- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06646939
Comparison of Community Reintegration Interventions When Using a Simulated Environment
Comparison of Community Reintegration Interventions Relative to the Institution of a Simulated Environment in Inpatient Rehabilitation and Pilot Study of the Impact of Simulated Environment on Functional Outcomes
Study Overview
Status
Intervention / Treatment
Detailed Description
Community reintegration training has always been a significant aspect of inpatient rehabilitation recovery. Community reintegration training involved therapists and patients going into the actual community to evaluate and practice their functional tasks such as negotiating curbs, crosswalks, or marketplaces. During the COVID-19 pandemic, this option was not available. The absence of this intervention made it challenging for therapists to evaluate a patient's safety to return home. Creating a simulated environment within the inpatient rehabilitation department became an alternative to taking patients to an outside environment. Saji, et al. (2015) demonstrated that utilization of a simulated environment enhanced functional improvements of post-acute stroke patients at 12 convalescent rehabilitation wards. New York Presbyterian Weill Cornell Medical Center (NYP- WCMC) has constructed a simulated environment for the purposes of enhancing community reintegration training. This project will test its use and efficacy.
The availability of this simulated environment may be more time-efficient and safer than community reintegration training outside of the department or hospital. Training in the simulated environment may improve the functional ability of individuals undergoing inpatient rehabilitation, in accordance with the degree of use of the simulated environment. Greater use of the simulated environment may predict greater functional improvements. This study will collect pilot data about functional outcomes and patient perspectives about their balance confidence, their ability to perform functional tasks, and the efficacy of the use of simulated environment for community reintegration. This pilot data will seed a future efficacy study with a comparison group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- NewYork Presbyterian Hospital Baker Pavilion
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Medical records of patients admitted to the IRU from January 1, 2015 through December 31, 2019 will be queried for number of minutes billed for Community Integration.
- Medical records of patients admitted to the IRU from April 2
- Patients admitted to the Inpatient Rehabilitation Unit (IRU) of at least 18 years of age and older
- Patients who can read and provide informed consent in English.
- Patients who will be discharged to home after inpatient rehabilitation.
- Patients who are ambulatory with a minimal QI score of 3 on "Walk 10 feet".
- Patients who utilized the simulated environment during their inpatient stay.
- Patients who score 8 or greater on the BIMS on initial evaluation.
Exclusion Criteria:
- The investigators will exclude medical records of patients admitted to the IRU from January 1, 2020 through December 31, 2021 because of the COVID restrictions that were in place.
- Patients who are less than 18 years of age.
- Patients who are not ambulatory due to medical reasons.
- Patients who cannot read and provide informed consent in English.
- Patients who were discharged to acute care, skilled nursing facility or long-term care facility after their inpatient rehabilitation stay.
- Patients who did not use the simulated environment during their inpatient stay.
- Patients who score 7 or lower on the BIMS on initial evaluation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Community Reintegration in Simulated Environment
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Upon admission to the inpatient rehabilitation unit, participants will undergo a physical and occupational therapy evaluation.
The evaluations will include the outcome measures chosen to track for this study (10-meter walk test and Quality Indicators).
If a patient meets inclusion/exclusion criteria, informed written consent will be obtained.
Throughout the patient's stay, therapists will have the opportunity to perform community integration treatments using the simulated environment.
This could include activities such as negotiating a curb, crossing a street, or shopping at a marketplace.
The therapist will document the amount of time (units billed) spent performing these interventions.
