search
Back to results

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

Primary Purpose

Breast Cancer, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Coordination Strategies
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Care Coordination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UT Southwestern Medical Center Department of Population and Data Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Complex Care Survivors

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Perception of Care (Scale)

Full Information

First Posted
October 20, 2016
Last Updated
May 4, 2022
Sponsor
University of Texas Southwestern Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02943265
Brief Title
Care Coordination for Complex Cancer Survivors in an Integrated Safety Net System
Official Title
Care Coordination for Complex Cancer Survivors in an Integrated Safety Net System (Project Connect)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer
Keywords
Care Coordination

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complex Care Survivors
Arm Type
Experimental
Arm Description
Patients eligible for the study who will receive Care Coordination Strategies.
Intervention Type
Other
Intervention Name(s)
Care Coordination Strategies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of complex cancer survivors meeting quality of care guidelines for multiple chronic conditions and follow-up cancer surveillance.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Patient Perception of Care (Scale)
Time Frame
Administered at baseline, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients over 18 years of age; AND diagnosed with Stage I-III incident breast or colorectal cancers; 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: Patients with in situ cancers (Stage 0) and those with metastatic disease (Stage IV); OR Patients with impaired hearing or speech; OR Inability to speak English or Spanish.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Craddock Lee, PhD, MPH
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bijal Balasubramanian, MD, PhD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center Department of Population and Data Sciences
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30514267
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs