Care Coordination for Complex Cancer Survivors in an Integrated Safety Net System (Project Connect)
Phase: NA
Conditions: Breast Cancer, Colorectal Cancer
Sponsor: University of Texas Southwestern Medical Center

 
 
 
Study Protocol and Statistical Analysis Plan 
 
 
Study Title: Care coordination for complex cancer survivors in an integrated safety-net system 
Principal Investigators: Simon Craddock Lee and Bijal Balasubramanian 
NCT Number: NCT02943265 
Initial Approval Date: March 25, 2016 
Version Date: May 26, 2022 
 
 
 

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1. Introduction and Purpose: 
Nearly 70% of the 13 million people living with cancer are “complex cancer survivors” who are 
also dealing with multiple other chronic conditions. The prevalence of complex cancer survivors is 
expected to continue growing because successful treatments result in longer survival and cancer 
diagnoses occur most often in older persons who are more likely to have multiple chronic conditions. 
The National Comprehensive Cancer Network (NCCN) emphasizes that managing survivors’ needs 
includes caring for their other chronic conditions. These complex patients need highly coordinated 
care to ensure optimal outcomes for their cancers, co-existing chronic conditions, and overall quality 
of life, but no effective models for doing this exist. 
 
This project is a pragmatic trial. We propose a quasi-experimental design where data will be 
collected both pre- and post-intervention on distinct cross-sections of patients with one or more 
highly prevalent ambulatory-sensitive chronic conditions (diabetes, hypertension, chronic lung 
disease, chronic kidney disease, depression, or heart disease) and newly diagnosed with breast or 
colorectal cancers (complex cancer survivors) in the Parkland Health & Hospital system (Dallas, TX). 
Guided by the Primary Care Change Model, Parkland will implement evidence-based care coordination 
strategies to improve care for complex cancer survivors in this integrated safety-net system as a part 
of quality assurance/quality improvement activities (Aim 1), then this study will comprehensively 
evaluate how these strategies are implemented in the safety-net setting (Aim 3), and whether 
implementing these strategies improves care coordination and care outcomes (Aim 2) within the 
Parkland Health and Hospital System.  
 
2. Background: 
Following initial cancer treatment, needs of complex cancer survivors are not well met, resulting in 
poor health outcomes. Management of a new cancer diagnosis often interrupts existing chronic 
disease care because patients undergo intensive oncology care for an extended period of time during 
which attention to their other conditions may wane. Further, patients with cancer often continue to be 
followed by oncologists after completion of initial treatment with little or no care coordination with 
primary care clinicians. Thus, care is fragmented and the providers siloed, resulting in suboptimal 
care quality. The Institute of Medicine (IOM) argues a lack of system-level approaches to navigate 
survivors between primary and oncology care contributes to fragmentation and poor outcomes. 
This is further complicated by ineffective use of clinical decision support tools (disease registries, 
alerts, referral tracking) and fragmented care delivery approaches. Effective care coordination 
organizes patient care activities and provider information-sharing to facilitate shared-care and 
appropriate service delivery.  
 
The burden of cancer, multiple chronic conditions, and fragmented care is greatest among under- 
and uninsured minority patients. For example, nationally, African Americans have worse quality-
of-care outcomes on 73 preventive and chronic disease care indicators. Similar disparities in 
quality-of-care outcomes exist particularly for cancer survivors who are racial/ethnic minorities, 
uninsured, and receiving care in safety-net health systems. At Parkland Health & Hospital System 
(Parkland)-Dallas County’s integrated safety-net system - 72% of cancer patients are racial/ethnic 
minorities, 70% are uninsured, and more than 60% have three or more chronic conditions. 
Parkland preliminary data show only 43% of colorectal cancer survivors met guidelines for both 
cancer surveillance and appropriate diabetes care. Our application proposes innovative research to 
improve care for this vulnerable group of patients.  
 

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Despite a significant body of evidence regarding best strategies to improve care for patients with 
multiple chronic conditions, there is little research on complex cancer survivors. The IOM, Agency 
for Healthcare Research & Quality (AHRQ), and Institute for Healthcare Improvement all support 
care coordination as a mainstay of interventions to improve care quality for complex patients The 
2007 AHRQ report, synthesizing 75 systematic reviews of care coordination interventions along with 
more recent research, shows that strategies with compelling evidence for improved outcomes include: 
(1) EMR-driven transitions using alerts and referral tracking; (2) intensive case management;  and (3) 
team-based care. These strategies improve transitions in care processes, enhance continuity, reduce 
lack of follow-through on referrals, and ensure that patients receive all recommended care through 
regular information-sharing. They also demonstrate improved patient experience of care and clinical 
outcomes. Further, care coordination interventions conducted in integrated systems like Parkland –
where primary and specialty care communicate through a common electronic medical record system 
(EMR) – have the greatest potential for improving outcomes. Evidence for effectiveness of case 
managers and automated reminders originated in insured integrated systems and have shown 
improvements in diabetes performance measures and cancer screening. Also, care coordination 
interventions among elderly patients with multiple chronic conditions show improved outcomes 
compared with those focusing on a single disease.  
 
Although there is sufficient evidence for using these strategies for common medical conditions in 
primary care, their effectiveness in coordinating care for complex cancer survivors has not been 
evaluated. Therefore, in Aim 1, Parkland will implement these care coordination strategies for 
complex survivors as a part of quality assurance/quality improvement, and Aim 2 and Aim 3 will 
evaluate these strategies. We will use mixed methods to comprehensively evaluate implementation of 
care coordination strategies among complex cancer survivors at Parkland. We use the empirically 
informed Primary Care Practice Change Model to guide our evaluation design. This intervention 
mixed-methods evaluation will examine not only whether the selected strategies were effective, but 
also how and why they worked (or did not work) is critical to generating transportable findings 
necessary for broader dissemination.  
 
3. Study Procedures: 
We expect approximately 1000 new survivors with ≥ 1 prevalent chronic condition to be eligible. We 
will not include patients diagnosed with in situ and metastatic disease (Stages 0 and IV) due to 
insufficient evidence for routine follow-up and management; many of the latter continue indefinitely 
on active treatment for symptom management. The chronic conditions we selected for inclusion are 
the most prevalent conditions cancer survivors have at Parkland as well as nationally.  
  
Aim 1: (Quality assurance/quality improvement) Parkland will implement system-level EMR-
driven evidence-based care coordination strategies; (1) EMR-driven registry to facilitate patient 
transitions between primary care and oncology care, (2) co-locate a nurse practitioner trained in care 
coordination within a complex care team, and (3) enhance teamwork through coaching and technical 
assistance.  
• 
Strategy 1: Using the Epic Reporting Workbench, Parkland EMR data will be extracted in 
order to create a registry of complex cancer patients to facilitate transitions primary care and 
oncology care.   
• 
Strategy 2: During Year 1 of this study, Parkland will educate clinicians and staff about the 
proposed system change and train primary care physicians on ways to identify and refer 
survivors to the complex care team. Parkland will designate a new complex care team for 

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eligible patients. This team will be housed within a Parkland community oriented primary 
care clinic. Due to the acuity and complexity of the needs of complex cancer survivors, the 
team will be staffed by a primary care physician and a nurse practitioner, and will include an 
RN/LVN nurse, a medical assistant, a social worker, and a mental health counselor.  
• 
Strategy 3:  Parkland will map team workflow around all aspects of delivering care to 
complex cancer survivors, establishing team goals, train team members in all aspects of cancer 
survivorship care including providing booster training sessions and coaching, enhance 
communication, set ground rules to make decisions, and finally pro-actively create standing 
orders to empower non-physician team members to share care delivery. Parkland will 
facilitate primary care teams in developing systems needed to enhance teamwork and 
implementing incremental practice change initiatives through quality improvement cycles.  
 
Aim 2: (Research Component) Test effectiveness of the care coordination strategies using a quasi-
experimental study, with system- and patient-level outcomes measured before and after 
implementation.  
 
System-level hypothesis: The primary outcome is proportion of complex cancer survivors meeting 
quality of care guidelines for multiple chronic conditions and follow-up cancer surveillance.  
We will use clinical care guidelines for chronic disease care and National Comprehensive Cancer Network 
(NCCN) guidelines for cancer surveillance to determine if patients are eligible for services. We will 
also determine whether patients received guideline-appropriate cancer surveillance, e.g., whether 
colorectal cancer patients received CEA testing every 6 months, endoscopy surveillance, and CT scans 
annually. We will also measure rates of ED and hospitalizations (secondary outcomes) for ambulatory 
care-sensitive chronic conditions at the same time points as the primary outcomes. The outcome 
measure will be derived from quality scores for: (a) chronic disease care and (b) cancer follow-up care. 
We will create these scores by, first, determining for each patient the percentage of eligible guideline-
recommended services received and clinical targets met, then, calculating the percentage of patients 
that met 100%, 75%, and 50% of these indicators. The 75% and 50% composites are less stringent and 
assess percentage of patients who achieved success on fewer indicators. Finally, we will calculate a 
composite overall care score that includes both chronic disease and cancer follow-up score. 
Computing composite scores will allow us to measure not only changes separately in chronic disease 
care and cancer follow-up care but also changes in overall care. This extends current research beyond 
single-disease measures to focus on overall care quality.  
 
Patient-level hypothesis: Patient-reported care coordination assessed via Patient Perception of Care 
Scale, which has been validated in primary care and is associated with improvements in reported 
problems with care coordination.  We will use the EMR-generated registry to randomly select 866 
complex cancer survivors to survey 402. Surveys will be administered three times by phone – once 
prior to their initial visit with the complex care team (baseline) and twice thereafter at 6 and 12 
months. Prior to fielding surveys, we will conduct 15 cognitive interviews (with patients who will be 
excluded from the larger project) to ensure measures not already validated in Spanish are adapted for 
language, literacy and culture. 
 
Aim 2 Statistical analyses: We will use segmented logistic regression and linear mixed regression 
models to assess effect of care coordination strategies on system and patient outcomes.  
 
To evaluate system-level hypotheses, the design is a repeated cross-sectional study with outcomes 

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measured for distinct cross-sectional samples of patients at five points. To analyze these data, we will 
first use chi-square tests to compare proportion of eligible patients meeting guidelines at 12 and 24 
months before implementation to proportion of patients meeting guidelines 12, 24 and 36 months 
after system-level strategies are in place. We will then use segmented logistic regression models to 
identify the time point at which observed trend in proportion of patients meeting guidelines. We 
expect a significant p-value for change in proportion of patients meeting guidelines after 
implementation of system-level strategies. Conversely, we expect the trend for proportion of patients 
meeting care guidelines before implementation to be stable with a larger p-value. This trend, in 
conjunction with additional qualitative information gathered about implementation (Aim 3), will 
provide evidence that implemented strategies resulted in changes in outcomes.  
 
Power/sample size: To demonstrate a minimum increase of 10% in the primary outcome after 
implementation of system-level strategies as compared to before implementation, a sample of 170 
patients at each time point will provide 80% power at the 0.05 significance level based on the chi-
square test for comparing proportions. We have many more patients than needed; as system-level 
outcomes will be evaluated using EMR data, we will include all eligible patients and conduct 
subgroup and sensitivity analyses to better characterize effects. 
 
For the patient-level hypothesis, the design is a repeated measures study with outcomes measured 
on the same patients at three time points; at baseline and 6 months, and 12 months after transition to 
the complex care team for each individual patient. We will use linear mixed models to estimate effects 
on change in scores. Through specification of fixed effects, the mixed model allows for control of 
confounding variables, and can account for sources of natural heterogeneity by adding random 
effects that are unique to a particular individual. We will test different covariance matrices for 
random effects and will choose the matrix yielding smallest Akaike information criterion or largest 
restricted maximum likelihood estimate. Residual analyses and plots will examine adequacy of the 
final model. We will use SAS Proc Mixed procedure for analysis. Retrospective data might be missing. 
If data are missing at random (MAR), a linear mixed regression model is appropriate to address the 
issues of repeated measures and missing data in longitudinal studies. If the missing data are not 
missing at random (NMAR), we will explore the missing data pattern and a technique such as pattern 
mixture model will be used to adjust for NMAR bias. 
 
