The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health

Colorectal Cancer Clinical Trial

Official title:

The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05345054
• Other study ID #: 300009121
• Status: Completed
• Start date: August 1, 2022
• Est. completion date: August 12, 2023

Study information

• Verified date: August 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rationale: Older African Americans undergoing surgery are a vulnerable and growing population at high risk for poor surgical outcomes and disparities. Few programs have focused on this population due to a fragmented understanding of the needs of this population.

Objectives: While socioecological determinants of health (SEDOH) such as health literacy and socioeconomic status are known drivers of surgical disparities, an estimated 36-47% of surgical disparities remains unexplained. This gap results from limitations of current clinical datasets in capturing SEDOHs. This pilot study aims to fill this gap by (i) collecting granular SEDOH data, (ii) identifying barriers to surgical care for older African Americans, and (iii) establishing a multi-institutional clinical database through a socioecological context. These findings will help understand how SEDOHs drive surgical disparities and inform development of interventions to eliminate them in elderly African Americans.

Design and Methods: Guided by the socioecological model of health, the investigators will use mixed-methods to achieve the objectives. First, the investigators will assess the acceptability and feasibility of a 58-item SEDOH survey based on the NIH PhenX toolkit. After distributing this survey to 36 elderly (≥65 years) African American patients undergoing surgery at 3 rural, UAB-affiliated hospitals (Alex-City, Greenville, Demopolis) the investigators will conduct detailed theory guided assessments of acceptability and feasibility (SA1). Second, the investigators will conduct key informant interviews of individuals from all 5 socioecological levels at each rural hospital (n=10) to identify additional barriers and facilitators to surgical care. The investigators will purposively sample 100% of participants at the patient and caregiver level (n=12) to be elderly African Americans (SA2). Finally, the investigators will link measured SEDOH data with standardized clinical data at each hospital to establish a novel database (SA3). These findings will establish a process to measure SEDOHs across the Deep South and set the foundation for a unique database to study surgical disparities.

Significance: Development of effective multilevel interventions to eliminate surgical disparities in older African Americans is dependent on a clearer understanding of the contextual drivers of these disparities. This pilot study will accelerate understanding of these mechanism(s) through SEDOHs. It will establish a process to measure SEDOHs, identify additional barriers to surgical care not captured by NIH instruments, and build the database to study these relationships. Such findings will have the potential to impact vulnerable surgical populations in the Deep South and support the Deep South RCMAR mission to promote health and optimize health outcomes for older and rural African Americans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 12, 2023
• Est. primary completion date: July 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Patients for Phase 1 and 2

-= 65 years old undergoing or having recently undergone colorectal surgery* (<7 days) for colorectal disease**

• All genders

• African American race

• Able to consent

• English-speaking

Exclusion Criteria for Patients for Phase 1 and 2

• <65 years old

• Race other than African American

• Undergoing operation other than colorectal surgery

• Unable to consent

• Limited mental state

Inclusion Criteria for other participants in Phase 2

-= 18 years old

• All genders

• All race/ethnicities

• Able to consent English-speaking

Exclusion Criteria for other participants in Phase 2

• Child (<18 years)

• Unable to consent

• Limited mental state

Inclusion Criteria for Phase 3

• = 18 years old undergoing or having recently undergone colorectal surgery* (<7 days) for colorectal disease**

• All genders

• All race/ethnicities

• Able to consent

• English-speaking

Exclusion Criteria for Phase 3

• Child (<18 years)

• Undergoing operation other than colorectal surgery

• Unable to consent

• Limited mental state

• Includes colectomy/proctectomies. ** Includes colorectal cancer, inflammatory bowel disease and diverticular disease.

Related Conditions & MeSH terms

• Colorectal Cancer
• Diverticulum
• Inflammatory Bowel Diseases
• Social Behavior

Intervention

Other:
• no intervention
This study will not involve an intervention of any sort. Participants will either take a survey or undergo an interview, and those taking the survey will have clinical data captured.

Locations

Country	Name	City	State
United States	Russell Medical Center	Alexander City	Alabama
United States	Whitfield Regional Medical Center	Demopolis	Alabama
United States	Regional Medical Center of Central Alabama	Greenville	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and Acceptability of a multidimensional survey in measuring socioecological determinants of health at rural hospitals in the Black Belt of Alabama (Demopolis, Alexander City, Greenville).	Using a theory guided framework and previously published measures of acceptability and feasibility, a post survey will be administered to all participants in specific aim 1. Feasibility and acceptability scores will be calculated, with positive acceptability and feasibility being indicated by scores of 4 or greater on a likert scale. The investigators will ensure that the survey is found to be acceptable and feasible to >70% of the target population, and will have areas for qualitative feedback and comments to adapt the survey as needed.	3 months
Primary	Barriers to surgical care for older African American patients in the Deep South.	To identify barriers to surgical care for older African American patients in the Deep South the investigators will conduct qualitative interviews of participants at all socioecological levels at each site. These interviews will be transcribed and coded using NVivo software, and themes from this analysis will be compared with the domains assessed in the survey used in specific aim 1 in order to ensure that all relevant domains are captured and assessed.	6 months
Primary	A database linking socioecological determinants of health with nationally validated surgical outcomes.	To establish a database linking socioecological determinants of health with nationally validated surgical outcomes the investigators will pair data obtained from the previously developed survey with chart abstracted clinical outcomes data. All data will be stored in a secure RedCap database, and entered only by trained abstractors.	12 months