The success of recruiting minorities, women, and elderly into a randomized controlled effectiveness trial

Abstract

Background: Heart failure, a leading cause of hospitalization among elderly people, disproportionately afflicts African-American and other non-White populations. Studies of health care interventions often do not include these groups in proportion to numbers in the patient population. Our objective was to assess whether a randomized controlled effectiveness trial enrolled patients by ethnicity/race, gender, and age in proportion to those eligible.

Methods: We conducted a randomized controlled trial comparing nurse management and usual care among ambulatory heart failure patients at the four hospitals in East and Central Harlem, New York. We incorporated culturally sensitive and age-appropriate strategies to enroll a demographically representative group into the trial. Recruitment proceeded in several steps: identifying patients with billing code and visit criteria, documenting systolic dysfunction, obtaining clinician permission and correct addresses, contacting patients, and enrolling eligible patients. We assessed differences by ethnicity/race and gender at successive steps in the recruitment process, and differences between enrollees and refusals regarding overall health, evaluation of medical care, and difficulty receiving care.

Results: We enrolled 406 ambulatory patients by ethnicity/race and gender in proportion to the numbers eligible to be contacted (46% African-American/Black, 33% Hispanic, and 47% female). Among patients contacted, however, those 18 through 74 years were 2.0 to 3.3 times more likely than those > or = 75 years to enroll (p < 0.001).

Conclusions: The recruitment strategy successfully enrolled patients by ethnicity/race, gender, and age through 74 years, but not those > or = 75 years. Registries of patients who refuse to enroll in trials could provide guidance for clinical and public policy.

Fig 1

Steps in the Recruitment Process.

Fig 2

Age distribution at different steps in the eligibility and recruitment process. [Color figure can be viewed in the online issue, which is available at www.interscience.wiley.com.]