Power/sample size: Assuming intra-subject correlation of 0.7 and minimum detectable 
standardized effect size of 0.25 (standardized effect size = effect size/standard deviation), we will 
need 402 patients to attain 80% power at α=0.05 using proposed mixed-effects linear regression 
analyses. 
 
Aim 3: (Research Component) Conduct an intervention mixed-methods evaluation of 
implementation of care coordination strategies. This is especially important for system interventions 
implemented in the context of real world settings as proposed in this application to: (a) describe how 
the system-level strategies are implemented; (b) elucidate contextual factors affecting implementation 
at system and patient-levels; and (c) identify alternate explanations for observed effects on outcomes 
to generate counterfactual inference. Gathering qualitative and quantitative data before, during, and 
after implementation will enable us to assess the factors that influence implementation at system- and 
patient levels. Data collection methods include structured observations, complex care team surveys 
and provider interviews, patient surveys and interviews, and EMR extraction.  
 

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Structured observations - quiet observation of daily clinical work with opportunistic discussion with 
staff at the primary care clinics, Patient Access Center, and the complex care team- will describe usual 
care prior to and document how workflow changes after strategies are implemented. Adapted from 
anthropological participant observation, this method lends itself to multiple levels of observation and 
analysis Led by Dr. Lee, research staff will conduct 40 hours of structured observation prior to 
implementation and at 3 and 6 months post-implementation.  
 
Patient surveys and interviews will assess experience of care coordination and its broader effects on 
health-related quality of life as well as the mediating and/or moderating effects of patient activation, 
attitudes toward follow-up cancer care, care quality, challenges of daily living (multiple low-wage 
jobs), competing demands/structural barriers to access (transportation, no paid time off), and health 
literacy. Administration of patient surveys is described in Aim 2 above. We will stratify across the 
two cancer types compared to a usual care sample of complex patients without cancer, and account 
for originating clinic. Interviewing across these groups will elucidate the experience of coordination 
for patients with multiple chronic conditions and enable us to see how cancer may create additional 
or different needs or perceptions. Additional patient interviews will be conducted to assess receipt of 
a care plan, survivor-level outcomes, experience with survivorship, and to understand the impact of 
COVID-19. These interviews will allow us to understand the patient experience throughout the cancer 
care continuum.  
 
Interviewing providers and focus groups from primary clinics with high and low rates of survivors’ 
referred to the complex care team will help identify “work-arounds” and protocols that impede or 
facilitate care coordination, e.g. primary and specialty physician communication. Providers (n=30), 
sampled based on their involvement in cancer survivor follow-up care and chronic disease 
management, will be invited to interviews which will assess perspectives on patient uptake and other 
perceived challenges and opportunities. The PIs will develop interview guides, train and supervise 
the team in conducting interviews. Focus groups (N=2) and additional provider interviews (N=10) 
will be conducted to understand provider perceptions and experience treating cardiovascular disease 
risk for cancer survivors. 
 
Epic EMR data Extraction will be used to characterize: (1) visit patterns with the nurse coordinator; 
(2) the extent to which care coordination, disease management and referrals to specialty providers 
and receipt of referrals occur; (3) patients who do not receive appropriate follow-up services; (4) 
missed appointments or loss-to-follow-up; and (5) processes related to care coordination. A separate 
data extraction of 1000 non-cancer patients with multiple chronic conditions will allow us to 
analytically characterize the non-cancer comorbid patient population at baseline as a comparator. We 
will also recruit a small subsample of these for baseline pre-intervention surveys and interviews. 
 
