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Care Coordination for Complex Cancer Survivors in an Integrated Safety Net System

Care Coordination for Complex Cancer Survivors in an Integrated Safety Net System (Project Connect)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02943265
Enrollment
4322
Registered
2016-10-24
Start date
2017-09-18
Completion date
2022-04-30
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colorectal Cancer

Keywords

Care Coordination

Brief summary

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.

Detailed description

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. * Aim 1: (Quality Assurance/ Improvement) Implement a system-level EMR-driven intervention for approximately 1000 complex cancer survivors at Parkland, combining three 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; * Aim 2: (Research component) Test effectiveness of the strategies on system- and patient-level outcomes using a rigorous, quasi-experimental design with outcomes measured before and after implementation; * Aim 3: (Research Component) Elucidate system and patient factors that facilitate or hinder implementation and result in differences in experiences of care coordination between complex patients with and without cancer. Investigators will collect quantitative (EMR data, patient surveys) and qualitative (structured observations, patient and provider interviews, EMR audits) data throughout.

Interventions

OTHERCare Coordination Strategies

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.

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adult patients over 18 years of age; 2. AND diagnosed with Stage I-III incident breast or colorectal cancers; 3. 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).

Exclusion criteria

1. Patients with in situ cancers (Stage 0) and those with metastatic disease (Stage IV); 2. OR Patients with impaired hearing or speech; 3. OR Inability to speak English or Spanish.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Complex Cancer Survivors Meeting Quality of Care Guidelines for Chronic Conditions and Follow-up Cancer Surveillance5 yearsProportion of complex cancer survivors meeting quality of care guidelines for multiple chronic conditions and follow-up cancer surveillance
Patient Perception of Care (Scale)Administered at baseline, 6, and 12 monthsPatient-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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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.
634
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.
2,092
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.
1,000
Total3,726

Baseline characteristics

CharacteristicProject CONNECT Care CoordinationRetrospective Comparison GroupNon-Cancer Retrospective GroupTotal
Age, Continuous57.5 years
STANDARD_DEVIATION 14.8
54.6 years
STANDARD_DEVIATION 11.6
52.8 years
STANDARD_DEVIATION 12.9
54.6 years
STANDARD_DEVIATION 12.7
Ethnicity (NIH/OMB)
Hispanic or Latino
285 Participants851 Participants461 Participants1597 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
345 Participants1241 Participants539 Participants2125 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants0 Participants0 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants3 Participants0 Participants3 Participants
Race (NIH/OMB)
Asian
25 Participants101 Participants17 Participants143 Participants
Race (NIH/OMB)
Black or African American
234 Participants736 Participants375 Participants1345 Participants
Race (NIH/OMB)
More than one race
0 Participants2 Participants0 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
4 Participants7 Participants0 Participants11 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants19 Participants11 Participants38 Participants
Race (NIH/OMB)
White
363 Participants1224 Participants597 Participants2184 Participants
Sex: Female, Male
Female
498 Participants1687 Participants544 Participants2729 Participants
Sex: Female, Male
Male
136 Participants405 Participants456 Participants997 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
39 / 6340 / 00 / 0
other
Total, other adverse events
0 / 6340 / 00 / 0
serious
Total, serious adverse events
39 / 6340 / 00 / 0

Outcome results

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.

Time frame: Administered at baseline, 6, and 12 months

Population: This analysis included participants who completed at least one assessment with all care coordination items completed.

ArmMeasureGroupValue (MEAN)Dispersion
Project CONNECT Care CoordinationPatient Perception of Care (Scale)Baseline Survey11.4 score on a scaleStandard Deviation 2.71
Project CONNECT Care CoordinationPatient Perception of Care (Scale)6-Month Survey11.2 score on a scaleStandard Deviation 2.37
Project CONNECT Care CoordinationPatient Perception of Care (Scale)12-Month Survey10.8 score on a scaleStandard Deviation 2.26
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

Time frame: 5 years

Population: COVID pandemic prevented community health system from being able to extract these data within study timeframe which prevented reporting and analysis on this outcome.

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026