Trial Outcomes & Findings for Care Coordination for Complex Cancer Survivors in an Integrated Safety Net System (NCT NCT02943265)

NCT ID: NCT02943265

Last Updated: 2024-03-06

Results Overview

Proportion of complex cancer survivors meeting quality of care guidelines for multiple chronic conditions and follow-up cancer surveillance

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 4322 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2024-03-06

Participant Flow

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.

Participant milestones

Measure	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.	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.	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.
Overall Study STARTED	648	2674	1000
Overall Study Eligible After Review	634	2092	1000
Overall Study COMPLETED	634	2092	1000
Overall Study NOT COMPLETED	14	582	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Project CONNECT Care Coordination n=634 Participants 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.	Retrospective Comparison Group n=2092 Participants 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.	Non-Cancer Retrospective Group n=1000 Participants 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.	Total n=3726 Participants Total of all reporting groups
Age, Continuous	57.5 years STANDARD_DEVIATION 14.8 • n=5 Participants	54.6 years STANDARD_DEVIATION 11.6 • n=7 Participants	52.8 years STANDARD_DEVIATION 12.9 • n=5 Participants	54.6 years STANDARD_DEVIATION 12.7 • n=4 Participants
Sex: Female, Male Female	498 Participants n=5 Participants	1687 Participants n=7 Participants	544 Participants n=5 Participants	2729 Participants n=4 Participants
Sex: Female, Male Male	136 Participants n=5 Participants	405 Participants n=7 Participants	456 Participants n=5 Participants	997 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	285 Participants n=5 Participants	851 Participants n=7 Participants	461 Participants n=5 Participants	1597 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	345 Participants n=5 Participants	1241 Participants n=7 Participants	539 Participants n=5 Participants	2125 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	25 Participants n=5 Participants	101 Participants n=7 Participants	17 Participants n=5 Participants	143 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) Black or African American	234 Participants n=5 Participants	736 Participants n=7 Participants	375 Participants n=5 Participants	1345 Participants n=4 Participants
Race (NIH/OMB) White	363 Participants n=5 Participants	1224 Participants n=7 Participants	597 Participants n=5 Participants	2184 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	19 Participants n=7 Participants	11 Participants n=5 Participants	38 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Proportion of complex cancer survivors meeting quality of care guidelines for multiple chronic conditions and follow-up cancer surveillance

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Administered at baseline, 6, and 12 months

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

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.

Outcome measures

Measure	Project CONNECT Care Coordination n=294 Participants 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.	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.
Patient Perception of Care (Scale) Baseline Survey	11.4 score on a scale Standard Deviation 2.71	—
Patient Perception of Care (Scale) 6-Month Survey	11.2 score on a scale Standard Deviation 2.37	—
Patient Perception of Care (Scale) 12-Month Survey	10.8 score on a scale Standard Deviation 2.26	—

Adverse Events

Project CONNECT Care Coordination

Serious events: 39 serious events

Other events: 0 other events

Deaths: 39 deaths

Retrospective Comparison Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Cancer Retrospective Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Project CONNECT Care Coordination n=634 participants at risk 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.	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.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Participant Death	6.2% 39/634 • Number of events 39 • 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.	— 0/0 • 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.	— 0/0 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Simon Lee

University of Kansas Medical Center

Phone: (913) 588-2689

Email: slee21@kumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place