Henry Ford Hospital
Detroit, Michigan, 48202, United States
NCT Number: NCT03117296
Implementation of Physical Therapy (PT) and Occupational Therapy (OT) pathway (initiation of services on Post procedure day #1 and continued daily with focus on education and activity progression) for all patients undergoing a transcatheter aortic value repair procedure began on December 2, 2014. Retrospective data was collected from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Aortic Valve Replacement Procedures (STS/ACC TVT, trademark) Registry - National database for Transcatherter Aortic Valve Replacement Procedures and included subjects from March 2012 through July 31, 2015. Patients included: s/p tAVR via transfemoral catheter approach, with or without minor intra or post procedure events (GI bleeds, minor access bleeds, afib, etc); Exclusions: Major events including stroke, pacemaker placement, other cardiovascular (CV) repair or surgery required, etc). Future data analysis will extend subjects to December 31, 2015 and annually.
Looking for future studies?
Notify MeAll sexes
Observational
Detroit, Michigan, 48202, United States
Rationale: Frequency of transcatheter and other structural heart procedures increased dramatically from 2012 to 2014 and is trending even higher for 2015. Procedures increased from 15 in 2012 to 50 cases in 2013 (233% increase) and to 70 cases in 2014 (40% increase from 2013 to 2014.) -- PT and OT identified a gap in consults and need for specific education targeted for a new surgery population (tAVR) without sternotomy. Often consults were placed on day of discharge to rehab facility or not at all. -- Structural Heart division of CV institute identified increased length of stay (LOS) and decreased activity of their patients in the hospital. -- No literature on this subject found via Henry Ford Hospital Sladen Library PubMed literature review
Aim: • Create a standardized pathway for new transcatheter aortic valve replacement patients in the Structural Heart Division (SHD)
Implementation:
Intervention: • Added PT and OT to Structural Heart Order Set.
Outcome measures: Hospital Length of stay, discharge disposition. Data Analysis: Chi-square tests are used to compare proportions between groups, while Wilcoxon two-sample tests are used to compare distributions of continuous variables between groups. This nonparametric test was chosen due to non-Gaussian distribution of the continuous outcomes within groups. Statistical significance was set at p<0.05. All analyses were performed using SAS 9.4 (SAS Institute Inc, Cary, North Carolina, USA).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time
post procedure day one: PT and OT assessment, education and intervention.
PT and OT Daily until goals met or patient discharge.
Routine PT or OT consulted by physician when identified discharge disposition of home
Time frame: at discharge
From date of procedure until date of hospital discharge, assessed up to 50 days.
Time frame: at discharge
Days from Hospital admission to Hospital Discharge
Time frame: on day of hospital discharge
Discharge destination at discharge. Home includes those discharge home, Home with assistance or Home with Home care.
Time frame: on day of hospital discharge
At hospital discharge, did the patient return Home or were they discharged to a post-acute care Rehab Facility
Henry Ford Health System
Other
Acronym: PTOTtAVR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07414485
Arrhythmias, Cardiac, Bundle-Branch Block
Montpellier, France
View Trial DetailsNCT04443023
Transcatheter Aortic Valve Implantation
Aarhus, Denmark
View Trial DetailsNCT05478161
Aortic Valve Disease, Aortic Valve Stenosis
Bad Rothenfelde, Lower Saxony, Germany
View Trial DetailsNCT05217888
Aortic Valve Disease, Cardiovascular Diseases
Bucheon-si, South Korea
View Trial Details