title: Strategies for conducting complex clinical trials in diverse community practices.
abstract: BACKGROUND
  Closing the gap between evidence and practice demands interventions targeting the whole practice. These system level interventions require more complex designs and require greater practice involvement. Current descriptions of trials use research designs that either limit practice involvement or make use of large health system resources.
  
  
  OBJECTIVE
  To share insights on retention of practices in a complex clinical trial aimed at improving care of multiple chronic conditions in 60 diverse community primary care practices not supported by large health system resources.
  
  
  METHODS
  Qualitative cross case analysis of field notes from meetings of a diverse research team.
  
  
  RESULTS
  Five interrelated factors were found to be important to the success of the study implementation process: (1) developing structure and activities for relationship building; (2) attention to consistent communication; (3) timely information sharing; (4) evolution of a cross-functional research team; (5) provision of technical assistance. Specific strategies were identified to overcome challenges to study implementation.
  
  
  CONCLUSIONS
  Diverse community primary care practices without support from health system resources will complete participation in complex trials. Researchers need not avoid answering questions requiring complex study designs; however, successful implementation requires an individualized approach tailored to the needs and characteristics of each practice.
authors.affiliation: Department of Family Medicine, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey 08873, USA. orzanoaj@umdnj.edu
authors.forename: A John
authors.initials: AJ
authors.lastname: Orzano
authors.forename: John
authors.initials: J
authors.lastname: Scott
authors.forename: Shawna V
authors.initials: SV
authors.lastname: Hudson
authors.forename: Dena
authors.initials: D
authors.lastname: O'Malley
authors.forename: Karissa A
authors.initials: KA
authors.lastname: Hahn
authors.forename: Sonja
authors.initials: S
authors.lastname: Haywood-Harris
authors.forename: Terry
authors.initials: T
authors.lastname: Falco
authors.forename: Melanie
authors.initials: M
authors.lastname: Johnson
authors.forename: Benjamin
authors.initials: B
authors.lastname: Crabtree
mesh_terms: D002908:Chronic Disease; D002986:Clinical Trials as Topic / Q000379:methods*; D003142:Communication; D003256:Community Participation / Q000379:methods*; D006801:Humans; D011320:Primary Health Care / Q000458:organization & administration*; D011364:Professional Practice / Q000458:organization & administration; D012111:Residence Characteristics