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

NCT ID: NCT02943265

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2022-04-30

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.

Conditions

Breast Cancer; Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Complex Care Survivors

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

Group Type: EXPERIMENTAL

Care Coordination Strategies

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Simon Craddock Lee

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Craddock Lee, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Bijal Balasubramanian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

UT Southwestern Medical Center Department of Population and Data Sciences

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30514267 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU 102015-090

Identifier Type: -

Identifier Source: org_study_id