Shifting Rehabilitation Paradigms in Skilled Nursing Facilities

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02927171
• Collaborator: University of Colorado, Denver (Other)
• Enrollment: 104
• Locations: 3
• Arms: 2
• Actual Duration (Months): 34.1
• Patients Per Site: 34.7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This study seeks to improve rehabilitation methods for restoring physical function with skilled nursing facility care. More specifically, this study is designed to evaluate the effectiveness of an intensive therapeutic rehabilitation program for older adult skilled nursing home residents compared to usual care.

Condition or Disease	Intervention/Treatment	Phase
Physical Deconditioning	Other: IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents	N/A

Detailed Description

There is growing recognition that acute hospitalization contributes to marked functional decline in older adults. Nearly 20% of all hospitalized older adults are discharged to a skilled nursing facility (SNF) to address these functional deficits. However, rehabilitation in SNFs may not adequately restore physical function, which potentially contributes to poor community discharge rates. Strikingly, only 37% of all patients admitted to SNFs are discharged to a community setting, which suggests a paradigm shift is required to optimize rehabilitation within SNFs. Currently, usual care rehabilitation in SNFs consists of low-intensity rehabilitation interventions, which are physiologically inadequate to induce meaningful changes in skeletal muscle strength and physical function. Therefore, the investigators propose a novel "IntenSive Therapeutic Rehabilitation for Older skilled NursinG HomE Residents" (I-STRONGER) program, which integrates principles of physiologic tissue overload into combined strengthening and functional interventions for greater gains in physical function. The overall goals of this investigation are to 1) demonstrate feasibility of I-STRONGER in SNF settings and 2) determine the effectiveness of I-STRONGER in improving physical function. A comparison of usual care (UC) with I-STRONGER will occur using a staged, 2 group design (independent cohorts), with a single SNF serving as its own control. The first cohort of SNF patients will participate in UC (Stage 1) and after therapist training on ISTRONGER is completed, a second cohort of patients entering the same facility will participate in I-STRONGER (Stage 2). The feasibility of I-STRONGER will be evaluated by patient acceptability and therapist compliance measures. Sample size estimates (using patients with mobility deficits in home health settings) suggest at least 86 participants are necessary to be adequately powered. Heterogeneity of the sample will be re-evaluated during the study period using SNF data and sample size estimates may be adjusted as appropriate.

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Shifting Rehabilitation Paradigms in Skilled Nursing Facilities
• Actual Study Start Date: Feb 28, 2016
• Actual Primary Completion Date: Oct 30, 2018
• Actual Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.
Experimental: I-STRONGER IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care.	Other: IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents; Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.; Other Names: I-STRONGER

Outcome Measures

Primary Outcome Measures

1. Short Physical Performance Battery (SPPB) [Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)]

   Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests. Minimum scores are 0 and maximum scores are 12. Higher scores indicate better function.

Secondary Outcome Measures

1. Gait Speed [Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)]

   Time it takes to walk a 4 meter path. Lower scores indicate better function.

Other Outcome Measures

1. Patient Satisfaction Survey [Quantification at SNF Discharge (Expected average length of stay: 21 days)]

   8 Question survey, scoring each questions on a 1-10 scale (1=not at all, 10=extremely). Higher scores indicate higher satisfaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adults > 18 years of age who are admitted to a skilled nursing facility following hospitalization

2. Qualify to receive at least physical therapy services

Exclusion Criteria:

• Patients with primary diagnoses related to neurological disorders will be excluded as patient needs require more of a motor control approach rather than the proposed high-intensity approach. Such patient populations include:

• Parkinson's Disease

• Traumatic Brain Injury

• Recent Cerebral Vascular Accident

• Alzheimer's Disease

• Patients on hospice care will be excluded as the approach is based on palliative principles.