Aim 3 Data analyses: We will use NVivo 9.0 (QSR International, AUS) to collate and analyze 
qualitative data. Use of this software makes the analytic process transparent so that investigators can 
track evolving analyses. Research staff will transcribe field notes from structured observations and 
gather existing protocols and documents relating to care of complex patients to enter into the 
database. We will develop flowcharts depicting complex care and primary care team members’ 
relationships, roles, responsibilities, and behaviors in relation to practice change. Drs. Lee and 
Balasubramanian will work with research staff to organize these source documents and develop a 
codebook relating data to practice change, behavioral and organizational theories. We will triangulate 
across diverse data sources, to understand how providers adapt the strategies to suit the Parkland 

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context. Through monthly meetings, we will test emergent themes and interpretation against the 
knowledge base of our study team. We will review coding agreement and resolve discrepancies 
through consensus. Cross-analysis of qualitative data from all sources will enable integration across 
strategies and implementation processes to assess key steps and the interface of oncology and 
primary care. Using waves of surveys from Aim 1, we will explore whether changes in teamwork 
scores correlates with changes in primary outcomes in Aim 2.   
 
4. Criteria for Inclusion of Subjects: 
Patient sample: The study eligible patient population includes adult patients over 18 years of age 
diagnosed with AJCC Stage I-III incident breast or colorectal cancers AND with one or more of the 
following highly prevalent ambulatory-sensitive chronic conditions (diabetes, hypertension, chronic 
lung disease, chronic kidney disease, depression, or heart disease). We will exclude patients with in 
situ cancers (Stage 0) and those with metastatic disease (Stage IV). 
 
Usual care pre-intervention sample: Our sample of 1000 non-cancer patients will include those with 
multiple chronic conditions (as above) and at least one doctor visit in the previous 12 months.  
 
For patient cognitive interviews, surveys and semi-structured interviews (Aim 2), we will apply the 
following additional eligibility criteria: ability to comprehend English or Spanish, and communicate 
with voice (to participate in interviews and telephone surveys). Patients with and without eligible 
cancers are interview candidates. 
 
Provider sample: Physicians and clinical staff (nurse practitioners, physician assistants, nurses, etc.) 
will be eligible if they have current clinical responsibilities in Parkland oncology clinics, involved in 
colorectal or breast cancer care; the Parkland complex care team; and Parkland Community-Oriented 
Primary Care Clinics (COPCS) who manage patients with multiple chronic conditions. 
 
5. Criteria for Exclusion of Subjects: 
Patients with impaired hearing or speech, inability to speak to English or Spanish, and refusal to 
consent (patient survey only) will be excluded from this study.  
 
6. Sources of Research Material: 
Data for this study will include:  
1) Electronic Health Record (patient demographics, cancer and comorbidity diagnoses, 
appointments and dates, lab results and dates, screening procedures including results and 
dates, smoking history, medications, cancer treatment data). For the retrospective component 
of the study, we will request the EMR data from 01/01/2010- 12/31/2016. An additional sample 
of patients without cancer, but with 2 or more chronic conditions and a doctor visit in the last 
12 months as a comparator group. 
2) Patient survey data about patient experiences of care - validated measures 
3) Audio-recordings of patient and provider interviews will collect qualitative data about patient 
experiences of care 
4) Field notes of structured observations of clinic workflow 
  
7. Recruitment Methods and Consenting Process: 
To evaluate the system-level outcome, we will use EMR data collected on approximately 1000 
patients from the Parkland system.  We will ask the IRB for Waiver of Consent and Waiver of HIPAA 

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Authorization for EMR review and extraction of outcome data, and to conduct a confirmatory audit 
of 50 patient records identified by the EMR algorithm for individual chart review to confirm our 
ability to accurately capture all complex, Stage I-III breast, colorectal cancer patients completing active 
treatment.   
 
To evaluate the patient-level outcome, we will use the EMR-generated patient list to randomly select 
~866 complex cancer survivors in order to survey at least 402 after their transition to the complex care 
team. Based on our prior research experience with contacting Parkland cancer patients, patients are 
able and willing to complete telephone surveys. Further, we can expect 55% of those eligible will 
participate (n~480); 12% will actively refuse, 13% will have a non-working number, and 20% will be 
unreachable. We will also request a Waiver of HIPAA Authorization to identify and invite patients, 
and to compare, subsequently, demographics of non-respondents with participants to examine 
selection bias. All patients included in the system-level and patient-level outcomes are Parkland 
patients of the study investigators.  
 
