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Nearly 70% of people living with cancer are "complex patients" with multiple chronic conditions who must deal not only with effects of their cancer but also continuing diseases such as diabetes, depression, hypertension, or heart disease. Care coordination strategies shown to be effective in improving outcomes for common medical conditions seen in primary care include: systematic transitions for patients to and from specialty care; intensive case management; and a team-based approach to comprehensive care. Despite an Institute of Medicine report suggesting these strategies as potential ways to improve care for cancer survivors, their implementation has not yet been evaluated for cancer survivors. Parkland Health and Hospital Systems will be implementing care coordinator strategies as part of as quality assurance/quality improvement activities, which Aim 2 and Aim 3 (research components) will evaluate. This protocol has been organized to reflect this distinction between the aims. The investigators expect no more than 1500 patients to be included in these study aims.
This project is a pragmatic trial. The investigators 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, colorectal, or gynecologic 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. Investigators expect approximately 1000 new survivors with ≥ 1 prevalent chronic condition to be eligible. The project does 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 selected for inclusion are the most prevalent conditions cancer survivors have at Parkland as well as nationally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complex Care Survivors | Experimental | Patients eligible for the study who will receive Care Coordination Strategies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care Coordination Strategies | Other | Co-located Care coordinator will use EMR-driven registry to facilitate patient transitions between primary care and oncology care and enhance teamwork through coaching and technical assistance. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Complex Cancer Survivors Meeting Quality of Care Guidelines for Chronic Conditions and Follow-up Cancer Surveillance | Proportion of complex cancer survivors meeting quality of care guidelines for multiple chronic conditions and follow-up cancer surveillance | 5 years |
| Patient Perception of Care (Scale) | Patient-reported perception of care coordination was measured using the Coordination of Care dimension adapted from the validated Picker Patient Experience Questionnaire. The adapted version used in this study consisted of eight items and was administered at baseline and at 6 and 12-months of follow-up. Each item is weighted from 1 to 3 and the cumulative care coordination score is the summation of all the survey items on a scale of 8 to 24. A Lower score indicates better care coordination. | Administered at baseline, 6, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Craddock Lee, PhD, MPH | University of Texas Southwestern Medical Center | Principal Investigator |
| Bijal Balasubramanian, MD, PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center Department of Population and Data Sciences | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30514267 | Derived | Lee SJC, Jetelina KK, Marks E, Shaw E, Oeffinger K, Cohen D, Santini NO, Cox JV, Balasubramanian BA. Care coordination for complex cancer survivors in an integrated safety-net system: a study protocol. BMC Cancer. 2018 Dec 4;18(1):1204. doi: 10.1186/s12885-018-5118-7. |
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Patients were recruited from Parkland Health and Hospital System in Dallas, Texas, USA from September 2017 - April 2021 with all follow up complete by April 30, 2022.
A retrospective comparison group was derived from Electronic Health Record (EHR) data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Project CONNECT Care Coordination | Patients with a primary diagnosis of stage I-III breast or colorectal cancer between September 1, 2017, and April 31, 2021 and a diagnosis of at least one comorbid chronic conditions (diabetes, hypertension, heart disease, chronic kidney disease, and chronic obstructive pulmonary disease). Eligible patients received care coordination strategies to facilitate patient transitions between primary care and oncology care. |
| FG001 | Retrospective Comparison Group | Patients with a primary diagnosis of stage I-III breast or colorectal cancer between January 1, 2010 - December 31, 2016 and a diagnosis of at least one comorbid chronic conditions (diabetes, hypertension, heart disease, chronic kidney disease, and chronic obstructive pulmonary disease).The retrospective cohort serves as a comparison group to the care coordination cohort. |
| FG002 | Non-Cancer Retrospective Group | A random sample of 1,000 patients seen January 1, 2010-December 31, 2016 with no history of cancer, at least two chronic conditions (diabetes, hypertension, chronic lung dis-ease, chronic kidney disease, or heart disease). This arm is used as a control to the retrospective comparison group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Project CONNECT Care Coordination | Patients with a primary diagnosis of stage I-III breast or colorectal cancer between September 1, 2017, and April 31, 2021 and a diagnosis of at least one comorbid chronic conditions (diabetes, hypertension, heart disease, chronic kidney disease, and chronic obstructive pulmonary disease). Eligible patients received care coordination strategies to facilitate patient transitions between primary care and oncology care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Complex Cancer Survivors Meeting Quality of Care Guidelines for Chronic Conditions and Follow-up Cancer Surveillance | Proportion of complex cancer survivors meeting quality of care guidelines for multiple chronic conditions and follow-up cancer surveillance | COVID pandemic prevented community health system from being able to extract these data within study timeframe which prevented reporting and analysis on this outcome. | Posted | 5 years |
|
Information on adverse events was collected from the time a patient was considered eligible through the final assessment (12 months after enrollment).
