title: Outreach to diversify clinical trial participation: A randomized recruitment study.
abstract: OBJECTIVE
  Racial and ethnic minorities remain underrepresented in clinical research, yet few recruitment strategies have been rigorously evaluated.
  
  
  METHODS
  We experimentally tested whether targeted recruitment letters acknowledging diabetes health disparities and health risks specific to recipients' racial/ethnic group improved two metrics of trial participation: willingness to be screened and enrollment. This experiment was efficiently nested within a randomized clinical trial examining a preventive lifestyle intervention among women at high risk for diabetes. Pregnant women with gestational diabetes or impaired glucose tolerance (N = 445) were randomized to receive a targeted recruitment letter with health risk information specific to their racial/ethnic group (n = 216), or a standard letter with risk information for the general population (n = 229). All letters were bilingual in English and Spanish.
  
  
  RESULTS
  The targeted as compared to the standard letter did not improve screening or enrollment rates overall or within separate racial/ethnic groups. Among Latina women who preferred Spanish, the targeted letter showed trends for improved screening (66.7% vs 33.3%, p = .06) and enrollment rates (38.9% vs 13.3%, p = .13). In contrast, among Latina women who preferred English, the targeted letter significantly lowered screening (29.6% vs 57.1%, p = .04) and showed trends for lowered enrollment rates (25.9% vs 50.0%, p = .07).
  
  
  CONCLUSIONS
  Results from this randomized study appear to suggest that recruitment letters with diabetes health risk information targeted to recipients' race/ethnicity may improve one metric of clinical trial participation among Latina women who prefer Spanish, but not English. Larger experimental studies, incorporating input from diverse participant stakeholders, are needed to develop evidence-based minority recruitment strategies.
authors: Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA susan.d.brown@kp.org.
authors: Susan D
authors: SD
authors: Brown
authors: Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
authors: Paula N
authors: PN
authors: Partee
authors: Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
authors: Juanran
authors: J
authors: Feng
authors: Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
authors: Charles P
authors: CP
authors: Quesenberry
authors: Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
authors: Monique M
authors: MM
authors: Hedderson
authors: Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
authors: Samantha F
authors: SF
authors: Ehrlich
authors: Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, USA.
authors: Michaela
authors: M
authors: Kiernan
authors: Division of Research, Kaiser Permanente Northern California, Oakland, CA, USA.
authors: Assiamira
authors: A
authors: Ferrara
mesh_terms: D000328:Adult; D016640:Diabetes, Gestational / Q000208:ethnology*; D057286:Electronic Health Records; D005006:Ethnicity; D005260:Female; D018149:Glucose Intolerance / Q000208:ethnology*; D015438:Health Behavior; D054624:Health Status Disparities; D006630:Hispanic or Latino; D006801:Humans; D007802:Language; D008019:Life Style; D018579:Patient Selection; D011247:Pregnancy; D044469:Racial Groups
keywords: Randomized clinical trials; communication; diabetes; direct mail; disease risk; health disparities; participation; racial and ethnic minorities; recruitment; targeting
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