Cognitive Interviews. Working with the Cancer Center’s Spanish Language Translation/Validation 
Resource, we will conduct 15 cognitive interviews in English or Spanish with a sample of Parkland 
cancer patients who were diagnosed with cancer in 2014 or earlier. These patients will not be included 
in the analyses for Aims 2 or 3.  This sample will be recruited from the Parkland cancer registry or the 
Community Health Registry (STU 112010-061). We will ask the IRB for a waiver of documentation of 
consent and waiver of documentation of HIPAA Authorization for these participants. Trained, 
bilingual staff will recruit potential participants by telephone, explaining the goal of the interview, 
and schedule an on-site interview to be conducted at UT Southwestern. At the interview, staff will 
review session purpose, solicit informed consent, and conduct a half-hour cognitive interview to 
ensure the survey is understandable by individuals with low literacy skills and culturally 
appropriate. We will also evaluate whether the English and Spanish versions are conceptually 
equivalent.  Cognitive interviews will be digitally audio-recorded; no HIPAA or other identifying 
information will be retained in the interview transcript. Gift card in the amount of $15 will be 
provided to interview participants as an acknowledgment of their time and effort. 
 
Patient telephone surveys. Patients identified for telephone survey will be mailed an invitation letter on 
Parkland letterhead, as appropriate, requesting participation in a “project to improve patient 
satisfaction with continuing care for their existing medical conditions.” The letter will provide a local 
telephone number parents can use to opt-out or ask questions. Letters will be in both English and 
Spanish. A few days after the mailing, patients who have not refused contact will be called by a 
bilingual research assistant (RA) who will explain the project, verify eligibility, obtain verbal 
informed consent and HIPAA authorization for EMR review, and conduct a 30-minute survey. Up to 
6 attempts per month for 2 months (day and evening) will be made to reach patients. Token gift cards 
will be provided to survey participants as an acknowledgment of their time and effort, per IRB 
stipulations. Provision of incremental remuneration (gift cards of $10, $20, $40) will be provided in 
appreciation of the participant’s time. Bilingual staff will invite a subset of survivors and usual care 
patients (n=90) for follow-up interviews (see below). We will also endeavor to sample an additional 10 
patients for interviews from among those who did not respond to the surveys to explore selection 
bias. 
 
Patients will complete surveys three times by phone – prior to their initial visit with the complex care 
team (baseline), and twice thereafter at 6 and 12 months. In addition to the primary measure, patients 

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will also be surveyed for key patient-reported confounding variables, potential mediators and 
moderators. Patients who have completed at least one survey will be invited to participate in an 
additional survey to assess the impact of COVID-19 on their overall health and well-being, including 
understand the effects of social distancing, patients' physical, emotional, and mental health, financial 
impact, and coping. Patients will receive a $20 gift card for their participation in the COVID-19 
survey. 
 
Structured observations and provider interviews and focus groups: For study procedures involving 
clinicians and staff, we will request a Waiver of Documentation of Consent from the IRB because 
signed consent forms would be the only written record of participation, observations and interviews 
will concern only professional roles and responsibilities and no personal personnel information will 
be collected. We plan to conduct approximately 40 hours of structured observation, to interview 
approximately 40 providers, and conduct 2 focus groups (10-20 providers).  Providers will be sampled 
on the basis of their involvement in cancer treatment, primary care and morbidity management 
(diabetes, hypertension, depression, heart disease, asthma); they will be invited to interview by 
faculty investigators. We will describe study objectives and purpose of the interview then solicit oral 
informed consent. No PHI will be collected.  
 
Patient semi-structured interviews:  A subset of 90 survey responders, (plus 10 non-responders, n=100) 
patients will be invited to complete a telephone interview. Following the existing recruitment 
procedure, additional eligible patients who did not complete a survey will be identified using EHR 
data and will be invited directly to interviews. An additional subset of 40 patients will be invited to 
complete a telephone interview focused on their experience with COVID-19. Patients will receive a 
$40 gift card for their participation in the COVID-19 interviews.  
 
