,40,41,42 Recent systematic reviews have documented many community and clinic 
based interventions developed over the past 20 years to address these various barriers to screening in low-
income minority populations.43,44,45,26 However, one potential common comorbidity that may create 
additional barriers to screening, yet has received comparatively little attention in the intervention 
literature, is mental illness,including depression.  
Cancer Screening among Women with Depression  
There is a growing body of research indicating that among women in particular, those who 
experience untreated mental health problems such as depression are significantly less likely to participate 
in cancer screening behaviors, especially mammography and Pap testing.47,48,49,14,50,51,52,53 Research has 
also shown that among depressed, low-income women, lack of physician recommendation, lack of self-

                                                                                                                                                                               
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efficacy, and lack of knowledge about cancer and screening were the greatest predictors of non-adherence 
to age appropriate screening.54 Two other qualitative research studies examining barriers and facilitators 
to cancer screening among women with mental illness highlighted physician recommendation and 
referrals as a facilitator, and deficiencies in knowledge about cancer and screening as a key barrier.55,56 
One of these studies pointed to gaps in communication between primary care and mental health providers 
as contributing to suboptimal screening in this population, and suggested a need for an enhanced role of 
mental health providers in facilitating cancer screening of women with mental illness.56 The relationship 
between screening and depression is of particular importance to address in low-income, predominantly 
minority counties like the Bronx. The Bronx not only has high rates of cancer mortality, but also the 
highest prevalence of self-reported serious psychological distress in New York City, a measure that has 
been shown to be closely associated with depression and other mental illness.3 Major depression, a 
chronic disease,57,58 is the most common mental health problem, affecting between 20% and 25% of poor 
minority women;59-61 in contrast, the prevalence of major depression among the general female population 
is 10%.62 An analysis of WHO World Health Survey data on more than 245,000 people in 60 countries 
showed that depression had the greatest impact on overall self-rated health, and thus the greatest disease 
burden, compared with other chronic diseases, including angina, arthritis, asthma, and diabetes.63 Recent 
results from a national study in the U.S. found that depression is more chronic, severe, and disabling 
among African Americans than other populations.64,65 When Hispanics and African Americans seek 
consultation for depression, it is most likely to be in primary care settings.66 However, current primary 
care depression management practices typically fall below accepted evidence-based standards,67,57,68 
particularly for minority patients,65 although a number of strategies have been shown to be effective in the 
primary care settings.69 Moreover, research has also shown that minority women are less likely than white 
women to go to specialty mental health care for depression when recommended by their primary care 
provider and are less likely to take anti-depressant medication when it is prescribed.70,71,72 
Research suggests that to improve colorectal cancer screening in primary care, there is a need for 
improved efficiency and quality of services, which will require better system supports; improved, 
culturally competent communication with patients about screening and screening options to facilitate 
informed decision-making; and multidisciplinary team care, including health educators and care 
managers.103 In this intervention we propose to test, the care manager’s role is specifically intended to 
improve the efficiency of patient provider communication as well as efficiency of communication 
between providers regarding individual patients’ needs, in order to maximize patient knowledge and 
informed decision making, and to optimize care.105 
The proposed study grew out two lines of research. The first is a recent NIH-funded community-
based participatory research (CBPR) pilot project conducted in the Bronx from 2009 through 2011 
(Clinical and Translational Science Award UL1 RR0257); project PI was Dr. Elisa Weiss, the co-
principal investigator on this grant. The second, described below, is a set of three related NCI-funded 
studies demonstrating the effectiveness of cancer prevention care management conducted by Dr. Jonathan 
N. Tobin and team members at Clinical Directors Network and Dartmouth Medical School in Community 
Health Centers and Medicaid Managed Care Organizations in Manhattan and the Bronx NY.76,77,78  
The proposed study will test the effectiveness of a novel, combined care management screening 
and depression intervention within Bronx community health centers, designed to improve uptake of 
mental health and cancer screening services, enhance quality of life, and increase satisfaction with care 
decisions. The year-long intervention will provide low-income, depressed minority women 50-64 years of 
age with the education, support, and assistance they need to make informed decisions about their 
depression treatment and cancer screening and overcome barriers to utilizing needed services. The 
findings of this study are relevant for a large number of underserved women and the health centers that 
serve them. All low-income minority women 50-64 years of age must make breast, cervical, and colon 
cancer screening decisions, and it is likely that close to one in four of these women will experience 
depression. In the Bronx alone this constitutes approximately 20,000 women. To our knowledge, despite 
the Institute of Medicine’s (IOM’s) identification of both cancer screening and depression as priority 
areas for action,73 there have been no studies that have specifically attempted to address major depression 
as a barrier to cancer screening for low income, minority women.  
 
B. OVERVIEW AND STUDY DESIGN  
Working with health centers, community-based organizations, and patient stakeholders, this study 
will seek to determine whether a collaborative care intervention that addresses depression and cancer 

                                                                                                                                                                               
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screening needs simultaneously among women ages 50-64 in the Bronx is more effective at improving 
cancer screening and patient-reported outcomes for women with depression than an existing evidence-
based cancer screening intervention alone.To achieve this, we will compare the effectiveness of these two 
interventions using a randomized controlled trial.  
The conceptual model guiding this comparative effectiveness study and the elements to be 
measured to determine effectiveness of the new intervention (see Figure 1) are guided by the theoretical 
frameworks (PRECEDE-PROCEED and Diffusion of Innovation) described previously, and the related 
mechanisms of change and expected outcomes that underpin both the PCM (screening facilitation) and 
TCM (depression reduction) intervention components. Additionally, although the concepts of self-
efficacy or stigma are not typically measured in PCM or TCM, these are key barriers to service utilization 
among depressed, minority women.47,54,72,99,106 Furthermore, because satisfaction with health care 
decisions (as distinct from satisfaction with care and one’s provider)107 captures a patient’s confidence in 
her decision and predicts future decisions (e.g., screening, medication adherence)107,108 we have 
incorporated this concept into our new, integrated care management intervention model – Collaborative 
Care Intervention (CCI; see Figure 1). 
 