Patients in the Retrospective Comparison group and Non-Cancer Historical Group were derived through EHR data extraction with no direct engagement with the study team. Adverse Events were not monitored/assessed for participants from these groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Project CONNECT Care Coordination | Patients with a primary diagnosis of stage I-III breast or colorectal cancer between September 1, 2017, and April 31, 2021 and a diagnosis of at least one comorbid chronic conditions (diabetes, hypertension, heart disease, chronic kidney disease, and chronic obstructive pulmonary disease). Eligible patients received care coordination strategies to facilitate patient transitions between primary care and oncology care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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Survey accrual was lower than target (N=402). Revised power calculations for the analysis of the patient-level primary outcome measure, change in patient perception of care coordination, demonstrated the actual survey sample (N=294) was large enough to detect meaningful improvement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simon Lee | University of Kansas Medical Center | (913) 588-2689 | slee21@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 26, 2022 | Apr 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| BG001 | Retrospective Comparison Group | Patients with a primary diagnosis of stage I-III breast or colorectal cancer between January 1, 2010 - December 31, 2016 and a diagnosis of at least one comorbid chronic conditions (diabetes, hypertension, heart disease, chronic kidney disease, and chronic obstructive pulmonary disease).The retrospective cohort serves as a comparison group to the care coordination cohort. |
| BG002 | Non-Cancer Retrospective Group | A random sample of 1,000 patients seen January 1, 2010-December 31, 2016 with no history of cancer, at least two chronic conditions (diabetes, hypertension, chronic lung dis-ease, chronic kidney disease, or heart disease). This arm is used as a control to the retrospective cancer group. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Retrospective Comparison Group | Patients with a primary diagnosis of stage I-III breast or colorectal cancer between January 1, 2010 - December 31, 2016 and a diagnosis of at least one comorbid chronic conditions (diabetes, hypertension, heart disease, chronic kidney disease, and chronic obstructive pulmonary disease).The retrospective cohort serves as a comparison group to the care coordination cohort. |
|
| Primary | Patient Perception of Care (Scale) | Patient-reported perception of care coordination was measured using the Coordination of Care dimension adapted from the validated Picker Patient Experience Questionnaire. The adapted version used in this study consisted of eight items and was administered at baseline and at 6 and 12-months of follow-up. Each item is weighted from 1 to 3 and the cumulative care coordination score is the summation of all the survey items on a scale of 8 to 24. A Lower score indicates better care coordination. | This analysis included participants who completed at least one assessment with all care coordination items completed. | Posted | Mean | Standard Deviation | score on a scale | Administered at baseline, 6, and 12 months |
|
|
|
| 39 |
| 634 |
| 39 |
| 634 |
| 0 |
| 634 |
| EG001 | Retrospective Comparison Group | Patients with a primary diagnosis of stage I-III breast or colorectal cancer between January 1, 2010 - December 31, 2016 and a diagnosis of at least one comorbid chronic conditions (diabetes, hypertension, heart disease, chronic kidney disease, and chronic obstructive pulmonary disease).The retrospective cohort serves as a comparison group to the care coordination cohort. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Non-Cancer Retrospective Group | A random sample of 1,000 patients seen January 1, 2010-December 31, 2016 with no history of cancer, at least two chronic conditions (diabetes, hypertension, chronic lung dis-ease, chronic kidney disease, or heart disease). This arm is used as a control to the retrospective cancer group. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
|
| 12-Month Survey |
|
|