An additional subset of 15 colorectal and breast cancer survivors identified from the retrospective 
cohort data will be invited to participate in semi-structured telephone interviews. Eligible participants 
will be mailed an invitation letter on Parkland letterhead requesting participation in a “project to 
improve satisfaction with cancer care” with a toll-free number to opt out or to ask questions. 
Bilingual staff members will contact patients by phone to 1) obtain informed consent and HIPAA 
authorization to review the patient’s EMR; and 2) conduct the semi-structured interview in the 
patient’s preferred language (English or Spanish).  The interview will last about 45 minutes to 1 hour, 
and will be audio-recorded.  All interviewers will be trained by Dr. Lee and supervised by Drs. Lee 
and Balasubramanian. Gift cards will be provided to interview participants as an acknowledgment of 
their time and effort, per IRB stipulations. All data will only be accessible to authorized study 
personnel and members of regulatory agencies.   
 
8. Potential Risks: 
This is a minimal-risk study. Main risks to patients are minimal because the proposed implementation 
of effective strategies to provide cancer patients with care coordination for multi-morbidities 
promotes appropriate medical care and follow-up. The system-level intervention combining three 
evidence-based care coordination strategies will be implemented by Parkland clinicians under the 
direction of Parkland leadership and evaluated by the research team. 
 
Care coordination is recommended by the Institute of Medicine and National Comprehensive Cancer 
Network. We are studying care coordination for complex cancer survivors to understand how best to 
provide for complex survivors in safety-net settings generally and to inform Parkland system-wide 

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adoption of team-based care coordination for all patients with multiple chronic conditions in the 
future. 
 
Patients:  The main potential risk of participation is that patient confidentiality may be compromised, 
leading to a third party gaining access to personal health information. There is also a small 
psychological risk that collecting data about care coordination following cancer treatment may cause 
patients to worry about their care. Patients will be identified through the EMR and approached with 
the knowledge of their treating physician or clinic director. No personal identifying information will 
be collected during the qualitative interviews and transcripts will be reviewed and purged for 
personal identifiers by study staff. Methods for protecting against risks are described below. Patients 
who chose not to participate in surveys or interviews will continue to receive their usual care.  
 
Physicians and Staff: Potential risks to participants include feelings of discomfort and concerns about 
continued employment, future promotion, or adverse evaluation resulting from their participation as 
well as privacy regarding the information they will provide in the interviews. However, the 
information solicited concerns only routine professional behaviors related to management of chronic 
conditions and cancer survivorship follow-up care; questions are not personal in nature. Data 
collection is analogous to routine quality improvement initiatives conducted at Parkland and all 
leading healthcare organizations. The oral informed consent process will explicitly seek their 
voluntary participation. Participants will be assured that names are not identified in transcripts or 
analysis, and that any information they might provide is confidential and will in no way be used in 
the evaluation of their professional roles. Methods for protecting against these risks are described 
below.  
 
9. Subject Safety and Data Monitoring: 
Our implementation study applies evidence-based care coordination strategies, as articulated by the 
IOM, NCCN, and AHRQ, to the clinical care of complex cancer survivors and anticipates the 
integration of patient-centered medical home models in safety-net settings. Monitoring will be 
conducted primarily by the Principal Investigators and through periodic review by the UT 
Southwestern IRB. 
 
All data transactions will run through controlled, secure transactions to ensure the preservation of 
database integrity and privacy. The data will reside on a secure, password-protected SQL database 
accessible by approved study personnel only. All personal identifying information will be kept by the 
investigators in a secure place with IRB approval. All data management procedures and databases 
will be HIPAA compliant. Any study data maintained as paper documents will be stored under lock 
and key.   
 
All study data will be backed up on a nightly, monthly, and biannual schedule; nightly backups are 
purged every 30 days. Monthly and biannual backups will be kept on static media throughout the 
duration of the study and up to 5 years after.  The process of restoring data from a backup will be 
conducted to preserve as many data as possible, while ensuring that database integrity has been 
preserved.   
 
10. Procedures to Maintain Confidentiality: 
We will use rigorous data security procedures to protect subject confidentiality and comply with 
federal HIPAA requirements. All personal identifying information will be kept by the investigators in 

10 
 
a secure server with IRB approval.  All data management procedures and databases will be HIPAA 
compliant. Any study data maintained as paper documents will be stored under lock and key in a 
secure filing cabinet in locked offices.   
 
