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

NCT ID: NCT04673890

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-06
• Study Completion Date: 2022-01-15

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.

Conditions

Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Heather Prendergast

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather Prendergast

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28408935 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29763753 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 24319253 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17367492 (View on PubMed)

Prendergast HM, Khosla S. Lessons learned about policymaking: Moving an emergency department-initiated screening protocol to systemwide input in the development and implementation process. Acad Emerg Med. 2023 Jun;30(6):683-686. doi: 10.1111/acem.14672. Epub 2023 Feb 24. No abstract available.

Reference Type: DERIVED

PMID: 36707976 (View on PubMed)

Other Identifiers

6U48DP006392

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-0170

Identifier Type: -

Identifier Source: org_study_id