Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement

Completed

Conditions: Transcatheter Aortic Valve Implantation

Interventions: Other: Routine PT or OT
Other: Post procedure daily PT and OT
Other: PT post procedure
Other: OT post procedure

Registration Number: NCT03117296

Lead Sponsor: Henry Ford Health System

Brief Summary: 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.

Detailed Description: 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.

Intervention: • Added PT and OT to Structural Heart Order Set.

* PT and OT assessments completed on post procedure day number day 1.

* PT and OT follow up treatments post procedure day number 2, 3 and beyond as appropriate.

* Patient education handouts individualized for patient population

* Pre-op education handouts individualized for patient population

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 189

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post Procedure PT and OT pathway	OT post procedure	Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention
Post procedure routine PT and or OT	Routine PT or OT	Routine PT and or OT
Post Procedure PT and OT pathway	Post procedure daily PT and OT	Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention
Post Procedure PT and OT pathway	PT post procedure	Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention

Primary Outcome Measures

Name	Time	Method
Post Procedure Hospital Length of Stay	at discharge	From date of procedure until date of hospital discharge, assessed up to 50 days.
Total Hospital Length of Stay	at discharge	Days from Hospital admission to Hospital Discharge

Secondary Outcome Measures

Name	Time	Method
Discharge Destination, Rehab Facility	on day of hospital discharge	At hospital discharge, did the patient return Home or were they discharged to a post-acute care Rehab Facility
Discharge Disposition, Home	on day of hospital discharge	Discharge destination at discharge. Home includes those discharge home, Home with assistance or Home with Home care.