Approach to Increasing Screening  
For the screening-focused components of the intervention, we will use as a foundation the 
collaborative work of Drs. Allen Dietrich, Jonathan N. Tobin, and colleagues, specifically the Prevention 
Care Management (PCM) program,87,77,78 mentioned above as a foundation for the proposed research. Dr. 
Tobin is PI of this proposed study and Dr. Dietrich will act as a consultant in each year of the project. Ms. 
Cassells, who oversaw the implementation of the studies to test the effectiveness of PCM is the Project 
Director of this proposed study. PCM is a telephone-based cancer screening support and system 
navigation program provided by a trained prevention care manager that has been shown to be effective in 
increasing rates of breast, cervical, and colon cancer screening across a number of trials and in different 
kinds of primary care settings, including Bronx community health centers.87,77,78 PCM is based on the 
PRECEDE-PROCEED planning framework for health behavior interventions,37 which posits that success 
in achieving change is enhanced by the active participation of the intended audience in defining their own 
barriers and goals and in identifying and implementing solutions.88,89,90 The implementation of PCM is 
also guided by Diffusion of Innovation theory,91 and it recognizes and responds to the different stages that 
individuals go through in adopting an innovation, here cancer screening. Consistent with Diffusion of 
Innovation theory, PCM views both knowledge and attitude change as influencing the decision to engage 
in screening, aims to improve self-efficacy to obtain physician recommendation and referral, and 
encourages a trial of the innovation. Findings across three NCI-funded PCM studies demonstrate a 
significant benefit of the PCM intervention in increasing screening rates across primary care practices and 
managed care organizations, providing strong evidence for its effectiveness, dissemination, 
implementation reach and sustainability.9 A Prevention Care Management Staff Training Manual was 

                                                                                                                                                                               
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developed and adopted by NCI as one of its Research-tested Intervention Programs (RTIPs) in efforts to 
encourage national adoption of this effective program.5 
Nonetheless, PCM was not specifically designed to address barriers to screening among 
depressed patients. The limited yet consistent research on screening among women with mental illness 
and our pilot study results suggest that a care management intervention aiming to improve screening 
among depressed women in the Bronx should also encourage active collaboration of mental health 
providers in cancer screening promotion; address stigma associated with screening and mental illness; and 
provide linkages to social services to address immediate crises getting in the way of screening and 
contributing to depression, such as domestic violence. These elements will be included in our new 
intervention. 
Approach to Reducing Depression  
To reduce depression in Community Health Center patients who are in need of one or more 
cancer screening tests, we will draw on an extensively used evidence-based mental health care 
management model called collaborative care, which grew out of the Chronic Care Model (CCM).92,68,93 
Collaborative care is a multi-component team-based intervention that uses a care manager with or without 
clinical training (e.g., nurse, social workers, or office medical assistant) to link primary care providers, 
patients, and mental health specialists; in addition, primary care providers receive 
consultation and decision support from mental health specialists (psychiatrists and/or psychologists). The 
collaboration is designed to: 1) improve routine screening for and diagnosis of depressive disorders; 2) 
increase provider use of evidence based protocols for the proactive management of diagnosed depressive 
disorders; and 3) improve support for active patient engagement in treatment goal-setting and self-
management.68,66  
For the integrated intervention, or “intervention package”86 that combines screening and 
depression care management, we will adapt the evidence-based Three Component Model (TCM) of 
collaborative care,97,98,57 and we will incorporate additional evidence-based socio-cultural collaborative 
care elements developed by Ell and colleagues.95,99 TCM, funded as part of the MacArthur Foundation 
Initiative on Depression and Primary care, provides a system for depression management as 
recommended by the U.S. Preventive Services Task Force, and its structure is complementary to that of 
PCM. Components include telephone care management, collaboration between mental health and primary 
care professionals, and preparation of primary care clinicians and practices to provide systematic 
depression management through training. Based on Ell’s successful collaborative care trials with low-
income Hispanic populations,95,99 we will draw on her work to add the following elements to TCM: 1) 
psychoeducation to dispel treatment misconceptions, reduce stigma associated with depression, and 
enhance the therapeutic alliance; and 2) patient navigation assistance specifically to facilitate patient self-
efficacy, patient-provider communication, access to financial and social resources, with a focus on 
specific behavioral activities to complete screening examinations and follow-up (e.g., scheduling 
appointments, reminders, transportation). 
Outcomes include: reduced depression, improved quality of life, improved satisfaction with 
healthcare decisions, increased self-efficacy, decreased internalized stigma, and decreased likelihood of 
morbidity and mortality from breast, cervical, and colorectal cancer.  
Main Hypotheses  
Our hypothesis that the 12-month CCI intervention we will implement at the six participating 
sites will be significantly more effective than the PCM comparison condition in improving key patient-
reported outcomes associated with cancer screening and depression, including cancer screening 
knowledge and attitudes, self-efficacy, depression- related stigma, provider referrals, participation in 
mental health care, medication adherence, quality of life, and satisfaction with care and treatment 
decisions, and depression (Aim 1). 
We expect the intervention to have a positive impact on screening participation itself (Aim 2) by 
reducing depression (Aim 3) and by influencing patient-reported outcomes associated with screening. 
Finally, as shown, we hypothesize that the effectiveness of CCI in comparison to the PCM condition in 
increasing screening may vary depending on patient characteristics, such as duration of depression, 
presence of other chronic conditions, obesity, personal experience with cancer, and demographic 
characteristics (Aim 4); we also hypothesize that depression outcomes will vary according to these patient 
characteristics as well. We recognize that change has both intended and unintended consequences and is 
not linear. However, our model depicts the hypothesized pathways for the study and analysis as 
described; any additional analyses of bi-directionality will be exploratory. 

