title: Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices.
abstract: BACKGROUND
  The decision aids for diabetes (DAD) trial explored the feasibility of testing the effectiveness of decision aids (DAs) about coronary prevention and diabetes medications in community-based primary care practices, including rural clinics that care for patients with type 2 diabetes.
  
  
  METHODS
  As originally designed, we invited clinicians in eight practices to participate in the trial, reviewed the patient panel of clinicians who accepted our invitation for potentially eligible patients, and contacted these patients by phone, enrolling those who accepted our invitation. As enrollment failed to meet targets, we recruited four new practices. After discussing the study with the clinicians and receiving their support, we reviewed all clinic panels for potentially eligible patients. Clinicians were approached to confirm participation and patient eligibility, and patients were approached before their visit to provide written informed consent. This in-clinic approach required study coordinators to travel and stay longer at the clinics as well as to screen more patient records for eligibility. The in-clinic approach was associated with better recruitment rates, lower patient retention and outcome completion rates, and a better intervention effect.
  
  
  RESULTS
  We drew four lessons: 1) difficulties identifying potentially eligible patients threaten the viability of practical trials of DAs; 2) to improve the recruitment yield, recruit clinicians and patients for the study at the clinic, just before their visit; 3) approaches that improve recruitment may be associated with reduced retention and survey response; and 4) procedures that involve working closely with the practice may improve recruitment and may also affect the quality of the implementation of the interventions.
  
  
  CONCLUSIONS
  Success in practice-based trials in usual primary care including rural clinics may require the smallest possible research footprint on the practice while implementing a streamlined protocol favoring in-clinic, in-person interactions with clinicians and patients.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01029288.
authors: Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA.
authors: Kari L
authors: KL
authors: Ruud
authors: Annie
authors: A
authors: Leblanc
authors: Rebecca J
authors: RJ
authors: Mullan
authors: Laurie J
authors: LJ
authors: Pencille
authors: Kristina
authors: K
authors: Tiedje
authors: Megan E
authors: ME
authors: Branda
authors: Holly K
authors: HK
authors: Van Houten
authors: Sara R
authors: SR
authors: Heim
authors: Margary
authors: M
authors: Kurland
authors: Nilay D
authors: ND
authors: Shah
authors: Barbara P
authors: BP
authors: Yawn
authors: Victor M
authors: VM
authors: Montori
mesh_terms: D003327:Coronary Disease / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D003661:Decision Support Techniques; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D005240:Feasibility Studies; D006801:Humans; D008910:Minnesota; D018579:Patient Selection; D011314:Preventive Health Services; D011320:Primary Health Care; D015203:Reproducibility of Results; D019035:Rural Health Services; D018401:Sample Size; D019036:Suburban Health Services; D013997:Time Factors; D016896:Treatment Outcome
references: Implement Sci. 2009 May 21;4:29
references: 19460163
references: Cochrane Database Syst Rev. 2011 Oct 05;(10):CD001431
references: 21975733
references: Arch Intern Med. 2007 May 28;167(10):1076-82
references: 17533211
references: J Clin Nurs. 2010 Jan;19(1-2):227-33
references: 20500260
references: PLoS Med. 2010 Nov 09;7(11):e1000368
references: 21085696
references: Med Decis Making. 2012 Jul-Aug;32(4):636-44
references: 22247423
references: Cochrane Database Syst Rev. 2010 Jan 20;(1):MR000013
references: 20091668
references: Cancer Nurs. 2003 Oct;26(5):376-84; quiz 385-6
references: 14710799
references: Contemp Clin Trials. 2009 Jan;30(1):13-9
references: 18761427
references: Phys Ther. 2006 Nov;86(11):1520-33
references: 17079752
references: Cochrane Database Syst Rev. 2007 Apr 18;(2):MR000013
references: 17443634
references: J Eval Clin Pract. 2006 Apr;12(2):174-81
references: 16579826
references: Med Decis Making. 1995 Jan-Mar;15(1):25-30
references: 7898294
references: J Clin Epidemiol. 2007 Aug;60(8):819-24
references: 17606178
references: Fam Pract. 2003 Feb;20(1):83-92
references: 12509377
references: BMC Med Res Methodol. 2004 Apr 17;4:8
references: 15090073
references: Qual Prim Care. 2012;20(2):115-23
references: 22824564
references: Arch Intern Med. 2009 Sep 28;169(17):1560-8
references: 19786674
references: BMC Health Serv Res. 2013 Aug 08;13:301
references: 23927490
references: BMC Health Serv Res. 2012 May 28;12:130
references: 22640439
references: J Clin Epidemiol. 2009 May;62(5):479-84
references: 18468856
references: J Am Board Fam Med. 2010 Jul-Aug;23(4):523-33
references: 20616295
references: Health Expect. 2005 Mar;8(1):34-42
references: 15713169