title: Assessment of patients' and caregivers' informational and decisional needs for left ventricular assist device placement: Implications for informed consent and shared decision-making.
abstract: BACKGROUND
  Several organizations have underscored the crucial need for patient-centered decision tools to enhance shared decision-making in advanced heart failure. The purpose of this study was to investigate the decision-making process and informational and decisional needs of patients and their caregivers regarding left ventricular assist device (LVAD) placement.
  
  
  METHODS
  In-depth, structured interviews with LVAD patients, candidates and caregivers (spouse, family members) (n = 45) were conducted. We also administered a Decisional Regret Scale.
  
  
  RESULTS
  Participants reported LVAD decision-making to be quick and reflexive (n = 30), and deferred heavily to clinicians (n = 22). They did not perceive themselves as having a real choice (n = 28). The 2 most prevalent informational domains that participants identified were lifestyle issues (23 items), followed by technical (drive-line, battery) issues (14 items). Participants easily and clearly identified their values: life extension; family; and mobility. Participants reported the need to meet other patients and caregivers before device placement (n = 31), and to have an involved caregiver (n = 28) to synthesize information. Some participants demonstrated a lack of clarity regarding transplant probability: 9 of 15 patients described themselves as on a transplant trajectory, yet 7 of these were destination therapy patients. Finally, we found that decisional regret scores were low (1.307).
  
  
  CONCLUSIONS
  Informed consent and shared-decision making should: (a) help patients offered highly invasive technologies for life-threatening disease get past the initial "anything to avoid thinking about death" reaction and make a more informed decision; (b) clarify transplant status; and (c) focus on lifestyle and technical issues, as patients have the most informational needs in these domains.
authors.affiliation: Center for Medical Ethics & Health Policy, Baylor College of Medicine, Houston, Texas. Electronic address: jennifer.blumenthal-barby@bcm.edu.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Blumenthal-Barby
authors.affiliation: Center for Medical Ethics & Health Policy, Baylor College of Medicine, Houston, Texas.
authors.forename: Kristin M
authors.initials: KM
authors.lastname: Kostick
authors.affiliation: Center for Medical Ethics & Health Policy, Baylor College of Medicine, Houston, Texas.
authors.forename: Estevan D
authors.initials: ED
authors.lastname: Delgado
authors.affiliation: Department of Health Services Research, The M.D. Anderson Cancer Center, University of Texas, Houston, Texas.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Volk
authors.affiliation: Center for Medical Ethics & Health Policy, Baylor College of Medicine, Houston, Texas.
authors.forename: Holland M
authors.initials: HM
authors.lastname: Kaplan
authors.affiliation: Center for Medical Ethics & Health Policy, Baylor College of Medicine, Houston, Texas.
authors.forename: L A
authors.initials: LA
authors.lastname: Wilhelms
authors.affiliation: School of Public Health, University of Texas, Houston, Texas.
authors.forename: Sheryl A
authors.initials: SA
authors.lastname: McCurdy
authors.affiliation: Houston Methodist DeBakey Heart & Vascular Center and J.C. Walter Jr. Transplant Center, Houston Methodist Hospital, Houston, Texas.
authors.forename: Jerry D
authors.initials: JD
authors.lastname: Estep
authors.affiliation: Houston Methodist DeBakey Heart & Vascular Center and J.C. Walter Jr. Transplant Center, Houston Methodist Hospital, Houston, Texas.
authors.forename: Matthias
authors.initials: M
authors.lastname: Loebe
authors.affiliation: Center for Medical Ethics & Health Policy, Baylor College of Medicine, Houston, Texas.
authors.forename: Courtenay R
authors.initials: CR
authors.lastname: Bruce
mesh_terms: D000328:Adult; D000368:Aged; D001290:Attitude; D017028:Caregivers / Q000523:psychology*; D003657:Decision Making; D005260:Female; D006333:Heart Failure / Q000628:therapy; D016027:Heart Transplantation; D006353:Heart-Assist Devices; D006801:Humans; D007258:Informed Consent; D007406:Interview, Psychological; D008019:Life Style; D008297:Male; D008875:Middle Aged; D010361:Patients / Q000523:psychology*
keywords: caregivers; decision making; heart failure; informed consent; shared decision making; transplant; ventricular assist device