                                                                                                                                                                               
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To determine the effectiveness of the CCI intervention in increasing cancer screening over a one-
year period, we will compare it to the performance of the traditional PCM cancer screening intervention 
among depressed women who are non-adherent with one or more screenings. Because PCM has 
demonstrated effectiveness among health center patients of the Bronx in general, such a comparison will 
be an ideal test of whether addressing and reducing depression are necessary steps to increase rates of 
screening among low-income depressed women. Utilizing a “usual or standard care” group as the 
comparison condition instead of the PCM intervention would make it impossible to isolate the effect of 
adding the depression reduction collaborative care components to PCM. Moreover, because PCM has 
already been demonstrated to be effective our MHC Connection partnership felt that offering PCM as the 
comparison condition would be the most ethical approach. If we find that PCM alone works just as well 
among depressed women as our new, integrated CCI intervention – i.e., if our findings do not enable us to 
reject the null hypothesis – this too has important implications for the delivery of patient-centered 
screening interventions in the Bronx and in other areas with a high density of low-income minority 
populations. 
Intervention Content  
The PCM intervention components, to be delivered to women randomized to the comparison arm, 
are a subset of the CCI intervention components, since the new CCIintervention is a combination of PCM 
cancer screening care management and TCM depression care management. In Figure 2 below, we outline 
the components of the interventions to be delivered by the care managers in the two study arms, based on 
the three previous randomized controlled trials of PCM in CHCs conducted by the CDN Team76,77,109 and 
on collaborative care. 97,99,110,111 A 12-month intervention period was chosen based on the depression 
collaborative care literature.42,96,99,112 PCM was shown to have an effect on cancer screening in eight 
months.77 
 
Figure 2. Intervention Content 
 
Care Managers and Intervention Delivery 
The care managers, performing the functions presented in Table 1, will be female bi-lingual 
college graduates with a social work or health education background, by education or job experience. A 
number of studies have found that professionals who are not clinically licensed can serve as effective 
depression care managers, and this reduces the cost and increases feasibility of dissemination and 
sustainability,97,110 and more resembles the CHC workforce. There will be two half-time care managers in 
each CHC, one for the CCI. Based on our discussions with our study sites, we expect that most if not all 

                                                                                                                                                                               
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care managers will be existing staff who are familiar with the health center culture, providers, and 
systems, including the electronic medical record and referral sources. For both study arms, the 
intervention is designed to be deliverable by phone, for efficiency in time and cost;113-115 however, we 
anticipate that enrolled patients may want to meet with the care manager in person as well, especially 
when at the health center for an appointment. 
 
C. STUDY PROCEDURES  
Female patients ages 50-64 years of age and identified as out-of-adherence with at least one 
cancer screening based on the CHCs’ electronic medical records will be recruited by care managers in the 
waiting room or by telephone following a mailed letter. Care managers will receive verbal consent to 
administer a brief screening tool to assess eligibility for the study, as outlined above; these data will be 
anonymized, so that it will not be possible to link the screening data back to the individual patient. All 
women screened will receive $5 for their time. Patients who are not eligible for the study but whose score 
on the PHQ-9 is indicative of depression (>  8) will be asked if they would like help making an 
appointment at the CHC.  
All women who agree to participate in this study will complete a process of informed consent, 
during which the care manager will discuss the study and its potential risks and benefits, and answer any 
questions that potential participants might have. It will be made clear that each woman’s decision 
regarding participation in the study will in no way impact her individual access to free or low cost 
medical care at that particular health center where consent is taking place, or at any other health center. 
The consent form, like the survey instruments, will be available to participants in English or in Spanish. 
Eligible women will be invited to participate in the study. When recruitment is conducted in 
person, the care manager will make every effort to complete the consent process at that time, and she will 
also attempt to complete the 45-minute baseline structured interview, described below. If this is not 
possible, the care manager will schedule another appointment, as soon as possible, to conduct the baseline 
interview by phone or in person at the CHC. Based on prior collaborative care research with minority 
patients in these Bronx CHCs and other similar settings, we expect a consent rate of about 70%.76,99 In 
keeping with PCM and other collaborative care research,76,112 we will use a randomized block algorithm, 
stratified by CHC to assign women to the PCM control arm or the CCI intervention arm. Block size will 
be allowed to vary randomly to preclude any exercise of judgement, or bias, in the allocation of 
participants to specific arms. Study participants will be randomized 1:1 to each of the two arms, according 
to a scheme prepared by the study statistician, who is not onsite at any of the CHCs. Randomization will 
occur after the baseline interview; women in the study will be notified of their assignment at the time of 
the first call with the care manager. Mr. Lin, study data coordinator, will disclose the block randomization 
process and will inform care mangers of the assignments. Ms. Cassells, Project Director, will supervise 
Mr. Lin and all aspects of data collection described below. 
Initial phone contact 
At the time of consent, all study patients will receive low-health literacy educational booklets 
about depression (provided by the NYC Department of Health and Mental Hygiene) and cancer 
prevention (provided by the NYC Department of Health and Mental Hygiene), in either English or 
Spanish, depending on their language preference. On the first call with patients, care managers will 
inform patients of their group assignment; in the PCM comparison arm, care managers will discuss only 
the cancer prevention information. If a patient asks questions related to depression, she will be 
encouraged to make an appointment with her primary care clinician. In the CCI intervention arm, care 
managers will review information provided about both cancer screening and depression. Additionally, in 
both groups and on the first call, care managers will assess the patient’s stage in intending to engage in 
cancer screening, for each of the types of screening for which she is not in adherence with guidelines. 
Care managers will use a structured approach to assess the patient’s stage of readiness, and she will use 
this monthly throughout the intervention period in both arms. Specifically, and guided by the 
Transtheoretical Model,116 study participants will select one of six descriptions that best matches their past 
screening behavior and future intentions, from Unaware (never thought about [colon, breast, cervical] 
screening for myself before now) to Maintenance (routinely undergo screening and plan to continue doing 
so in the future). Such an assessment approach has been used extensively and validated in ethnically 
diverse groups with respect to screening intention.117-120 Finally, the initial phone calls with women in 
both study arms will include a barriers assessment, which, informed by the Precede-Proceed Framework, 
involves working with patients to collaboratively identify and problem-solve barriers to screening 

