Clinical trial NCT04673890: Improving Cancer Survival and Reducing Treatment Variations With Protocols for Emergency Care
Official title: Improving Cancer Survival and Reducing Treatment Variations With Protocols for Emergency Care (ICARE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-12-17
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient recruitment will be completed in the UI Health ED with ED patients who have had a cancer in their lifetime.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: ED utilization rate
timeFrame: 6 months from study entry
measure: Mortality
timeFrame: 30 days from study entry
measure: Mortality
timeFrame: 90 days from study entry
measure: Mortality
timeFrame: 1 year from study entry
Secondary outcomes:
measure: Admission and Readmission rate
timeFrame: 6 months from study entry
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Heather Prendergast
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Connolly GC, Francis CW. Cancer-associated thrombosis. Hematology Am Soc Hematol Educ Program. 2013;2013:684-91. doi: 10.1182/asheducation-2013.1.684.
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.