An interventional study of Care Coordination Strategies in Breast Cancer and Colorectal Cancer, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Health services research
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 4,322 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Exclusion Criteria:
Patients eligible for the study who will receive Care Coordination Strategies.
Other: Care 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.
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
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
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.
| Milestone | Project CONNECT Care Coordination | Retrospective Comparison Group | Non-Cancer Retrospective Group |
|---|---|---|---|
| Started | 648 | 2674 | 1000 |
| Eligible after review | 634 | 2092 | 1000 |
| Completed | 634 | 2092 | 1000 |
| Not completed | 14 | 582 | 0 |
Proportion of complex cancer survivors meeting quality of care guidelines for multiple chronic conditions and follow-up cancer surveillance
No measurements were reported for this outcome.
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.
| score on a scale | Project CONNECT Care Coordination |
|---|---|
| Baseline Survey | 11.4 ± 2.71 |
| 6-Month Survey | 11.2 ± 2.37 |
| 12-Month Survey | 10.8 ± 2.26 |
Collected over Information on adverse events was collected from the time a patient was considered eligible through the final assessment (12 months after enrollment).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Project CONNECT Care Coordination | 39/634 (6.2%) | 39/634 (6.2%) | 0/634 (0%) |
| Retrospective Comparison Group | — | — | — |
| Non-Cancer Retrospective Group | — | — | — |
| Event | Project CONNECT Care Coordination | Retrospective Comparison Group | Non-Cancer Retrospective Group |
|---|---|---|---|
| Participant DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 39/634 | — | — |
| Age, Continuous(years) | Project CONNECT Care Coordination | Retrospective Comparison Group | Non-Cancer Retrospective Group | Total |
|---|---|---|---|---|
| Mean | 57.5 ± 14.8 | 54.6 ± 11.6 | 52.8 ± 12.9 | 54.6 ± 12.7 |
| Sex: Female, Male(Participants) | Project CONNECT Care Coordination | Retrospective Comparison Group | Non-Cancer Retrospective Group | Total |
|---|---|---|---|---|
| Female | 498 | 1687 | 544 | 2729 |
| Male | 136 | 405 | 456 | 997 |
| Ethnicity (NIH/OMB)(Participants) | Project CONNECT Care Coordination | Retrospective Comparison Group | Non-Cancer Retrospective Group | Total |
|---|---|---|---|---|
| Hispanic or Latino | 285 | 851 | 461 | 1597 |
| Not Hispanic or Latino | 345 | 1241 | 539 | 2125 |
| Unknown or Not Reported | 4 | 0 | 0 | 4 |
| Race (NIH/OMB)(Participants) | Project CONNECT Care Coordination | Retrospective Comparison Group | Non-Cancer Retrospective Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 3 | 0 | 3 |
| Asian | 25 | 101 | 17 | 143 |
| Native Hawaiian or Other Pacific Islander | 4 | 7 | 0 | 11 |
| Black or African American | 234 | 736 | 375 | 1345 |
| White | 363 | 1224 | 597 | 2184 |
| More than one race | 0 | 2 | 0 | 2 |
| Unknown or Not Reported | 8 | 19 | 11 | 38 |
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University of Texas Southwestern Medical Center