                                                                                                                                                                               
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participation.37,87 Women in the CCI intervention arm will also engage in a barriers assessment relating to 
participation in mental health care utilization and/or medication adherence, as well as participation in 
social services and self-care. This assessment will be based on the collaborative care work of Ell.95 The 
barriers assessments will guide the care managers in working with the patients effectively to achieve self-
identified goals screening and mental health goals, which may evolve over the course of the intervention 
period. 
Subsequent phone contact and activities 
Following the first phone discussion, care managers assigned to the CCI intervention condition 
will reach out to patients at least every three to four weeks.99,121 During these monthly conversations, the 
care managers will conduct symptom monitoring with the PHQ-9, which works well by phone.95 They 
will also provide the elements of depression care management and motivational support as shown in 
Table 1 above to facilitate treatment decision-making and adherence, and to reduce depression. The care 
managers will not introduce the topic of screening and screening barriers until barriers to utilization of 
mental health care and/or adherence have been addressed. However, patients will be aware that the 
intervention is designed both to reduce depression and increase screening, and if a patient raises screening 
before the care manager does, this will open the dialogue. Between calls, the care manager will perform 
the navigation and linkage functions presented in Table 1. Care managers assigned to the PCM control 
condition will reach out to patients by phone once per month and more as necessary to assist women in 
overcoming barriers, including negative screening attitudes and transportation barriers, arrange 
appointments, answer questions, provide needed information, etc., for one year, or until the patient is up-
to-date for all screenings.87,123 The standard, structured PCM phone scripts developed previously will be 
used to review and problem-solve screening barriers in both study arms,76 and care managers will 
facilitate decision-making about the right colorectal screening test for the patient. 
Emergency Protocol 
Based on the PI’s present study of PTSD among Bronx CHC patients, we have developed an 
emergency protocol for the care managers to follow if, in the course of administering the PHQ-9, the 
patient endorses thoughts of suicide, or if the patient expresses suicidal thoughts outside the PHQ-9 
administration. Prior experience in these settings and other research suggests that we can expect about 
10% of the patients to express suicidal ideation.121  
Care Manager Training 
The care managers will be 
assigned to the CCIintervention group or the PCM comparison condition prior to training. The care 
managers assigned to the comparison condition will not be trained on depression care management (the 
second part of the training) during the active study, to further avoid the possibility of contamination 
across the groups. They will, however, receive training about what to do when a woman is in acute 
distress and/or is suicidal. The first part of the training, which will be attended by all care managers, will 
last eight to ten hours over two days. Care managers will be expected to review all study materials prior to 
the training. PCM Training will be based on the NIH RTIPS for the Dartmouth-CDN Prevention 
Care Management Project124 and will be conducted by Ms. Andrea Cassells, the study Project Director, 
who has conducted PCM training across multiple studies of care management in cancer screening and 
PTSD in the past 10 years, with support from  the study clinical psychologist. Dr. Allen Dietrich, PI for 
the previous PCM RCTs and the developer of both the PCM and CCI Interventions is a member of the 
research team and provides training and oversight to the Care Managers.  Guided by PCM,76 care 
managers will receive an overview of current screening guidelines of the U.S. Preventive Services Task 
Force; a review of barriers to breast, cervical, and colorectal cancer screenings; and detailed explanations 
of the screenings themselves. They will role play in the training about how to elicit barriers from women 
and how to provide motivational support to help women overcome them. Standard scripts will be 
provided to support the care managers and facilitate uniformity delivery, and they will need to pass a 
competency test.  
The second part of the manual-based training, which will last ten hours over two days, will be 
didactic and interactive; it will be led by the project psychologist, with support from Ms. Cassells. Only 
care managers assigned to the CCI  intervention will participate in this training; as with the first training, 
they will be expected to review materials beforehand. The focus will be on depression care management 
and will entail a review of what depression is, including key symptoms, as well as a brief overview of 
anxiety, which is likely to present in approximately 50% of the depressed women.121 Guided by the work 
of Ell and colleagues95,99 care managers will also learn about barriers to help-seeking for mental health 

                                                                                                                                                                               
8
problems, depression medications and barriers to adherence, and stigma and related cultural beliefs. 
Additionally, the mental health services offered in each care site will be reviewed, and there will be a 
discussion about how to best communicate with the primary care clinician regarding a patient’s mental 
health needs, and how to fulfill the essential linkage role between the primary care clinician and a mental 
health specialist.57,111 Also, in order for the care manager to be effective in her role, she must learn how to 
monitor treatment-response and depression through patient self-report.57,105 For this monitoring, and to 
guide changes in treatment, we will use the PHQ-9, which is already widely used in many CHCs, and in 
studies of collaborative care,57 and is described in the measures section. 
Care Manager Supervision 
Dr. Allen Dietrich, PI for the previous PCM RCTs and the developer of both the PCM and CCI 
Interventions is a member of the research team and provides training and oversight to the Care Managers.  
The  care managers assigned to theCCI intervention arm and the PCM intervention arm will have monthly 
case management meetings, in order to facilitate group problem-solving, skill-building and to provide a 
forum for mutual support.. 57,67 
Care Management Monitoring and Process Evaluation 
To help ensure that both arms of the intervention are implemented as planned (i.e., to assess 
treatment fidelity), care managers will use an electronic database to document all contacts with patient, 
including date, time, duration and mode (by phone or in-person), and content of the discussion. Care 
managers will also document specific barriers or problems mentioned and how these were addressed, 
stage of screening readiness at monthly intervals, and issues that arise in the CHC that either facilitate or 
hinder their work. The investigators on the research team will systematically review these process data 
weekly during the first month of implementation, and then again monthly in the first year. An 
implementation science framework that recognizes the challenges in translating evidence-based practices 
to CHCs86,111 will guide our approach to the process evaluation. These data will be brought for 
discussion to the Stakeholder Advisory Group meetings, as described in the Stakeholder Engagement 
Plan. 
Education of CHC Clinicians and Staff 
Primary care capacity-building is a key aspect of TCM, and we will incorporate some of this here. 
Specifically, in keeping with TCM, primary care clinicians at each CHC will be told about the study and 
will receive a two-hour CME-accredited onsite educational program/refresher that addresses the diagnosis 
of depression, assessment of suicidal thoughts, use of the PHQ-9 as an aid to diagnosis and treatment 
monitoring, the role of care management, and the use of decision support to modify management and 
achieve remission of depression.121 
Office staff will receive a one-hour in-service session about the study, an overview of depression 
diagnoses and management, and procedures to facilitate communication between providers and the care 
manager.121 We do not believe that this education will contaminate the comparison condition, because 
literature repeatedly shows that basic training alone to providers about depression does bring about 
practice chance in and of itself.57 A key part of collaborative care is to encourage and support clinicians to 
identify and treat depression, with mental health consultation and as they feel comfortable, and the site 
investigators/PIs (described in People and Places) will play a key role in facilitating this. At all 
health center sites sites, there is mental health consultation and patients will have access to short-term 
therapy as well as cancer screening services or referral to nearby services with only short wait times. 
Procedures for Data Collection to Evaluate the Comparative Effectiveness of the Two Interventions 
To compare the effectiveness of the two interventions, we will collect structured interview data 
from study participants, including data at baseline and then again six and 12 months later. Data will be 
collected by phone or in person as needed by  bi-lingual recruitment coordinators, who will be blinded to 
the participants’ study assignments. To maintain this, before beginning each interview, the Recruitment 
Coordinators will ask participants not to refer to their care manager by name, but rather as “my care 
manager.” All measures described below as patient self-report (rather than chart review) will appear in 
each of the three interviews, with the exception of basic demographic items. We expect that 
the interviews will take about 45 minutes to complete. Patients will receive $10 for participating in the 
first and second interviews and $15 for the third interview. 
 
