The success of recruiting minorities, women, and elderly into a randomized controlled effectiveness trial.
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.
Sisk
Jane E
JE
Department of Health Policy, Mount Sinai School of Medicine, New York, NY 10029, USA. jsisk@cdc.gov
Horowitz
Carol R
CR
Wang
Jason J
JJ
McLaughlin
Mary Ann
MA
Hebert
Paul L
PL
Tuzzio
Leah
L
D001741:Black or African American / Q000706:statistics & numerical data; D000368:Aged; D000553:Ambulatory Care; D005260:Female; D006333:Heart Failure; D006630:Hispanic or Latino / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D008913:Minority Groups / Q000706:statistics & numerical data*; D009732:Nursing Care; D010342:Patient Acceptance of Health Care; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012648:Self Care; D044465:White People / Q000706:statistics & numerical data