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

Cancer Clinical Trial

— ICARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673890
• Other study ID #: 2020-0170
• Secondary ID: 6U48DP006392
• Status: Completed
• Start date: August 6, 2020
• Est. completion date: January 15, 2022

Study information

• Verified date: November 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: January 15, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Emergencies

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (4)

Connolly GC, Francis CW. Cancer-associated thrombosis. Hematology Am Soc Hematol Educ Program. 2013;2013:684-91. doi: 10.1182/asheducation-2013.1.684. — View Citation

Moore JX, Akinyemiju T, Bartolucci A, Wang HE, Waterbor J, Griffin R. A prospective study of cancer survivors and risk of sepsis within the REGARDS cohort. Cancer Epidemiol. 2018 Aug;55:30-38. doi: 10.1016/j.canep.2018.05.001. Epub 2018 May 25. — View Citation

Naess IA, Christiansen SC, Romundstad P, Cannegieter SC, Rosendaal FR, Hammerstrom J. Incidence and mortality of venous thrombosis: a population-based study. J Thromb Haemost. 2007 Apr;5(4):692-9. doi: 10.1111/j.1538-7836.2007.02450.x. — View Citation

Singh GK, Jemal A. Socioeconomic and Racial/Ethnic Disparities in Cancer Mortality, Incidence, and Survival in the United States, 1950-2014: Over Six Decades of Changing Patterns and Widening Inequalities. J Environ Public Health. 2017;2017:2819372. doi: 10.1155/2017/2819372. Epub 2017 Mar 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ED utilization rate	Emergency department utilization over 6 month period	6 months from study entry
Primary	Mortality	Mortality due to deep vein thrombosis/pulmonary embolism, due to sepsis, and overall mortality	30 days from study entry
Primary	Mortality	Mortality due to deep vein thrombosis/pulmonary embolism, due to sepsis, and overall mortality	90 days from study entry
Primary	Mortality	Mortality due to deep vein thrombosis/pulmonary embolism, due to sepsis, and overall mortality	1 year from study entry
Secondary	Admission and Readmission rate	all cause, and related to sepsis	6 months from study entry