D. STUDY DRUGS 
N/A 
 

                                                                                                                                                                               
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E. MEDICAL DEVICES 
N/A 
 
 
F. STUDY QUESTIONNAIRES AND MEASUREMENT 
We chose measures that are based on the conceptual model, have been validated and used widely 
with minority populations, and have been translated into Spanish; as needed, we will use a translating 
service with forward and back translation to translate the measures. All items taken from the National 
Cancer Institute’s HINTS survey have been translated. We organize the measures by: primary outcomes, 
intermediate outcomes, and co-variates.  
Primary Outcomes  
Participation in colorectal, breast, and cervical cancer screening  
We will assess participation in age-appropriate cancer screening behaviors in two ways: 
a.Chart Review: Review of electronic medical records at each of the three CHCs. 
b.Self-Report: We will ask participants about their participation (yes/no) in specific screening methods: 
Pap testing (past 3 years), mammography (past 2 years), and colorectal screening (FOBT/FIT, past year; 
flexible sigmoidocopy, the past 5 years; and colonoscopy, past 10 years). We will use standardized items 
from the NCI’s HINTS Survey.127 
Depression 
a. Patient Health Questionnaire (PHQ)-9. The PHQ-9 is the 9-item depression module from the full 
PHQ, and is a well-validated Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) 
criterion-based measure for screening and diagnosing depressive episode, assessing severity, and 
monitoring treatment response,128,129,130,131 either in person or over the phone.132 It has been shown to 
measure a common concept of depression across racial and ethnic groups, including African Americans 
and Latinos.128 133 Cronbach’s alpha was 0.80 in both African American and Latino samples.128 As a 
severity measure, the score can range from 0-27, since each of the 9 items can be scored from 0 
(not at all) to 3 (nearly every day). Meta-analysis showed pooled sensitivity of 0.80 and specificity of 0.92 
to a diagnosis of major depression among primary care patients in a structured psychiatric interview by a 
mental health professional using DSM-IV diagnostic criteria.131 As a practical screening tool, patients 
with a score of > 10 are considered to have clinically significant depressive symptoms.99,134,96,112,135,129 
b. The Hopkins Symptom Checklist (SCL-20). The SCL-20 consists of the 20 depression items on a 4-
point scale from the SCL-90, and has been shown to be a valid and reliable measure of depression in 
diverse outpatient and community populations (Cronbach’s alpha = 0.87; test-retest r=0.81).136,137 It has 
been shown to be sensitive to change in studies of collaborative care in primary care 
settings99,97,121,96,112,134,135 and among minority group patients.95,99,133 
We will consider clinically meaningful improvement of depressive symptoms to be a > 50% 
reduction in baseline SCL-20 or PHQ-9, and depression remission as an SCL-20 score <0.5 or a 
PHQ-9<5.  
Intermediate Outcomes 
Quality of Life/Health Status. We will measure quality of life with the Medical Outcomes Study (MOS) 
Short Form Health Survey (SF-12), which includes heterogeneous items from the SF-36 physical and 
mental component scales. This general measure of health status assesses the patient’s perceived health 
status and whether health problems interfere with normal functioning. The SF-12 has with demonstrated 
validity and test-retest reliability in the general population and in patients with chronic health conditions, 
and has been tested in five languages, including Spanish.138 It has been used extensively as a quality of 
life measure in collaborative care studies,42 including with low-income minority populations.95,99 It has 
also been used frequently in screening studies, for cancer and other conditions.139-142 The SF-12 has been 
validated as an indicator of effects of depression on quality of life in ethnically diverse patients.143 
Mental Health Care Utilization.  
We will assess mental health care utilization in two ways: 
c. Chart review. We will use data from the electronic medical record to determine the number of health 
visits, and the kind of provider seen for mental health care (psychiatrist, psychologist, and/or clinical 
social worker). 
d. Patient report. At baseline, we will ask respondents how many times in the past six months they have 
seen a provider to talk about or get medication for feeling sad, nervous, hopeless, or blue. In addition, we 
will ask participants about their ability to arrange to get mental health treatment, as well as whether they 

                                                                                                                                                                               
10 
have the financial resources to access mental health services. These questions will be adapted from the 
NCI’s HINTS survey.127 
 
Satisfaction with decision to participate in screening and mental health care. The Satisfaction with 
Decision Scale is a 6-item measure that uses a five-point Likert-type scale and can be tailored to any 
healthcare decision; it is grounded in a conceptual model of an effective decision, i.e., one that is 
informed, consistent with the decision-maker’s values, and behaviorally implemented.107 It has excellent 
validity and reliability (Chronbach’s alpha=0.86) in samples of women 40 and older,107 among depressed 
patients,108 and among participants of a large national cancer screening trial.140 
 
Attitude Toward Cancer Screening  
We will use questions from the NCI’s HINTS survey127 to assess patients’ attitudes and beliefs about 
colon cancer screening that might prevent them from obtaining this cancer screening.  We will adapt this 
item to also assess patients’ attitudes and beliefs about cervical cancer and breast cancer screening. 
 