All interviews will be digitally voice-recorded and transcribed by a professional vendor under a 
Business Associates agreement to ensure confidentiality. All resulting transcripts, together with field 
notes from structured observations in the clinics, will be de-identified and stored on password-
protected computers. 
 
A systems administrator will monitor server hardware, operating system and database service 
performance. Workstations, laptops, and other devices will receive periodic back-up and maintenance 
to ensure high performance and secure operation. 
 
All data protocols will be approved by the UT Southwestern Medical Center, UT School of Public 
Health, Institutional Review Board (Parkland uses the UTSW IRB). All protocols will follow 
University policies that confine all personal information on paper or only on password-protected 
computers that are not accessible through the web, as per University of Texas System interpretations 
of HIPAA regulations.   
 
Finally, the study will proceed with the full knowledge and approval of Parkland leadership; we will 
ensure all research activities that take place in the Parkland system do not disrupt clinic operations. 
To execute this study protocol, we will work closely with our clinic partners and believe the steps we 
outline below are adequate to ensure patient privacy and overall data security for the course of the 
study. We will also work with Parkland to publicize results of the study to inform the patient 
community of the knowledge gained. 
 
We will include cancer patients with chronic conditions at Parkland as a part of the initial database. 
We have requested waivers for these participants for retrospective and prospective data to 
accomplish recruitment and analysis goals. To conduct the system-level analysis, we will need to 
include all incident cancer patients with chronic conditions.  
 
If we remove participants who decline to participate in these surveys/interviews from the total EMR 
cohort, we risk a significant percentage of cancer patients with chronic conditions treated at Parkland. 
Removing EMR data for these individuals would result in selection bias and also adversely impact 
our power to detect an effect as a result of our intervention. Inclusion/exclusion criteria (a finite 
number of eligible patients) eliminate our ability to replace patients who would decline to participate. 
 
Therefore, we are requesting to consent participants for survey and interview participation, and 
maintain a full waiver of HIPAA authorization for eligible patients to conduct the system-level 
analysis. 
 
11. Potential Benefits: 
This research will inform future local, regional and national efforts to improve the quality of care and 
comprehensive management of complex cancer survivors in resource-limited settings, especially 
those caring for safety-net populations. There is prospect of direct benefit from the research, in that 
our implementation is designed to increase care coordination between oncology and primary care for 
patients completing active cancer treatment and to increase referrals and management for relevant 

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care of chronic conditions. However, there is no prospect of direct benefit for participation in surveys, 
interviews, or structured observation, save the possibility of increased awareness and attention to 
survivorship care in the context of multi-morbidities as a result of discussion in the course of data 
collection. We also expect indirect benefit from future quality improvement initiatives in the Parkland 
system that might flow from our findings.  
 
The potential benefit of the quality of care information to improving care to Parkland patients and 
others receiving care through safety-net networks is significant and greatly outweighs the minimal 
risks. 
 
12. Importance of the Knowledge to be Gained: 
Despite increasing numbers of cancer survivors, survivorship care coordination and follow-up 
processes are suboptimal nationwide, particularly for survivors living with other chronic conditions. 
Because cancer survivors have risks related to surveillance, treatment effects and lifestyle behaviors, it 
is critically important to be able standardize the coordination of all complex (multi-morbidity) cancer 
patients ending initial cancer treatment, as well as to identify the barriers and facilitators of care 
coordination in the safety-net setting. This information will inform local, regional and national quality 
improvement initiatives. Examining effectiveness of care coordination for complex patients in a 
community-based, safety-net setting has important health policy and public health significance. Low-
income, under- and uninsured minorities have higher rates of cancer and complicating chronic 
conditions, thus our focus on the effectiveness of care coordination among the vulnerable populations 
treated in the Parkland system offers great potential public health gains for the care of complex 
(multi-morbidity) cancer survivors. The proposed study’s potential contributions to care coordination 
justify the minimal risks to patients.