TY - JOUR
T1 - A pilot clinical trial of a self-management intervention in patients with a left ventricular assist device
AU - Casida, Jesus M.
AU - Pavol, Marykay
AU - Budhathoki, Chakra
AU - Craddock, Heidi
AU - Schroeder, Sarah E.
AU - Hoff, Danyelle
AU - Tiburcio, Millie
AU - Ewald, Gregory
N1 - Funding Information:
This study was funded by the NIH National Institute of Nursing Research (P20NR015331) and the D. K. Allen Foundation administered by the University of Michigan School of Nursing, Ann Arbor, MI. We also would like to acknowledge the contributions of VAD RNs and NPs in completing this study in the following VAD Centers in the United States: Barnes-Jewish Hospital, St. Louis, MO, University of Michigan, Ann Arbor, MI, Columbia University, New York, NY, and Bryant Heart, Lincoln, NE.
Funding Information:
This study was funded by the NIH National Institute of Nursing Research (P20NR015331) and the D. K. Allen Foundation administered by the University of Michigan School of Nursing, Ann Arbor, MI. We also would like to acknowledge the contributions of VAD RNs and NPs in completing this study in the following VAD Centers in the United States: Barnes-Jewish Hospital, St. Louis, MO, University of Michigan, Ann Arbor, MI, Columbia University, New York, NY, and Bryant Heart, Lincoln, NE.
Publisher Copyright:
© 2021, The Japanese Society for Artificial Organs.
PY - 2022/6
Y1 - 2022/6
N2 - Self-management is a health behavior known to predict treatment outcomes in patients with multiple co-morbidities and/or chronic conditions. However, the self-management process and outcomes in the left-ventricular assist device (LVAD) population are understudied. This pilot randomized control trial (RCT) evaluated the feasibility of a novel “smartphone app-directed and nurse-supported self-management intervention” in patients implanted with durable LVADs. Assessments included behavioral (self-efficacy and adherence), clinical (complications), and healthcare utilization (unplanned clinic, emergency room (ER) visits, and re-hospitalization) outcomes, completed at baseline (pre-hospital discharge) and months 1, 3, and 6 post-hospital discharge. Intervention patients (n = 14) had favorable patterns/trends of results across study outcomes than control patients (n = 16). Notably, intervention patients had much lower complications and healthcare utilization rates than controls. For example, intervention patients had 2 (14.3%) driveline infections in 6 months while control patients had 3 (19.0%). Additionally, at month 3, intervention patients had 0% ER visits versus 36% of control patients. At month 6, the mean cumulative number of re-hospitalizations for the control group was higher (0.9 ± 0.93) than intervention (0.3 ± 0.61) group. Despite the small sample size and limitations of feasibility/pilot studies, our outcomes data appeared to favor the novel intervention. Lessons learned from this study suggest the intervention should be implemented for 6 months post-hospital discharge. Further research is needed including large and rigorous multi-center RCTs to generate knowledge explaining the mechanism of the effect of self-management on LVAD treatment outcomes.
AB - Self-management is a health behavior known to predict treatment outcomes in patients with multiple co-morbidities and/or chronic conditions. However, the self-management process and outcomes in the left-ventricular assist device (LVAD) population are understudied. This pilot randomized control trial (RCT) evaluated the feasibility of a novel “smartphone app-directed and nurse-supported self-management intervention” in patients implanted with durable LVADs. Assessments included behavioral (self-efficacy and adherence), clinical (complications), and healthcare utilization (unplanned clinic, emergency room (ER) visits, and re-hospitalization) outcomes, completed at baseline (pre-hospital discharge) and months 1, 3, and 6 post-hospital discharge. Intervention patients (n = 14) had favorable patterns/trends of results across study outcomes than control patients (n = 16). Notably, intervention patients had much lower complications and healthcare utilization rates than controls. For example, intervention patients had 2 (14.3%) driveline infections in 6 months while control patients had 3 (19.0%). Additionally, at month 3, intervention patients had 0% ER visits versus 36% of control patients. At month 6, the mean cumulative number of re-hospitalizations for the control group was higher (0.9 ± 0.93) than intervention (0.3 ± 0.61) group. Despite the small sample size and limitations of feasibility/pilot studies, our outcomes data appeared to favor the novel intervention. Lessons learned from this study suggest the intervention should be implemented for 6 months post-hospital discharge. Further research is needed including large and rigorous multi-center RCTs to generate knowledge explaining the mechanism of the effect of self-management on LVAD treatment outcomes.
KW - LVAD self-management
KW - Mechanical circulatory support
KW - Nurse-supported self-management
KW - Smartphone app intervention
KW - Ventricular assist devices
UR - http://www.scopus.com/inward/record.url?scp=85111819818&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85111819818&partnerID=8YFLogxK
U2 - 10.1007/s10047-021-01289-x
DO - 10.1007/s10047-021-01289-x
M3 - Article
C2 - 34342807
AN - SCOPUS:85111819818
SN - 1434-7229
VL - 25
SP - 91
EP - 104
JO - Journal of Artificial Organs
JF - Journal of Artificial Organs
IS - 2
ER -