Stigma associated with depression and help-seeking. Internalized stigma, also referred to as self or felt 
stigma,158 will be measured with Link’s Devaluation-Discrimination Scale (DDS) (Link, 1987; Link et al., 
1989 and 1991). This 12- item extensively used measure, based on modified labeling theory, uses a six-
point Likert format and assesses the extent to which an individual believes that people with mental illness 
are devalued or discriminated against (Link et al., 2004). It has established validity and reliability in 
diverse and low-income urban patients.159,160 The average Cronbach’s alpha for this scale was .83.158 We 
will also measure stigma-related concerns about seeking care, based a large study of lowincome 
Black and Latina women with depression.72 A care-seeking stigma variable will be created from 3 yes/no 
in response to the query: Would any of the following keep you from getting professional help? 
Participants will be categorized as having stigma -related concerns if they endorse one or more of the 
following: being embarrassed to talk about personal matters with others, being afraid of what others might 
think and family members might not approve. 
Satisfaction with care. In keeping with the Institute of Medicine’s report Crossing the Quality Chasm 
(2001) and with recommendations based on a systematic literature review (Crow et al., 2002), we will use 
a 34-item multidimensional scale of patient satisfaction that has demonstrated high reliability and 
construct validity in large outpatient samples, including Medicaid patients and Spanish-speaking patients 
(Safran et al., 2005; Fanjiang et al., 2007). The Ambulatory Care Experiences Survey produces 11 
summary measures covering 2 broad dimensions of patients’ experiences: quality of physician-patient 
interactions and organizational features of care. All measures range from 0 to 100 points, with 
higher scores indicating more favorable performance. Cronbach’s alphas for the 11 measures range from 
.70 to .90. 
Self-Efficacy. We will use the 10-item General Self-Efficacy Scale (GSE).161 The scale measures a 
general sense of perceived self-efficacy associated with coping with daily hassles and adapting to stressful 
life events. This unidimensional scale is available in 33 languages and has Cronbach’s alphas ranging 
from .76 to .91 based on samples from 23 countries.162 Perceived self-efficacy is an operative construct, 
meaning that it is related to subsequent behavior and is relevant for clinical practice and bringing about 
behavior change.161 However, it does not tap specific behavior change, and thus it will be necessary to add 
items to focus on the three different types of screening and utilization of needed mental health services; 
the development of such items will be based on the guidelines of Schwarzer161 as well as the valid and 
reliable breast cancer screening self-efficacy measurement work of Champion163,164; the cervical cancer 
screening self-efficacy work of Fernandez; 157,165 and research by Maly166 on efficacy in patient-physician 
interactions. 
Physician recommendation of screening/mental health care. We will use questions from the NCI’s 
HINTS survey127 to assess whether patients report their primary care physician has recommended 
cervical, breast, and colon cancer screening. We will adapt this item to determine whether their primary 
care physician has recommended that the patient make an appointment with a mental health provider 
and/or take psychotropic medication.  
Mental health treatment adherence. We will ask respondents if they have been prescribed medication 
for depression and about difficulties taking medication(s) regularly. Questions will adapted from Katon’s 
Team Care Intervention.112 
 

                                                                                                                                                                               
11 
Co-variates 
Sociodemographics. We will draw the following measures from the NCI’s HINTS survey;127 race, 
ethnicity, age, education, language spoken, foreign born, years in the U.S., marital status, parental status, 
household composition, employment status, insurance status, education, and income.  
Past history of cancer. We will use questions from the NCI’s HINTS survey127 to determine whether the 
respondent has ever been diagnosed with cancer, and if so, what type of cancer and when. We will also 
ask women if they have had a hysterectomy and confirm through the electronic medical record whether 
this was a full hysterectomy that included removal of the cervix.  
Family history of cancer. Questions about family history of cancer will come from the NCI’s HINTS 
survey.127  
Chronic medical conditions and obesity. 
Information about the respondents’ chronic medical conditions as well as weight, height, and body mass 
index as an indicator of obesity will be drawn from the electronic medical records. Anxiety (GAD-7). 
The GAD (Generalized Anxiety Disorder)-7 is based on diagnostic criteria in the DSM-IV and measures 
probably anxiety disorder and severity of anxiety symptoms. Patients are asked to rate how often they 
have been bothered by 7 problems in the last 2 weeks on a 4-point (0-4) scale (“not at all” to “nearly 
every day”). At a cut point of 10, sensitivity is 89% and specificity is 82%. In multiple diverse primary 
care samples of over 2000 patients, the measure demonstrated excellent validity as well as high 
internal reliability and test-retest reliability (Cronbach’s alpha=0.92 and intraclass correlation=0.83, 
resp.).167,168 Factoral analysis demonstrated that the GAD-7 measures anxiety as distinct from 
depression.168 A Spanish-language version has also demonstrated very good specificity and sensitivity as 
well as excellent reliability and validity.169 
 
 
G. STUDY SUBJECTS 
We will recruit 800 women to the study. To be eligible for the study, women must be patients at 
one of the six  participating Bronx CHCs. They must also be between 50 and 64 years of age, speak 
English or Spanish, reside in the Bronx, screen positive for depression based on the PHQ-9 (> 8) at time 
of recruitment, and be out-of-adherence with current U.S. Preventive Services Task Force cancer 
screening guidelines for breast, cervical, and/or colorectal cancer screening. Women will be considered 
out of adherence if they have not received a Pap test without HPV in the past three years or a Pap test 
with HPV in the past five years, a mammogram in the past two  
years, and/or one of the following forms of colorectal screening: FOBT (or FIT) within the past year, 
flexible sigmoidoscopy in the past five years, or colonoscopy in the past 10 years. A woman who has had 
total hysterectomy is considered up-to-date for cervical cancer screening after the date on which the 
hysterectomy was performed.76 We aim to be as inclusive as possible in this study. However, to maximize 
feasibility and in keeping with prior collaborative care research99,112, we will exclude women who report 
the following when screened: terminal illness, current pregnancy (albeit unlikely in this age range), 
substance  use, decisionally impaired or suicidal thoughts. We will exclude prisoners. Data received from 
the six  health center sites support the availability of potential study participants and demonstrate the need 
for a study such as this one. In 2011, across the study sites, mammography rates for women 50-64 years 
of age were 56%, 57% and 64%; Pap testing rates were 62%, 50% and 53%. All of these rates fell 
substantially below the New York City target of 85% or greater. For colon cancer screening, rates in 2011 
were 24%, 52%, and 27%, also much lower than the New York City target of 60% or greater. 
Additionally, depression rates for women of this age range in 2011 were 35% (including dysthymia), 
21%, and 21%, which is consistent with the literature.  
 
