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

NCT02943265 | Completed Results

• 1 other identifier: STU 102015-090
• Study Type: interventional
• Target: 4,322
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Colorectal Cancer

Keywords

Care Coordination

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Administered at baseline, 6, and 12 months

Study Arms (1)

Complex Care Survivors

EXPERIMENTAL

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

Other: Care Coordination Strategies

Interventions

Care Coordination Strategies 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.

Complex Care Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center Department of Population and Data Sciences

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 30514267 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

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.

Results Point of Contact

• Title: Simon Lee
• Organization: University of Kansas Medical Center

slee21@kumc.edu

(913) 588-2689

Study Officials

• Simon Craddock Lee, PhD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Bijal Balasubramanian, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 24, 2016
• Study Start: September 18, 2017
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: March 6, 2024
• Results First Posted: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)