Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement (PTOTtAVR)

April 18, 2022 updated by: Adele Myszenski, Henry Ford Health System
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.

Study Overview

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).

Study Type

Observational

Enrollment (Actual)

189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive population sample of patients at Henry Ford Hospital, Detroit, Michigan undergoing transcatheter aortic valve replacement via femoral access in cath lab from March 2012 to present.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post procedure routine PT and or OT
Routine PT and or OT
Routine PT or OT consulted by physician when identified discharge disposition of home
Post Procedure PT and OT pathway
Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Procedure Hospital Length of Stay
Time Frame: at discharge
From date of procedure until date of hospital discharge, assessed up to 50 days.
at discharge
Total Hospital Length of Stay
Time Frame: at discharge
Days from Hospital admission to Hospital Discharge
at discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discharge Disposition, Home
Time Frame: on day of hospital discharge
Discharge destination at discharge. Home includes those discharge home, Home with assistance or Home with Home care.
on day of hospital discharge
Discharge Destination, Rehab Facility
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
on day of hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Adele Myszenski, MPT, Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2014

Primary Completion (Actual)

July 31, 2015

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 7, 2017

First Submitted That Met QC Criteria

April 14, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 10437 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IRB was closed March 08-2021 and no plans to share data from this preliminary study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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