H. RECRUITMENT OF SUBJECTS 
Participating sites are Morris Heights Health Center, Urban Health Plan and Montefiore Primary 
Care Practice.  We have added Segundo Ruiz Belvis and Morrisania Diagnostic and Treatment Centers 
and Lincoln Primary Care Practice as three additional sites.  We will recruit approximately 800 women 
ages 50-64 who screen positive for depression and who are non-adherent with cervical, breast, and/or 
colorectal cancer screening guidelines from one of the participating Bronx sites.   Women in this age 
range should receive all three types of cancer screening. We are focusing solely on women because 
estimates of depression among minority women in the Bronx are 20%-25%, at least twice that of men, 
and depression has been shown to be a barrier to screening, with consequences for cancer morbidity and 
mortality. Patients will be approached and screened in the participating  sites in person or by phone to 

                                                                                                                                                                               
12 
determine whether they meet initial study inclusion criteria; they will have been identified as potentially 
eligible by the electronic medical record. Only patients who speak English or Spanish are eligible. For 
this screening, patients will provide verbal consent; the data will be anonymized. Patients will receive $5 
for their participation in the screening. If a patient confirms through this initial screening that she is out-
of-adherence for one or more types of cancer screening (breast, cervical, and/or colorectal), the patient 
will be administered the Patient Health Questionnaire (PHQ)-9 to determine whether she meets criteria 
for depression. Those patients who score greater than or equal to  8 on the PHQ-9, do not have a terminal 
illness, are not pregnant, are not prisoners, are not decisionally impaired and are not active substance 
users will be asked to provide written informed consent to participate in the study. Patients will be told 
that study involvement entails speaking with a care manager at least once per month by phone or in-
person, as they prefer, and they will be told about the two arms of the study and the randomization 
process. They will also be informed that participation will involve completing a baseline interview at the 
time of screening or within the week, as well as two follow-up interviews at 6 and 12-months after the 
baseline assessment.  
The interviews can also take place by phone. Interview content will include basic demographics, 
questions about barriers to and use of medical and mental health services, physical and mental functioning 
including depression and anxiety symptoms, self-efficacy, stigma, attitudes towards cancer screening, 
satisfaction with care and decision-making, and health history information. Interviews will last 
approximately 45 minutes, and respondents will be compensated for their time: $5 for the prescreening; 
$10 for the first assessment; $10 for the 6-month assessment; and $15 for the 12-month assessment. This 
study is open to accrual of women only, because women are significantly more likely to suffer from 
depression, which has been shown to be related to cancer screening. We are also limiting our sample to 
women ages 50-64, since only women within this age range need all three types of preventive cancer 
screening: breast, cervical, and colorectal. Based on the demographics of patients treated at the health 
centers in our study, we expect that our female study sample will closely mirror the population of the 
Bronx. Subjects will not be excluded from participating in this study on the basis of race, ethnicity, 
socioeconomic status, or insurance status. Every attempt will be made to enter all eligible subjects into 
this protocol and therefore address the study objectives in a population representative of depressed 
females 50-64 years of age in the Bronx.  
Finally, our analysis plan includes strategies to examine whether study outcomes differ by 
patients’ demographic characteristics, including race, ethnicity, and language spoken. Patient recruitment 
and follow up need to be optimized in a randomized controlled trial. In order to maximize our likelihood 
of reaching our recruitment and follow-up goals, we have recruited and engaged three Community Health 
Centers and three NYC Health + Hospitals Corporation (HHC) practices that that have worked with  
CDN and Einstein previously on NIH-funded research studies, and have the infrastructure and senior 
clinical leadership support for initiatives of this kind. Morris Height Health Center, Urban Health Plan, 
Montefiore CFCC, Segundo Ruiz Belvis D&TC, Morrisania D&TC and Lincoln Ambulatory Practice  
have all collaborated with CDN on previous NIH-funded randomized controlled trials with interventions 
and evaluations that include many of the same elements that are proposed in this study, and these 
practices  have been successful at meeting their recruitment goals, and have achieved retention rates of 
80% or greater. 
 
For recruitment of patients, we will use a dual approach, clinician referral and identification of 
prospective participants by encounter data, which has been proven to be successful in previous CDN 
practice based research initiatives. In order to maximize the number of patients that complete the 6-month 
and 12-month study visits, we will use a standardized system to track participants through the study. We 
will obtain extensive locator information subsequent to informed consent, including addresses/phone and 
cell numbers of participants’ family and friends as well caseworkers and social service agencies with 
which they are involved. Locator information will be updated at each study visit. An EXCEL database 
will be maintained to track projected study visit dates of each participant. Tangible incentives, including 
incentives in escalating amounts were built in for compensation of all study visits.  
The proposed study will be open to women of all ethnic and racial backgrounds between the ages 
of 50 and 64 years who speak either English or Spanish. Based on data obtained from our previous cancer 
prevention projects in Bronx sites;we expect that this female sample will be half African-American and 
half Latino, roughly reflecting the racial and ethnic profile of the Bronx. We also expect that about half 
the sample will speak Spanish as their primary language. 

                                                                                                                                                                               
13 
 
I. CONFIDENTIALITY OF STUDY DATA 
Confidentiality of each participant’s self-report information from the interviews as well as 
information extracted from the medical records will be secured to ensure patient confidentiality. 
Study data that will record participant names include informed consents and contact forms. This 
information will be maintained by CDN staff and stored in a locked cabinet and separate from all other 
study data. All data sheets will be coded with an ID number to protect confidentiality and will be kept in 
locked filing cabinets that will be accessible only to the research staff. A master list with matching 
participant names and code numbers will be maintained in a password protected file on CDN’s Local 
Area Network.on separate sheets of paper, which will be kept in locked storage accessible only to the 
CDN staff. Any computers that are used to maintain 
project data will require passwords for access, and any files containing patient names will also be 
encrypted and protected by password. Participants will be told that discussions and interview data will be 
kept confidential. The CDN staff will never link participant responses with identifiable data – that will 
only be used for the purposes of recruiting participants. 
 
The master list of names will be destroyed at the end of the project .  The signed consent form will be 
kept in a locked file cabinet and then destroyed, along with all remaining project records, seven (7) years 
after the end of the project  
 
 
 
All backup devices containing project data will be kept in a locked cabinet and only project staff 
authorized by the PI will have access to these data. Scientific presentations and publications will not use 
identifying information and will preserve the confidentiality of the participating CHCs, clinicians and 
patients; data will only be reported in aggregate form. 
 