• Other patients to be excluded will include those with conditions where strength training is contraindicated (as indicated by the American College of

Sports Medicine Guidelines for Exercise Testing and Prescription):

• Recent unstable fracture

• Advanced congestive heart failure

• Bone metastasis sites

• Tumors in strengthening target areas

• Acute Illness

• Recent myocardial infarction (within 3-6 weeks)

• Weight bearing restrictions on graft or fracture sites

• Exposed tendon or muscle

• Absence of pedal pulses

• Presence of fistula

• Platelet levels <50,000/ L

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado	United States	80045
2	VA Community Living Center	Aurora	Colorado	United States	80045
3	Brookdale Senior Living	Denver	Colorado	United States	80247

Sponsors and Collaborators

• VA Office of Research and Development
• University of Colorado, Denver

Investigators

• Principal Investigator: Jennifer E. Stevens-Lapsley, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 6, 2018

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02927171
• Other Study ID Numbers: E2193-P; I21RX002193
• First Posted: Oct 6, 2016
• Last Update Posted: Apr 3, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Skilled Nursing Facility; Post-Acute Care; Older Adults; Physical Function; Rehabilitation

Study Results

Participant Flow

Recruitment Details	Participants were recruited from a skilled nursing facility between the dates of 02.28.2016 and 10.30.2018
Pre-assignment Detail	There were no exclusions of participants. All eligible, willing participants were allocated to one of two arms.

Arm/Group Title	Usual Care	I-STRONGER
Arm/Group Description	Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.	IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
Period Title: Overall Study
STARTED	53	51
COMPLETED	53	50
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Usual Care	I-STRONGER	Total
Arm/Group Description	Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.	IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.	Total of all reporting groups
Overall Participants	53	50	103
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	78.0 (9.6)	77.3 (10.8)	77.65 (10.2)
Sex: Female, Male (Count of Participants)
Female	9 17%	2 4%	11 10.7%
Male	44 83%	48 96%	92 89.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 3.8%	4 8%	6 5.8%
Not Hispanic or Latino	51 96.2%	43 86%	94 91.3%
Unknown or Not Reported	0 0%	3 6%	3 2.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.9%	0 0%	1 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	16 30.2%	12 24%	28 27.2%
White	34 64.2%	31 62%	65 63.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 3.8%	7 14%	9 8.7%
Region of Enrollment (Count of Participants)
United States	53 100%	50 100%	103 100%

Outcome Measures

1. Primary Outcome

Title	Short Physical Performance Battery (SPPB)
Description	Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests. Minimum scores are 0 and maximum scores are 12. Higher scores indicate better function.
Time Frame	Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	I-STRONGER
Arm/Group Description	Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.	IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
Measure Participants	53	50
Mean (Standard Deviation) [score on a scale]	3.6 (2.3)	4.3 (2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	t-test, 1 sided
	Comments

2. Secondary Outcome

Title	Gait Speed
Description	Time it takes to walk a 4 meter path. Lower scores indicate better function.
Time Frame	Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	I-STRONGER
Arm/Group Description	Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.	IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
Measure Participants	53	50
Mean (Standard Deviation) [seconds]	0.3 (0.2)	0.5 (0.3)

3. Other Pre-specified Outcome

Title	Patient Satisfaction Survey
Description	8 Question survey, scoring each questions on a 1-10 scale (1=not at all, 10=extremely). Higher scores indicate higher satisfaction.
Time Frame	Quantification at SNF Discharge (Expected average length of stay: 21 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	I-STRONGER
Arm/Group Description	Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.	IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
Measure Participants	53	50
Mean (Standard Deviation) [score on a scale]	54.6 (7.9)	59.4 (7.3)

Adverse Events

Time Frame	Baseline through discharge from Skilled Nursing Facility (average 21 days)
Arm/Group Title	Usual Care		I-STRONGER
Arm/Group Description	Skilled nursing facility rehabilitation therapists provide all patients with usual standard of care.		IntenSive Therapeutic Rehabilitation for Older Skilled NursinG HomE Residents (I-STRONGER) Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities. Skilled nursing facility rehabilitation therapists will be trained in I-STRONGER intervention and will implement to all eligible patients as new standard of care. IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents: Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
All Cause Mortality
	Usual Care		I-STRONGER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/50 (0%)
Serious Adverse Events
	Usual Care		I-STRONGER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care		I-STRONGER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.