Emergency departments (EDs) present a unique opportunity for recruiting patients for observational studies, particularly those focusing on prevalent conditions like hypertension and heart disease. A recent study published in the International Journal of Emergency Medicine assessed the feasibility of recruiting ED patients with asymptomatic hypertension for a prospective observational study investigating a blood biomarker for subclinical heart disease.
The study, conducted at two ED sites in New York City, aimed to determine the utility of a blood biomarker as a proxy for detecting subclinical heart disease in emergency patients with asymptomatic hypertension and how nurse-led risk communication impacts blood pressure control at 6 months. Researchers manually reviewed recruitment and retention data, following an eight-step framework for assessing recruitment feasibility.
Recruitment Goals and Processes
The study targeted adult patients (≥18 years) with initial blood pressure readings at or above 160/100 mmHg and second readings at or above 140/90 mmHg, who were pending discharge and proficient in English or Spanish. Exclusion criteria included diagnoses of congestive heart failure, renal insufficiency, atrial fibrillation, pregnancy, incarceration, cognitive impairment, or experiencing symptoms of hypertension. The goal was to recruit a diverse sample reflecting the demographics of the EDs, which are approximately 35% Hispanic, 29% African American, 19% White, 1% Asian, and 16% other.
A priori sample size calculation determined that 76 participants were needed to achieve 97% sensitivity and 90% specificity of a blood biomarker for detecting subclinical heart disease. The planned distribution of subjects was 13 individuals from more than one race and/or ethnicity, 22 African Americans, 26 Hispanics, 14 Caucasians, and 1 Asian.
Training and Data Collection
Following Institutional Review Board (IRB) approval, a comprehensive 80-hour training program was implemented for all research personnel, including program management, research coordinators, physicians, and sonographers. The training included practical elements such as shadowing experienced personnel to ensure adherence to the study protocol. Sonographers underwent retraining to address any discordance in echocardiogram measurements, while research coordinators were trained in electrocardiogram (ECG) and venipuncture procedures. A Spanish-speaking research coordinator was appointed to facilitate communication with patients proficient only in Spanish.
Research coordinators used Microsoft Teams to coordinate with sonographers and the Epic chat feature to inform ED physicians about prospective participants. Informed consent was obtained electronically, and data were recorded using the secure Research Electronic Data Capture (REDCap) system. Patients received up to $100 compensation.
Tracking and Monitoring
Each enrolled patient was assigned a unique record ID within REDCap to monitor their progress throughout the study. Clinical research coordinators screened and enrolled patients during three 8-hour daytime shifts each week at the two study sites. Data on screened, excluded, approached, enrolled, and completed patients were recorded in a spreadsheet at the end of each shift, along with reasons for declining participation. Weekly meetings were held to discuss challenges and ensure data accuracy.
Implications for Future Research
The study demonstrates the feasibility of recruiting ED patients with asymptomatic hypertension for research on subclinical heart disease. The robust training program, use of electronic data capture systems, and close monitoring of recruitment processes contributed to the successful implementation of the study. These findings can inform future research efforts targeting similar patient populations in the emergency department setting.
