title: The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Advance care planning (ACP) is a process whereby patients prepare for medical decision-making. The traditional objective of ACP has focused on the completion of advance directives. We have developed a new paradigm of ACP focused on preparing patients and their loved ones for communication and informed medical decision-making. To operationalize this new paradigm of ACP, we created an interactive, patient-centered website called PREPARE ( www.prepareforyourcare.org ) designed for diverse older adults.
  
  
  METHODS
  This randomized controlled trial with blinded outcome assessment is designed to determine the efficacy of PREPARE to engage older Veterans in the ACP process. Veterans who are ≥ 60 years of age, have ≥ two medical conditions, and have seen a primary care physician ≥ two times in the last year are being randomized to one of two study arms. The PREPARE study arm reviews the PREPARE website and an easy-to-read advance directive. The control arm only reviews the advance directive. The primary outcome is documentation of an advance directive and ACP discussions. Other clinically important outcomes using validated surveys include ACP behavior change process measures (knowledge, contemplation, self-efficacy, and readiness) and a full range of ACP action measures (identifying a surrogate, identifying values and goals, choosing leeway or flexibility for the surrogate, communicating with clinicians and surrogates, and documenting one's wishes). We will also assess satisfaction with decision-making and Veteran activation within primary care visits by direct audio recording. To examine the outcomes at 1 week, 3 months, and 6 months between the two study arms, we will use mixed effects linear, Poisson, or negative binomial regression and mixed effects logistic regression.
  
  
  CONCLUSIONS
  This study will determine whether PREPARE increases advance directive completion rates and engagement with the ACP process. If PREPARE is efficacious, it could prove to be an easy and effective intervention to help older adults engage in the ACP process within or outside of the medical environment. PREPARE may also help older adults communicate their medical wishes and goals to their loved ones and clinicians, improve medical decision-making, and ensure their wishes are honored over the life course.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01550731 . Registered on 8 December 2011.
authors.affiliation: Division of Geriatrics, Department of Medicine, University of California, San Francisco, 3333 California St. Suite 380, San Francisco, CA, 94143, USA. rebecca.sudore@ucsf.edu.|San Francisco Veterans Administration Medical Center, 4150 Clement Street, #151R, San Francisco, CA, 94121, USA. rebecca.sudore@ucsf.edu.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Sudore
authors.affiliation: Division of Geriatrics, Department of Medicine, University of California, San Francisco, 3333 California St. Suite 380, San Francisco, CA, 94143, USA. gem.le@ucsf.edu.|Division of General Internal Medicine, San Francisco General Hospital, Center for Vulnerable Populations, University of California, San Francisco, 2789 25th Street Suite 350, San Francisco, CA, 94110, USA. gem.le@ucsf.edu.
authors.forename: Gem M
authors.initials: GM
authors.lastname: Le
authors.affiliation: San Francisco Veterans Administration Medical Center, 4150 Clement Street, #151R, San Francisco, CA, 94121, USA. ryan.mcmahan@ucsf.edu.
authors.forename: Ryan
authors.initials: R
authors.lastname: McMahan
authors.affiliation: San Francisco Veterans Administration Medical Center, 4150 Clement Street, #151R, San Francisco, CA, 94121, USA. ryan.mcmahan@ucsf.edu.
authors.forename: Ryan
authors.initials: R
authors.lastname: McMahon
authors.affiliation: San Francisco Veterans Administration Medical Center, 4150 Clement Street, #151R, San Francisco, CA, 94121, USA. mariko.feuz@ucsf.edu.
authors.forename: Mariko
authors.initials: M
authors.lastname: Feuz
authors.affiliation: San Francisco Veterans Administration Medical Center, 4150 Clement Street, #151R, San Francisco, CA, 94121, USA. mary.katen@ucsf.edu.
authors.forename: Mary
authors.initials: M
authors.lastname: Katen
authors.affiliation: Division of Geriatrics, Department of Medicine, University of California, San Francisco, 3333 California St. Suite 380, San Francisco, CA, 94143, USA. deborah.barnes@ucsf.edu.|Department of Psychiatry, University of California, San Francisco, CA, USA. deborah.barnes@ucsf.edu.|Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA. deborah.barnes@ucsf.edu.
authors.forename: Deborah E
authors.initials: DE
authors.lastname: Barnes
mesh_terms: D032722:Advance Care Planning; D000367:Age Factors; D000368:Aged; D002755:Choice Behavior; D002908:Chronic Disease / Q000523:psychology / Q000628:therapy*; D003142:Communication; D005195:Family Relations; D005260:Female; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D020407:Internet; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D010358:Patient Participation; D017060:Patient Satisfaction; D018802:Patient-Centered Care; D010817:Physician-Patient Relations; D012107:Research Design; D012495:San Francisco; D011795:Surveys and Questionnaires; D014728:Veterans / Q000523:psychology*; D058014:Veterans Health