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CompletedNCT02943265Updated Mar 6, 2024Results posted

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

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

Phase
Not applicable
Study type
Interventional
Enrollment
4,322
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Breast Cancer
  • Colorectal Cancer

Keywords

  • Care Coordination
03

In context

Colorectal Neoplasms

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4,322 participants (actual)

Study arms

  • Experimental
    Complex Care Survivors

    Patients eligible for the study who will receive Care Coordination Strategies.

    Other: Care Coordination Strategies

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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Results

Posted Mar 6, 2024
Limitations and caveats
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.

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 flow — Overall Study
MilestoneProject CONNECT Care CoordinationRetrospective Comparison GroupNon-Cancer Retrospective Group
Started64826741000
Eligible after review63420921000
Completed63420921000
Not completed145820

Outcome measures

PrimaryProportion 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

No measurements were reported for this outcome.

PrimaryPatient 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
Reported as:
Mean · score on a scale
Patient Perception of Care (Scale)
score on a scaleProject CONNECT Care Coordination
Baseline Survey11.4 ± 2.71
6-Month Survey11.2 ± 2.37
12-Month Survey10.8 ± 2.26

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Project CONNECT Care Coordination39/634 (6.2%)39/634 (6.2%)0/634 (0%)
Retrospective Comparison Group———
Non-Cancer Retrospective Group———
Most frequent serious events
Most frequent serious events
EventProject CONNECT Care CoordinationRetrospective Comparison GroupNon-Cancer Retrospective Group
Participant DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps)39/634——

Baseline characteristics

Age, Continuous
Age, Continuous(years)Project CONNECT Care CoordinationRetrospective Comparison GroupNon-Cancer Retrospective GroupTotal
Mean57.5 ± 14.854.6 ± 11.652.8 ± 12.954.6 ± 12.7
Sex: Female, Male
Sex: Female, Male(Participants)Project CONNECT Care CoordinationRetrospective Comparison GroupNon-Cancer Retrospective GroupTotal
Female49816875442729
Male136405456997
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Project CONNECT Care CoordinationRetrospective Comparison GroupNon-Cancer Retrospective GroupTotal
Hispanic or Latino2858514611597
Not Hispanic or Latino34512415392125
Unknown or Not Reported4004
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Project CONNECT Care CoordinationRetrospective Comparison GroupNon-Cancer Retrospective GroupTotal
American Indian or Alaska Native0303
Asian2510117143
Native Hawaiian or Other Pacific Islander47011
Black or African American2347363751345
White36312245972184
More than one race0202
Unknown or Not Reported8191138
08

Study locations

1 site
  • UT Southwestern Medical Center Department of Population and Data Sciences
    Dallas, Texas 75390, United States
09

References and documents

Publications

  • 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. PubMed 30514267 ↗

Study documents

  • Protocol and statistical analysis plan · May 26, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02943265
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Simon Craddock Lee (Principal Investigator, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Oct 24, 2016
Start date
Sep 18, 2017
Primary completion
Apr 30, 2022
Completion
Apr 30, 2022
Results posted
Mar 6, 2024
Last update
Mar 6, 2024

Study contacts

Simon Craddock Lee, PhD, MPH
principal investigator · University of Texas Southwestern Medical Center
Bijal Balasubramanian, MD, PhD
principal investigator · University of Texas Southwestern Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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