Clinical trial NCT05345054: The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health
Official title: The Deep South Surgical Equity Research Network: Addressing Socioecological Determinants of Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Inflammatory Bowel Diseases
Diverticular Diseases
Social Behavior
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for participation in Phases 1, 2, and 3 will be selected from those undergoing colorectal surgery at UAB affiliated sites in Alabama (Demopolis, Greenville, Alexander City).

Additional participants for Phase 2 will come from all other socioecological levels (caregiver, provider, organizational leaders, community leaders, public policy/governmental leaders).

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: 3 months
measure: Barriers to surgical care for older African American patients in the Deep South.
timeFrame: 6 months
measure: A database linking socioecological determinants of health with nationally validated surgical outcomes.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Russell Medical Center
state: Alabama
city: Demopolis
country: United States
facility: Whitfield Regional Medical Center
state: Alabama
city: Greenville
country: United States
facility: Regional Medical Center of Central Alabama
state: Alabama
Study officials:
affiliation: University of Alabama in Birmingham
name: Daniel I Chu, MD
role: PRINCIPAL_INVESTIGATOR
References: