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临床试验/NCT03117296
NCT03117296已完成不适用

Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement

Henry Ford Health System1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2014年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
189
试验地点
1
主要终点
Post Procedure Hospital Length of Stay

研究概览

简要总结

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.

详细描述

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)

  • Improve patient outcomes including increasing the percentage of patients returning to home rather than a rehab facility destination at discharge
  • Decrease length of stay

Implementation:

  • Plan: PT and OT identified a gap in consults and need for specific education targeted at a new surgeries population (tAVR); Structural Heart division of CV institute identified an increase LOS and decreased activity of their patients in the hospital. In October 2014 planning began to introduce a SHD tAVR pathway that would include post procedure day number 0 nursing requirements and training, post procedure day number 1-3 PT and OT assessment and interventions.
  • Do: Implemented pathway in November 2014.
  • Check: Order set revision; Patient handouts ; Cardiac Rehab; Weekend criteria; staff training
  • Act: February 2015, order sets in place, patient handouts finalized and full pathway finalized for post op tAVR patients.
  • Continued checks identified additional SHD procedures and team determined that Mitral Clips and LARIATs were not criteria for tAVR pathway but would receive routine PT and OT consults.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • admission to henry ford hospital after March 1, 2012
  • status post transcatheter aortic valve replacement via transfemoral catheter approach, with or without minor intra or post procedure events (GI bleeds, minor access bleeds, afib, etc)

排除标准

  • Occurrence of major events including stroke, pacemaker placement, other CV repair or surgery required, etc)
  • procedure via appropriate other than femoral access (transapical, transcaval)

结局指标

主要结局

Post Procedure Hospital Length of Stay

时间窗: at discharge

From date of procedure until date of hospital discharge, assessed up to 50 days.

Total Hospital Length of Stay

时间窗: at discharge

Days from Hospital admission to Hospital Discharge

次要结局

  • Discharge Destination, Rehab Facility(on day of hospital discharge)
  • Discharge Disposition, Home(on day of hospital discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adele Myszenski

Supervisor, Physical Therapist

Henry Ford Health System

研究点 (1)

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