Kristin M Kostick1, Courtenay R Bruce2, Charles G Minard3, Robert J Volk4, Andrew Civitello5, Selim R Krim6, Douglas Horstmanshof7, Vinay Thohan8, Matthias Loebe9, Mazen Hanna10, Brian A Bruckner11, J S Blumenthal Barby2, Jerry D Estep11. 1. Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas. Electronic address: Kristin.Kostick@bcm.edu. 2. Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas. 3. Dan L. Duncan Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, Texas. 4. Department of Health Services Research, University of Texas MD Anderson Cancer Center, Houston, Texas. 5. Texas Heart Institute, Baylor College of Medicine, Houston, Texas. 6. Ochsner Clinic Foundation, New Orleans, Louisiana. 7. Integris Health, Oklahoma City, Oklahoma. 8. Aurora St Luke's Medical Center, Milwaukee, Wisconsin. 9. University of Miami Miller School of Medicine, Miami, Florida. 10. Cleveland Clinic, Cleveland, Ohio. 11. Houston Methodist Hospital, Houston, Texas.
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).
RCT Entities:
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).
Authors: Rebecca S Steinberg; Aditi Nayak; Celena O'Connell; Sharon Burford; Ann Pekarek; Neile Chesnut; Robert T Cole; Divya Gupta; S Raja Laskar; Kunal Bhatt; Michael Burke; Tamer Attia; Andrew Smith; J David Vega; Alanna A Morris Journal: Clin Transplant Date: 2020-03-16 Impact factor: 2.863
Authors: Johanna Glaser; Sarah Nouri; Alicia Fernandez; Rebecca L Sudore; Dean Schillinger; Michele Klein-Fedyshin; Yael Schenker Journal: Med Decis Making Date: 2020-01-16 Impact factor: 2.583
Authors: Inna Tchoukina; Keyur B Shah; Jennifer T Thibodeau; Jerry D Estep; Anuradha Lala; David E Lanfear; Nisha A Gilotra; Salpy V Pamboukian; Douglas A Horstmanshof; Dennis M Mcnamara; Donald C Haas; Ulrich P Jorde; Rhondalyn C Mclean; Thomas M Cascino; Shokoufeh Khalatbari; Blair Richards; Matheos Yosef; Cathie Spino; J Timothy Baldwin; Douglas L Mann; Keith D Aaronson; Garrick C Stewart Journal: J Card Fail Date: 2019-12-04 Impact factor: 6.592
Authors: Kristin M Kostick; Meredith Trejo; Arvind Bhimaraj; Andrew Civitello; Jonathan Grinstein; Douglas Horstmanshof; Ulrich P Jorde; Matthias Loebe; Mandeep R Mehra; Nasir Z Sulemanjee; Vinay Thohan; Barry H Trachtenberg; Nir Uriel; Robert J Volk; Jerry D Estep; J S Blumenthal-Barby Journal: BMC Med Inform Decis Mak Date: 2021-03-20 Impact factor: 2.796
Authors: Mary Amanda Dew; Andrea F DiMartini; Fabienne Dobbels; Kathleen L Grady; Sheila G Jowsey-Gregoire; Annemarie Kaan; Kay Kendall; Quincy-Robyn Young Journal: Curr Heart Fail Rep Date: 2019-12