title: Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial.
abstract: The Systolic Blood Pressure Intervention Trial is a multicenter, randomized clinical trial of 9361 participants with hypertension who are ≥50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal <120 mm Hg) compared to standard control (systolic blood pressure goal <140 mm Hg) on cardiovascular events using commonly prescribed antihypertensive medications and lifestyle modification.
  
  
  
  To describe the recruitment strategies and lessons learned during recruitment of the Systolic Blood Pressure Intervention Trial cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥75 years, women, and minorities.
  
  
  
  In collaboration with the National Institutes of Health Project Office and Systolic Blood Pressure Intervention Trial Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began on 8 November 2010 and ended on 15 March 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches.
  
  
  
  Recruitment was scheduled to last 24 months to enroll a target of 9250 participants; in just over 28 months, the trial enrolled 9361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by Systolic Blood Pressure Intervention Trial staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, Internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized/number screened) was 64% (9361 randomized/14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those aged ≥75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional clinics were included and inclusion criteria were broadened, keeping event rates and trial power in mind. As overall recruitment improved, a greater focus on subgroup recruitment was implemented.
  
  
  
  Systolic Blood Pressure Intervention Trial met its overall projected recruitment goal using diverse, locally adapted enrollment strategies to specifically target persons with cardiovascular disease, chronic kidney disease, ≥75 years old, women, and minority subgroups. The trial exceeded its recruitment goal for minorities but found it a challenge to meet the competing demands of the targeted goals for recruiting into the remaining four subgroups. Important lessons include the imperative to monitor the recruitment process carefully, decide early to add new clinics or modify inclusion and exclusion criteria if recruitment lags, and consider limiting enrollment to subgroups only. We found benefit in using multiple recruitment sources simultaneously; mass mailing produced the largest number of participants, but referrals resulted in the greater randomization yield.
authors.affiliation: School of Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA tramsey@uabmc.edu.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Ramsey
authors.affiliation: National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Joni K
authors.initials: JK
authors.lastname: Snyder
authors.affiliation: School of Medicine, Wake Forest University, Winston-Salem, NC, USA.
authors.forename: Laura C
authors.initials: LC
authors.lastname: Lovato
authors.affiliation: Geriatric Research, Education, Clinical Center (GRECC), Veterans Health Administration-Tennessee Valley Healthcare System, Nashville, TN, USA.
authors.forename: Christianne L
authors.initials: CL
authors.lastname: Roumie
authors.affiliation: School of Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Steven P
authors.initials: SP
authors.lastname: Glasser
authors.affiliation: Cardiovascular Institute, Rutgers University-New Brunswick, New Brunswick, NJ, USA.
authors.forename: Nora M
authors.initials: NM
authors.lastname: Cosgrove
authors.affiliation: Veterans Health Administration, Minneapolis, MN, USA.
authors.forename: Christine M
authors.initials: CM
authors.lastname: Olney
authors.affiliation: Columbia University, New York, NY, USA.
authors.forename: Rocky H
authors.initials: RH
authors.lastname: Tang
authors.affiliation: The University of Tennessee Health Science Center (UTHSC), Memphis, TN, USA.
authors.forename: Karen C
authors.initials: KC
authors.lastname: Johnson
authors.affiliation: School of Nursing, Case Western Reserve University, Cleveland, OH, USA.
authors.forename: Carolyn H
authors.initials: CH
authors.lastname: Still
authors.affiliation: University of Utah, Salt Lake City, UT, USA.
authors.forename: Lisa H
authors.initials: LH
authors.lastname: Gren
authors.affiliation: University of Utah, Salt Lake City, UT, USA.
authors.forename: Jeffery C
authors.initials: JC
authors.lastname: Childs
authors.affiliation: School of Medicine, Wake Forest University, Winston-Salem, NC, USA.
authors.forename: Osa L
authors.initials: OL
authors.lastname: Crago
authors.affiliation: School of Medicine, Wake Forest University, Winston-Salem, NC, USA.
authors.forename: John H
authors.initials: JH
authors.lastname: Summerson
authors.affiliation: Veterans Health Administration, Memphis, TN, USA.
authors.forename: Sandy M
authors.initials: SM
authors.lastname: Walsh
authors.affiliation: School of Medicine, Wake Forest University, Winston-Salem, NC, USA.
authors.forename: Letitia H
authors.initials: LH
authors.lastname: Perdue
authors.affiliation: Cardiovascular Institute, Rutgers University-New Brunswick, New Brunswick, NJ, USA.
authors.forename: Denise M
authors.initials: DM
authors.lastname: Bankowski
authors.affiliation: Colorado School of Public Health, University of Colorado Denver, Aurora, CO, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Goff
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008402:Mass Media; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010174:Pamphlets; D010347:Patient Care Planning; D018579:Patient Selection; D011177:Postal Service; D016032:Randomized Controlled Trials as Topic; D012017:Referral and Consultation; D051436:Renal Insufficiency, Chronic
chemical_list: D000959:Antihypertensive Agents
keywords: Clinical Center Networks; SPRINT; hypertension; recruitment