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. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

NCT02344576.

Trial name or title PCORI‐1310‐06998 Trial of a decision support intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device (DECIDE‐LVAD)
Methods RCT
Participants Inclusion criteria

  • Adult patients who have advanced heart failure and are being evaluated for DT LVAD

  • Caregivers of patients who are being evaluated for DT LVAD


Exclusion criteria

  • Under 18 years of age

  • Non‐English Speaking

  • Unable to consent

  • Prisoner

  • Already implanted with DT LVAD
Interventions No intervention: control: usual care
Quote: "Patients and caregivers will receive the current usual education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials."
Experimental: DT LVAD Decision Support Intervention
Quote: "In the intervention phase of the study, patients and caregivers will receive the new decision support intervention, which consists primarily of decision aid materials about DT LVAD. The standard consent process will also still take place, but will be supplemented with additional decision support."
Outcomes Primary outcomes

  • Reach of Intervention (proportion of the target population who participate in the intervention)

  • Effectiveness of Intervention (Knowledge: DT LVAD knowledge and Values: Concordance between patients' and caregivers' values and the treatment they choose according)

  • Adoption of Intervention (absolute number, proportion, and representativeness of settings and intervention agents (people who deliver the program) who are willing to initiate a program)

  • Implementation of Intervention (extent to which the intervention is implemented as intended)

  • Maintenance of Intervention (whether sites decide at the conclusion of the study to maintain, modify, or discontinue the DT LVAD decision support intervention)


Secondary outcomes

  • Changes in Decision Conflict (Decision Conflict Scale)

  • Changes in Decision Regret (Decision Regret Scale)

  • Changes in Stress, Anxiety and Depression (Perceived Stress Scale, Hospital Anxiety and Depression Scale)

  • Changes in Quality of life (EuroQol EQ5D (patients only)

  • Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale (caregivers only)

  • Changes in Bereaved Caregiver Satisfaction with End‐of‐Life Care (Canadian Health Care Evaluation Project ‐ Bereavement Questionnaire (bereaved caregivers only)

  • Changes in Preferences for Control of Medical Decisions (Control Preferences Scale (patients only)

  • Changes in Illness Acceptance (PEACE Illness Acceptance Measure (patients only)

  • Changes in Patient Satisfaction with Caregiver Involvement (Canadian Health Care Evaluation Project ‐ Patient Questionnaire (patients only)

  • Changes in Family Satisfaction with Patient's Care (Family Satisfaction with Care (caregivers only)

  • Changes in Cognition, literacy and numeracy (Short Portable Mental Status Questionnaire; REALM‐R Literacy Assessment

  • Changes in Patient Health Status (Medical record review (patients only)
Starting date May 2015
Contact information Principal investigator: Larry Allen, MD, MHS, University of Colorado School of Medicine
Notes No contact details provided