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Trial Outcomes & Findings for Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement (NCT NCT03117296)

NCT ID: NCT03117296

Last Updated: 2023-01-20

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

189 participants

Primary outcome timeframe

at discharge

Results posted on

2023-01-20

Participant Flow

Retrospective study of patients whom received a tAVR procedure via transfemoral catheter percutaneous access site in the catheterization laboratory at HFH from March 1, 2012, to December 31, 2015. Exclusion criteria included access sites other than femoral, the occurrence of major events.

Patients excluded from database included those with an access sites other than femoral, the occurrence of major events including death, stroke, myocardial infarction (MI), additional cardiac or vascular surgery, electrophysiological monitoring, pacemaker placement, atrial fibrillation, other car-diovascular repair or surgery required, gastrointestinal bleeds, hematoma or access bleeds, or complications

Participant milestones

Participant milestones
Measure
Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation
Routine PT and or OT Routine PT or OT: Routine PT or OT consulted by physician when identified discharge disposition of home
Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation
Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention Post procedure daily PT and OT: PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time PT post procedure: post procedure day one: PT and OT assessment, education and intervention. OT post procedure: PT and OT Daily until goals met or patient discharge.
Overall Study
STARTED
74
115
Overall Study
COMPLETED
74
115
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation
n=74 Participants
Routine PT and or OT Routine PT or OT: Routine PT or OT consulted by physician when identified discharge disposition of home
Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation
n=115 Participants
Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention Post procedure daily PT and OT: PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time PT post procedure: post procedure day one: PT and OT assessment, education and intervention. OT post procedure: PT and OT Daily until goals met or patient discharge.
Total
n=189 Participants
Total of all reporting groups
Age, Continuous
79.5 years
STANDARD_DEVIATION 11.2 • n=5 Participants
81.6 years
STANDARD_DEVIATION 8.4 • n=7 Participants
80.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male
Female
32 Participants
n=5 Participants
47 Participants
n=7 Participants
79 Participants
n=5 Participants
Sex: Female, Male
Male
42 Participants
n=5 Participants
68 Participants
n=7 Participants
110 Participants
n=5 Participants
Region of Enrollment
United States
74 participants
n=5 Participants
115 participants
n=7 Participants
189 participants
n=5 Participants
BMI
28.4 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
28.4 kg/m^2
STANDARD_DEVIATION 6.1 • n=7 Participants
28.4 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
Society of Thoracic Surgeons Risk Score
8.5 Percentage
STANDARD_DEVIATION 8.5 • n=5 Participants
7.0 Percentage
STANDARD_DEVIATION 4.6 • n=7 Participants
7.75 Percentage
STANDARD_DEVIATION 6.6 • n=5 Participants
Valve Sheath Delivery Size
18.1 milimeter diameter of tAVR device
STANDARD_DEVIATION 4.2 • n=5 Participants
19.3 milimeter diameter of tAVR device
STANDARD_DEVIATION 3.8 • n=7 Participants
18.7 milimeter diameter of tAVR device
STANDARD_DEVIATION 4 • n=5 Participants

PRIMARY outcome

Timeframe: at discharge

Population: Adults admitted to Henry Ford Hospital and received a transcatheter aortic valve replacement via femoral access site and free from major events or complications.

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

Outcome measures

Outcome measures
Measure
Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation
n=74 Participants
Routine PT and or OT Routine PT or OT: Routine PT or OT consulted by physician when identified discharge disposition of home
Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation
n=115 Participants
Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention Post procedure daily PT and OT: PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time PT post procedure: post procedure day one: PT and OT assessment, education and intervention. OT post procedure: PT and OT Daily until goals met or patient discharge.
Post Procedure Hospital Length of Stay
4.8 days
Standard Deviation 2.9
3.5 days
Standard Deviation 4.0

PRIMARY outcome

Timeframe: at discharge

Population: Adults admitted to HFH and s/p tAVR via femoral site, free from events or complications

Days from Hospital admission to Hospital Discharge

Outcome measures

Outcome measures
Measure
Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation
n=74 Participants
Routine PT and or OT Routine PT or OT: Routine PT or OT consulted by physician when identified discharge disposition of home
Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation
n=115 Participants
Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention Post procedure daily PT and OT: PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time PT post procedure: post procedure day one: PT and OT assessment, education and intervention. OT post procedure: PT and OT Daily until goals met or patient discharge.
Total Hospital Length of Stay
6.9 days
Standard Deviation 5.4
4.5 days
Standard Deviation 5.4

SECONDARY outcome

Timeframe: on day of hospital discharge

Population: Adults admit to HFH and s/p TAVR via femoral access, free from events or complications

Discharge destination at discharge. Home includes those discharge home, Home with assistance or Home with Home care.

Outcome measures

Outcome measures
Measure
Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation
n=74 Participants
Routine PT and or OT Routine PT or OT: Routine PT or OT consulted by physician when identified discharge disposition of home
Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation
n=115 Participants
Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention Post procedure daily PT and OT: PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time PT post procedure: post procedure day one: PT and OT assessment, education and intervention. OT post procedure: PT and OT Daily until goals met or patient discharge.
Discharge Disposition, Home
57 Participants
99 Participants

SECONDARY outcome

Timeframe: on day of hospital discharge

Population: Adults admit to HFH and s/p tavr via femoral, no events or complications

At hospital discharge, did the patient return Home or were they discharged to a post-acute care Rehab Facility

Outcome measures

Outcome measures
Measure
Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation
n=74 Participants
Routine PT and or OT Routine PT or OT: Routine PT or OT consulted by physician when identified discharge disposition of home
Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation
n=115 Participants
Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention Post procedure daily PT and OT: PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time PT post procedure: post procedure day one: PT and OT assessment, education and intervention. OT post procedure: PT and OT Daily until goals met or patient discharge.
Discharge Destination, Rehab Facility
17 Participants
16 Participants

Adverse Events

Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adele Myszenski, PT, DPT

Henry Ford Hospital

Phone: 313-916-1334

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place