ABSTRACT
Background
Studies indicate that decision making and informed consent among patients considering
left ventricular assist device (LVAD) support for advanced heart failure could be
improved. In the VADDA (Ventricular Assist Device Decision Aid) trial, we tested a
patient-centered decision aid (DA) to enhance the quality of decision making about
LVAD therapy.
Methods
After an extensive user-centered design process, we conducted a multisite randomized
trial of the DA compared with standard education (SE) among inpatients considering
LVAD treatment for advanced heart failure The main outcome was LVAD knowledge at 1
week and 1 month after administration of the DA versus the SE, according to a validated
scale. Secondary measures included prespecified quality decision making measures recommended
by the International Patient Decision Aid Standards collaboration.
Results
Of 105 eligible patients, 98 consented and were randomly assigned to the DA and SE
arms. Patients receiving the VADDA exhibited significantly greater LVAD knowledge
than the SE group at 1 week of follow-up (P = .01) but not at 1 month (P = .47). No differences were found between DA and SE patients in rates of acceptance
versus decline of LVAD treatment (85% vs 78%; P = .74). Recipients in the DA arm reported greater satisfaction with life after implantation
compared with nonrecipients (28 vs 23 out of 30; P = .008), although both arms reported high satisfaction. Patients rated the DA high
in acceptability and usability.
Conclusions
The VADDA enhances LVAD knowledge, particularly in the short term (1 week) during
the peak period of decision making. The DA does not encourage decision direction and
reflects patient, caregiver, and physician preferences for content and format.
Clinical Trial Registration
https://clinicaltrials.gov/ct2/show/NCT02248974. The trial is registered with clinicaltrials.gov (NCT02248974).
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Article info
Publication history
Published online: September 06, 2018
Accepted:
August 30,
2018
Received in revised form:
August 24,
2018
Received:
March 22,
2018
Footnotes
Funding: This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Program Award (1306-01769). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the PCORI, its Board of Governors, or its Methodology Committee.
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