- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03117296
Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement (PTOTtAVR)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post Procedure Hospital Length of Stay
Time Frame: at discharge
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From date of procedure until date of hospital discharge, assessed up to 50 days.
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at discharge
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Total Hospital Length of Stay
Time Frame: at discharge
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Days from Hospital admission to Hospital Discharge
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at discharge
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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
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Discharge Destination, Rehab Facility
Time Frame: on day of hospital discharge
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At hospital discharge, did the patient return Home or were they discharged to a post-acute care Rehab Facility
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on day of hospital discharge
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Adele Myszenski, MPT, Henry Ford Health System
Publications and helpful links
General Publications
- Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.
- Babaliaros V, Devireddy C, Lerakis S, Leonardi R, Iturra SA, Mavromatis K, Leshnower BG, Guyton RA, Kanitkar M, Keegan P, Simone A, Stewart JP, Ghasemzadeh N, Block P, Thourani VH. Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis. JACC Cardiovasc Interv. 2014 Aug;7(8):898-904. doi: 10.1016/j.jcin.2014.04.005. Epub 2014 Jul 30.
- Marcantuono R, Gutsche J, Burke-Julien M, Anwaruddin S, Augoustides JG, Jones D, Mangino-Blanchard L, Hoke N, Houseman S, Li R, Patel P, Stetson R, Walsh E, Szeto WY, Herrmann HC. Rationale, development, implementation, and initial results of a fast track protocol for transfemoral transcatheter aortic valve replacement (TAVR). Catheter Cardiovasc Interv. 2015 Mar;85(4):648-54. doi: 10.1002/ccd.25749. Epub 2014 Nov 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10437 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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