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OpenTrials
Completed

NCT Number: NCT04673890

Improving Cancer Survival and Reducing Treatment Variations With Protocols for Emergency Care

Significant challenges and gaps remain in navigating transitions between acute care and outpatient care for many cancer survivors. This study underscores 1) implementation of Emergency Department (ED) risk-stratified treatments protocols that standardize patient care and would allow for rapid re-assessment and access to specialist care with well-coordinated cancer care plans, and 2) the significant numbers of minority cancer survivors seeking episodic care in the ED that are at increased risk of not receiving recommended post cancer treatment surveillance.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

The over-arching goal of this study is to develop a portable model for ED cancer treatment guidelines and management using evidence based protocols in a population at high risk for poor cancer -related outcomes by identifying & overcoming specific barriers to enhanced survivorship. Based on the demographics of ED population (currently, 70% racial/ethnic minorities), the majority of participants will be underrepresented (African-American and Hispanic) and low-income individuals. The investigators propose a feasibility study of 150 patients in the ED over a 1 year period.

The specific aims are:

Aim 1: Evaluate the effectiveness of ED Risk-Stratified, Evidence-Based Treatment protocols on the primary outcome of ED utilization rates and subsequent acute inpatient admissions at 6 -months post-intervention.

Aim 2: Evaluate the effectiveness of an ED-based Cancer Patient Navigator on the secondary outcomes of patient engagement and primary care engagement at 6 -months post-intervention.

Aim 3: Examine barriers and facilitators to compliance for cancer survivorship recommendations that occur in an ED setting at 6-months post intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cancer survivor (has had cancer in their lifetime, and is currently disease-free)
  • Verbal fluency in English or Spanish
  • Age 18-75 years

Exclusion criteria

  • Unable to verbalize comprehension of study or impaired decision making (e.g., dementia)
  • Plans to move from Chicago area within the next year

Treatment and study plan

Primary outcomes

  1. ED utilization rate

    Time frame: 6 months from study entry

    Emergency department utilization over 6 month period

  2. Mortality

    Time frame: 30 days from study entry

    Mortality due to deep vein thrombosis/pulmonary embolism, due to sepsis, and overall mortality

  3. Mortality

    Time frame: 90 days from study entry

    Mortality due to deep vein thrombosis/pulmonary embolism, due to sepsis, and overall mortality

  4. Mortality

    Time frame: 1 year from study entry

    Mortality due to deep vein thrombosis/pulmonary embolism, due to sepsis, and overall mortality

Secondary outcomes

  1. Admission and Readmission rate

    Time frame: 6 months from study entry

    all cause, and related to sepsis

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Improving Cancer Survival and Reducing Treatment Variations With Protocols for Emergency Care (ICARE)

Acronym: ICARE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2020
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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