The research investigators will not act as a patient's therapist throughout their admission.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Utilization of community reintegration, as measured by number of 15-minute units billed
Time Frame: Duration of IRU stay, an average of 11 days
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Current Procedural Terminology (CPT) code 9753, is a billing code where one unit of the code is used for each 15 minutes the provider spends with the patient teaching them return to work and the community. For this measure, the therapist will document the amount of time spent performing each study activity when utilizing the simulated environment, as measured by number of 15-minute units billed.. This will be compared to units billed in 2015 - 2019 prior to the implementation of the simulated environment for this study. |
Duration of IRU stay, an average of 11 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality Indicators
Time Frame: Duration of IRU stay, an average of 11 days
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Qualitative assessment by the therapist of 1 step onto and off a curb
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Duration of IRU stay, an average of 11 days
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Quality Indicators
Time Frame: Duration of IRU stay, an average of 11 days
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Qualitative assessment by the therapist of picking up an object
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Duration of IRU stay, an average of 11 days
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Quality Indicators
Time Frame: Duration of IRU stay, an average of 11 days
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Qualitative assessment by the therapist of walking 10 feet on uneven surface
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Duration of IRU stay, an average of 11 days
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Quality Indicators
Time Frame: Duration of IRU stay, an average of 11 days
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Qualitative assessment by the therapist of car transfer
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Duration of IRU stay, an average of 11 days
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|
Gait Speed
Time Frame: Duration of IRU stay, an average of 11 days
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Meters/second
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Duration of IRU stay, an average of 11 days
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Activities Specific Balance Confidence Scale
Time Frame: Duration of IRU stay, an average of 11 days
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The Activities-specific Balance Confidence (ABC) scale is scored by adding up the ratings for each item and dividing by 16, the total number of items. The scale uses a range of 0-100%, with 0 representing no confidence and 100 representing complete confidence. The resulting score indicates the participant's overall balance confidence. 80% or higher: The participant has a high level of physical functioning and is at low risk for falls 50-80%: The participant has a moderate level of physical functioning Less than 50%: The participant has a low level of physical functioning and is at a high risk of falling Less than 67%: The participant has a substantial risk of falling |
Duration of IRU stay, an average of 11 days
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Patient satisfaction
Time Frame: Date of Discharge (at approximately Day 11)
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Likert scale, with a low score of 1 and a high score of 5.
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Date of Discharge (at approximately Day 11)
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Patient satisfaction
Time Frame: 30 days post discharge
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Likert scale, with a low score of 1 and a high score of 5.
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30 days post discharge
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Length of Stay
Time Frame: Duration of IRU stay, an average of 11 days
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Days
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Duration of IRU stay, an average of 11 days
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nasim Chowdhury, MD, Weill Medical College of Cornell University
Publications and helpful links
General Publications
- Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
- Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.
- Karssemeijer EGA, Aaronson JA, Bossers WJ, Smits T, Olde Rikkert MGM, Kessels RPC. Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Ageing Res Rev. 2017 Nov;40:75-83. doi: 10.1016/j.arr.2017.09.003. Epub 2017 Sep 12.
- Bohannon RW. Comfortable and maximum walking speed of adults aged 20-79 years: reference values and determinants. Age Ageing. 1997 Jan;26(1):15-9. doi: 10.1093/ageing/26.1.15.
- Eyssen IC, Beelen A, Dedding C, Cardol M, Dekker J. The reproducibility of the Canadian Occupational Performance Measure. Clin Rehabil. 2005 Dec;19(8):888-94. doi: 10.1191/0269215505cr883oa.
- Saliba D, Buchanan J, Edelen MO, Streim J, Ouslander J, Berlowitz D, Chodosh J. MDS 3.0: brief interview for mental status. J Am Med Dir Assoc. 2012 Sep;13(7):611-7. doi: 10.1016/j.jamda.2012.06.004. Epub 2012 Jul 15.
- Richardson J, Law M, Wishart L, Guyatt G. The use of a simulated environment (easy street) to retrain independent living skills in elderly persons: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2000 Oct;55(10):M578-84. doi: 10.1093/gerona/55.10.m578.
- Peel NM, Kuys SS, Klein K. Gait speed as a measure in geriatric assessment in clinical settings: a systematic review. J Gerontol A Biol Sci Med Sci. 2013 Jan;68(1):39-46. doi: 10.1093/gerona/gls174. Epub 2012 Aug 24.
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
Other Study ID Numbers
- 22-07025042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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