Enhanced Medical Rehabilitation for Spinal Cord Injury

NCT03952416 | Completed

• 1 other identifier: 201803164
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Patient engagement is a cornerstone of patient-centered care. Studies show that an increased level of patient engagement in medical rehabilitation is associated with greater functional recovery. To achieve higher levels of patient engagement, it is important to improve therapists' techniques for goal setting and clinician-therapist communication. Thus, we have developed a manualized intervention for post-acute rehabilitation, Enhanced Medical Rehabilitation (EMR), which is an evidence-based program to increase patient engagement and achieve a greater intensity of therapy, thereby optimizing the patient's functional and psychosocial recovery. EMR is an integrated set of skills for occupational and physical therapists that transform rehabilitation through (1) a patient-directed, interactive approach; (2) increased treatment intensity; and (3) frequent feedback to patients on effort and progress. We have developed training and supervision methods to enable therapists to carry out these skills with high fidelity. In our previous EMR study of older adults in skilled nursing facilities, patients treated by EMR-trained therapists had greater engagement in therapy, higher-intensity therapy sessions, and better functional outcomes. Due to the complexity of the inpatient spinal cord injury (SCI) rehabilitation environment, it is unknown whether the EMR program will be clinically relevant to inpatient rehabilitation settings and acceptable to SCI populations. Therefore, it is necessary to conduct a systematic adaptation approach to address all hospital- and provider-level barriers, and test this adapted program to a new setting (inpatient rehabilitation) and a new population (patients with SCI), without compromising the core elements of the original EMR. Objective: We propose to adopt the EMR program for use in inpatient SCI rehabilitation settings using an implementation science-driven approach. We also propose a randomized trial of 80 patients with SCI to test the effects of EMR on improving engagement and treatment intensity, as well as functional and psychosocial outcomes over standard of care (SOC) rehabilitation. Methods: We will randomize patients into EMR or SOC groups. For the EMR group, four therapists will be trained and supervised in EMR and will incorporate EMR techniques into therapy sessions. In the SOC group, four therapists will carry out therapy sessions as usual. Expected Outcomes: With respect to EMR intervention adaptions, we hypothesize that the EMR program, including a treatment manual and other materials, will be customized with input from our Spinal Cord Injury-Community Advisory Board (SCI-CAB). Patients randomized to EMR will have greater engagement and intensity and greater functional and psychosocial recovery compared to those randomized to SOC rehabilitation. Significance: The impact is high. EMR is patient-centered rehabilitation, and it is designed for real-world clinical practice. Success in this line of research will improve therapists' skills working with patients and optimizing patient outcomes, ensuring that inpatient SCI rehabilitation is more patient-centered, to the benefit of individuals with SCI.

Conditions

Spinal Cord Injuries

Keywords

Occupational Therapy; Physical Therapy; Spinal Cord Injury; Patient Engagement; Medical Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Function: CARE Tool

  The investigators will use the CARE tool to measure the level of independence as the primary outcome at both admission and discharge. At admission, the investigators will use the CARE tool to measure the patient's independence before the treatment. At discharge, the investigators will use the same CARE tool to measure the patient's independence after the treatment. This clinician-rated measure contains 18 items composed of 13 motor and 5 cognitive tasks. Tasks are rated on a 6-point ordinal scale that ranges from the minimum score of 1 (dependent) to a maximum score of 6 (independence). A higher score indicates greater independence. The investigators will use CARE mobility and self-care scores to reflect patient's ability to perform mobility and self-care tasks, respectively.

  1 Month

Secondary Outcomes (2)

• Life Satisfaction: Satisfaction with Life Scale

  1 Month

• Depression: Patient Health Questionnaire-9

  1 Month

Study Arms (2)

Standard of Care (SOC)

NO INTERVENTION

The control group for this study will receive rehabilitation therapy that is recommended and provided by the current healthcare structure. The SOC group will receive therapy only from four therapists who are not trained and supervised in EMR. These therapists will be monitored (videotaped or observed) but will not be not asked to do anything differently with their patients. The investigators recognize that spillover of therapist EMR training to untrained therapists is a concern. Thus, the investigators will ask therapists in the EMR group to agree not to share any of the training with non-trained therapists over the course of the study, and the investigators will provide free EMR training to the non-trained therapists once the treatment phase of the study is complete.

Enhanced Medical Rehabilitation (EMR)

EXPERIMENTAL

Patients in the EMR group will also receive the recommended rehabilitation therapy, but they will receive therapy only from four therapists who are trained and supervised in EMR. The therapy sessions will follow EMR protocol. EMR is a set of behavioral skills that therapists can incorporate into their daily therapy sessions to increase patient engagement and achieve a high intensity of therapy, thereby improving functional and psychosocial outcomes of patients in medical rehabilitation.

Behavioral: Enhanced Medical Rehabilitation (EMR)

Interventions

Enhanced Medical Rehabilitation (EMR) BEHAVIORAL

EMR is a set of behavioral skills that therapists can incorporate into their daily therapy sessions to increase patient engagement and achieve a high intensity of therapy, thereby improving functional and psychosocial outcomes of patients in medical rehabilitation. EMR was built on theories of behavior change, including social cognitive theory and self-regulatory theory, and their applications to patient engagement, such as the Health Action Process Approach and motivational interviewing. It has three foci: (1) a patient-directed, interactive approach stemming from patient-centered goals ("Patient as boss"); (2) frequent feedback to patients on their efforts and progress ("Link activities to personal goals"); and (3) increased rehabilitation intensity ("Optimize intensity").

Enhanced Medical Rehabilitation (EMR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) inpatient therapists specializing in SCI patients for at least six months
• (2) practicing on one of two SCI units at the SRAL
• (3) willing to collect study measures
• (4) willing to be videotaped for therapy sessions with patients
• (5) willing and able to participate in EMR training and supervision sessions.

You may not qualify if:

• (1) inpatient therapists specializing in SCI for less than six months
• (2) not willing/able to follow study protocol

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

Shirley Ryan Ability Lab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Patient Participation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Piper Hansen, OTD

  Shirley Ryan Ability Lab

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants are masked. The care provide and investigator are not mask. Only one research assistant (outcomes assessor) will be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eighty participants with spinal cord injury (SCI) who are admitted to the SCI rehabilitation (at Shirley Ryan Ability Lab) will be split into two groups. This will be randomized. Group 1 will receive the intervention, enhanced medical rehabilitation (EMR) while Group 2 will receive the standard existing rehabilitation, standard of care (SOC).

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 16, 2019
• Study Start: November 15, 2022
• Primary Completion: June 15, 2024
• Study Completion: July 30, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)