Enhanced Medical Rehabilitation in Older Adults (EMR)

The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an effective treatment for older adults after disabling medical events.

Study Overview

• Status: Completed
• Conditions: Depression; Disabling Medical Events; Disabled
• Intervention / Treatment: Behavioral: Standard of Care Rehabilitation; Behavioral: Enhanced Medical Rehabilitation

Detailed Description

The intervention involves physical and occupational therapy for patients who have been admitted to a skilled nursing facility for therapy following a disabling medical event.

Participants in this study will be randomly assigned to receive either Enhanced or standard of care therapy, meaning they will either receive their PT (Physical Therapy)& OT(Occupational Therapy) from therapists who have been specially trained in the study intervention or from therapists with normal training. Participants will be assessed at baseline, 30, 60, and 90 days after baseline, and at the date of their discharge from the skilled nursing facility.

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63105
      • Barnes-Jewish Extended Care
    • Saint Louis, Missouri, United States, 63125
      • Alexian Brothers Sherbrooke Village

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 65 and older
• Admitted to a skilled nursing facility for post-acute care from PT and OT for 2 weeks or more.

Exclusion Criteria:

• Language, visual or hearing barriers to participation
• Medical illness preventing study participation or accurate data collection
• Moderate-severe dementia (demonstrated by chart diagnosis and/or short blessed score greater than 13)
• Progressive neurological condition such that recovery of function is not feasible
• Patient did not have the ability to walk prior to hospitalization (e.g. paraplegic)
• Schizophrenia or other chronic or current psychotic disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care Rehabilitation	Behavioral: Standard of Care Rehabilitation; Daily PT/OT provided by therapists not trained in the treatment intervention.
Experimental: Enhanced Medical Rehabilitation	Behavioral: Enhanced Medical Rehabilitation; Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Barthel Index Score	Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function.	Baseline and Discharge, an average of 24 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Speed (Determined by 4 or 10 Meter Walk Test)	Meters walked per second.	Discharge, an average of 24 days after baseline.
Distance Ambulated in 6-Minute Walk Test	Feet walked during 6 minute interval.	Discharge, an average of 24 days after baseline.
Self-reported Barthel Index	Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function. Conducted as a self-report at timepoints where patient was not in an institutional setting.	30, 60, and 90 Days Post Admission to the SNF
Discharge Disposition	Number of participants discharged from skilled nursing facility to home	Discharge, an average of 24 days after baseline.
Rehospitalizations	Assesses whether the participant was readmitted to the hospital.	Days 30, 60, and 90 post admission to a SNF as well as at Discharge

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Mental Health (NIMH); National Institutes of Health (NIH)

Publications and helpful links

General Publications

• Bland MD, Birkenmeier RL, Barco P, Lenard E, Lang CE, Lenze EJ. Enhanced Medical Rehabilitation: Effectiveness of a clinical training model. NeuroRehabilitation. 2016 Oct 14;39(4):481-498. doi: 10.3233/NRE-161380.
• Ercal B, Rodebaugh TL, Bland MD, Barco P, Lenard E, Lang CE, Miller JP, Yingling M, Lenze EJ. Executive Function Moderates Functional Outcomes of Engagement Strategies During Rehabilitation in Older Adults. Am J Phys Med Rehabil. 2021 Jul 1;100(7):635-642. doi: 10.1097/PHM.0000000000001739.
• Lenze EJ, Lenard E, Bland M, Barco P, Miller JP, Yingling M, Lang CE, Morrow-Howell N, Baum CM, Binder EF, Rodebaugh TL. Effect of Enhanced Medical Rehabilitation on Functional Recovery in Older Adults Receiving Skilled Nursing Care After Acute Rehabilitation: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jul 3;2(7):e198199. doi: 10.1001/jamanetworkopen.2019.8199.

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2014
• Primary Completion (Actual): July 13, 2018
• Study Completion (Actual): July 13, 2018

Study Registration Dates

• First Submitted: April 2, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Depression; Physical Therapy; Occupational Therapy; Older adults; Physical Functioning
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: R01 MH099011A1; 5R01MH099011-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• 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