 
 
All investigators who have not done so already will complete necessary coursework regarding 
protection of human subjects and will receive certification from the Collaborative IRB Training 
Initiative (CITI). The CDN IRB and the IRBs of the three health centers will oversee this study. Also, a 
Data and Safety Monitoring Plan (DSMP) will be developed and will examine mental health adverse 
effects (e.g., frequency of severe depression requiring hospitalization, expressions of suicidality), as well 
as evidence of early superiority of either arm at increasing cancer screening, both requiring early study 
termination.  
The PI/Co-PI and project staff will remain blinded and only the study statistician will have access 
to unblinded data. Should statistically significant differences arise during the interim analyses, these 
results will be shared with the IRBs at CDN and the health centers, and a decision to terminate the study 
will be made at that time. The DSMP developed will be designed to ensure the health and safety of 
research participants, and it will be designed collaboratively, with involvement of all investigators and the 
Stakeholder Working Group. 
 
J. POTENTIAL CONFLICT OF INTEREST 
None noted. 
 
K. LOCATION OF THE STUDY 
The primary institution of the PI, CDN, has seven contractual agreements that bring together 
community organizations, mental health experts, community health centers, and an academic university 
with faculty expertise in cross-sector partnerships and biostatistics. The PI, Dr. Tobin, along with his 
parent institution, CDN, as well as the contractors and their parent institutions are all aware of and agree 
on the appropriate programmatic and administrative personnel at each organization involved in the 
PCORI application and are aware of the applicant organization’s consortium agreement policy. Should 
this study be funded, all agencies and individuals are prepared to establish the necessary inter-
organizational agreement consistent with that policy.  
Practice Sites 
The proposed study brings together six practices,  including two federally qualified health centers 
(Urban Health Plan, Inc. and Morris Heights Health Center), two  Diagnostic and Treatment Centers that 
have FQHC look-alike designation (Segundo Ruiz Belvis and Morrisania D&TCs) and two  ambulatory 
care practices (Montefiore Family Care Center and Lincoln Ambulatory Practice) to be the recruitment 

                                                                                                                                                                               
14 
sites for this study. These centers bring their years of expertise delivering primary and specialty care to 
the residents of the Bronx and will act as the medical providers for all participants in this study. Briefly, 
Urban Health Plan, (UHP), is a network of community health centers in the Bronx and Queens, NY 
(this study will work with all of UHP’s Bronx based sites). The mission of UHP is to improve the health 
status of underserved communities. As a Federally Qualified Health Center (FQHC) and a level III patient 
centered medical home, UHP offers a broad array of primary and preventative medical services, dental, 
mental health and specialty services. In 2011, UHP served 48,000 patients through 250,000 patient visits 
at eight clinic sites, seven school-based clinics, and four off-sites (e.g., homeless shelters, adult day care 
centers). UHP was one of the first FQHCs in the country to implement an EHR. 
As a result, UHP is in a unique position to assist in customizing systems to meet the service–
reporting and quality improvement demands of both New York State and the Federal government. In fact, 
UHP is nationally recognized for its quality improvement initiatives (QI) and has conducted QI initiatives 
for both cancer screening and mental health. This expertise and experience with QI is a great strength that 
UHP will bring to this study as both a recruitment and intervention site and as a key stakeholder. Like 
UHP, Morris Heights Health Center (MHHC) is also a non-profit organization, a Federally Qualified 
Health Center, and a level III patient centered medical home. It has been a leading provider of primary 
healthcare to Morris Heights and the surrounding areas in the Bronx since 1981, and its mission is to 
provide high-quality, affordable, and accessible healthcare to all. The Center serves more than 48,000 
patients annually, 76% of whom live at, or under, the poverty level providing primary, specialty, dental, 
mental health, educational and social services. MHHC is unique in the Bronx in that it operates both 
article 28 and article 31 mental health clinics. As a result, they bring not only expertise providing care to 
their patients and the community, but also an in depth understanding of the mental health care system in 
the Bronx. As the largest and oldest ambulatory care teaching site in the Montefiore system, the 
Montefiore Family Care Center (FCC) brings the unique strength and perspective of an academic 
teaching center. Like UHP and MHHC, FCC serves a primarily low-income population providing both 
primary and specialty care services. In 2011 the Adult Medical Practice had nearly 45,000 visits serving 
approximately 15,000 unique patients. CDN, the lead institution, has long-standing collaborative 
relationships with UHP, MHHC, and Montefiore. 
 
Lincoln Hospital Ambulatory Care Services, Morrisania Diagnostic and Treatment Center and 
Segundo Ruiz Belvis Diagnostic and Treatment Center are part of NYC Health + Hospitals Corporation 
and have a longstanding history of providing quality comprehensive medical care to low income and 
underserved patients in the Bronx.   
 
 
L. POTENTIAL RISKS 
There are no physical risks posed by this study, and the risks of participation are minimal. However, we 
are targeting patients with depression who may report experiencing distress during an in-person or phone 
interview with study staff, or during a phone or in-person visit with a care manager. The level of distress 
participants may experience can range from minimal distress (fleeting and not disruptive to the patient’s 
functioning) to significant distress (patient is unable to refocus and activities are disrupted). Our 
experience from prior research studies is that such extreme reactions are very rare; however, patients who 
experience distress at any of the study visits will be referred to their Primary Care Clinician for follow-up 
care. An Emergency Protocol has been developed detailing the steps and key personnel that 
need to be contacted in the event of an emergency, such as suicidal thoughts. 
 
M. POTENTIAL BENEFITS 
Although we cannot guarantee benefits from participation in this study, all participants will be 
randomized to one of the intervention conditions and will receive care management services with a focus 
on cancer screening, or on cancer screening and depression management. All participants will receive 
information about cancer screening and support to help them make cancer screening decisions. Some 
participants will also receive information about depression and depression care management. 
 
N. ALTERNATIVE THERAPIES 
N/A 
 
 

                                                                                                                                                                               
15 
O. COMPENSATION TO SUBJECTS 
All women screened will receive $5 for their time. Patients will receive $10 for participating in the first 
and second interviews and $15 for the third interview. 
 
P. COSTS TO SUBJECTS 
 
The cost to each patient  for taking part in this project is the time spent with the Care Manager,  the time 
spent taking the screening tests, and  the time  spent answering the questions during the three (3) 
interviews.  If the patient has  health insurance, the screening tests will be covered by the patient’s 
insurance.  If the patient does not have health insurance, we will work with the patients and their  
practices to find ways to pay for the breast, cervical, and colon cancer screening tests they need.  
 
 
 
Q. RADIATION OR RADIOACTIVE SUBSTANCES 
N/A 
 
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