title: Pre-Visit Prioritization for complex patients with diabetes: Randomized trial design and implementation within an integrated health care system.
abstract: OBJECTIVE
  Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care.
  
  
  METHODS
  We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system.
  
  
  RESULTS
  This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015-6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) navigating research vs. quality improvement requirements; (2) addressing informed consent considerations; and (3) introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for "self-learning health system" research.
  
  
  CONCLUSIONS
  By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations.
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, CA, United States. Electronic address: Richard.W.Grant@KP.org.
authors.forename: Richard W
authors.initials: RW
authors.lastname: Grant
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, CA, United States.
authors.forename: Connie S
authors.initials: CS
authors.lastname: Uratsu
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, CA, United States.
authors.forename: Karen R
authors.initials: KR
authors.lastname: Estacio
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, CA, United States.
authors.forename: Andrea
authors.initials: A
authors.lastname: Altschuler
authors.affiliation: Department of Medicine, Oakland Medical Center, Kaiser Permanente Northern California, United States.
authors.forename: Eileen
authors.initials: E
authors.lastname: Kim
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, CA, United States.
authors.forename: Bruce
authors.initials: B
authors.lastname: Fireman
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, CA, United States.
authors.forename: Alyce S
authors.initials: AS
authors.lastname: Adams
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, CA, United States.
authors.forename: Julie A
authors.initials: JA
authors.lastname: Schmittdiel
authors.affiliation: University of Michigan, Department of Internal Medicine, Ann Arbor, MI, United States; Center for Clinical Management Research, Ann Arbor VA, Ann Arbor, MI, United States.
authors.forename: Michele
authors.initials: M
authors.lastname: Heisler
mesh_terms: D000328:Adult; D000368:Aged; D002140:California; D002985:Clinical Protocols; D019033:Delivery of Health Care, Integrated; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy*; D057286:Electronic Health Records; D005260:Female; D005500:Follow-Up Studies; D006292:Health Priorities; D006801:Humans; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D010817:Physician-Patient Relations; D011320:Primary Health Care / Q000379:methods*; D012107:Research Design
keywords: Doctor–patient communication; Health informatics interventions; Primary care; Randomized clinical trial; Translation into practice; Type 2 diabetes
references.citation: Diabetes Care. 2006 Nov;29(11):2415-9
references.pmid: 17065677
references.citation: Healthc (Amst). 2015 Jun;3(2):80-8
references.pmid: 26179728
references.citation: J Am Geriatr Soc. 2008 Aug;56(8):1409-16
references.pmid: 18662210
references.citation: J Gen Intern Med. 1990 Jan-Feb;5(1):29-33
references.pmid: 2299426
references.citation: Ann Fam Med. 2010 May-Jun;8(3):256-9
references.pmid: 20458110
references.citation: J Am Geriatr Soc. 2008 Oct;56(10):1839-44
references.pmid: 18771453
references.citation: Healthc (Amst). 2013 Dec;1(3-4):117-122
references.pmid: 24944911
references.citation: J Gen Intern Med. 2004 Jun;19(6):646-53
references.pmid: 15209603
references.citation: BMC Health Serv Res. 2008;8:245
references.pmid: 19046443
references.citation: Diabetes Care. 2010 May;33(5):1055-60
references.pmid: 20185736
references.citation: Diabet Med. 2011 Jul;28(7):781-4
references.pmid: 21395674
references.citation: J Econ Perspect. 2008 Fall;22(4):27-50
references.pmid: 19305645
references.citation: Am J Manag Care. 2005 Apr;11(4):262-70
references.pmid: 15839186
references.citation: N Engl J Med. 2012 Mar 1;366(9):777-9
references.pmid: 22375966
references.citation: J Gen Intern Med. 2007 Dec;22(12):1635-40
references.pmid: 17647065
references.citation: Am J Public Health. 2014 Feb;104(2):e16-31
references.pmid: 24328648
references.citation: Trials. 2013;14:15
references.pmid: 23311722
references.citation: Med Care. 2005 May;43(5):436-44
references.pmid: 15838407
references.citation: N Engl J Med. 2013 Apr 25;368(17):1613-24
references.pmid: 23614587
references.citation: J Rheumatol. 2007 Jun;34(6):1392-400
references.pmid: 17552066
references.citation: Arch Intern Med. 2004 May 24;164(10):1134-9
references.pmid: 15159272
references.citation: Ann Intern Med. 2010 Jul 20;153(2):69-75
references.pmid: 20643988
references.citation: Ann Fam Med. 2006 Jan-Feb;4(1):40-5
references.pmid: 16449395
references.citation: J Gen Intern Med. 2015 Jul;30(7):880-2
references.pmid: 25591970
references.citation: N Engl J Med. 2003 Jun 26;348(26):2635-45
references.pmid: 12826639
references.citation: Patient Educ Couns. 2005 Jul;58(1):4-12
references.pmid: 15950831
references.citation: Arch Intern Med. 2002 Nov 11;162(20):2269-76
references.pmid: 12418941
references.citation: Diabetes Care. 2015 Jan;38(1):6-8
references.pmid: 25538309
references.citation: J Am Med Inform Assoc. 2002 May-Jun;9(3):230-8
references.pmid: 11971884
references.citation: Milbank Q. 1996;74(4):511-44
references.pmid: 8941260
references.citation: BMJ. 2000 May 6;320(7244):1246-50
references.pmid: 10797036
references.citation: Ann Intern Med. 2000 Jan 4;132(1):80-4
references.pmid: 10627256
references.citation: N Engl J Med. 2014 Feb 20;370(8):766-8
references.pmid: 24552325
references.citation: J Gen Intern Med. 2008 Dec;23(12):2058-65
references.pmid: 18830762
references.citation: Lancet. 2012 Jun 16;379(9833):2252-61
references.pmid: 22683130
references.citation: Diabetes Care. 2006 Jun;29(6):1386-8
references.pmid: 16732027
references.citation: J Am Geriatr Soc. 1998 Jul;46(7):889-94
references.pmid: 9670878
references.citation: Hastings Cent Rep. 2013 Jan-Feb;Spec No:S4-S15
references.pmid: 23315895
references.citation: J Gen Intern Med. 2007 Jun;22(6):805-10
references.pmid: 17406952